79C3C34C52B45572883A05D425EB0F82

Public Law 24-326

https://leaux.net/URLS/General/Guam_1999_PublicLaw24-326.pdf

http://leaux.net/URLS/ConvertAPI Text Files/B4288B5712B8E160A62E0E1DDE5C7ECF.en.txt

Examining the file media/Synopses/B4288B5712B8E160A62E0E1DDE5C7ECF.html:

This file was generated: 2020-12-01 07:31:12

Indicators in focus are typically shown highlighted in yellow;

Peer Indicators (that share the same Vulnerability association) are shown highlighted in pink;

"Outside" Indicators (those that do NOT share the same Vulnerability association) are shown highlighted in green;

Trigger Words/Phrases are shown highlighted in gray.

Link to Orphaned Trigger Words (Appendix (Indicator List, Indicator Peers, Trigger Words, Type/Vulnerability/Indicator Overlay)

Applicable Type / Vulnerability / Indicator Overlay for this Input

Vulnerability Type	Vulnerability	Indicator	# Matches
Political	Criminal Convictions	prisoners	8
Political	criminal	criminal	2
Political	political affiliation	party	3
Political	political affiliation	political	2
Political	stateless persons	nation	1
Political	vulnerable	vulnerable	6
Health	Cognitive Impairment	cognitive	4
Health	Drug Usage	drug	3
Health	Drug Usage	influence	4
Health	Mentally Disabled	disabled	4
Health	Mentally Disabled	mentally	4
Health	Mentally Disabled	disability	1
Health	Motherhood/Family	family	1
Health	Physically Disabled	illness	2
Health	Pregnant	pregnant	8
Health	sexually transmitted disases	std	1
Social	Access to Social Goods	access	1
Social	Child	children	6
Social	Elderly	elderly	4
Social	Fetus/Neonate	fetus	2
Social	Incarcerated	liberty	1
Social	Incarcerated	prison	1
Social	Linguistic Proficiency	language	7
Social	Occupation	job	1
Social	Police Officer	police	1
Social	Presence of Coercion	coerced	1
Social	Religion	religious	3
Social	Student	student	4
Social	Women	women	6
Social	Youth/Minors	minor	1
Social	education	education	21
Social	education	educational	9
Social	embryo	embryo	2
Social	employees	employees	2
Social	philosophical differences/differences of opinion	opinion	2
Economic	Economic/Poverty	poor	1
General/Other	Diminished Autonomy	diminished	1
General/Other	Impaired Autonomy	autonomy	4
General/Other	Incapacitated	incapacitated	2
General/Other	Public Emergency	emergency	2
General/Other	Relationship to Authority	authority	15
General/Other	Undue Influence	undue influence	4
General/Other	belmont	belmont	2
General/Other	common rule	common rule	1
General/Other	declaration of helsinki	helsinki	1

Political / Criminal Convictions

Searching for indicator prisoners:

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p.000009: to
p.000009: 23 anticipated benefits, if any, to subjects and the importance of the
p.000009: 24 knowledge that may reasonably be expected to result. In
p.000009: 25 evaluating risks and beneflts, the Board should consider only
p.000009:
p.000010: 10
p.000010:
p.000010:
p.000010: those risks and benefits that may result from the research, as
p.000010: 2 distinguished from risks and benefits of therapies subject would
p.000010: 3 receive even if not participating in the research. The Board should
p.000010: 4 not consider possible long range effects of applying knowledge
p.000010: 5 gained in the research (for example, the possible effects of the
p.000010: 6 research on public policy) as among those research risks that fall
p.000010: 7 within the purview of lts responsibility.
p.000010: 8 (c) Selection of the subjects is equitable. In making this
p.000010: 9 assessment the Board should take into account the purposes of the
p.000010: 10 research and the setting in which the research would be
p.000010: 11 conducted and should be particularly cognizant of the special
p.000010: 12 problems that research involving vulnerable populations, such as
p.000010: 13 children, prisoners, pregnant woman, persons with dlsabilities,
p.000010: 14 the elderly, or economically or educationally disadvantaged
p.000010: 15 persons.
p.000010: 16 (d) Informed consent will be sought from each
p.000010: 17 prospective subject or the subject’s legally authorized
p.000010: 18 representative, in accordance with, and to the extent required by
p.000010: 19 Board regulation.
p.000010: 20 (e) lrdormed consent will be appropriately documented,
p.000010: 21 in accordance with, and to the extent required by Board
p.000010: 22 regulation.
p.000010: 23 ( When appropriate, the research plan makes adequate
p.000010: 24 provision for monitoring the data collected to ensure the safety of
p.000010: 25 subjects.
p.000010:
p.000010:
p.000010: 1 (g) When appropriate, there are adequate provisions to
p.000010: 2 protect the privacy of subjects and to maintain the confidentiality
p.000010: 3 of data.
p.000010: 4 When some or all of the subjects are likely to be vulnerable
p.000010: 5 to coercion or undue influence, such as children, the elderly,
p.000010: 6 prisoners, pregnant women, mentally disabled persons or
p.000010: 7 economically or educatiOnally disadvantaged persons, additional
p.000010: 8 safeguards have been included in the research plans, procedures
p.000010: 9 or protocols to protect the rights and welfare of these subjects.
p.000010: 10 (h) Progress reports or thesis shall be made available to
p.000010: 11 subjects participating in the research as appropriate.
p.000010: 12 Section 24108. Grievance Procedure. lf application for
p.000010: 13 approval is denied for a research proposal, investigators may appeal to
p.000010: 14 the Dean of the Graduate School and Research. The Dean will appoint
p.000010: 15 an ad hoc committee for a second, independent review of the research
p.000010: 16 project. The findings of the ad hoc committee are to be presented to the
p.000010: 17 Committee on Human Subjects in Research no later than ninety (90)
p.000010: 18 days after receipt of grievance from the investigator, to determine the
p.000010: 19 final decision to approve or not to approve a research project.
p.000010: 20 Section 24109. Fines and Penalties. Upon determination of
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p.000007: 35 unnecessarily expose subject's to risk; and (ii) whenever appropriate
p.000007: 36 by using procedures already being performed on the subjects for
p.000007: 37 diagnostic or treatment purposes;
p.000007: 38 (b) Risks to subject are reasonable in relation to anticipated
p.000007: 39 benefits, if any, to subjects and the importance of the knowledge that
p.000007: 40 may reasonably be expected to result. In evaluating risks and
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p.000008: 8
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p.000008: benefits, the Board should consider only those risks and benefits that
p.000008: 2 may result from the research (as distinguished from risks and
p.000008: 3 benefits of therapies subject would receive even if not participating
p.000008: 4 in the research). The Board should not consider possible long range
p.000008: 5 effects of applying knowledge gained in the research (for example,
p.000008: 6 the possible effects of the research on public poñcy) as among those
p.000008: 7 research risks that fall within the purview of its responsibility;
p.000008: 8 (c) Selection of the subjects is equitable. In making this
p.000008: 9 assessment the Board should take into account the purposes of the
p.000008: 10 research and the setting in which the research would be conducted
p.000008: 11 and should be particularly cognizant of the special problems that research involving vulnerable
p.000008: populations such as children,
p.000008: 13 prisoners, pregnant woman, persons with disabilities, the elderly, or
p.000008: 14 economically or educationally disadvantaged persons;
p.000008: 15 (d) Informed consent will be sought from each prospective
p.000008: 16 subject or the subject's legally authorized representative, in
p.000008: 17 accordance with, and to the extent required by Board regulation.
p.000008: 18 (e) Informed consent will be appropriately documented, in
p.000008: 19 accordance with, and to the extent required by Board regulation.
p.000008: 20 (O When appropriate, the research plan makes adequate
p.000008: 21 provision for monitoring the data collected to ensure the safety of
p.000008: 22 subjects; and
p.000008: 23 (g) When appropriate, there are adequate provisions to protect
p.000008: 24 the privacy of subjects and to maintain the confidentiality of data.
p.000008: 25 When some or all of the subject are likely to be vulnerable to
p.000008: 26 coercion or undue influence, such as children, the elderly, prisoners,
p.000008: 27 pregnant women, mentally disabled persons or economically or
p.000008: 28 educationally disadvantaged persons, additional safeguards have
p.000008: 29 been included in the research plans, procedures or protocols to
p.000008: 30 protect the rights and welfare of these subjects.
p.000008: 31 §24108. Grievance Procedure. II application for approval is
p.000008: 32 denied for a research proposal, investigators may appeal to the
p.000008: 33 Dean of the Graduate School & Research. The Dean will appoint an
p.000008: 34 ad hoc committee for a second, independent review of the research
p.000008: 35 project. The findings of the ad hoc committee are presented to the
p.000008: 36 Research Review Committee no later than ninety (90) days after
p.000008: 37 receipt of grievance from investigator, to determine the final
p.000008: 38 decision to approve or not to approve a research project.
p.000008:
p.000008: 39 §24109. Fines and Penalties. Upon determination of
p.000008: 40 review board through the approved rules and regulations,
p.000008: the any
p.000008:
p.000009: 9
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p.000009: investigator, research sponsor, or their agents, which conducts
p.000009: 2 research subject to regulation in violation of this chapter shall be
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p.000010: It may be cba€ a aeandacd oC ^€he z'eaaonab1e vo1un2eec" shou16 be Co11oued:
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p.000010: risk and the voluntary nature of participation.
p.000010: Information about risks ehould never be withheld for tAe purpose of eliciting the cooperation of subjects, and truthful
p.000010: answers should always be given to direct questions about tAe research.
p.000010: gmqprehensioq. The manner and context in which information is conveyed is as important as the information itself. Por
p.000010: example, presenting information in a disorganized and rapid fashion, allowing too little time for
p.000010: consideration or curtailing opportunities for questioning, all may adversely affect a subject's ability to make an
p.000010: informed choice.
p.000010: Because the subject's ability to understand is a function of intelligence, rationality, maturity and language, it is
p.000010: necessary to adapt the presentation of the information to the subject's capacities. Investigators are responsible for
p.000010: ascertaining that the subject has comprehended the information.
p.000010: Voluntaripess. This element of informed consent requires condlñinns feee of coercion and undue influence.
p.000010: tfndue Influence occurs through an offer of an excessive, unwarranted, inappropriate or improper reward or other
p.000010: overture in order to obtain compliance. Also, inducements that would ordinarily be acceptable may become
p.000010:
p.000010: hand, lt would seem that respect requires that prisoners and students not be depz'1ved of the
p.000010: oppoz•gun1t:y tO volunteer Com research. On t2ie otlter hand, under prison and classroom
p.000010: conAlelonu both may be subtly coerced or unduly influenced to engage in research acVivieies for which they uould
p.000010: not: otherwise volunteer.
p.000010:
p.000010: g. Beneflcsnce: Is a term often understood to cover acte of kindness or charity that go beyond etrict obligations. In
p.000010: tAis document, beneficence is understood in a stronger aense, as an obligation. Two general mles are complementary
p.000010: oxpreasione of beneficent actions in tAis sense: (1) do not harm and (2) maximize possible benefits and minimize
p.000010: possible barme.
p.000010: obligations of baneJ°1cence agdecrg bottt J.nd1v1dua1 Invas1z1ga€o=s and soc1et:y at: 1acqa,
p.000010: because tbey extand botb to particular research projects and to tAe entira Enterprise ef research. In the case of
p.000010: particular projects, investigators and
p.000010: archers of their lns€lVu€ions ara obllqeñ to give foretbouqhe en
p.000010: tbe maximization oZ benefits and the reduction of risk that night occur from the research investigation.
p.000010: A difficult atbical problem remains about research tbat present:s aore Than niniztal rlsk ulehouV
p.000010: lmeeñ£aea prospects ed d1 acrg bene€1c No the subgecca tnvo1ved. Soae bave acqued that auch resesrnh
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p.000003: requirement to protect tAose witA diNinished 6UtOüOWy.
p.000003: An autonomous person is an individual capable of dellberation aboulz personal goals and oC act;£ng under
p.000003: tbe 41xec€1on oC atzch dellberacion • To respect autonomy is €o glva weight: go autonomous
p.000003: persons' considered opinions and choices. Fo show lack of respect
p.000003: for an autonomous agent is to repudiate that person's considered
p.000003:
p.000003: judgements considered
p.000003: eo deny an indlvidual the freedom eo act on those
p.000003: judgements, or to withholdinformation necessary to make
p.000003: a considered judgement.
p.000003: The capacity for self-determination matures during an individual's like, and some individuals lose this capacity
p.000003: wholly or in part because of illness, mental disability, or oircumstancea that severely restrict liberty. Respect for
p.000003: tAe immature and the incapacitated may require protecting them as they matura or while they are incapacitated.
p.000003: Respect Yor persons demands that subjects enter into the
p.000003: research voluntarily and with adequate information. In eome situations, however, application of the principle is
p.000003: not obvious. The involvement of prisoners, at one extreme, or of students in more normal circumstances, provide
p.000003: instructive examples. On the one
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p.000005: reviewers designated by the chairperson. Reviewers may exercise all of the authorities of the IRB except that the
p.000005: reviewersmay not disapprove the research•
p.000005:
p.000005:
p.000005:
p.000005: a) To approve research covered by this policy the IRB shall determine that all of the following requirements are
p.000005: satisfied:
p.000005: 1 • Risks to subjects are minimized.
p.000005: 2. Risks to subjects are reasonable in relation to anticipated benefits. The IRB should not consider possible
p.000005: long-range effects of applying knowledge gained in The research (foe example, the peesible effecrt:s og
p.000005: I:he research on public policy) as among thoae research risks that fall within the purview of its responsibility.
p.000005: 3. Selection of subjects is equitable.
p.000005: 4. Informed consent will be sought from each prospsctive subject or the subject's legally authorized.
p.000005: 5. Informed consent will be appropriately documented.
p.000005: 6. When appropriate, the research plan makes adequate provision for monitoring the data collected to ensure the safety
p.000005: of subjects.
p.000005: 7. There are adequate provisions to protect the privacy of subjects and to maintain the confidentiality of data.
p.000005: b) When some or all of the subjects are likely to be vulnerable to coercion or undue influence, such as children,
p.000005: prisoners, pregnant women, mentally disabled persona, or econoaicallY or educationally disadvantaged persons,
p.000005: additional safeguards have been included in the study to protect tAe rights and welfare of tRese subjects.
p.000005:
p.000005:
p.000005: Research covered by this policy that has been approved by ah IRB may be subject to further appropriate review by
p.000005: officials of the institution.
p.000005:
p.000005: 8•C*1O» 113 6UfipaO81OO or ¢eza1:aa61on OC Zea &ppg'Ova1.
p.000005:
p.000005: An IRB shall have autAoritY to suspend or terminate approval of research that is not being conducted in accordance with
p.000005: the IRB's requirements or that has been associated witA unexpected serious harm to subjects.
p.000005:
p.000005: Bec21oo 114 coopaxa€1ve Raseacaa.
p.000005:
p.000005: Cooperative research projects are those projects covered by this policy which involve more than one institution. In
p.000005: the conduct of cooperative research projects, each institution is responsible for safeguarding the rights and welfare
p.000005: of husmn subjects and for complying with this policy.
p.000005:
p.000005: An institution participating in a cooperative project may enter into a joint review arrangement, rely upon the review
p.000005: of another qualified ZRB, or nake similar arrangement:a for avoi‹:ling duplication of
p.000005: effort.
p.000005: sactioo us zRe xecora•.
...

p.000010: agencies (e.g., DPHSS, MHSA, etc.).
p.000010: The UOG CHRS is experienced and can provide an on-island irb review service to any agency, private entity, or
p.000010: off-island institution that does not have its own or other access to a Gtiam based irb. This is based on the idea
p.000010: that the legislative intent is to mandate that any research study involving human subjects has at least one
p.000010: on-island review. If that is the intent, then Guam has a ready mechanism in the form of the UOG CHRS to
p.000010: ensure that all of the following federal requirements are satisfied by any research covered by this law:
p.000010:
p.000010: 1. Risks to subjects are minimized.
p.000010: 2. Risks to subjects am reasonable in relation to anticipated benefits.
p.000010: 3. Selection of subjects is equitable.
p.000010: 4. Informed consent will be sought from each prospective subject or the subject's legally authorized .
p.000010: 5. Informed consent will be appropriately documented.
p.000010: 6. When appropriate, the research plan makes adequate provision for monitoring the data collected to ensure the
p.000010: safety of subjects.
p.000010: 7. Thème are adequate provisions to protect the privacy of subjects and to maintain the confidentiality of
p.000010:
p.000010: 8. When some or all of the subjects are likely to be vulnerable to coercion or undue inBuence, such as children,
p.000010: prisoners, pregnant women, mentally disabled persons, or economimlly or educationally disadvantaged persons, additional
p.000010: safeguards have been included in the study to pixitcct tlu rights and welfare of these subjects.
p.000010: I-However, as currently written, B’ 47 establishes an unnecessary additional‘
p.000010: Moreover, it includes a section 24102. Bonr- me; ppoin end Mntinnancp Renal. which is a confusing listing
p.000010: of membership, and does not fit the federal guidelines for irb stricture. For example, why only include the Director
p.000010: of DPHSS or his/her designee, and not the director of MHSA, DDPR, DOE, or the new agency for disabilities; and why is
p.000010: it so heavily weighted with people having no expertise in research or any academic science† What is the purpose of
p.000010: including an odd assemblage of persons — who may not have the skill and luiowledge for reviewing technical
p.000010: methodologies to ensure informed consent and procedures to handle any risks involved? Within the federal policy for
p.000010: irb’s it states:
p.000010:
p.000010: SOURCE’ Fedeml Rcgjstu June l8 199lJegu1atio«s •ffwtive xc is jeer j Section 107 IRB membership.
p.000010: a) Each IRB shall have at least five memberi with varying backgrounds to promote complete and adequate
p.000010: review of research activities commonly conducted by the institution. In addition to pouessing the
p.000010: professional competence necessary to review specific reseamh activities the IRB shall be able to ascertain
...

Political / criminal

Searching for indicator criminal:

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p.000004: 21 educational practices, such as (i) research on regular
p.000004: 22 and special education instructional strategies or (ii)
p.000004: 23 research on the effectiveness or the comparison among
p.000004: 24 instructional techniques, curricula or classroom
p.000004: 25 management methods;
p.000004: 26 (3) Research involving the use of educational tests
p.000004: 27 (cognitive, diagnostic, aptitude, achievement), survey
p.000004: 28 procedures, interview procedures or observation of
p.000004: 29 public behavior, unless: ;(i) information obtained is
p.000004: 30 recorded in such a manner that human subjects can be
p.000004: 31 identified, directly or through identifier's linked to the
p.000004: 32 subjects; and (ü) any disclosure of the human subject's
p.000004: 33 responses outside the research could reasonably place
p.000004: 34 the subject at risk of criminal or civil liability or be
p.000004: 35 damaging to the subject's financial standing,
p.000004: 36 employability or reputation;
p.000004: 37 (4) Research involving the use of educational tests
p.000004: 38 (cognitive, diagnostic, aptitude, achievement), survey
p.000004: 39 procedures or observation or public behavior that is not
p.000004: 40 exempted under paragraph (d)(2) of this section, if: (i)
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p.000002: • UOO Ouidt inns rcgardmg the “Ethical Principles wxl Guidelines for the Protection
p.000002: ofHwnan 5 objects of Research"
p.000002: - GMH Insti» poiul R« io Bard Policies *od Pr»cc«u cs ef13/9i3
p.000002: - Applicabb I sdemt R orii (1974 end hta) as issoed by the U.S. Oepartment of
p.000002: Heelth, Edu pgon, nid Welhre
p.000002: • Applicable i:gntioos of flu Office Hi Rotcction from Resee*h Risks (OPRR),
p.000002: N#Æm@knÿmhofHnü#Depmmœ#ofIoü1mdHmnanSwüA
p.000002: £pÿmbkçpAdm#ofWcUSPoÆxdDmçhJmWümaémÇD%
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p.000002: Protection c
p.000002: - Applicable
p.000002: Any::rican
p.000002: I-luiDan Sobjecti
p.000002: ;xles ofconduct ofio‹4al ind behavioml mear*h as adopted by the
p.000002: *ho ’cal Association APA since l9D
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p.000003: accordance with the requirements of this policy, that a research project or activity involvinghuman subjects has been
p.000003: reviewed and approved by an IRB in accordance with an approved assurance.
p.000003:
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p.000003: (b) Unless otherwise required . . . research activities in which the only involvement of human subjects will be in one
p.000003: or more of the foLloWing categories are exempt from this policy:
p.000003: (1) Research conducted in established or commonly accepted educational settings, involving normal educational
p.000003: practices, such as (i) research On regular and special education instructional strategies, or (ii)
p.000003: research on the effectiveness oY or the comparison among instructional techniques, curricula, or classroom
p.000003: management methods.
p.000003: (2) Research involving the use of educational tests (cognitive, diagnostic, aptitude, achievement), survey
p.000003: procedures or observation of public behavior, unless:
p.000003: (i) Information obtained is recorded in such a manner that human subjects can be iaent:if1e‹t, directly
p.000003: or through identifiers linked to the subjects; and (ii) any disclosure of the human subjects' responses outside
p.000003: the research could reasonably place the subjects at risk of criminal or civil liability or be damaging tO the
p.000003: subjects' financial standing, employability, or reputation.
p.000003: (3) Research [under 101(b)(2)] that is not exempt under paragraph (b)(2) of this section, if: (i) ... subjects are
p.000003: elected or appointed public officials or candidates for public office; or (ii) federal statute(s) require(s)
p.000003: without exception that the confidentiality of the personally identifiable information will be maintained
p.000003: throughout the research and thereafter.
p.000003: (4) Research, involving the collection or study Of existing data, documents, records, pathological specimens, or
p.000003: diagnostic specimens, if these sources are publicly available or if the information is recorded by the investigator in
p.000003: such a manner that subjects cannot be identified, directly or through identifiers linked to the subjects.
p.000003: (5) Research and demonstration projects... which are designed to study, evaluate or otherwise examine: (i) Public
p.000003: benefit or service programs; (ii) procedures for obtaining benefits or services under those programs; (iii) possible
p.000003: changes in or alternatives to those programs ...(iv) possible changes in methods or ... payment ... or services under
p.000003: those programs.
p.000003: (6) Taste and food quality evaluation and consumer acceptance studies, (i) if wholesome foods without additives are
p.000003: consumed or (ii) if a food is consumed that contains a food ingredient at or below the level and for a use found to be
p.000003: safe, or agricultural chsrical or environmental contaminant at or below the level found to be aafe, by the Food
p.000003: and Drug Administration or approved by the Environmental Protection Agency or the Food Safety and Inspection Service
...

Political / political affiliation

Searching for indicator party:

(return to top)
p.000003: 24 human subjects participating in the research subject to regulation.
p.000003: 25 At the Board’s discretion, require additional irdormation be given
p.000003:
p.000004: 4
p.000004:
p.000004:
p.000004: 1 to the subjects which would add to the protection of the rights and
p.000004: 2 welfare of the subjects;
p.000004: 3 (c) notify the investigators and the institution in writing
p.000004: 4 of its decision to approve or disapprove the proposed research
p.000004: 5 activity, or of modifications required to secure approval of the
p.000004: 6 research activity. If the Board decides to disapprove a research
p.000004: 7 activity, it shall include in its written notification a statement of
p.000004: 8 the reasons for lts decision and give the investigator an
p.000004: 9 opportunity to respond in person or in writing;
p.000004: 10 (d) conduct continuing review of research subject to
p.000004: 11 regulation at intervals appropriate to the degree of risk, but not
p.000004: 12 less than once per year and shall have authority to observe or have
p.000004: 13 a third party observe and consent to the process and the research;
p.000004: 14 and
p.000004: 15 (e) to disapprove research subject to regulation which had
p.000004: 16 been previously approved.
p.000004: 17 Section 24105. Duties of Investigators. The
p.000004: 18 proposals, plans, procedures and protocols for all proposed research
p.000004: 19 subject to regulation shall be submitted to the Board for review,
p.000004: 20 approval, modification or dlsapproval. No research subject to
p.000004: 21 regulation shall be conducted without Board approval. The plans,
p.000004: 22 procedures and protocols for all research subject to regulation which is
p.000004: 23 being conducted at the time of the enactment of this legislation shall be
p.000004: 24 submitted to the Board for review, approval, modification or
p.000004: 25 disapproval within thirty (30) days of this bill becoming law. Research
p.000004:
p.000004:
p.000004: i subject to regulation which is being conducted at the time of the
p.000004: 2 enactment or this legislation may continue pending Board action.
p.000004: 3 Section 24106. General Requirements for Informed Consent.
p.000004: 4 No investigator may involve a human being in research subject to
...

p.000004: (a) Review and have authority to approve, require
p.000004: 7 modifications to secure approval or disapprove all research
p.000004: 8 activities covered by the rules and regulations.
p.000004: 9 (b) Require documentation of informed consent of all human
p.000004: 10 subjects participating in the research subject to regulation. At the
p.000004: 11 Board's discretion, require additional information be given to the
p.000004: 12 subjects which would add to the protection of the rights and welfare
p.000004: 13 of the subjects;
p.000004: 14 (c) Notify the investigators and the institution in writing of its
p.000004: 15 decision to approve or disapprove the proposed research activity, or
p.000004: 16 of modifications required to secure approval of the research activity.
p.000004: 17 If the Board decides to disapprove a research activity, it shall include
p.000004: 18 in its written notification a statement of the reasons for its decision
p.000004: 19 and give the investigator an opportunity to respond in person or in
p.000004: 20 writing;
p.000004: 21 (d) Conduct continuing review of research subject to regulation
p.000004: 22 at intervals appropriate to the degree of risk, but not less than once
p.000004: 23 per year and shall have authority to observe or have a third party
p.000004: 24 observe and consent to the process and the research; and
p.000004: 25 (e) To disapprove research subject to regulation which had
p.000004: 26 been previously approved.
p.000004: 27 §24105. Dufies of Investigators. The proposals, plans,
p.000004: 28 procedures and protocols for all proposed research subject to
p.000004: 29 regulation shall be submitted to the Board for review, approval,
p.000004: 30 modification, or disapproval. No research subject to regulation shall
p.000004: 31 be conducted without Board approval. The plans, procedures and
p.000004: 32 protocols for all research subject to regulation which is being
p.000004: 33 conducted at the time of the enactment of this legislation shall be
p.000004: 34 submitted to the Board for review, approval, modification or
p.000004: 35 disapproval within thirty (30) days of this bill becoming law.
p.000004: 36 Research subject to regulation which is being conducted at the time
p.000004:
p.000004: 37 of the enactment of this leglslation
p.000004: 38 action.
p.000004: may continue pending Board
p.000004: 39 §24106. General Requirements for Informed Consent. No
p.000004: 40 investigator may involve a human being in research subject to
p.000004:
p.000005: 5
p.000005:
p.000005: regulation unless the investigator has obtained the legally effective
p.000005: 2 informed consent of the subject or the subject's legally authorized
...

p.000002: primary concerns are in nonscientific areas. In order for the research to be approved, it shall receive the approval
p.000002: of a majority of those members present at the meeting.
p.000002:
p.000005: 5
p.000005:
p.000005: Section 109 IRB Review of Research.
p.000005: a) An IRB shall review and have authority to approve, require modifications in (to secure approval), or disapprove all
p.000005: research activities.
p.000005: b) An IRB shall require that information given to subjects as part of informed consent is in accordance with
p.000005: Section.116. The IRB may require that information, in addition to that specifically mentioned in Section.116,
p.000005: be given to the subjects when in the IRB's judgment the information would meaningfully add to the protection of the
p.000005: rights and welfare of subjects.
p.000005: c) An IRB shall require documentation of informed consent.
p.000005: d) An IRB shall notify investigators and the institution in writing of its decision to approve or disapprove the
p.000005: proposed research activity, or of modifications required to secure IRB approval of the research activity.
p.000005: e) An IRB shall conduct continuing review of research covered by this policy at intervals appropriate to the degree of
p.000005: risk, but nOt less than once per year, and shall have authority to observe or have a third party observe the consent
p.000005: process and the research.
p.000005: 8ec€1on 11O Bs$seé1•ad z'•e1ew' pgocaduzeg fog' m €a1O 3c1odo of
p.000005: zogeaacb fgsoo1a1ag no aoaa Oban a1a3ma1 g'1o$t, aoQ Coz' a1zzot cbaBgeo
p.000005:
p.000005: a) In the Federal Register, a list of categories of research that may be reviewed by the IRB through an expedited
p.000005: review procedure will be amended, as appropriate after consultation with other departments and agencies.
p.000005: b) An IRB may use the expedited review procedure to review
p.000005: 1. Some or all of the research appearing on the list and found by the reviewer(s) to involve no more than minimal
p.000005: risk.
p.000005: 2. Minor changes in previously approved research.
p.000005: Under an expedited review procedure, the review may be carried out by the IRB chairperson or by one or more experienced
p.000005: reviewers designated by the chairperson. Reviewers may exercise all of the authorities of the IRB except that the
p.000005: reviewersmay not disapprove the research•
p.000005:
p.000005:
p.000005:
p.000005: a) To approve research covered by this policy the IRB shall determine that all of the following requirements are
p.000005: satisfied:
p.000005: 1 • Risks to subjects are minimized.
p.000005: 2. Risks to subjects are reasonable in relation to anticipated benefits. The IRB should not consider possible
p.000005: long-range effects of applying knowledge gained in The research (foe example, the peesible effecrt:s og
p.000005: I:he research on public policy) as among thoae research risks that fall within the purview of its responsibility.
p.000005: 3. Selection of subjects is equitable.
...

Searching for indicator political:

(return to top)
p.000003: Reyiew Boaid in œmplianœ with fedeial policy eatabliahed by the U.S. Oflîœ of Söenœ and Technology. Your
p.000003: understanding of thèse regulations is important for the Unh/eisity's adhereriæ to fsdeial policy on this topic, and
p.000003: for your own fiabilité assumed in the pæformanœ ofreseamh and #aining prof
p.000003: Each of thèse federal deparbnenfs and agencjes have adopted ö›ese regulations for the
p.000003: protection of human subjects irivoI›/ed in research œnducted or funded by the following:
p.000003: US Department of Agñadture; Department of Ene‹gy; National Aeronautics and Space Administraëon; Departmœt
p.000003: of Commerce; Consurner P‹odud Safety Commission; International Development Coopera0on Agericy; Agency
p.000003: for International Deælopment; Department of Housing and Urban Development; Deparbnent of Justice; Deparbnent
p.000003: of
p.000003: , Department of Eduœtion; Department of Vejgian Alfaiæ; Environmental Protection
p.000003: Agency; National Scienœ Foundatlan; Department of Health and Human Seiviœs; Deparbnent of Transponalfon.
p.000003: Researchers should be awaæ of other regional æview boards in addition to Elle Unfærsity CHRS. The Guazi
p.000003: Memorial Hospital has an IRB for mœliœl æsearch on Guam.” Alao, permit reyiews are æquired by tf›e Fæjerajed
p.000003: Statæ of Mioonesia, with similar législation being œnsdered by othœ Paöfîc laland entitles. The FSM has an
p.000003: eslablished deaiinghouse pioceduæ Jbr anyone p«›posing ræearch in the areas of atchaeoloqy, oial histDry, SoÔaI
p.000003: CLlltufe, Œ/stDm, arls/cfalfs, afŒliyal, political histDfy, or anything to do with hietoric and culturat resounæs
p.000003: in the FSM.
p.000003:
p.000003: To what does this policy apply†
p.000003:
p.000003: Uni /ersity policy applies to all ‹eaærŒ iwoNing human subjects œnducted, supported or o0›etwiæ subject to ægulaton by
p.000003: any federal department or aqency whidi takes appfopñate adminisbaöve action to make the policy applkable to suŒ
p.000003: research. lt also indudœ ‹œeaia œnduÖed, supported, or otherwise subject to regulalton by the federal govemrnent
p.000003: outside the United States. Research If›at is neîlher œnduöed nor suppo‹ted by a fède‹al deparbnent or agency but is
p.000003: subject to regulation must be /eyiewed and appnwed by an instîtutional
p.000003: /eview board (IRB) 0›at operales in aa›o‹danos with the peitinœt ‹equî‹ements ofbiis policy.
p.000003: Unless otherwise required, /eseatch actñ/iges wheie One only in ‹olvement of human subjects will be in one or more of
p.000003: the fdlowing ‹ategories may be ezemptad or subjected only to expedited reyiew prooedures as assessed from ‹he CHRS
p.000003: Reyiew Application:
p.000003: (1) Research œnduond in establîdæd or commonly accepted eduœtîanal Settings, involving normal eduætîonal practî‹æs,
p.000003: such as (i) research on regular and apeôal eduœtion instrucôonal etrategîœ, or (ii) æseatoi on the eflbcbæneœ ofor the
p.000003: œmparîson among insbucêonal techniques, artîcula, or ciaasmom management rnethods.
p.000003: (2) Research involving the uee of eduæôonal taets (cognitive, &ægriostic, aptitude,
p.000003: - ›hîevernent), sun/ey ptoœduæs or obseræêon of public behavÔr, unleæ:
p.000003: (i) Irtfonœtîon obtained ia æœrded in such a manner Oæt human subjects can be dentilted, diieclfty or through
...

p.000010: legislation goes forward.
p.000010: UOG has a fine record of grantsmanship and compliance with federal standards because it strives to meet rules and
p.000010: regulations through the policies set by Research Council and enforced by GS&R.
p.000010: The third issues I will briefly address is the concern that an added review process would cause delays that could
p.000010: hinder the excellent research that is pre”sentIy being conducted by undergraduate students in various programs.
p.000010: Undergraduate students only have one semester or fifteen weeks in which to complete their research projects. It is our
p.000010: desire to encourage undergraduate students to conduct research under the mentorship of their professors. Review
p.000010: processes take time to complete , but unusual delays could damage a student’s enthusiasm for the research project.
p.000010: ”the UOG's Committee on Human Subjects in
p.000010:
p.000010: GRRDURTE SCHOOL RND RESEflRCH DERN'S TESTIMONY, 1998
p.000010:
p.000010: Research is currently expediting the review process for undergraduate
p.000010: students who have limited weeks to complete research.
p.000010: Finally, I will state my concerns about the composition o1 the committee. Section 3 on page 4 states the proposed
p.000010: composition of the Guam Research Review Board. This entire section of Bill No. 347 should be deleted and replaced with
p.000010: the composition of the CHRS which is:
p.000010: 3 or 4 professional research proficient experts from UOG
p.000010: at least 1 Guam community representative at least 1 local religious leader
p.000010: at least 1 licensed practicing local medical doctor
p.000010: This composition allows the IRB to remain relatively free from political interference. The UOG President is kept
p.000010: informed of changes in the membership and may appoint qualifi a the CHSR when there are v
p.000010: s.
p.000010: et me assure you, senators, that I am willing to revise Bill No. 347 by working with you and your staff. We all need
p.000010: to work towards the protection of the citizens of Guam who agree to participate in research projects.
p.000010:
p.000010:
p.000010:
p.000010:
p.000010:
p.000010:
p.000010:
p.000010:
p.000010:
p.000010:
p.000010:
...

Political / stateless persons

Searching for indicator nation:

(return to top)
p.000001: additional island wide IRB.
p.000001:
p.000001: Dr. Kyle Smith teaches psychology and research methods at the University of Guam and fully supports the call for all
p.000001: research conducted on Guam to undergo review. The bill, as in its existing form may produce some unnecessary affects
p.000001: on the training available for standards at the University of Guam and creates redundant delays. He supports the
p.000001: option to modify the bill to accommodate student and research projects. Dr.Smith believes that it was not the
p.000001: intent of the author to impede research projects. He will fully support the bill with modifications.
p.000001:
p.000001: Mr. Roy Adonay testified in support of Bill 347. Mr. Adonay expressed the need to review the are of fines and
p.000001: penalties and needs to be expanded. There is no indication as to who will monitor and
p.000001:
p.000001:
p.000003: 3
p.000003:
p.000003: fine and who will collect. The Universlty of Guam Will not have the power or authority to police all research.
p.000003:
p.000003: Ms. Gregoria Smith testified in favor of Bill 347. She also submitted written testimony that states obtaining
p.000003: consents from participants are necessary in the practice of research to protect the rights of those who
p.000003: participates. Researchers must be trained; research, especially scientific research, requires special training.
p.000003:
p.000003: Ms. Debbie Quinata, a member of OPIR, Chamorro Nation, ancestral/original landowners. Ms. Quinata is opposed
p.000003: to Bill 347. Guam already has an IRB for grant applicant that review standards at the Guam Memorial Hospital.
p.000003: This bill will create more loopholes. Ms. Quinata also stated that all off-island researchers should share in
p.000003: the results of the national research and charge fees. Mechanisms should be in place to ask for accountability - what
p.000003: are they doing for our island and educating our students.
p.000003:
p.000003: Dr. Bert Weiderholt, physician /neurologist and professor of neuroscience at the University of California, San
p.000003: Diego. NIA (National Institutes of Aging) funded program project for 5 years to study disease on Guam. Dr.
p.000003: Wiederholt is in full support of Bill 347 and further supports Drs. Nededog and Camacho, Workman and Smith. He has
p.000003: conducted research in various states and it is very important to submit research project for local review, although
p.000003: not federally required. Dr. Weiderholt and the project he is now involved in on Guam, had no hesitation in
p.000003: submitting application for research to the University of Guam and the Guam Memorial Hospital - both were
p.000003: approved.
p.000003:
p.000003: Senator Charfauros supports research and Bill 347. He suggested various amendments to the bill: need
p.000003: rules/regulations, more liability for researchers, require license to practice, progress reports made available to
p.000003: public, increase fine to $10,000 for violation, commercial profits need to be shared with research subjects and no
p.000003: exploitation of research subjects.
p.000003:
p.000003:
p.000004: 4
p.000004:
p.000004: Senator Kasperbauer shared his concerns with exploited research subjects and need protection.
p.000004:
...

Political / vulnerable

Searching for indicator vulnerable:

(return to top)
p.000009: 22 (b) Risks to subject are reasonable in relation
p.000009: to
p.000009: 23 anticipated benefits, if any, to subjects and the importance of the
p.000009: 24 knowledge that may reasonably be expected to result. In
p.000009: 25 evaluating risks and beneflts, the Board should consider only
p.000009:
p.000010: 10
p.000010:
p.000010:
p.000010: those risks and benefits that may result from the research, as
p.000010: 2 distinguished from risks and benefits of therapies subject would
p.000010: 3 receive even if not participating in the research. The Board should
p.000010: 4 not consider possible long range effects of applying knowledge
p.000010: 5 gained in the research (for example, the possible effects of the
p.000010: 6 research on public policy) as among those research risks that fall
p.000010: 7 within the purview of lts responsibility.
p.000010: 8 (c) Selection of the subjects is equitable. In making this
p.000010: 9 assessment the Board should take into account the purposes of the
p.000010: 10 research and the setting in which the research would be
p.000010: 11 conducted and should be particularly cognizant of the special
p.000010: 12 problems that research involving vulnerable populations, such as
p.000010: 13 children, prisoners, pregnant woman, persons with dlsabilities,
p.000010: 14 the elderly, or economically or educationally disadvantaged
p.000010: 15 persons.
p.000010: 16 (d) Informed consent will be sought from each
p.000010: 17 prospective subject or the subject’s legally authorized
p.000010: 18 representative, in accordance with, and to the extent required by
p.000010: 19 Board regulation.
p.000010: 20 (e) lrdormed consent will be appropriately documented,
p.000010: 21 in accordance with, and to the extent required by Board
p.000010: 22 regulation.
p.000010: 23 ( When appropriate, the research plan makes adequate
p.000010: 24 provision for monitoring the data collected to ensure the safety of
p.000010: 25 subjects.
p.000010:
p.000010:
p.000010: 1 (g) When appropriate, there are adequate provisions to
p.000010: 2 protect the privacy of subjects and to maintain the confidentiality
p.000010: 3 of data.
p.000010: 4 When some or all of the subjects are likely to be vulnerable
p.000010: 5 to coercion or undue influence, such as children, the elderly,
p.000010: 6 prisoners, pregnant women, mentally disabled persons or
p.000010: 7 economically or educatiOnally disadvantaged persons, additional
p.000010: 8 safeguards have been included in the research plans, procedures
p.000010: 9 or protocols to protect the rights and welfare of these subjects.
p.000010: 10 (h) Progress reports or thesis shall be made available to
p.000010: 11 subjects participating in the research as appropriate.
p.000010: 12 Section 24108. Grievance Procedure. lf application for
p.000010: 13 approval is denied for a research proposal, investigators may appeal to
p.000010: 14 the Dean of the Graduate School and Research. The Dean will appoint
p.000010: 15 an ad hoc committee for a second, independent review of the research
p.000010: 16 project. The findings of the ad hoc committee are to be presented to the
...

p.000007: 33 (a) Risks to subject are minimized: (i) by using procedures
p.000007: 34 which are consistent with sound research design and which do not
p.000007: 35 unnecessarily expose subject's to risk; and (ii) whenever appropriate
p.000007: 36 by using procedures already being performed on the subjects for
p.000007: 37 diagnostic or treatment purposes;
p.000007: 38 (b) Risks to subject are reasonable in relation to anticipated
p.000007: 39 benefits, if any, to subjects and the importance of the knowledge that
p.000007: 40 may reasonably be expected to result. In evaluating risks and
p.000007:
p.000008: 8
p.000008:
p.000008: benefits, the Board should consider only those risks and benefits that
p.000008: 2 may result from the research (as distinguished from risks and
p.000008: 3 benefits of therapies subject would receive even if not participating
p.000008: 4 in the research). The Board should not consider possible long range
p.000008: 5 effects of applying knowledge gained in the research (for example,
p.000008: 6 the possible effects of the research on public poñcy) as among those
p.000008: 7 research risks that fall within the purview of its responsibility;
p.000008: 8 (c) Selection of the subjects is equitable. In making this
p.000008: 9 assessment the Board should take into account the purposes of the
p.000008: 10 research and the setting in which the research would be conducted
p.000008: 11 and should be particularly cognizant of the special problems that research involving vulnerable
p.000008: populations such as children,
p.000008: 13 prisoners, pregnant woman, persons with disabilities, the elderly, or
p.000008: 14 economically or educationally disadvantaged persons;
p.000008: 15 (d) Informed consent will be sought from each prospective
p.000008: 16 subject or the subject's legally authorized representative, in
p.000008: 17 accordance with, and to the extent required by Board regulation.
p.000008: 18 (e) Informed consent will be appropriately documented, in
p.000008: 19 accordance with, and to the extent required by Board regulation.
p.000008: 20 (O When appropriate, the research plan makes adequate
p.000008: 21 provision for monitoring the data collected to ensure the safety of
p.000008: 22 subjects; and
p.000008: 23 (g) When appropriate, there are adequate provisions to protect
p.000008: 24 the privacy of subjects and to maintain the confidentiality of data.
p.000008: 25 When some or all of the subject are likely to be vulnerable to
p.000008: 26 coercion or undue influence, such as children, the elderly, prisoners,
p.000008: 27 pregnant women, mentally disabled persons or economically or
p.000008: 28 educationally disadvantaged persons, additional safeguards have
p.000008: 29 been included in the research plans, procedures or protocols to
p.000008: 30 protect the rights and welfare of these subjects.
p.000008: 31 §24108. Grievance Procedure. II application for approval is
p.000008: 32 denied for a research proposal, investigators may appeal to the
p.000008: 33 Dean of the Graduate School & Research. The Dean will appoint an
p.000008: 34 ad hoc committee for a second, independent review of the research
p.000008: 35 project. The findings of the ad hoc committee are presented to the
p.000008: 36 Research Review Committee no later than ninety (90) days after
p.000008: 37 receipt of grievance from investigator, to determine the final
p.000008: 38 decision to approve or not to approve a research project.
p.000008:
p.000008: 39 §24109. Fines and Penalties. Upon determination of
...

p.000005: risk.
p.000005: 2. Minor changes in previously approved research.
p.000005: Under an expedited review procedure, the review may be carried out by the IRB chairperson or by one or more experienced
p.000005: reviewers designated by the chairperson. Reviewers may exercise all of the authorities of the IRB except that the
p.000005: reviewersmay not disapprove the research•
p.000005:
p.000005:
p.000005:
p.000005: a) To approve research covered by this policy the IRB shall determine that all of the following requirements are
p.000005: satisfied:
p.000005: 1 • Risks to subjects are minimized.
p.000005: 2. Risks to subjects are reasonable in relation to anticipated benefits. The IRB should not consider possible
p.000005: long-range effects of applying knowledge gained in The research (foe example, the peesible effecrt:s og
p.000005: I:he research on public policy) as among thoae research risks that fall within the purview of its responsibility.
p.000005: 3. Selection of subjects is equitable.
p.000005: 4. Informed consent will be sought from each prospsctive subject or the subject's legally authorized.
p.000005: 5. Informed consent will be appropriately documented.
p.000005: 6. When appropriate, the research plan makes adequate provision for monitoring the data collected to ensure the safety
p.000005: of subjects.
p.000005: 7. There are adequate provisions to protect the privacy of subjects and to maintain the confidentiality of data.
p.000005: b) When some or all of the subjects are likely to be vulnerable to coercion or undue influence, such as children,
p.000005: prisoners, pregnant women, mentally disabled persona, or econoaicallY or educationally disadvantaged persons,
p.000005: additional safeguards have been included in the study to protect tAe rights and welfare of tRese subjects.
p.000005:
p.000005:
p.000005: Research covered by this policy that has been approved by ah IRB may be subject to further appropriate review by
p.000005: officials of the institution.
p.000005:
p.000005: 8•C*1O» 113 6UfipaO81OO or ¢eza1:aa61on OC Zea &ppg'Ova1.
p.000005:
p.000005: An IRB shall have autAoritY to suspend or terminate approval of research that is not being conducted in accordance with
p.000005: the IRB's requirements or that has been associated witA unexpected serious harm to subjects.
p.000005:
p.000005: Bec21oo 114 coopaxa€1ve Raseacaa.
p.000005:
p.000005: Cooperative research projects are those projects covered by this policy which involve more than one institution. In
p.000005: the conduct of cooperative research projects, each institution is responsible for safeguarding the rights and welfare
p.000005: of husmn subjects and for complying with this policy.
p.000005:
...

p.000010: studies by graduate and undergraduate students, with 3-4 major studies involving UOG faculty affiliated with local
p.000010: agencies (e.g., DPHSS, MHSA, etc.).
p.000010: The UOG CHRS is experienced and can provide an on-island irb review service to any agency, private entity, or
p.000010: off-island institution that does not have its own or other access to a Gtiam based irb. This is based on the idea
p.000010: that the legislative intent is to mandate that any research study involving human subjects has at least one
p.000010: on-island review. If that is the intent, then Guam has a ready mechanism in the form of the UOG CHRS to
p.000010: ensure that all of the following federal requirements are satisfied by any research covered by this law:
p.000010:
p.000010: 1. Risks to subjects are minimized.
p.000010: 2. Risks to subjects am reasonable in relation to anticipated benefits.
p.000010: 3. Selection of subjects is equitable.
p.000010: 4. Informed consent will be sought from each prospective subject or the subject's legally authorized .
p.000010: 5. Informed consent will be appropriately documented.
p.000010: 6. When appropriate, the research plan makes adequate provision for monitoring the data collected to ensure the
p.000010: safety of subjects.
p.000010: 7. Thème are adequate provisions to protect the privacy of subjects and to maintain the confidentiality of
p.000010:
p.000010: 8. When some or all of the subjects are likely to be vulnerable to coercion or undue inBuence, such as children,
p.000010: prisoners, pregnant women, mentally disabled persons, or economimlly or educationally disadvantaged persons, additional
p.000010: safeguards have been included in the study to pixitcct tlu rights and welfare of these subjects.
p.000010: I-However, as currently written, B’ 47 establishes an unnecessary additional‘
p.000010: Moreover, it includes a section 24102. Bonr- me; ppoin end Mntinnancp Renal. which is a confusing listing
p.000010: of membership, and does not fit the federal guidelines for irb stricture. For example, why only include the Director
p.000010: of DPHSS or his/her designee, and not the director of MHSA, DDPR, DOE, or the new agency for disabilities; and why is
p.000010: it so heavily weighted with people having no expertise in research or any academic science† What is the purpose of
p.000010: including an odd assemblage of persons — who may not have the skill and luiowledge for reviewing technical
p.000010: methodologies to ensure informed consent and procedures to handle any risks involved? Within the federal policy for
p.000010: irb’s it states:
p.000010:
p.000010: SOURCE’ Fedeml Rcgjstu June l8 199lJegu1atio«s •ffwtive xc is jeer j Section 107 IRB membership.
p.000010: a) Each IRB shall have at least five memberi with varying backgrounds to promote complete and adequate
...

Health / Cognitive Impairment

Searching for indicator cognitive:

(return to top)
p.000004: 12 constitute research for purposes of this policy, whether or not they
p.000004: t3 are conducted or supported under a program which is considered
p.000004: 14 research for other purposes. For example, some demonstration and
p.000004: 15 service programs may fall under this definition of research. Not
p.000004: 16 included in this definition are:
p.000004: 17 (1) Opinion polls or other similar investigations of the
p.000004: 18 human subjects' opinions or beliefs;
p.000004: 19 (2) Research conducted in established or commorily
p.000004: 20 accepted educational settings, involving normal
p.000004: 21 educational practices, such as (i) research on regular
p.000004: 22 and special education instructional strategies or (ii)
p.000004: 23 research on the effectiveness or the comparison among
p.000004: 24 instructional techniques, curricula or classroom
p.000004: 25 management methods;
p.000004: 26 (3) Research involving the use of educational tests
p.000004: 27 (cognitive, diagnostic, aptitude, achievement), survey
p.000004: 28 procedures, interview procedures or observation of
p.000004: 29 public behavior, unless: ;(i) information obtained is
p.000004: 30 recorded in such a manner that human subjects can be
p.000004: 31 identified, directly or through identifier's linked to the
p.000004: 32 subjects; and (ü) any disclosure of the human subject's
p.000004: 33 responses outside the research could reasonably place
p.000004: 34 the subject at risk of criminal or civil liability or be
p.000004: 35 damaging to the subject's financial standing,
p.000004: 36 employability or reputation;
p.000004: 37 (4) Research involving the use of educational tests
p.000004: 38 (cognitive, diagnostic, aptitude, achievement), survey
p.000004: 39 procedures or observation or public behavior that is not
p.000004: 40 exempted under paragraph (d)(2) of this section, if: (i)
p.000004:
p.000002: 2
p.000002:
p.000002:
p.000002:
p.000002:
p.000002:
p.000002:
p.000002:
p.000002:
p.000002:
p.000002:
p.000002:
p.000002:
p.000002:
p.000002:
p.000002: • UOO Ouidt inns rcgardmg the “Ethical Principles wxl Guidelines for the Protection
p.000002: ofHwnan 5 objects of Research"
p.000002: - GMH Insti» poiul R« io Bard Policies *od Pr»cc«u cs ef13/9i3
p.000002: - Applicabb I sdemt R orii (1974 end hta) as issoed by the U.S. Oepartment of
p.000002: Heelth, Edu pgon, nid Welhre
p.000002: • Applicable i:gntioos of flu Office Hi Rotcction from Resee*h Risks (OPRR),
p.000002: N#Æm@knÿmhofHnü#Depmmœ#ofIoü1mdHmnanSwüA
p.000002: £pÿmbkçpAdm#ofWcUSPoÆxdDmçhJmWümaémÇD%
p.000002:
p.000002: Protection c
p.000002: - Applicable
p.000002: Any::rican
p.000002: I-luiDan Sobjecti
p.000002: ;xles ofconduct ofio‹4al ind behavioml mear*h as adopted by the
p.000002: *ho ’cal Association APA since l9D
p.000002:
p.000002:
p.000002: £‹•s• NO NEED TO DUPMcxTs THsSs SXIST G R£VisW BOARus CY
p.000002: ESTABL@HING A NEW REViEW BOARD that has no gcarMse ofproviding equal quality reviews or poN#ômMÆWP kofoœml
p.000002: [DGCœmÆœlœHumanGJQeœæRmwam CHS§ VdM#AæmMmoñNH MbmÆÆœÆRwicwBomdÇRB)fo ufpRV*Aügom€onM
p.000002: Oic Pcop)¢ ofGuarn, arid wM continue to jxovide this protectian to tha Pe¢$ils of¢?uam if’pcmiibed to
p.000002: cantñtuc s¢zvtng the Peopk o£Guam as tfi¢y pesently do, This points in Ote direction of&e ncad Iboa major revision
...

p.000003: eslablished deaiinghouse pioceduæ Jbr anyone p«›posing ræearch in the areas of atchaeoloqy, oial histDry, SoÔaI
p.000003: CLlltufe, Œ/stDm, arls/cfalfs, afŒliyal, political histDfy, or anything to do with hietoric and culturat resounæs
p.000003: in the FSM.
p.000003:
p.000003: To what does this policy apply†
p.000003:
p.000003: Uni /ersity policy applies to all ‹eaærŒ iwoNing human subjects œnducted, supported or o0›etwiæ subject to ægulaton by
p.000003: any federal department or aqency whidi takes appfopñate adminisbaöve action to make the policy applkable to suŒ
p.000003: research. lt also indudœ ‹œeaia œnduÖed, supported, or otherwise subject to regulalton by the federal govemrnent
p.000003: outside the United States. Research If›at is neîlher œnduöed nor suppo‹ted by a fède‹al deparbnent or agency but is
p.000003: subject to regulation must be /eyiewed and appnwed by an instîtutional
p.000003: /eview board (IRB) 0›at operales in aa›o‹danos with the peitinœt ‹equî‹ements ofbiis policy.
p.000003: Unless otherwise required, /eseatch actñ/iges wheie One only in ‹olvement of human subjects will be in one or more of
p.000003: the fdlowing ‹ategories may be ezemptad or subjected only to expedited reyiew prooedures as assessed from ‹he CHRS
p.000003: Reyiew Application:
p.000003: (1) Research œnduond in establîdæd or commonly accepted eduœtîanal Settings, involving normal eduætîonal practî‹æs,
p.000003: such as (i) research on regular and apeôal eduœtion instrucôonal etrategîœ, or (ii) æseatoi on the eflbcbæneœ ofor the
p.000003: œmparîson among insbucêonal techniques, artîcula, or ciaasmom management rnethods.
p.000003: (2) Research involving the uee of eduæôonal taets (cognitive, &ægriostic, aptitude,
p.000003: - ›hîevernent), sun/ey ptoœduæs or obseræêon of public behavÔr, unleæ:
p.000003: (i) Irtfonœtîon obtained ia æœrded in such a manner Oæt human subjects can be dentilted, diieclfty or through
p.000003: dîdeennttiî55eerrs linked to the esub{edz; and gi) any diacbsuæ of the human subjects’ responses outside the
p.000003: ould taasonably place the subjects at ñsk of cittiinal or civil febility or be damaging to the subjects’ financial
p.000003:
p.000003: (3)ResemhndsæmWundwpsœgmPh2dRüeœRq1(#æ#aÆeœëœÆdor
p.000003: appointed public oflîcials or mndidatea for public oflîce; or (i) fedeial statele(s)
p.000003: information will be maîmained thtoughout tlæ æsearch and thereañer.
p.000003: (4) Research involvîng the oolbctian or study of exîetîng data, dœxnerits, records. pathologîœl speörnens, or &ægnostîc
p.000003: specà'neiæ, if 0›eee eounæs are publîcly æailable or ifthe information is recordaf by0is itweati$ator in auofi a manner
p.000003: Oiat su#jéc/s cannot be kfentilied, directly or Oirough identifiers linked to tta subs
p.000003: (5) Research and demonslratbn pro}ecB which aia designed to study, evaluate or otherwise examine: #) Public beneE or
p.000003: ser¥ica pto$tams; (g) ptocedurea for obtaining benefits or eenfioae under Oiæe progærna; (A) poesble dænges in or
p.000003: alBmatîves to those p‹ogæms; or (iv) possible changea in methods, payment or senñces under thoee
p.000003:
p.000003: (6) Taste and food quality evaluation and consumer aaxplarice sbzdie8, (i) if wholesome foods without addîtîves an
p.000003: œneumed or §§ ifa food is œnsumed that œntains a food ingredîent at or bebw the Iesel and for a usa Jöund æ be safe,
p.000003: or agñcultuæl chemiœl or eiwironmental œri/aminant at or below gie lœel Iôund to be aafe, by the Food and Drug
...

p.000003: private information. (]xterventlon and private information are given expanded definition)
p.000003:
p.000003:
p.000003: (h) IRB appz-ova-I ...
p.000003:
p.000003: (i) Blzimal rlsk means that the probability and magnitude of harm or discomfort anticipated in the research are not
p.000003: greater in and of themselves than those ordinarily encountered in daily life or during the performance of routine
p.000003: physical or psychological examinations or tests.
p.000003: (j) Certification means the official notification by the institution to the supporting department or agency, in
p.000003: accordance with the requirements of this policy, that a research project or activity involvinghuman subjects has been
p.000003: reviewed and approved by an IRB in accordance with an approved assurance.
p.000003:
p.000003:
p.000003:
p.000003:
p.000003:
p.000003:
p.000003: 3
p.000003:
p.000003: (b) Unless otherwise required . . . research activities in which the only involvement of human subjects will be in one
p.000003: or more of the foLloWing categories are exempt from this policy:
p.000003: (1) Research conducted in established or commonly accepted educational settings, involving normal educational
p.000003: practices, such as (i) research On regular and special education instructional strategies, or (ii)
p.000003: research on the effectiveness oY or the comparison among instructional techniques, curricula, or classroom
p.000003: management methods.
p.000003: (2) Research involving the use of educational tests (cognitive, diagnostic, aptitude, achievement), survey
p.000003: procedures or observation of public behavior, unless:
p.000003: (i) Information obtained is recorded in such a manner that human subjects can be iaent:if1e‹t, directly
p.000003: or through identifiers linked to the subjects; and (ii) any disclosure of the human subjects' responses outside
p.000003: the research could reasonably place the subjects at risk of criminal or civil liability or be damaging tO the
p.000003: subjects' financial standing, employability, or reputation.
p.000003: (3) Research [under 101(b)(2)] that is not exempt under paragraph (b)(2) of this section, if: (i) ... subjects are
p.000003: elected or appointed public officials or candidates for public office; or (ii) federal statute(s) require(s)
p.000003: without exception that the confidentiality of the personally identifiable information will be maintained
p.000003: throughout the research and thereafter.
p.000003: (4) Research, involving the collection or study Of existing data, documents, records, pathological specimens, or
p.000003: diagnostic specimens, if these sources are publicly available or if the information is recorded by the investigator in
p.000003: such a manner that subjects cannot be identified, directly or through identifiers linked to the subjects.
p.000003: (5) Research and demonstration projects... which are designed to study, evaluate or otherwise examine: (i) Public
p.000003: benefit or service programs; (ii) procedures for obtaining benefits or services under those programs; (iii) possible
p.000003: changes in or alternatives to those programs ...(iv) possible changes in methods or ... payment ... or services under
p.000003: those programs.
...

Health / Drug Usage

Searching for indicator drug:

(return to top)
p.000002: 10 available or if the information is reported by the
p.000002: 11 investigator in such a manner that subjects cannot be
p.000002: 12 identified, directly or through identifiers that link
p.000002: i3 through the subject;
p.000002: 14 (6) Research and demonstration projects which are
p.000002: i5 designed to study, evaluate, or otherwise examine: (i)
p.000002: 16 public benefits or service programs; (ii) procedures for
p.000002: 17 obtalning benefits or services under those programs; (ii)
p.000002: 18 possible changes and/or alternatives to those programs
p.000002: 19 or procedures; or (iv) possible changes in methods or
p.000002: 20 levels of payments for benefits or services under those
p.000002: 21 programs; and
p.000002: 22 (7) Taste and food quality evaluation and consumer
p.000002: 23 acceptance studies, (i) if wholesome foods without
p.000002: 24 additives are consumed or (ii) if a good is consumed that
p.000002: 25 contains a food ingredient at or below the level an for a
p.000002: 26 use found to be safe, or agricultural chemical or
p.000002: 27 environmental contaminant at or below the level found
p.000002: 28 to be safe, by the Food and Drug Administration or
p.000002: 29 approved by the Environmental Protection Agency or
p.000002: 30 the Food Safety Inspection Service of the United States
p.000002: 31 Department of Agriculture.
p.000002: 32 (e) Research subject to regulation means research involving
p.000002: 33 human subjects.
p.000002: 34 (0 Human sub jects means a living individual about whom an
p.000002: 35 investigator conducting research obtains
p.000002: 36 (1) Data through intervention or interaction with the
p.000002: 37 individual. Intervention includes both physical
p.000002: 38 procedures by which data are gathered and
p.000002: 39 manipulations of the subject or the subject's
p.000002: 40 environment that are performed for research purposes.
p.000002:
p.000002: 1 Interaction includes communication or interpersonal
p.000002: 2 contact between investigator and subject.
p.000002: 3 (2) Identifiable private information. Private information
p.000002: 4 may include information about behavior that occurs in a
p.000002: 5 context in which an individual can reasonably expect
p.000002: that no observation or recording is taking place, and
p.000002: 7 information which has been provided for specific
p.000002: purposes by an individual and which the individual can
p.000002: 9 reasonably expect will not be made public (for example,
...

p.000003: - ›hîevernent), sun/ey ptoœduæs or obseræêon of public behavÔr, unleæ:
p.000003: (i) Irtfonœtîon obtained ia æœrded in such a manner Oæt human subjects can be dentilted, diieclfty or through
p.000003: dîdeennttiî55eerrs linked to the esub{edz; and gi) any diacbsuæ of the human subjects’ responses outside the
p.000003: ould taasonably place the subjects at ñsk of cittiinal or civil febility or be damaging to the subjects’ financial
p.000003:
p.000003: (3)ResemhndsæmWundwpsœgmPh2dRüeœRq1(#æ#aÆeœëœÆdor
p.000003: appointed public oflîcials or mndidatea for public oflîce; or (i) fedeial statele(s)
p.000003: information will be maîmained thtoughout tlæ æsearch and thereañer.
p.000003: (4) Research involvîng the oolbctian or study of exîetîng data, dœxnerits, records. pathologîœl speörnens, or &ægnostîc
p.000003: specà'neiæ, if 0›eee eounæs are publîcly æailable or ifthe information is recordaf by0is itweati$ator in auofi a manner
p.000003: Oiat su#jéc/s cannot be kfentilied, directly or Oirough identifiers linked to tta subs
p.000003: (5) Research and demonslratbn pro}ecB which aia designed to study, evaluate or otherwise examine: #) Public beneE or
p.000003: ser¥ica pto$tams; (g) ptocedurea for obtaining benefits or eenfioae under Oiæe progærna; (A) poesble dænges in or
p.000003: alBmatîves to those p‹ogæms; or (iv) possible changea in methods, payment or senñces under thoee
p.000003:
p.000003: (6) Taste and food quality evaluation and consumer aaxplarice sbzdie8, (i) if wholesome foods without addîtîves an
p.000003: œneumed or §§ ifa food is œnsumed that œntains a food ingredîent at or bebw the Iesel and for a usa Jöund æ be safe,
p.000003: or agñcultuæl chemiœl or eiwironmental œri/aminant at or below gie lœel Iôund to be aafe, by the Food and Drug
p.000003: Adminia#atîon orappioved bythe Eiwironmental Protection Agency orthe Food Safaty and Inspectbn Service ofgie USDA.
p.000003:
p.000003: 8actioo i03 Assuring compliance Pitt this policy--research
p.000003: corductad or supported by aoy federal department or ageocy.
p.000003: (a) Each institution engaged in research which is covered by this policy and which is conducted or supported by a
p.000003: federal department or agency shall provide written assurance satisfactory to the department or agency head that it will
p.000003: comply witA the requirements set forth in this policy. In lieu of requiring submission of an assurance, appropriate for
p.000003: the research in question, on file with the Office for Protection from Research Risks, RHS, and approved for federal
p.000003: wide use by that office.
p.000003: (b) Departments and agencies will conduct or support researeA covered by this policy pnly if the institution has an
p.000003: assurance
p.000003: approvea aa provided by this section, and only t§ the institution
p.000003: chas lfled co The departztene or agency head thai I:he research
p.000003: has been reviewed and approved by an xRB provided for in the assurance, and will be subject
p.000003: to continuing review by the IRB. Assurances applicable to federally supported or conducted research shall at a minimum
p.000003: include:
p.000003: (1) A statement ofprincipals governing the institution in the discharge of its responsibilities for protecting the
p.000003: rights and welfare of human subjects of research conducted at or sponsored by tAe institution, reqardlpss o w et e
p.000003: the peseqpch js subject to federql peoulation.
...

p.000003: subjects' financial standing, employability, or reputation.
p.000003: (3) Research [under 101(b)(2)] that is not exempt under paragraph (b)(2) of this section, if: (i) ... subjects are
p.000003: elected or appointed public officials or candidates for public office; or (ii) federal statute(s) require(s)
p.000003: without exception that the confidentiality of the personally identifiable information will be maintained
p.000003: throughout the research and thereafter.
p.000003: (4) Research, involving the collection or study Of existing data, documents, records, pathological specimens, or
p.000003: diagnostic specimens, if these sources are publicly available or if the information is recorded by the investigator in
p.000003: such a manner that subjects cannot be identified, directly or through identifiers linked to the subjects.
p.000003: (5) Research and demonstration projects... which are designed to study, evaluate or otherwise examine: (i) Public
p.000003: benefit or service programs; (ii) procedures for obtaining benefits or services under those programs; (iii) possible
p.000003: changes in or alternatives to those programs ...(iv) possible changes in methods or ... payment ... or services under
p.000003: those programs.
p.000003: (6) Taste and food quality evaluation and consumer acceptance studies, (i) if wholesome foods without additives are
p.000003: consumed or (ii) if a food is consumed that contains a food ingredient at or below the level and for a use found to be
p.000003: safe, or agricultural chsrical or environmental contaminant at or below the level found to be aafe, by the Food
p.000003: and Drug Administration or approved by the Environmental Protection Agency or the Food Safety and Inspection Service
p.000003: of the USDA.
p.000002: 2
p.000002:
p.000002: UxSVBeszzg or auazg
p.000002: tJDlBsKsBaAz ouaanx
p.000002: COMMITTEE on IlTJhfWf RZSZAItCIE SUBJECTS
p.000002: RESEARCH COUNCIL GRADUATE SCHOOL & RESEARCH
p.000002:
p.000002:
p.000002:
p.000002: SOURCE: Pederg} Reqister, Jupg 18, 1991 (Regq}atioqs effective Augugt 19, 1991)
p.000002:
p.000002:
p.000002: "This document sets forth a common Federal Poliwy for the Protection of Human Subjects accepted by the office
p.000002: of Science aod TacRoology Pollwy and promulgated in regulation by each of the listed Departments and Agencies.•
p.000002: Each of these Departments and Agencies have adopted the common rule as regulations for the protection of human subjects
p.000002: involved in research conducted or funded by the following:
p.000002: Cs Depactzsenc o£ hgu1cu1cure› Dapaztaian€ o£ znecgy; mac1ona1 Aeronautics and Spaoe Adm£n1e€cac1ozt›
p.000002: Dapaz-haiarzc oC Coaaaocce; Conauaiou product Sa£ecy Cozam1ee ton; InVecna€1one1 Deva1ogxaan€ Coopora¢1oa
p.000002: kgency; urgency Com IncecnahLonaL Deea1o$man€; Depactaian€ of Bous1ng aztd Ocban Davalogaaanc;
p.000002: Depaccmenc o£ 6uac1ce› Depaz-ba›nnc oC De£anee; Depaz€a›anc o£ 6duoac1on; Depaz-beanjr o£ ve€aran
p.000002: ACCa1ce;
p.000002:
p.000002:
p.000002:
p.000002:
p.000002: 8ecc1on for g'o abas doea fib1a po11oy app1g's
p.000002:
p.000002: (a) . . . this policy applies to all research involving human subjects conducted, supported or otherwise subject to
...

Searching for indicator influence:

(return to top)
p.000010: 15 persons.
p.000010: 16 (d) Informed consent will be sought from each
p.000010: 17 prospective subject or the subject’s legally authorized
p.000010: 18 representative, in accordance with, and to the extent required by
p.000010: 19 Board regulation.
p.000010: 20 (e) lrdormed consent will be appropriately documented,
p.000010: 21 in accordance with, and to the extent required by Board
p.000010: 22 regulation.
p.000010: 23 ( When appropriate, the research plan makes adequate
p.000010: 24 provision for monitoring the data collected to ensure the safety of
p.000010: 25 subjects.
p.000010:
p.000010:
p.000010: 1 (g) When appropriate, there are adequate provisions to
p.000010: 2 protect the privacy of subjects and to maintain the confidentiality
p.000010: 3 of data.
p.000010: 4 When some or all of the subjects are likely to be vulnerable
p.000010: 5 to coercion or undue influence, such as children, the elderly,
p.000010: 6 prisoners, pregnant women, mentally disabled persons or
p.000010: 7 economically or educatiOnally disadvantaged persons, additional
p.000010: 8 safeguards have been included in the research plans, procedures
p.000010: 9 or protocols to protect the rights and welfare of these subjects.
p.000010: 10 (h) Progress reports or thesis shall be made available to
p.000010: 11 subjects participating in the research as appropriate.
p.000010: 12 Section 24108. Grievance Procedure. lf application for
p.000010: 13 approval is denied for a research proposal, investigators may appeal to
p.000010: 14 the Dean of the Graduate School and Research. The Dean will appoint
p.000010: 15 an ad hoc committee for a second, independent review of the research
p.000010: 16 project. The findings of the ad hoc committee are to be presented to the
p.000010: 17 Committee on Human Subjects in Research no later than ninety (90)
...

p.000004: 30 modification, or disapproval. No research subject to regulation shall
p.000004: 31 be conducted without Board approval. The plans, procedures and
p.000004: 32 protocols for all research subject to regulation which is being
p.000004: 33 conducted at the time of the enactment of this legislation shall be
p.000004: 34 submitted to the Board for review, approval, modification or
p.000004: 35 disapproval within thirty (30) days of this bill becoming law.
p.000004: 36 Research subject to regulation which is being conducted at the time
p.000004:
p.000004: 37 of the enactment of this leglslation
p.000004: 38 action.
p.000004: may continue pending Board
p.000004: 39 §24106. General Requirements for Informed Consent. No
p.000004: 40 investigator may involve a human being in research subject to
p.000004:
p.000005: 5
p.000005:
p.000005: regulation unless the investigator has obtained the legally effective
p.000005: 2 informed consent of the subject or the subject's legally authorized
p.000005: representative. An investigator shall seek such consent only under
p.000005: 4 circumstances that provide the prospective subject or the
p.000005: 5 representative sufficient opportunity to consider whether or not to
p.000005: 6 participate and that minimize the possibility of coercion or undue
p.000005: 7 influence. The information that is given to the subject or the
p.000005: 8 representative shall be in language understandable to the subject or
p.000005: 9 the representative. Unless otherwise provided by law or regulation,
p.000005: 10 no informed consent, whether oral or written, may include any
p.000005: 11 exculpatory language through which the subject or the
p.000005: 12 representative is made to waive or appear to waive any of the
p.000005: 13 subject's legal rights, or releases or appears to release the
p.000005: 14 investigator, the research sponsor, if different, or their agents from
p.000005: 15 liability for negligence;
p.000005: 16 (a) Basic elements of Informed Consent. Except as provided in
p.000005: 17 paragraphs (c) or (d) of this section, in seeking informed consent the
p.000005: 18 following information shall be provided to each human subject or the
p.000005: 19 subject's legally authorized representative:
p.000005: 20 (1) A statement that the study involves research, an
p.000005: 21 explanation of the purpose of the research and the
p.000005: 22 expected duration of the subject's participation,
p.000005: 23 description of the procedures to be followed, and
...

p.000010: eubJ eel Cha oppocfiun1 €y e aak gues£1ono and to alt araw at any Time froa the
p.000010: raseaech. AddlLional 1.been have been proposed, including how subjects sre selected, tAe person responsible
p.000010: for the research, *tc.
p.000010: However, a listing of items does not clarify waYs for judging how much and what sOFt Of infOrmation should be provided.
p.000010: It may be cba€ a aeandacd oC ^€he z'eaaonab1e vo1un2eec" shou16 be Co11oued:
p.000010:
p.000010:
p.000010: risk and the voluntary nature of participation.
p.000010: Information about risks ehould never be withheld for tAe purpose of eliciting the cooperation of subjects, and truthful
p.000010: answers should always be given to direct questions about tAe research.
p.000010: gmqprehensioq. The manner and context in which information is conveyed is as important as the information itself. Por
p.000010: example, presenting information in a disorganized and rapid fashion, allowing too little time for
p.000010: consideration or curtailing opportunities for questioning, all may adversely affect a subject's ability to make an
p.000010: informed choice.
p.000010: Because the subject's ability to understand is a function of intelligence, rationality, maturity and language, it is
p.000010: necessary to adapt the presentation of the information to the subject's capacities. Investigators are responsible for
p.000010: ascertaining that the subject has comprehended the information.
p.000010: Voluntaripess. This element of informed consent requires condlñinns feee of coercion and undue influence.
p.000010: tfndue Influence occurs through an offer of an excessive, unwarranted, inappropriate or improper reward or other
p.000010: overture in order to obtain compliance. Also, inducements that would ordinarily be acceptable may become
p.000010:
p.000010: hand, lt would seem that respect requires that prisoners and students not be depz'1ved of the
p.000010: oppoz•gun1t:y tO volunteer Com research. On t2ie otlter hand, under prison and classroom
p.000010: conAlelonu both may be subtly coerced or unduly influenced to engage in research acVivieies for which they uould
p.000010: not: otherwise volunteer.
p.000010:
p.000010: g. Beneflcsnce: Is a term often understood to cover acte of kindness or charity that go beyond etrict obligations. In
p.000010: tAis document, beneficence is understood in a stronger aense, as an obligation. Two general mles are complementary
p.000010: oxpreasione of beneficent actions in tAis sense: (1) do not harm and (2) maximize possible benefits and minimize
p.000010: possible barme.
p.000010: obligations of baneJ°1cence agdecrg bottt J.nd1v1dua1 Invas1z1ga€o=s and soc1et:y at: 1acqa,
p.000010: because tbey extand botb to particular research projects and to tAe entira Enterprise ef research. In the case of
p.000010: particular projects, investigators and
p.000010: archers of their lns€lVu€ions ara obllqeñ to give foretbouqhe en
p.000010: tbe maximization oZ benefits and the reduction of risk that night occur from the research investigation.
...

Health / Mentally Disabled

Searching for indicator disabled:

(return to top)
p.000010: 20 (e) lrdormed consent will be appropriately documented,
p.000010: 21 in accordance with, and to the extent required by Board
p.000010: 22 regulation.
p.000010: 23 ( When appropriate, the research plan makes adequate
p.000010: 24 provision for monitoring the data collected to ensure the safety of
p.000010: 25 subjects.
p.000010:
p.000010:
p.000010: 1 (g) When appropriate, there are adequate provisions to
p.000010: 2 protect the privacy of subjects and to maintain the confidentiality
p.000010: 3 of data.
p.000010: 4 When some or all of the subjects are likely to be vulnerable
p.000010: 5 to coercion or undue influence, such as children, the elderly,
p.000010: 6 prisoners, pregnant women, mentally disabled persons or
p.000010: 7 economically or educatiOnally disadvantaged persons, additional
p.000010: 8 safeguards have been included in the research plans, procedures
p.000010: 9 or protocols to protect the rights and welfare of these subjects.
p.000010: 10 (h) Progress reports or thesis shall be made available to
p.000010: 11 subjects participating in the research as appropriate.
p.000010: 12 Section 24108. Grievance Procedure. lf application for
p.000010: 13 approval is denied for a research proposal, investigators may appeal to
p.000010: 14 the Dean of the Graduate School and Research. The Dean will appoint
p.000010: 15 an ad hoc committee for a second, independent review of the research
p.000010: 16 project. The findings of the ad hoc committee are to be presented to the
p.000010: 17 Committee on Human Subjects in Research no later than ninety (90)
p.000010: 18 days after receipt of grievance from the investigator, to determine the
p.000010: 19 final decision to approve or not to approve a research project.
p.000010: 20 Section 24109. Fines and Penalties. Upon determination of
p.000010: 21 the Review Board through the approved rules and regulations, any
p.000010: 22 investigator, research sponsor or their agents, which conducts research
...

p.000008: 15 (d) Informed consent will be sought from each prospective
p.000008: 16 subject or the subject's legally authorized representative, in
p.000008: 17 accordance with, and to the extent required by Board regulation.
p.000008: 18 (e) Informed consent will be appropriately documented, in
p.000008: 19 accordance with, and to the extent required by Board regulation.
p.000008: 20 (O When appropriate, the research plan makes adequate
p.000008: 21 provision for monitoring the data collected to ensure the safety of
p.000008: 22 subjects; and
p.000008: 23 (g) When appropriate, there are adequate provisions to protect
p.000008: 24 the privacy of subjects and to maintain the confidentiality of data.
p.000008: 25 When some or all of the subject are likely to be vulnerable to
p.000008: 26 coercion or undue influence, such as children, the elderly, prisoners,
p.000008: 27 pregnant women, mentally disabled persons or economically or
p.000008: 28 educationally disadvantaged persons, additional safeguards have
p.000008: 29 been included in the research plans, procedures or protocols to
p.000008: 30 protect the rights and welfare of these subjects.
p.000008: 31 §24108. Grievance Procedure. II application for approval is
p.000008: 32 denied for a research proposal, investigators may appeal to the
p.000008: 33 Dean of the Graduate School & Research. The Dean will appoint an
p.000008: 34 ad hoc committee for a second, independent review of the research
p.000008: 35 project. The findings of the ad hoc committee are presented to the
p.000008: 36 Research Review Committee no later than ninety (90) days after
p.000008: 37 receipt of grievance from investigator, to determine the final
p.000008: 38 decision to approve or not to approve a research project.
p.000008:
p.000008: 39 §24109. Fines and Penalties. Upon determination of
p.000008: 40 review board through the approved rules and regulations,
p.000008: the any
p.000008:
p.000009: 9
p.000009:
p.000009: investigator, research sponsor, or their agents, which conducts
p.000009: 2 research subject to regulation in violation of this chapter shall be
p.000009: 3 subject to a fine of One Thousand Dollars ($1,000.00) per each
p.000009: 4 violation and shall be prohibited from continuing and conducting
p.000009: 5 human research studies for not less than 2 (two) years. “
p.000009:
p.000009:
p.000009:
p.000009:
p.000009:
p.000009:
p.000009:
...

p.000005: satisfied:
p.000005: 1 • Risks to subjects are minimized.
p.000005: 2. Risks to subjects are reasonable in relation to anticipated benefits. The IRB should not consider possible
p.000005: long-range effects of applying knowledge gained in The research (foe example, the peesible effecrt:s og
p.000005: I:he research on public policy) as among thoae research risks that fall within the purview of its responsibility.
p.000005: 3. Selection of subjects is equitable.
p.000005: 4. Informed consent will be sought from each prospsctive subject or the subject's legally authorized.
p.000005: 5. Informed consent will be appropriately documented.
p.000005: 6. When appropriate, the research plan makes adequate provision for monitoring the data collected to ensure the safety
p.000005: of subjects.
p.000005: 7. There are adequate provisions to protect the privacy of subjects and to maintain the confidentiality of data.
p.000005: b) When some or all of the subjects are likely to be vulnerable to coercion or undue influence, such as children,
p.000005: prisoners, pregnant women, mentally disabled persona, or econoaicallY or educationally disadvantaged persons,
p.000005: additional safeguards have been included in the study to protect tAe rights and welfare of tRese subjects.
p.000005:
p.000005:
p.000005: Research covered by this policy that has been approved by ah IRB may be subject to further appropriate review by
p.000005: officials of the institution.
p.000005:
p.000005: 8•C*1O» 113 6UfipaO81OO or ¢eza1:aa61on OC Zea &ppg'Ova1.
p.000005:
p.000005: An IRB shall have autAoritY to suspend or terminate approval of research that is not being conducted in accordance with
p.000005: the IRB's requirements or that has been associated witA unexpected serious harm to subjects.
p.000005:
p.000005: Bec21oo 114 coopaxa€1ve Raseacaa.
p.000005:
p.000005: Cooperative research projects are those projects covered by this policy which involve more than one institution. In
p.000005: the conduct of cooperative research projects, each institution is responsible for safeguarding the rights and welfare
p.000005: of husmn subjects and for complying with this policy.
p.000005:
p.000005: An institution participating in a cooperative project may enter into a joint review arrangement, rely upon the review
p.000005: of another qualified ZRB, or nake similar arrangement:a for avoi‹:ling duplication of
p.000005: effort.
p.000005: sactioo us zRe xecora•.
p.000005: An IRB, shall prepare and maintain adequate documentation of IRB activities, including the following:
p.000005: 1. Copies of all research proposals reviewed.
p.000005: 2. of IRB meetings
p.000005: s. Records of continuing review activities.
...

p.000010: that the legislative intent is to mandate that any research study involving human subjects has at least one
p.000010: on-island review. If that is the intent, then Guam has a ready mechanism in the form of the UOG CHRS to
p.000010: ensure that all of the following federal requirements are satisfied by any research covered by this law:
p.000010:
p.000010: 1. Risks to subjects are minimized.
p.000010: 2. Risks to subjects am reasonable in relation to anticipated benefits.
p.000010: 3. Selection of subjects is equitable.
p.000010: 4. Informed consent will be sought from each prospective subject or the subject's legally authorized .
p.000010: 5. Informed consent will be appropriately documented.
p.000010: 6. When appropriate, the research plan makes adequate provision for monitoring the data collected to ensure the
p.000010: safety of subjects.
p.000010: 7. Thème are adequate provisions to protect the privacy of subjects and to maintain the confidentiality of
p.000010:
p.000010: 8. When some or all of the subjects are likely to be vulnerable to coercion or undue inBuence, such as children,
p.000010: prisoners, pregnant women, mentally disabled persons, or economimlly or educationally disadvantaged persons, additional
p.000010: safeguards have been included in the study to pixitcct tlu rights and welfare of these subjects.
p.000010: I-However, as currently written, B’ 47 establishes an unnecessary additional‘
p.000010: Moreover, it includes a section 24102. Bonr- me; ppoin end Mntinnancp Renal. which is a confusing listing
p.000010: of membership, and does not fit the federal guidelines for irb stricture. For example, why only include the Director
p.000010: of DPHSS or his/her designee, and not the director of MHSA, DDPR, DOE, or the new agency for disabilities; and why is
p.000010: it so heavily weighted with people having no expertise in research or any academic science† What is the purpose of
p.000010: including an odd assemblage of persons — who may not have the skill and luiowledge for reviewing technical
p.000010: methodologies to ensure informed consent and procedures to handle any risks involved? Within the federal policy for
p.000010: irb’s it states:
p.000010:
p.000010: SOURCE’ Fedeml Rcgjstu June l8 199lJegu1atio«s •ffwtive xc is jeer j Section 107 IRB membership.
p.000010: a) Each IRB shall have at least five memberi with varying backgrounds to promote complete and adequate
p.000010: review of research activities commonly conducted by the institution. In addition to pouessing the
p.000010: professional competence necessary to review specific reseamh activities the IRB shall be able to ascertain
p.000010: the acceptability of proposed research in terms of institutional commitments and regulations, applicable
p.000010: law, and standards of professional conduct and practice.
...

Searching for indicator mentally:

(return to top)
p.000010: 19 Board regulation.
p.000010: 20 (e) lrdormed consent will be appropriately documented,
p.000010: 21 in accordance with, and to the extent required by Board
p.000010: 22 regulation.
p.000010: 23 ( When appropriate, the research plan makes adequate
p.000010: 24 provision for monitoring the data collected to ensure the safety of
p.000010: 25 subjects.
p.000010:
p.000010:
p.000010: 1 (g) When appropriate, there are adequate provisions to
p.000010: 2 protect the privacy of subjects and to maintain the confidentiality
p.000010: 3 of data.
p.000010: 4 When some or all of the subjects are likely to be vulnerable
p.000010: 5 to coercion or undue influence, such as children, the elderly,
p.000010: 6 prisoners, pregnant women, mentally disabled persons or
p.000010: 7 economically or educatiOnally disadvantaged persons, additional
p.000010: 8 safeguards have been included in the research plans, procedures
p.000010: 9 or protocols to protect the rights and welfare of these subjects.
p.000010: 10 (h) Progress reports or thesis shall be made available to
p.000010: 11 subjects participating in the research as appropriate.
p.000010: 12 Section 24108. Grievance Procedure. lf application for
p.000010: 13 approval is denied for a research proposal, investigators may appeal to
p.000010: 14 the Dean of the Graduate School and Research. The Dean will appoint
p.000010: 15 an ad hoc committee for a second, independent review of the research
p.000010: 16 project. The findings of the ad hoc committee are to be presented to the
p.000010: 17 Committee on Human Subjects in Research no later than ninety (90)
p.000010: 18 days after receipt of grievance from the investigator, to determine the
p.000010: 19 final decision to approve or not to approve a research project.
p.000010: 20 Section 24109. Fines and Penalties. Upon determination of
p.000010: 21 the Review Board through the approved rules and regulations, any
...

p.000008: 14 economically or educationally disadvantaged persons;
p.000008: 15 (d) Informed consent will be sought from each prospective
p.000008: 16 subject or the subject's legally authorized representative, in
p.000008: 17 accordance with, and to the extent required by Board regulation.
p.000008: 18 (e) Informed consent will be appropriately documented, in
p.000008: 19 accordance with, and to the extent required by Board regulation.
p.000008: 20 (O When appropriate, the research plan makes adequate
p.000008: 21 provision for monitoring the data collected to ensure the safety of
p.000008: 22 subjects; and
p.000008: 23 (g) When appropriate, there are adequate provisions to protect
p.000008: 24 the privacy of subjects and to maintain the confidentiality of data.
p.000008: 25 When some or all of the subject are likely to be vulnerable to
p.000008: 26 coercion or undue influence, such as children, the elderly, prisoners,
p.000008: 27 pregnant women, mentally disabled persons or economically or
p.000008: 28 educationally disadvantaged persons, additional safeguards have
p.000008: 29 been included in the research plans, procedures or protocols to
p.000008: 30 protect the rights and welfare of these subjects.
p.000008: 31 §24108. Grievance Procedure. II application for approval is
p.000008: 32 denied for a research proposal, investigators may appeal to the
p.000008: 33 Dean of the Graduate School & Research. The Dean will appoint an
p.000008: 34 ad hoc committee for a second, independent review of the research
p.000008: 35 project. The findings of the ad hoc committee are presented to the
p.000008: 36 Research Review Committee no later than ninety (90) days after
p.000008: 37 receipt of grievance from investigator, to determine the final
p.000008: 38 decision to approve or not to approve a research project.
p.000008:
p.000008: 39 §24109. Fines and Penalties. Upon determination of
p.000008: 40 review board through the approved rules and regulations,
p.000008: the any
p.000008:
p.000009: 9
p.000009:
p.000009: investigator, research sponsor, or their agents, which conducts
p.000009: 2 research subject to regulation in violation of this chapter shall be
p.000009: 3 subject to a fine of One Thousand Dollars ($1,000.00) per each
p.000009: 4 violation and shall be prohibited from continuing and conducting
...

p.000005: reviewersmay not disapprove the research•
p.000005:
p.000005:
p.000005:
p.000005: a) To approve research covered by this policy the IRB shall determine that all of the following requirements are
p.000005: satisfied:
p.000005: 1 • Risks to subjects are minimized.
p.000005: 2. Risks to subjects are reasonable in relation to anticipated benefits. The IRB should not consider possible
p.000005: long-range effects of applying knowledge gained in The research (foe example, the peesible effecrt:s og
p.000005: I:he research on public policy) as among thoae research risks that fall within the purview of its responsibility.
p.000005: 3. Selection of subjects is equitable.
p.000005: 4. Informed consent will be sought from each prospsctive subject or the subject's legally authorized.
p.000005: 5. Informed consent will be appropriately documented.
p.000005: 6. When appropriate, the research plan makes adequate provision for monitoring the data collected to ensure the safety
p.000005: of subjects.
p.000005: 7. There are adequate provisions to protect the privacy of subjects and to maintain the confidentiality of data.
p.000005: b) When some or all of the subjects are likely to be vulnerable to coercion or undue influence, such as children,
p.000005: prisoners, pregnant women, mentally disabled persona, or econoaicallY or educationally disadvantaged persons,
p.000005: additional safeguards have been included in the study to protect tAe rights and welfare of tRese subjects.
p.000005:
p.000005:
p.000005: Research covered by this policy that has been approved by ah IRB may be subject to further appropriate review by
p.000005: officials of the institution.
p.000005:
p.000005: 8•C*1O» 113 6UfipaO81OO or ¢eza1:aa61on OC Zea &ppg'Ova1.
p.000005:
p.000005: An IRB shall have autAoritY to suspend or terminate approval of research that is not being conducted in accordance with
p.000005: the IRB's requirements or that has been associated witA unexpected serious harm to subjects.
p.000005:
p.000005: Bec21oo 114 coopaxa€1ve Raseacaa.
p.000005:
p.000005: Cooperative research projects are those projects covered by this policy which involve more than one institution. In
p.000005: the conduct of cooperative research projects, each institution is responsible for safeguarding the rights and welfare
p.000005: of husmn subjects and for complying with this policy.
p.000005:
p.000005: An institution participating in a cooperative project may enter into a joint review arrangement, rely upon the review
p.000005: of another qualified ZRB, or nake similar arrangement:a for avoi‹:ling duplication of
p.000005: effort.
p.000005: sactioo us zRe xecora•.
p.000005: An IRB, shall prepare and maintain adequate documentation of IRB activities, including the following:
p.000005: 1. Copies of all research proposals reviewed.
...

p.000010: off-island institution that does not have its own or other access to a Gtiam based irb. This is based on the idea
p.000010: that the legislative intent is to mandate that any research study involving human subjects has at least one
p.000010: on-island review. If that is the intent, then Guam has a ready mechanism in the form of the UOG CHRS to
p.000010: ensure that all of the following federal requirements are satisfied by any research covered by this law:
p.000010:
p.000010: 1. Risks to subjects are minimized.
p.000010: 2. Risks to subjects am reasonable in relation to anticipated benefits.
p.000010: 3. Selection of subjects is equitable.
p.000010: 4. Informed consent will be sought from each prospective subject or the subject's legally authorized .
p.000010: 5. Informed consent will be appropriately documented.
p.000010: 6. When appropriate, the research plan makes adequate provision for monitoring the data collected to ensure the
p.000010: safety of subjects.
p.000010: 7. Thème are adequate provisions to protect the privacy of subjects and to maintain the confidentiality of
p.000010:
p.000010: 8. When some or all of the subjects are likely to be vulnerable to coercion or undue inBuence, such as children,
p.000010: prisoners, pregnant women, mentally disabled persons, or economimlly or educationally disadvantaged persons, additional
p.000010: safeguards have been included in the study to pixitcct tlu rights and welfare of these subjects.
p.000010: I-However, as currently written, B’ 47 establishes an unnecessary additional‘
p.000010: Moreover, it includes a section 24102. Bonr- me; ppoin end Mntinnancp Renal. which is a confusing listing
p.000010: of membership, and does not fit the federal guidelines for irb stricture. For example, why only include the Director
p.000010: of DPHSS or his/her designee, and not the director of MHSA, DDPR, DOE, or the new agency for disabilities; and why is
p.000010: it so heavily weighted with people having no expertise in research or any academic science† What is the purpose of
p.000010: including an odd assemblage of persons — who may not have the skill and luiowledge for reviewing technical
p.000010: methodologies to ensure informed consent and procedures to handle any risks involved? Within the federal policy for
p.000010: irb’s it states:
p.000010:
p.000010: SOURCE’ Fedeml Rcgjstu June l8 199lJegu1atio«s •ffwtive xc is jeer j Section 107 IRB membership.
p.000010: a) Each IRB shall have at least five memberi with varying backgrounds to promote complete and adequate
p.000010: review of research activities commonly conducted by the institution. In addition to pouessing the
p.000010: professional competence necessary to review specific reseamh activities the IRB shall be able to ascertain
p.000010: the acceptability of proposed research in terms of institutional commitments and regulations, applicable
...

Searching for indicator disability:

(return to top)
p.000003:
p.000003: g. Basio gtbical Principles
p.000003: z. Respect for Persons• incorporates at least two ethical convictions; first, that individuals should be treatad
p.000003: as autonomous agents, and second, that persons with diminished autonomy are entitled to protection. The
p.000003: principle thus divides into two separate moral requirements: the requirement to acknowledge autonomy and the
p.000003: requirement to protect tAose witA diNinished 6UtOüOWy.
p.000003: An autonomous person is an individual capable of dellberation aboulz personal goals and oC act;£ng under
p.000003: tbe 41xec€1on oC atzch dellberacion • To respect autonomy is €o glva weight: go autonomous
p.000003: persons' considered opinions and choices. Fo show lack of respect
p.000003: for an autonomous agent is to repudiate that person's considered
p.000003:
p.000003: judgements considered
p.000003: eo deny an indlvidual the freedom eo act on those
p.000003: judgements, or to withholdinformation necessary to make
p.000003: a considered judgement.
p.000003: The capacity for self-determination matures during an individual's like, and some individuals lose this capacity
p.000003: wholly or in part because of illness, mental disability, or oircumstancea that severely restrict liberty. Respect for
p.000003: tAe immature and the incapacitated may require protecting them as they matura or while they are incapacitated.
p.000003: Respect Yor persons demands that subjects enter into the
p.000003: research voluntarily and with adequate information. In eome situations, however, application of the principle is
p.000003: not obvious. The involvement of prisoners, at one extreme, or of students in more normal circumstances, provide
p.000003: instructive examples. On the one
p.000003:
p.000003:
p.000003:
p.000003:
p.000003:
p.000003:
p.000003:
p.000003:
p.000003:
p.000003:
p.000003:
p.000003:
p.000003:
p.000003:
p.000003:
p.000003: 1•26 Accum ia Reports te Payars aad
p.000003:
p.000003:
p.000003: i=m 4i ‹r mice preri appii=nk, in «k=«iy
p.000003:
p.000003: L27 Referrals nod Fees
p.000003:
p.000003:
p.000003:
p.000003:
p.000003:
p.000003:
p.000003:
p.000003:
p.000003:
p.000003:
p.000003:
p.000003:
p.000003:
p.000003:
p.000003:
p.000003:
p.000003:
p.000003:
p.000003:
p.000003: 2•02 Competence sod Appropriate thee of
p.000003: 107 Obsolete 7mts aad Ouutet•d
p.000003:
p.000003:
p.000003:
p.000003:
p.000003:
p.000003:
p.000003:
p.000003:
p.000003:
p.000003:
p.000003:
p.000003:
p.000003:
p.000003:
p.000003:
p.000003:
p.000003: Smmnœm
p.000003:
p.000003:
p.000003:
p.000003:
p.000003:
p.000003:
p.000003:
p.000003:
p.000003:
p.000003:
p.000003:
p.000003:
p.000003:
p.000003:
p.000003:
p.000003:
p.000003:
p.000003:
p.000003:
p.000003: 3. Ai• ' aad Otbcr
p.000003: c tafezaœts
...

Health / Motherhood/Family

Searching for indicator family:

(return to top)
p.000010: of DPHSS or his/her designee, and not the director of MHSA, DDPR, DOE, or the new agency for disabilities; and why is
p.000010: it so heavily weighted with people having no expertise in research or any academic science† What is the purpose of
p.000010: including an odd assemblage of persons — who may not have the skill and luiowledge for reviewing technical
p.000010: methodologies to ensure informed consent and procedures to handle any risks involved? Within the federal policy for
p.000010: irb’s it states:
p.000010:
p.000010: SOURCE’ Fedeml Rcgjstu June l8 199lJegu1atio«s •ffwtive xc is jeer j Section 107 IRB membership.
p.000010: a) Each IRB shall have at least five memberi with varying backgrounds to promote complete and adequate
p.000010: review of research activities commonly conducted by the institution. In addition to pouessing the
p.000010: professional competence necessary to review specific reseamh activities the IRB shall be able to ascertain
p.000010: the acceptability of proposed research in terms of institutional commitments and regulations, applicable
p.000010: law, and standards of professional conduct and practice.
p.000010: b) Every nondiscriminatory effort will be made to ensure that no IRB consists entirely of men or
p.000010: entirely of women.
p.000010: c) Each IRB shall include at least one member whose primary concerns are in scientific areas and at least one member
p.000010: whose primary concerns are in nonscientific areas.
p.000010: d) Each IRB shall include at least one member who is not otherwise affiliated with the institution and who is not part
p.000010: of the immediate family of a person who is afliliated with the institution.
p.000010: e) No IRB may have a member participate in review of any project in which the member has a conflicting interest,
p.000010: except to provide information.
p.000010: f) An IRB may, in its discretion, invite individuals with competence in special areas to assist in the review
p.000010: of issues which require expertise beyond or in addition to that available on the IRB. These individuals may not vote
p.000010: with the IRB.
p.000010:
p.000010:
p.000010: I recommend tire following changes be made to Bill No. 347 In Section 1. Legislative Findings
p.000010: Replace the second sentence on lines 7-10 which reads: “It further finds thai the creation of a review board is the
p.000010: appropriate body to review proposals, plans, procedures and protocols for research involving human subjects and to
p.000010: approve or disapprove the same.”
p.000010: With: “It further finds that there are institutional review boards on Guam +rbirfi con[omi. to federal guidelines for
p.000010: such entities which are the appropriate bodies to review proposals, plans, procedures and protocols for research
p.000010: involving human subjects and to approve or disapprove the came."
p.000010:
p.000010: Insert into the second paragraph on lines 11-15 an additional condition confronting Guam, so it reads:
p.000010: “Further more, the legislature finds that on occassions human research conducted on Guam does not always acquire
p.000010: informed consent fiom persons participating in the programs, thai come research although hnving obtained off-island
p.000010: irb reverts fail to take into eonsoiñeration uni‹tue islnnd cultural rind socinf condifions that confound or negnte nn
...

Health / Physically Disabled

Searching for indicator illness:

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p.000010: bg/ Federal IRB
p.000010: egu
p.000010: amons. 7ts state+tes also foltow
p.000010: guideline pertaining
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p.000010: WO
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p.000010: z. We have speci6c infie.rest•
p.000010: patients we
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p.000010: We recommend that tHe e Eng 1RBs w Gh
p.000010: v boarp.000010:
p.000010: the advantages tHat you to see In Che new r
p.000010: ia m& posMbm Men me hop e you TH Wedd
p.000010: we heve raised.
p.000010: Thank you foe consulting n e and Ore Guard
p.000010: preser,r ciii t o clamp the co•@r '• co ana B•dig .Bssociazion in t1'sis
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p.000010: Distinguished Senadors,
p.000010: Buenas yan hsfa adai.
p.000010:
p.000010: My name is Gregoria Smith, ciirrcntly servint as the psychometrist for the UOO/ UCSD Research project on Litigo and
p.000010: Bodlg Research. I speak in favor of the intent of Bill 347. First, I wisli to commend the introducers of this
p.000010: bill as it is time to define what researcli is on Guam, However, I w'oiild like to suggest that a corresponding
p.000010: mechanism of iiT1 OSÍIig fines to violators be included . Whether the Attofney General’s officc should be the
p.000010: investigatiog agency and wliere the
p.000010: collecied fines should go are issues that may be includcd as aiucndiiients.
p.000010:
p.000010: As an associate professor at the University of Guam for 25 years, I have done social science reseai‘ch on the cultice
p.000010: of the peoples of the Western Pacific. These past few years, I have researched On the Meaning of Illness and
p.000010: Coming with ALS and Parkinsonisin Dementia, Sioce they involve human su ejects, all of thc researches treat I
p.000010: have done had to go through institutional review boards of New York Universi) , UOG, or of the Federal agencies for
p.000010: whom I performed the studies and who fended the studies.
p.000010:
p.000010: Going tir ougl review boards and obtain ing consent horn participants are pi'ocesses that are necessary in
p.000010: the practice of research, a practicc that has come ft out past histories of uHkiowing subjects being
p.000010: 9J *had I› haunted b› experiiiients, set jects who have appeared its filnls and )f1nted m‹di:‹ v ithout their
p.000010: consent I !ook at this bill as not
p.000010: '* °e "' i °' that » ould haiiipei any pi ospcctive rcscai cher but one
p.000010: int°n ticd Io p i’o t ec t t lie rigli ts of t most ii ho Jia rticip;i tc.
p.000010:
p.000010: 1 belleve thai a iiong these rights are tint 11ie researcher be triliiicd in
p.000010: Conductin’g a xoJ ei in estigation Of thai he/she be super vised by
p.000010:
p.000010:
p.000010: someone or agency ’who' ’is kno 1 dgeable on ethica c'onduct of researchers. Being a doctor, teacher or a
p.000010: social worker, for instance, does not always mean a pel son can conduct research. One may be a gon d, honest,
p.000010: knowledgeable doctor / teacher but a poor or inept researcher. Reseai ch, espccially scientific research, requires
p.000010: special training in many skills among which is imdcrstanding the language of statistics and a knowledge of the
p.000010: various steps one follows in
...

p.000003:
p.000003: g. Basio gtbical Principles
p.000003: z. Respect for Persons• incorporates at least two ethical convictions; first, that individuals should be treatad
p.000003: as autonomous agents, and second, that persons with diminished autonomy are entitled to protection. The
p.000003: principle thus divides into two separate moral requirements: the requirement to acknowledge autonomy and the
p.000003: requirement to protect tAose witA diNinished 6UtOüOWy.
p.000003: An autonomous person is an individual capable of dellberation aboulz personal goals and oC act;£ng under
p.000003: tbe 41xec€1on oC atzch dellberacion • To respect autonomy is €o glva weight: go autonomous
p.000003: persons' considered opinions and choices. Fo show lack of respect
p.000003: for an autonomous agent is to repudiate that person's considered
p.000003:
p.000003: judgements considered
p.000003: eo deny an indlvidual the freedom eo act on those
p.000003: judgements, or to withholdinformation necessary to make
p.000003: a considered judgement.
p.000003: The capacity for self-determination matures during an individual's like, and some individuals lose this capacity
p.000003: wholly or in part because of illness, mental disability, or oircumstancea that severely restrict liberty. Respect for
p.000003: tAe immature and the incapacitated may require protecting them as they matura or while they are incapacitated.
p.000003: Respect Yor persons demands that subjects enter into the
p.000003: research voluntarily and with adequate information. In eome situations, however, application of the principle is
p.000003: not obvious. The involvement of prisoners, at one extreme, or of students in more normal circumstances, provide
p.000003: instructive examples. On the one
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p.000003: 1•26 Accum ia Reports te Payars aad
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p.000003: i=m 4i ‹r mice preri appii=nk, in «k=«iy
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p.000003: L27 Referrals nod Fees
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p.000003: 2•02 Competence sod Appropriate thee of
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...

Health / Pregnant

Searching for indicator pregnant:

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p.000006: 21 subject’s rights, and whom to contact in the event of a
p.000006: 22 research-related injury to the subject; and
p.000006: 23 (8) a statement that participation is
p.000006: voluntary,
p.000006: 24 refusal to participate will involve no penalty or loss of
p.000006: '5 benefits to which the subject is otherwise entitled, and the
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p.000023: 23
p.000024: 24
p.000024: -'5
p.000024: subject may discontinue participation at any time without penalty OF lOsS of benefits to which the
p.000024: subject is otherwise entitled.
p.000024: (b) Additional Elements of Informed Consent.
p.000024: When appropriate, the Board may require that one (1) or more of the following elements of
p.000024: information shall also be provided to each subject:
p.000024: (1) a statement that the particular treatment or procedure may involve risks to the subject, or
p.000024: to the embryo or fetus, if the subject is or may become pregnant, which are currently urrforeseeable;
p.000024: (2) anticipated circumstances under which the subject's participation may be terminated by an
p.000024: investigator without regard to the subject’s consent;
p.000024: (3) any additional cost to the subject that may result from participation in the research;
p.000024: (4) the consequences of a subject's decision to withdraw from the research and
p.000024: procedures for orderly termination of participation by the subject;
p.000024: (5) a statement that significant new findings developed during the course of the
p.000024: research which may relate to the subject's willingness to continue participation will be provided to the
p.000024: subject; and
p.000024: (6) the approximate number of subjects involved in
p.000024: the study.
p.000024:
p.000008: 8
p.000008:
p.000008:
p.000008: i (c) The Board may approve a consent procedure which
p.000008: 2 does not include, or which alters, some or all of the elements of
p.000008: 3 irdormed consent set forth above, or waive the requirements to
p.000008: 4 obtain informed consent; provided, that the Board finds and
p.000008: 5 documents that:
p.000008: 6 (1) the research or demonstration project is to be
p.000008: 7 conducted by, or subject to, the approval of Federal, state,
...

p.000009: 24 knowledge that may reasonably be expected to result. In
p.000009: 25 evaluating risks and beneflts, the Board should consider only
p.000009:
p.000010: 10
p.000010:
p.000010:
p.000010: those risks and benefits that may result from the research, as
p.000010: 2 distinguished from risks and benefits of therapies subject would
p.000010: 3 receive even if not participating in the research. The Board should
p.000010: 4 not consider possible long range effects of applying knowledge
p.000010: 5 gained in the research (for example, the possible effects of the
p.000010: 6 research on public policy) as among those research risks that fall
p.000010: 7 within the purview of lts responsibility.
p.000010: 8 (c) Selection of the subjects is equitable. In making this
p.000010: 9 assessment the Board should take into account the purposes of the
p.000010: 10 research and the setting in which the research would be
p.000010: 11 conducted and should be particularly cognizant of the special
p.000010: 12 problems that research involving vulnerable populations, such as
p.000010: 13 children, prisoners, pregnant woman, persons with dlsabilities,
p.000010: 14 the elderly, or economically or educationally disadvantaged
p.000010: 15 persons.
p.000010: 16 (d) Informed consent will be sought from each
p.000010: 17 prospective subject or the subject’s legally authorized
p.000010: 18 representative, in accordance with, and to the extent required by
p.000010: 19 Board regulation.
p.000010: 20 (e) lrdormed consent will be appropriately documented,
p.000010: 21 in accordance with, and to the extent required by Board
p.000010: 22 regulation.
p.000010: 23 ( When appropriate, the research plan makes adequate
p.000010: 24 provision for monitoring the data collected to ensure the safety of
p.000010: 25 subjects.
p.000010:
p.000010:
p.000010: 1 (g) When appropriate, there are adequate provisions to
p.000010: 2 protect the privacy of subjects and to maintain the confidentiality
p.000010: 3 of data.
p.000010: 4 When some or all of the subjects are likely to be vulnerable
p.000010: 5 to coercion or undue influence, such as children, the elderly,
p.000010: 6 prisoners, pregnant women, mentally disabled persons or
p.000010: 7 economically or educatiOnally disadvantaged persons, additional
p.000010: 8 safeguards have been included in the research plans, procedures
p.000010: 9 or protocols to protect the rights and welfare of these subjects.
p.000010: 10 (h) Progress reports or thesis shall be made available to
p.000010: 11 subjects participating in the research as appropriate.
p.000010: 12 Section 24108. Grievance Procedure. lf application for
p.000010: 13 approval is denied for a research proposal, investigators may appeal to
p.000010: 14 the Dean of the Graduate School and Research. The Dean will appoint
p.000010: 15 an ad hoc committee for a second, independent review of the research
p.000010: 16 project. The findings of the ad hoc committee are to be presented to the
p.000010: 17 Committee on Human Subjects in Research no later than ninety (90)
p.000010: 18 days after receipt of grievance from the investigator, to determine the
p.000010: 19 final decision to approve or not to approve a research project.
p.000010: 20 Section 24109. Fines and Penalties. Upon determination of
...

p.000005: 40 whether further information my be obtained;
p.000005:
p.000005: t (7) An explanation of whom to contact for answers to
p.000005: 2 pertinent questions about the research and research
p.000005: 3 subject's rights, and whom to contact in the event of a
p.000005: 4 research-related injury to the subject; and
p.000005: 5 (8) A statement that participation is voluntary, refusal to
p.000005: 6 participate will involve no penalty or loss of benefits to
p.000005: 7 which the subject is otherwise entitled and the subject
p.000005: 8 may discontinue participation at any time without
p.000005: 9 penalty or loss of benefits to which the subject is
p.000005: to otherwise entitled.
p.000005: i1 (b) Additional Elements of Informed Consent. When
p.000005: 12 appropriate, the Board may require that one (1) or more of the
p.000005: 13 following elements of information shall also be provided to each
p.000005: 14 subject;
p.000005: 15 (1) A statement that the particular treatment or procedure
p.000005: 16 may involve risks to the subject (or to the embryo or
p.000005: 17 fetus, if the subject is or may become pregnant) which
p.000005: 18 are currently unforeseeable;
p.000005: 19 (2) Anticipated circumstances under which the subject's
p.000005: 20 participation may be terminated by an investigator
p.000005: 21 without regard to the subject's consent;
p.000005: 22 (3) Any additional cost to the subject that may result from
p.000005: 23 participation in the research;
p.000005: 24 (4) The consequences of a subject's decision to withdraw
p.000005: 25 from the research and procedures for orderly
p.000005: 26 termination of participation by the subject;
p.000005: 27 (5) A statement that significant new findings developed
p.000005: 28 during the course of the research which may relate to
p.000005: 29 the subject's willingness to continue participation will
p.000005: 30 be provided to the subject; and
p.000005: 31 (6) The approximate number of subjects involved in the
p.000005: 32 study.
p.000005: 33 (c) The Board may approve a consent procedure which does not
p.000005: 34 include, or which alters, some or all of the elements of informed
p.000005: 35 consent set forth above, or waive the requirements to obtain
...

p.000007: 36 by using procedures already being performed on the subjects for
p.000007: 37 diagnostic or treatment purposes;
p.000007: 38 (b) Risks to subject are reasonable in relation to anticipated
p.000007: 39 benefits, if any, to subjects and the importance of the knowledge that
p.000007: 40 may reasonably be expected to result. In evaluating risks and
p.000007:
p.000008: 8
p.000008:
p.000008: benefits, the Board should consider only those risks and benefits that
p.000008: 2 may result from the research (as distinguished from risks and
p.000008: 3 benefits of therapies subject would receive even if not participating
p.000008: 4 in the research). The Board should not consider possible long range
p.000008: 5 effects of applying knowledge gained in the research (for example,
p.000008: 6 the possible effects of the research on public poñcy) as among those
p.000008: 7 research risks that fall within the purview of its responsibility;
p.000008: 8 (c) Selection of the subjects is equitable. In making this
p.000008: 9 assessment the Board should take into account the purposes of the
p.000008: 10 research and the setting in which the research would be conducted
p.000008: 11 and should be particularly cognizant of the special problems that research involving vulnerable
p.000008: populations such as children,
p.000008: 13 prisoners, pregnant woman, persons with disabilities, the elderly, or
p.000008: 14 economically or educationally disadvantaged persons;
p.000008: 15 (d) Informed consent will be sought from each prospective
p.000008: 16 subject or the subject's legally authorized representative, in
p.000008: 17 accordance with, and to the extent required by Board regulation.
p.000008: 18 (e) Informed consent will be appropriately documented, in
p.000008: 19 accordance with, and to the extent required by Board regulation.
p.000008: 20 (O When appropriate, the research plan makes adequate
p.000008: 21 provision for monitoring the data collected to ensure the safety of
p.000008: 22 subjects; and
p.000008: 23 (g) When appropriate, there are adequate provisions to protect
p.000008: 24 the privacy of subjects and to maintain the confidentiality of data.
p.000008: 25 When some or all of the subject are likely to be vulnerable to
p.000008: 26 coercion or undue influence, such as children, the elderly, prisoners,
p.000008: 27 pregnant women, mentally disabled persons or economically or
p.000008: 28 educationally disadvantaged persons, additional safeguards have
p.000008: 29 been included in the research plans, procedures or protocols to
p.000008: 30 protect the rights and welfare of these subjects.
p.000008: 31 §24108. Grievance Procedure. II application for approval is
p.000008: 32 denied for a research proposal, investigators may appeal to the
p.000008: 33 Dean of the Graduate School & Research. The Dean will appoint an
p.000008: 34 ad hoc committee for a second, independent review of the research
p.000008: 35 project. The findings of the ad hoc committee are presented to the
p.000008: 36 Research Review Committee no later than ninety (90) days after
p.000008: 37 receipt of grievance from investigator, to determine the final
p.000008: 38 decision to approve or not to approve a research project.
p.000008:
p.000008: 39 §24109. Fines and Penalties. Upon determination of
p.000008: 40 review board through the approved rules and regulations,
p.000008: the any
p.000008:
p.000009: 9
p.000009:
p.000009: investigator, research sponsor, or their agents, which conducts
p.000009: 2 research subject to regulation in violation of this chapter shall be
p.000009: 3 subject to a fine of One Thousand Dollars ($1,000.00) per each
...

p.000005: reviewers designated by the chairperson. Reviewers may exercise all of the authorities of the IRB except that the
p.000005: reviewersmay not disapprove the research•
p.000005:
p.000005:
p.000005:
p.000005: a) To approve research covered by this policy the IRB shall determine that all of the following requirements are
p.000005: satisfied:
p.000005: 1 • Risks to subjects are minimized.
p.000005: 2. Risks to subjects are reasonable in relation to anticipated benefits. The IRB should not consider possible
p.000005: long-range effects of applying knowledge gained in The research (foe example, the peesible effecrt:s og
p.000005: I:he research on public policy) as among thoae research risks that fall within the purview of its responsibility.
p.000005: 3. Selection of subjects is equitable.
p.000005: 4. Informed consent will be sought from each prospsctive subject or the subject's legally authorized.
p.000005: 5. Informed consent will be appropriately documented.
p.000005: 6. When appropriate, the research plan makes adequate provision for monitoring the data collected to ensure the safety
p.000005: of subjects.
p.000005: 7. There are adequate provisions to protect the privacy of subjects and to maintain the confidentiality of data.
p.000005: b) When some or all of the subjects are likely to be vulnerable to coercion or undue influence, such as children,
p.000005: prisoners, pregnant women, mentally disabled persona, or econoaicallY or educationally disadvantaged persons,
p.000005: additional safeguards have been included in the study to protect tAe rights and welfare of tRese subjects.
p.000005:
p.000005:
p.000005: Research covered by this policy that has been approved by ah IRB may be subject to further appropriate review by
p.000005: officials of the institution.
p.000005:
p.000005: 8•C*1O» 113 6UfipaO81OO or ¢eza1:aa61on OC Zea &ppg'Ova1.
p.000005:
p.000005: An IRB shall have autAoritY to suspend or terminate approval of research that is not being conducted in accordance with
p.000005: the IRB's requirements or that has been associated witA unexpected serious harm to subjects.
p.000005:
p.000005: Bec21oo 114 coopaxa€1ve Raseacaa.
p.000005:
p.000005: Cooperative research projects are those projects covered by this policy which involve more than one institution. In
p.000005: the conduct of cooperative research projects, each institution is responsible for safeguarding the rights and welfare
p.000005: of husmn subjects and for complying with this policy.
p.000005:
p.000005: An institution participating in a cooperative project may enter into a joint review arrangement, rely upon the review
p.000005: of another qualified ZRB, or nake similar arrangement:a for avoi‹:ling duplication of
p.000005: effort.
p.000005: sactioo us zRe xecora•.
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p.000010: The UOG CHRS is experienced and can provide an on-island irb review service to any agency, private entity, or
p.000010: off-island institution that does not have its own or other access to a Gtiam based irb. This is based on the idea
p.000010: that the legislative intent is to mandate that any research study involving human subjects has at least one
p.000010: on-island review. If that is the intent, then Guam has a ready mechanism in the form of the UOG CHRS to
p.000010: ensure that all of the following federal requirements are satisfied by any research covered by this law:
p.000010:
p.000010: 1. Risks to subjects are minimized.
p.000010: 2. Risks to subjects am reasonable in relation to anticipated benefits.
p.000010: 3. Selection of subjects is equitable.
p.000010: 4. Informed consent will be sought from each prospective subject or the subject's legally authorized .
p.000010: 5. Informed consent will be appropriately documented.
p.000010: 6. When appropriate, the research plan makes adequate provision for monitoring the data collected to ensure the
p.000010: safety of subjects.
p.000010: 7. Thème are adequate provisions to protect the privacy of subjects and to maintain the confidentiality of
p.000010:
p.000010: 8. When some or all of the subjects are likely to be vulnerable to coercion or undue inBuence, such as children,
p.000010: prisoners, pregnant women, mentally disabled persons, or economimlly or educationally disadvantaged persons, additional
p.000010: safeguards have been included in the study to pixitcct tlu rights and welfare of these subjects.
p.000010: I-However, as currently written, B’ 47 establishes an unnecessary additional‘
p.000010: Moreover, it includes a section 24102. Bonr- me; ppoin end Mntinnancp Renal. which is a confusing listing
p.000010: of membership, and does not fit the federal guidelines for irb stricture. For example, why only include the Director
p.000010: of DPHSS or his/her designee, and not the director of MHSA, DDPR, DOE, or the new agency for disabilities; and why is
p.000010: it so heavily weighted with people having no expertise in research or any academic science† What is the purpose of
p.000010: including an odd assemblage of persons — who may not have the skill and luiowledge for reviewing technical
p.000010: methodologies to ensure informed consent and procedures to handle any risks involved? Within the federal policy for
p.000010: irb’s it states:
p.000010:
p.000010: SOURCE’ Fedeml Rcgjstu June l8 199lJegu1atio«s •ffwtive xc is jeer j Section 107 IRB membership.
p.000010: a) Each IRB shall have at least five memberi with varying backgrounds to promote complete and adequate
p.000010: review of research activities commonly conducted by the institution. In addition to pouessing the
p.000010: professional competence necessary to review specific reseamh activities the IRB shall be able to ascertain
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Health / sexually transmitted disases

Searching for indicator std:

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p.000010: 6.t7 Hinlmlzi9g
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p.000010: O LOGI CIATIOȘ
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p.000010: ICA1 ğ,//NCIPLES OF ËS CHO1OG/STş
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p.000010: - } I4o§pitd Administrator
p.000010: - &e Prmfdo t ofMcdicat 5Bg
p.000010: ° Department of Surgery of Medicine
p.000010:
p.000010:
p.000010: : ! «siiy'o for Human Sub ‹a a Rc«a ch (SSR) tcpres••t•a u AND has standing
p.000010: pttlicics ltiat empower the IRB to requmt and ébtain relevant inputs from
p.000010:
p.000010: Existing Review Boards do not need to be Duplicated
p.000010: BiJl ¥347 prepmm the licafion elite misting ah pioccssu and proccdums #ial we conducted by t}n
p.000010: UO'£i Committee for Human Subject in Receamli (CHsg) and M Guem Memeñel jjQpit4l IfMtitotioff4l Review Board(IRB) fer
p.000010: RescamK THE PEOPLE OF GUAM ARE SWERBLT PRO1ECTbD BT THE BXiSTINO REVIEW BOARDS when arch0 proesued tbrougit
p.000010: &cni.
p.000010: m ei rd Board. GUAM FiEEDS TO HAVE THS UOtS
p.000010: E FOR H IN RESEARCH (CHSR) DESIGNATED BY TH6 GUAM
p.000010: LEGISLATURE AS THE REVIEW BODY POR nLL RESEARCH RELATED TO HU$4AN SUBJEC
p.000010: nuraces r;mcz or cm. ,tin uoc rai‹i« in r«›«i»ma«trms t»ma
p.000010:
p.000010:
p.000010: Todoto,
p.000010:
p.000010:
p.000010:
p.000010: . I STD * URG8 YOLI AND YOUR COI fdITTEE ON EDUCATfOX TC RS- CONMDBIT TIIBp ARGUMENTS RSGABOING B!LL #34?.
p.000010: URG6 TI4B COMMI B TO Mt)VB THAT BILk C347 \JND5RGO SERIOUS REVJfiION SO THAT JT WILL EI POWER MD EU 7POR7 THE
p.000010: UOG COMMTTTg£ FOCI HUMAN 3U0JECT IN RESSAItCI4
p.000010: (cusp›'• ›h ‹»•=a•t /›g voc gait•ie u«t »« M due cvAu zzssAecn ›‹Evisw aoARo FOR IfUMAN SUB48 CTS.
p.000010: Dankoto Na Si Yu’os \4a’ese for tire opportupity to voice en opinion repealing whx Bill ¥347 should be
p.000010:
p.000010: —1998 (fi: 49HN FRON ABS
p.000010: P. 81
p.000010:
p.000010: NI RSITY OF GuAM
p.000010: NI ETSEDAT GLAHAN
p.000010: P6YCHOLOGY PROGRAM
p.000010: ŒVT9ION OF 8OCIAL/BENAVFORAL 9ŒENCEB SOCtAL YORK
p.000010: eyda 7Qck Smith, Ph. D.
p.000010: C )O i3t&tort, zhao, 9 28
p.000010: Tei«t›t›e»e. (671) 7eS-ze»i F•«: {871) 7e4-5zs«
p.000010: e-hill Ttsmilhfluog9 edu
p.000010:
p.000010:
p.000010: Sejjator Lawfenee F. Kasperbauer
p.000010:
p.000010: Twenty-fourth Gtiam Legiolatgre Committee on Education
p.000010: Reference : Bill #34s Relaäve to Creafing a Guani Research Review Board
p.000010: As a researcfiez ans an eduœtox teachîng zeseacch stethodotogy and mtpefv’‘iaing undergraduate research at
p.000010: the University of Guari, I finally oppooe tp the mtablislurient of a new "Guam heseamh Review Board"
p.000010: that will oversea all research conducted on Guam This will make undergraduate march impossible to
p.000010: cenduct and will deprive UOG stpdents of valuabl!e.reseamh experience. I would like to state some of œy
p.000010:
p.000010: 1. And rmearch thatis cnndncted at the UOG is being feviewed - and will
p.000010:
...

Searching for indicator access:

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p.000010: cmpciative project may enter into a joint review arrangement, fuly upon the review of another qualified IRB, or make
p.000010: similar arrangeinmts for avoiding duplication of effort.
p.000010:
p.000010: Unfortunately, this is not required for the island territory of Guam, rather it only becomes mandated between
p.000010: institutions. Thus it is possible for federally funded research projects from off-island institutions, to go through
p.000010: or affiliate with a Guam instituüon not covered b its own irb and OG or GMH (e g., a private
p.000010: medical clinic, Naval Hospital, or DPHSS, MHSA, DPR, etc.) AND THEY CAN CHOOSE NOT TO HAVE A GUAM BASED IRB
p.000010:
p.000010: Yet, the UOG CHRS, a Guam based irb, is very capable of handling these few occassional cases which may arise in any
p.000010: given year, and has the developed organizational mechanisms to efficiently and effectively process such cases. The UOG
p.000010: CHRS can fully achieve the intent of Bill 347, minimize and avoid any delay or obstruction that could adversely affect
p.000010: such research projects, and do this in a cost effective manner because it would fit within their normal processing of
p.000010: on-island research studies. The UOG CHRS handles about 25-30 studies each year, most of these being Expedited/low risk
p.000010: studies by graduate and undergraduate students, with 3-4 major studies involving UOG faculty affiliated with local
p.000010: agencies (e.g., DPHSS, MHSA, etc.).
p.000010: The UOG CHRS is experienced and can provide an on-island irb review service to any agency, private entity, or
p.000010: off-island institution that does not have its own or other access to a Gtiam based irb. This is based on the idea
p.000010: that the legislative intent is to mandate that any research study involving human subjects has at least one
p.000010: on-island review. If that is the intent, then Guam has a ready mechanism in the form of the UOG CHRS to
p.000010: ensure that all of the following federal requirements are satisfied by any research covered by this law:
p.000010:
p.000010: 1. Risks to subjects are minimized.
p.000010: 2. Risks to subjects am reasonable in relation to anticipated benefits.
p.000010: 3. Selection of subjects is equitable.
p.000010: 4. Informed consent will be sought from each prospective subject or the subject's legally authorized .
p.000010: 5. Informed consent will be appropriately documented.
p.000010: 6. When appropriate, the research plan makes adequate provision for monitoring the data collected to ensure the
p.000010: safety of subjects.
p.000010: 7. Thème are adequate provisions to protect the privacy of subjects and to maintain the confidentiality of
p.000010:
p.000010: 8. When some or all of the subjects are likely to be vulnerable to coercion or undue inBuence, such as children,
...

Searching for indicator children:

Searching for indicator elderly:

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p.000009: 25 evaluating risks and beneflts, the Board should consider only
p.000009:
p.000010: 10
p.000010:
p.000010:
p.000010: those risks and benefits that may result from the research, as
p.000010: 2 distinguished from risks and benefits of therapies subject would
p.000010: 3 receive even if not participating in the research. The Board should
p.000010: 4 not consider possible long range effects of applying knowledge
p.000010: 5 gained in the research (for example, the possible effects of the
p.000010: 6 research on public policy) as among those research risks that fall
p.000010: 7 within the purview of lts responsibility.
p.000010: 8 (c) Selection of the subjects is equitable. In making this
p.000010: 9 assessment the Board should take into account the purposes of the
p.000010: 10 research and the setting in which the research would be
p.000010: 11 conducted and should be particularly cognizant of the special
p.000010: 12 problems that research involving vulnerable populations, such as
p.000010: 13 children, prisoners, pregnant woman, persons with dlsabilities,
p.000010: 14 the elderly, or economically or educationally disadvantaged
p.000010: 15 persons.
p.000010: 16 (d) Informed consent will be sought from each
p.000010: 17 prospective subject or the subject’s legally authorized
p.000010: 18 representative, in accordance with, and to the extent required by
p.000010: 19 Board regulation.
p.000010: 20 (e) lrdormed consent will be appropriately documented,
p.000010: 21 in accordance with, and to the extent required by Board
p.000010: 22 regulation.
p.000010: 23 ( When appropriate, the research plan makes adequate
p.000010: 24 provision for monitoring the data collected to ensure the safety of
p.000010: 25 subjects.
p.000010:
p.000010:
p.000010: 1 (g) When appropriate, there are adequate provisions to
p.000010: 2 protect the privacy of subjects and to maintain the confidentiality
p.000010: 3 of data.
p.000010: 4 When some or all of the subjects are likely to be vulnerable
p.000010: 5 to coercion or undue influence, such as children, the elderly,
p.000010: 6 prisoners, pregnant women, mentally disabled persons or
p.000010: 7 economically or educatiOnally disadvantaged persons, additional
p.000010: 8 safeguards have been included in the research plans, procedures
p.000010: 9 or protocols to protect the rights and welfare of these subjects.
p.000010: 10 (h) Progress reports or thesis shall be made available to
p.000010: 11 subjects participating in the research as appropriate.
p.000010: 12 Section 24108. Grievance Procedure. lf application for
p.000010: 13 approval is denied for a research proposal, investigators may appeal to
p.000010: 14 the Dean of the Graduate School and Research. The Dean will appoint
p.000010: 15 an ad hoc committee for a second, independent review of the research
p.000010: 16 project. The findings of the ad hoc committee are to be presented to the
p.000010: 17 Committee on Human Subjects in Research no later than ninety (90)
p.000010: 18 days after receipt of grievance from the investigator, to determine the
p.000010: 19 final decision to approve or not to approve a research project.
...

p.000007: 37 diagnostic or treatment purposes;
p.000007: 38 (b) Risks to subject are reasonable in relation to anticipated
p.000007: 39 benefits, if any, to subjects and the importance of the knowledge that
p.000007: 40 may reasonably be expected to result. In evaluating risks and
p.000007:
p.000008: 8
p.000008:
p.000008: benefits, the Board should consider only those risks and benefits that
p.000008: 2 may result from the research (as distinguished from risks and
p.000008: 3 benefits of therapies subject would receive even if not participating
p.000008: 4 in the research). The Board should not consider possible long range
p.000008: 5 effects of applying knowledge gained in the research (for example,
p.000008: 6 the possible effects of the research on public poñcy) as among those
p.000008: 7 research risks that fall within the purview of its responsibility;
p.000008: 8 (c) Selection of the subjects is equitable. In making this
p.000008: 9 assessment the Board should take into account the purposes of the
p.000008: 10 research and the setting in which the research would be conducted
p.000008: 11 and should be particularly cognizant of the special problems that research involving vulnerable
p.000008: populations such as children,
p.000008: 13 prisoners, pregnant woman, persons with disabilities, the elderly, or
p.000008: 14 economically or educationally disadvantaged persons;
p.000008: 15 (d) Informed consent will be sought from each prospective
p.000008: 16 subject or the subject's legally authorized representative, in
p.000008: 17 accordance with, and to the extent required by Board regulation.
p.000008: 18 (e) Informed consent will be appropriately documented, in
p.000008: 19 accordance with, and to the extent required by Board regulation.
p.000008: 20 (O When appropriate, the research plan makes adequate
p.000008: 21 provision for monitoring the data collected to ensure the safety of
p.000008: 22 subjects; and
p.000008: 23 (g) When appropriate, there are adequate provisions to protect
p.000008: 24 the privacy of subjects and to maintain the confidentiality of data.
p.000008: 25 When some or all of the subject are likely to be vulnerable to
p.000008: 26 coercion or undue influence, such as children, the elderly, prisoners,
p.000008: 27 pregnant women, mentally disabled persons or economically or
p.000008: 28 educationally disadvantaged persons, additional safeguards have
p.000008: 29 been included in the research plans, procedures or protocols to
p.000008: 30 protect the rights and welfare of these subjects.
p.000008: 31 §24108. Grievance Procedure. II application for approval is
p.000008: 32 denied for a research proposal, investigators may appeal to the
p.000008: 33 Dean of the Graduate School & Research. The Dean will appoint an
p.000008: 34 ad hoc committee for a second, independent review of the research
p.000008: 35 project. The findings of the ad hoc committee are presented to the
p.000008: 36 Research Review Committee no later than ninety (90) days after
p.000008: 37 receipt of grievance from investigator, to determine the final
p.000008: 38 decision to approve or not to approve a research project.
p.000008:
p.000008: 39 §24109. Fines and Penalties. Upon determination of
p.000008: 40 review board through the approved rules and regulations,
p.000008: the any
p.000008:
p.000009: 9
p.000009:
p.000009: investigator, research sponsor, or their agents, which conducts
p.000009: 2 research subject to regulation in violation of this chapter shall be
...

Searching for indicator fetus:

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p.000006: 20 to pertinent questions about the research and research
p.000006: 21 subject’s rights, and whom to contact in the event of a
p.000006: 22 research-related injury to the subject; and
p.000006: 23 (8) a statement that participation is
p.000006: voluntary,
p.000006: 24 refusal to participate will involve no penalty or loss of
p.000006: '5 benefits to which the subject is otherwise entitled, and the
p.000006:
p.000007: 7
p.000007:
p.000007:
p.000007:
p.000001: 1
p.000002: 2
p.000003: 3
p.000004: 4
p.000005: 5
p.000006: 6
p.000007: 7
p.000008: 8
p.000009: 9
p.000010: 10
p.000011: 11
p.000012: 12
p.000013: 13
p.000014: 14
p.000015: 15
p.000016: 16
p.000017: 17
p.000018: 18
p.000019: 19
p.000020: 20
p.000021: 21
p.000022: 22
p.000023: 23
p.000024: 24
p.000024: -'5
p.000024: subject may discontinue participation at any time without penalty OF lOsS of benefits to which the
p.000024: subject is otherwise entitled.
p.000024: (b) Additional Elements of Informed Consent.
p.000024: When appropriate, the Board may require that one (1) or more of the following elements of
p.000024: information shall also be provided to each subject:
p.000024: (1) a statement that the particular treatment or procedure may involve risks to the subject, or
p.000024: to the embryo or fetus, if the subject is or may become pregnant, which are currently urrforeseeable;
p.000024: (2) anticipated circumstances under which the subject's participation may be terminated by an
p.000024: investigator without regard to the subject’s consent;
p.000024: (3) any additional cost to the subject that may result from participation in the research;
p.000024: (4) the consequences of a subject's decision to withdraw from the research and
p.000024: procedures for orderly termination of participation by the subject;
p.000024: (5) a statement that significant new findings developed during the course of the
p.000024: research which may relate to the subject's willingness to continue participation will be provided to the
p.000024: subject; and
p.000024: (6) the approximate number of subjects involved in
p.000024: the study.
p.000024:
p.000008: 8
p.000008:
p.000008:
p.000008: i (c) The Board may approve a consent procedure which
p.000008: 2 does not include, or which alters, some or all of the elements of
p.000008: 3 irdormed consent set forth above, or waive the requirements to
p.000008: 4 obtain informed consent; provided, that the Board finds and
p.000008: 5 documents that:
p.000008: 6 (1) the research or demonstration project is to be
...

p.000005: 39 available if injury occurs and, if so, what it consist of or
p.000005: 40 whether further information my be obtained;
p.000005:
p.000005: t (7) An explanation of whom to contact for answers to
p.000005: 2 pertinent questions about the research and research
p.000005: 3 subject's rights, and whom to contact in the event of a
p.000005: 4 research-related injury to the subject; and
p.000005: 5 (8) A statement that participation is voluntary, refusal to
p.000005: 6 participate will involve no penalty or loss of benefits to
p.000005: 7 which the subject is otherwise entitled and the subject
p.000005: 8 may discontinue participation at any time without
p.000005: 9 penalty or loss of benefits to which the subject is
p.000005: to otherwise entitled.
p.000005: i1 (b) Additional Elements of Informed Consent. When
p.000005: 12 appropriate, the Board may require that one (1) or more of the
p.000005: 13 following elements of information shall also be provided to each
p.000005: 14 subject;
p.000005: 15 (1) A statement that the particular treatment or procedure
p.000005: 16 may involve risks to the subject (or to the embryo or
p.000005: 17 fetus, if the subject is or may become pregnant) which
p.000005: 18 are currently unforeseeable;
p.000005: 19 (2) Anticipated circumstances under which the subject's
p.000005: 20 participation may be terminated by an investigator
p.000005: 21 without regard to the subject's consent;
p.000005: 22 (3) Any additional cost to the subject that may result from
p.000005: 23 participation in the research;
p.000005: 24 (4) The consequences of a subject's decision to withdraw
p.000005: 25 from the research and procedures for orderly
p.000005: 26 termination of participation by the subject;
p.000005: 27 (5) A statement that significant new findings developed
p.000005: 28 during the course of the research which may relate to
p.000005: 29 the subject's willingness to continue participation will
p.000005: 30 be provided to the subject; and
p.000005: 31 (6) The approximate number of subjects involved in the
p.000005: 32 study.
p.000005: 33 (c) The Board may approve a consent procedure which does not
p.000005: 34 include, or which alters, some or all of the elements of informed
...

Searching for indicator liberty:

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p.000003: as autonomous agents, and second, that persons with diminished autonomy are entitled to protection. The
p.000003: principle thus divides into two separate moral requirements: the requirement to acknowledge autonomy and the
p.000003: requirement to protect tAose witA diNinished 6UtOüOWy.
p.000003: An autonomous person is an individual capable of dellberation aboulz personal goals and oC act;£ng under
p.000003: tbe 41xec€1on oC atzch dellberacion • To respect autonomy is €o glva weight: go autonomous
p.000003: persons' considered opinions and choices. Fo show lack of respect
p.000003: for an autonomous agent is to repudiate that person's considered
p.000003:
p.000003: judgements considered
p.000003: eo deny an indlvidual the freedom eo act on those
p.000003: judgements, or to withholdinformation necessary to make
p.000003: a considered judgement.
p.000003: The capacity for self-determination matures during an individual's like, and some individuals lose this capacity
p.000003: wholly or in part because of illness, mental disability, or oircumstancea that severely restrict liberty. Respect for
p.000003: tAe immature and the incapacitated may require protecting them as they matura or while they are incapacitated.
p.000003: Respect Yor persons demands that subjects enter into the
p.000003: research voluntarily and with adequate information. In eome situations, however, application of the principle is
p.000003: not obvious. The involvement of prisoners, at one extreme, or of students in more normal circumstances, provide
p.000003: instructive examples. On the one
p.000003:
p.000003:
p.000003:
p.000003:
p.000003:
p.000003:
p.000003:
p.000003:
p.000003:
p.000003:
p.000003:
p.000003:
p.000003:
p.000003:
p.000003:
p.000003: 1•26 Accum ia Reports te Payars aad
p.000003:
p.000003:
p.000003: i=m 4i ‹r mice preri appii=nk, in «k=«iy
p.000003:
p.000003: L27 Referrals nod Fees
p.000003:
p.000003:
p.000003:
p.000003:
p.000003:
p.000003:
p.000003:
p.000003:
p.000003:
p.000003:
p.000003:
p.000003:
p.000003:
p.000003:
p.000003:
p.000003:
p.000003:
p.000003:
p.000003:
p.000003: 2•02 Competence sod Appropriate thee of
p.000003: 107 Obsolete 7mts aad Ouutet•d
p.000003:
p.000003:
p.000003:
p.000003:
p.000003:
p.000003:
p.000003:
p.000003:
p.000003:
p.000003:
p.000003:
p.000003:
p.000003:
p.000003:
p.000003:
p.000003:
p.000003: Smmnœm
p.000003:
p.000003:
p.000003:
p.000003:
p.000003:
p.000003:
p.000003:
p.000003:
p.000003:
p.000003:
p.000003:
p.000003:
p.000003:
p.000003:
p.000003:
p.000003:
p.000003:
p.000003:
p.000003:
p.000003: 3. Ai• ' aad Otbcr
p.000003: c tafezaœts
p.000003: 3.01 Pab jamœ
p.000003: aazœia«smt " yæ j»ofœ‹œd m. p‹aöuœ.e
...

Searching for indicator prison:

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p.000010: answers should always be given to direct questions about tAe research.
p.000010: gmqprehensioq. The manner and context in which information is conveyed is as important as the information itself. Por
p.000010: example, presenting information in a disorganized and rapid fashion, allowing too little time for
p.000010: consideration or curtailing opportunities for questioning, all may adversely affect a subject's ability to make an
p.000010: informed choice.
p.000010: Because the subject's ability to understand is a function of intelligence, rationality, maturity and language, it is
p.000010: necessary to adapt the presentation of the information to the subject's capacities. Investigators are responsible for
p.000010: ascertaining that the subject has comprehended the information.
p.000010: Voluntaripess. This element of informed consent requires condlñinns feee of coercion and undue influence.
p.000010: tfndue Influence occurs through an offer of an excessive, unwarranted, inappropriate or improper reward or other
p.000010: overture in order to obtain compliance. Also, inducements that would ordinarily be acceptable may become
p.000010:
p.000010: hand, lt would seem that respect requires that prisoners and students not be depz'1ved of the
p.000010: oppoz•gun1t:y tO volunteer Com research. On t2ie otlter hand, under prison and classroom
p.000010: conAlelonu both may be subtly coerced or unduly influenced to engage in research acVivieies for which they uould
p.000010: not: otherwise volunteer.
p.000010:
p.000010: g. Beneflcsnce: Is a term often understood to cover acte of kindness or charity that go beyond etrict obligations. In
p.000010: tAis document, beneficence is understood in a stronger aense, as an obligation. Two general mles are complementary
p.000010: oxpreasione of beneficent actions in tAis sense: (1) do not harm and (2) maximize possible benefits and minimize
p.000010: possible barme.
p.000010: obligations of baneJ°1cence agdecrg bottt J.nd1v1dua1 Invas1z1ga€o=s and soc1et:y at: 1acqa,
p.000010: because tbey extand botb to particular research projects and to tAe entira Enterprise ef research. In the case of
p.000010: particular projects, investigators and
p.000010: archers of their lns€lVu€ions ara obllqeñ to give foretbouqhe en
p.000010: tbe maximization oZ benefits and the reduction of risk that night occur from the research investigation.
p.000010: A difficult atbical problem remains about research tbat present:s aore Than niniztal rlsk ulehouV
p.000010: lmeeñ£aea prospects ed d1 acrg bene€1c No the subgecca tnvo1ved. Soae bave acqued that auch resesrnh
p.000010: is inadmissible, while otAers have pointed eut tAat this liBit would rule out research promising great benefit to
p.000010: people in the future. As with all haFd cases, the different Glaims coYazed by the principle of beneZicencz -- benefits
p.000010: versus harms - may come into conflict and force difficulty choices.
p.000010:
...

Searching for indicator language:

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p.000004: 23 being conducted at the time of the enactment of this legislation shall be
p.000004: 24 submitted to the Board for review, approval, modification or
p.000004: 25 disapproval within thirty (30) days of this bill becoming law. Research
p.000004:
p.000004:
p.000004: i subject to regulation which is being conducted at the time of the
p.000004: 2 enactment or this legislation may continue pending Board action.
p.000004: 3 Section 24106. General Requirements for Informed Consent.
p.000004: 4 No investigator may involve a human being in research subject to
p.000004: 5 regulation unless the investigator has obtained the legally effective
p.000004: 6 informed consent of the subject, or the subject's legally authorized
p.000004: 7 representative. An investigator shall seek such consent only under
p.000004: 8 circumstances that provide the prospective subject or the representative
p.000004: 9 sufficient opporturñty to consider whether or not to participate, and that
p.000004: 10 minimize the possibility of coercion or undue irifluence. The
p.000004: 11 information that is given to the subject or the representative shall be in
p.000004: 12 language understandable to the subject or the representative. Unless
p.000004: 13 otherwise provided by law or regulation, no informed consent, whether
p.000004: 14 oral or written, may include any exculpatory language through which
p.000004: 15 the subject or the representative is made to waive or appear to waive
p.000004: 16 any of the subject’s legal rights, or releases or appears to release the
p.000004: 17 investigator, the research sponsor, if different, or their agents from
p.000004: 18 liability for negligence.
p.000004: 19 (a) Basic Elements of Informed Consent. Except as
p.000004: 20 provided in Paragraphs (c) or (d) of this Section, in seeking
p.000004: 21 informed consent the following information shall be provided to
p.000004: 22 each human subject or the subject's legally authorized
p.000004: 23 representative:
p.000004: 24 (1) a statement that the study involves research, an
p.000004: 25 explanation of the purpose of the research and the expected
p.000004:
p.000006: 6
p.000006:
p.000006:
p.000006: 1 duration of the subject’s participation, description of the
p.000006: 2 procedures to be followed and identification of any
p.000006: 3 procedures which are experimental;
p.000006: 4 (2) a description of any reasonably foreseeable risk
p.000006: 5 or discomforts to the subject;
...

p.000004: 32 protocols for all research subject to regulation which is being
p.000004: 33 conducted at the time of the enactment of this legislation shall be
p.000004: 34 submitted to the Board for review, approval, modification or
p.000004: 35 disapproval within thirty (30) days of this bill becoming law.
p.000004: 36 Research subject to regulation which is being conducted at the time
p.000004:
p.000004: 37 of the enactment of this leglslation
p.000004: 38 action.
p.000004: may continue pending Board
p.000004: 39 §24106. General Requirements for Informed Consent. No
p.000004: 40 investigator may involve a human being in research subject to
p.000004:
p.000005: 5
p.000005:
p.000005: regulation unless the investigator has obtained the legally effective
p.000005: 2 informed consent of the subject or the subject's legally authorized
p.000005: representative. An investigator shall seek such consent only under
p.000005: 4 circumstances that provide the prospective subject or the
p.000005: 5 representative sufficient opportunity to consider whether or not to
p.000005: 6 participate and that minimize the possibility of coercion or undue
p.000005: 7 influence. The information that is given to the subject or the
p.000005: 8 representative shall be in language understandable to the subject or
p.000005: 9 the representative. Unless otherwise provided by law or regulation,
p.000005: 10 no informed consent, whether oral or written, may include any
p.000005: 11 exculpatory language through which the subject or the
p.000005: 12 representative is made to waive or appear to waive any of the
p.000005: 13 subject's legal rights, or releases or appears to release the
p.000005: 14 investigator, the research sponsor, if different, or their agents from
p.000005: 15 liability for negligence;
p.000005: 16 (a) Basic elements of Informed Consent. Except as provided in
p.000005: 17 paragraphs (c) or (d) of this section, in seeking informed consent the
p.000005: 18 following information shall be provided to each human subject or the
p.000005: 19 subject's legally authorized representative:
p.000005: 20 (1) A statement that the study involves research, an
p.000005: 21 explanation of the purpose of the research and the
p.000005: 22 expected duration of the subject's participation,
p.000005: 23 description of the procedures to be followed, and
p.000005: 24 identification of any procedures which are
p.000005: 25 experimental;
p.000005: 26 (2) A description of any reasonably foreseeable risk or
p.000005: 27 discomforts to the subject;
p.000005: 28 (3) A description of any benefits to the subject or to others
p.000005: 29 which may reasonably be expected from the research;
...

p.000010: Coming with ALS and Parkinsonisin Dementia, Sioce they involve human su ejects, all of thc researches treat I
p.000010: have done had to go through institutional review boards of New York Universi) , UOG, or of the Federal agencies for
p.000010: whom I performed the studies and who fended the studies.
p.000010:
p.000010: Going tir ougl review boards and obtain ing consent horn participants are pi'ocesses that are necessary in
p.000010: the practice of research, a practicc that has come ft out past histories of uHkiowing subjects being
p.000010: 9J *had I› haunted b› experiiiients, set jects who have appeared its filnls and )f1nted m‹di:‹ v ithout their
p.000010: consent I !ook at this bill as not
p.000010: '* °e "' i °' that » ould haiiipei any pi ospcctive rcscai cher but one
p.000010: int°n ticd Io p i’o t ec t t lie rigli ts of t most ii ho Jia rticip;i tc.
p.000010:
p.000010: 1 belleve thai a iiong these rights are tint 11ie researcher be triliiicd in
p.000010: Conductin’g a xoJ ei in estigation Of thai he/she be super vised by
p.000010:
p.000010:
p.000010: someone or agency ’who' ’is kno 1 dgeable on ethica c'onduct of researchers. Being a doctor, teacher or a
p.000010: social worker, for instance, does not always mean a pel son can conduct research. One may be a gon d, honest,
p.000010: knowledgeable doctor / teacher but a poor or inept researcher. Reseai ch, espccially scientific research, requires
p.000010: special training in many skills among which is imdcrstanding the language of statistics and a knowledge of the
p.000010: various steps one follows in
p.000010: adIi4inistei’ing the project. If it is complex, it might 1 equire knowledge of thc l’oject’s algorithm,
p.000010: requiring, decision-making in every step of the way. This is why most researches are conducted under the auspices of
p.000010: eiilicr the federal government, educational lnstitutions or foundations Who conduct training courses for the
p.000010: discipline of research.
p.000010:
p.000010: Ttaining for research includes aniong otl er things, luiowledge and explication of the “iucthodology” beirg proposed
p.000010: that would fit the stateil objectives of the project. One can not just think of soitiething and say tte wants to do
p.000010: research on it. Onc has to ha› e hypothèses and sky how tte/she is going to prove that his Results ai c going to
p.000010: make a SlÇI11f)caol difference front what e assortie tO be normal in the general sc)ieiiie c›f thitigs. The
p.000010: tests have to bc riq•orous so thal the results can witlistand the scrutiny of other scientlsts who are coiiducting
p.000010: related studios. For there is a socicty of scholars to whoui ose communicates and s)iares knowlcdge with One hope›
p.000010: iiiat the results Of one’s studies won id l earl to a different wa of loOklng at something whether it is a
p.000010: discale, specie in nature or the Relationship 21T1Ong categories or concepts l’e are familial with
p.000010:
p.000010: New d!cs› i‹ say, the ultimate benefactors of the rcsu1ts of one's
p.000010: schs I +‘l) eLfortS are neither the conductor of the reseai ch although he n*>l ^* ñ‹ ‹›?,iiized by his
p.000010: pecrs in one w ay or anotliei’ nn' ltte assistants vl r* o idc so-called leg v ork for the researcher.
...

p.000010: ia widespread agreement
p.000010: eon4sainlnq three
p.000010: elements - information, comprehension and vo1un€aclneaa.
p.000010: In1 **ien- Most codes of research establish specific Items for disclosure intended to assure that aubjects are
p.000010: given su££iulene 1nroraat:ion. These It:ema generally Include: tha raneareh procedure, their purposes, risks
p.000010: and anticipated benefits, alternative procedures (where therapy is involved), and a statement oC€aclng the
p.000010: eubJ eel Cha oppocfiun1 €y e aak gues£1ono and to alt araw at any Time froa the
p.000010: raseaech. AddlLional 1.been have been proposed, including how subjects sre selected, tAe person responsible
p.000010: for the research, *tc.
p.000010: However, a listing of items does not clarify waYs for judging how much and what sOFt Of infOrmation should be provided.
p.000010: It may be cba€ a aeandacd oC ^€he z'eaaonab1e vo1un2eec" shou16 be Co11oued:
p.000010:
p.000010:
p.000010: risk and the voluntary nature of participation.
p.000010: Information about risks ehould never be withheld for tAe purpose of eliciting the cooperation of subjects, and truthful
p.000010: answers should always be given to direct questions about tAe research.
p.000010: gmqprehensioq. The manner and context in which information is conveyed is as important as the information itself. Por
p.000010: example, presenting information in a disorganized and rapid fashion, allowing too little time for
p.000010: consideration or curtailing opportunities for questioning, all may adversely affect a subject's ability to make an
p.000010: informed choice.
p.000010: Because the subject's ability to understand is a function of intelligence, rationality, maturity and language, it is
p.000010: necessary to adapt the presentation of the information to the subject's capacities. Investigators are responsible for
p.000010: ascertaining that the subject has comprehended the information.
p.000010: Voluntaripess. This element of informed consent requires condlñinns feee of coercion and undue influence.
p.000010: tfndue Influence occurs through an offer of an excessive, unwarranted, inappropriate or improper reward or other
p.000010: overture in order to obtain compliance. Also, inducements that would ordinarily be acceptable may become
p.000010:
p.000010: hand, lt would seem that respect requires that prisoners and students not be depz'1ved of the
p.000010: oppoz•gun1t:y tO volunteer Com research. On t2ie otlter hand, under prison and classroom
p.000010: conAlelonu both may be subtly coerced or unduly influenced to engage in research acVivieies for which they uould
p.000010: not: otherwise volunteer.
p.000010:
p.000010: g. Beneflcsnce: Is a term often understood to cover acte of kindness or charity that go beyond etrict obligations. In
p.000010: tAis document, beneficence is understood in a stronger aense, as an obligation. Two general mles are complementary
p.000010: oxpreasione of beneficent actions in tAis sense: (1) do not harm and (2) maximize possible benefits and minimize
...

p.000005:
p.000005: Bec21oo 114 coopaxa€1ve Raseacaa.
p.000005:
p.000005: Cooperative research projects are those projects covered by this policy which involve more than one institution. In
p.000005: the conduct of cooperative research projects, each institution is responsible for safeguarding the rights and welfare
p.000005: of husmn subjects and for complying with this policy.
p.000005:
p.000005: An institution participating in a cooperative project may enter into a joint review arrangement, rely upon the review
p.000005: of another qualified ZRB, or nake similar arrangement:a for avoi‹:ling duplication of
p.000005: effort.
p.000005: sactioo us zRe xecora•.
p.000005: An IRB, shall prepare and maintain adequate documentation of IRB activities, including the following:
p.000005: 1. Copies of all research proposals reviewed.
p.000005: 2. of IRB meetings
p.000005: s. Records of continuing review activities.
p.000005: 4. Copies of all correspondence.
p.000005: 5. A list of IRB members.
p.000005: 6. Writ:I:en procedures for the ZRB .
p.000005:
p.000005:
p.000005: An investigator shall seeE such consent only under circumstances that provide the prospective subject or the
p.000005: representative sufficient opportunity to consider whether or not to participate and that minimize the possibility of
p.000005: coercion or undue influence. The information that is given to the subject or the representative shall be in language
p.000005: understandable to the subject or the representative.
p.000005: a) Basic elements of informed consent
p.000005: 1. A statement that the study involves research, an explanation of the purposes of the research and the expected
p.000005: duratiOn of the subject's participation, a description of the procedures to be followed, and identification of any
p.000005: procedures which are experimental,
p.000005:
p.000005: 2. A description of any reasonably foreseeable risks or discomforts to the subject,
p.000005:
p.000005: 3 . A description of any benefits to the subject or to others which may reasonably bm expected from the research;
p.000005: 4. A disclosure of appropriate alternative procedures or courses of treatment, if any;
p.000005: 5. & statement describing the extent, if any,
p.000005: to which confidentiality of records identifying the subject will be maintained;
p.000005: 6. An explanation as to whether any compensation and
p.000005: an explanatioñ as to whether any medical treatments are available lf injury occura and, if so, what they consist of, or
p.000005: where further information xay be obtained,
p.000005: 7. An explanation of whom to contact for answers to pertinent questions;
p.000005: 8. A statement that participati on is voluntary, refusal to participate will involve no penalty or loss of benefits to
p.000005: which the subject is otherwise entitled, and the subject say discontinue participation at any time.
p.000005: b) When appropriate, one or more of the following elements of information shall also be provided to each subject:
p.000005: 1. L statement that the particular treatment or procedure may involve rieks;
p.000005: 2. Anticipated circumstances under which the subject's participation may be terminated;
p.000005: 3. Any additional costs tO the subject;
...

Searching for indicator job:

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p.000010: UOG Station, Mangilao, Guain 96923
p.000010: Telephone: (671) 735-2990• Fax: (67 I) 734-2296
p.000010:
p.000010:
p.000010:
p.000010:
p.000010: May 5, 1998
p.000010: The Honorable Lawrence Kasperbauer Chairman, Committee on Education 24th Guam Legislature
p.000010: 155 Hessler Drive
p.000010: Agana, GU 96910
p.000010:
p.000010: Re: AN ACT TO CREATE A REVIEW BOARD FOR REVIEW AND APPROVAL OF RESEARCH CONDUCTED ON GUAM WITH REGARD TO
p.000010: HUMAN SUBJECTS.
p.000010: Dear Chairman Kasperbauer:
p.000010: I am here today to testify in support of Bill No. 347. This bill proposes to create a Guam Research Review Board
p.000010: for review and approval of research conducted on Guam with regard to human subjects. University
p.000010: administrators and faculty agree that any research on our island must undergo one review process.
p.000010: However, since the Guam Research Review Board would be a dnplication of the University of Guam’s Committee on Human
p.000010: Subjects in Researeh (CHSR), I iecommcnd that CHSR, under the Office of Graduate School and Research, be
p.000010: designated as the Institutional Review Board (IRB) for researchers and collaborators at the University and for
p.000010: researchers who are not under other IRBs.
p.000010:
p.000010: lt is noted that theie is no mention of additional financial or human resources to accomplish the
p.000010: numerous tasks as specified in the bill. At the present time, Graduate School and Research has only
p.000010: three employees listed in its staffing pattern, and each of these employees has a clearly defined job
p.000010: description and delineated tasks. To comply with the bill’s proposed tasks, it is essential to add one clerical
p.000010: staff position and funding for a computer, office fumiture, and supplies. In addition, funds would
p.000010: be needed for advertising or informing the community about the Committee on Human Subjects in Research
p.000010: to assure that researchers submit research proposals for review.
p.000010: Sincerely,
p.000010:
p.000010:
p.000010: Jose T. Nededog
p.000010:
p.000010: JOHN C. STEELE, M.D., FRCP(C)
p.000010: NEUROLOGIST
p.000010: FELLOW, AMERICAN COLLEGE OF PHYSICIANS
p.000010:
p.000010:
p.000010: May 11, 1998
p.000010:
p.000010: Senator Lawrence F. Kasperbauer Chairman, Committee on Education Twenty-Fourth Guam Legislature
p.000010:
p.000010: Dear Dr. Kasperbauer
p.000010:
p.000010:
p.000010: TePFax: (671) 828-30¢)0
p.000010:
p.000010: I am writing to provide testimony about Bill 347 to “create a review board for review and approval of research
p.000010: conducted on Guam with regard to human subjects”.
p.000010:
p.000010: I agree with the intent of the Bill but I have concerns about the mechanism it proposes to achieve the intent. It is a
p.000010: bill which proposes a “ fox to guard the hen house”
p.000010:
p.000010: That intent of bill 347 is to be certain that all medical research on Guam is reviewed and approved by a Committee
p.000010: which will assure protection of human subjects.
p.000010:
p.000010: In October 1995 at a Legislative Oversight Hearing about lytico-bodig research on Guam which was chaired by Senator
p.000010: Leon Guerrero all participants, including myself agreed that such review and approval was desireable.
p.000010:
...

Searching for indicator police:

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p.000001:
p.000001: As with Dr. Nededog comments, clerlcal staff need to be assigned to ensure that the functions of the Committee
p.000001: are carried out.
p.000001:
p.000001: Dr. Randall Workman, Professor of Sociology and Community Development at the University of Guam testified in support
p.000001: of the intent of Bill 347. His written testimony outlined his concerns which includes the importance of informed
p.000001: consent and assessment of risks and benefits. Further, the bill, as currently written, establishes unnecessary
p.000001: additional island wide IRB.
p.000001:
p.000001: Dr. Kyle Smith teaches psychology and research methods at the University of Guam and fully supports the call for all
p.000001: research conducted on Guam to undergo review. The bill, as in its existing form may produce some unnecessary affects
p.000001: on the training available for standards at the University of Guam and creates redundant delays. He supports the
p.000001: option to modify the bill to accommodate student and research projects. Dr.Smith believes that it was not the
p.000001: intent of the author to impede research projects. He will fully support the bill with modifications.
p.000001:
p.000001: Mr. Roy Adonay testified in support of Bill 347. Mr. Adonay expressed the need to review the are of fines and
p.000001: penalties and needs to be expanded. There is no indication as to who will monitor and
p.000001:
p.000001:
p.000003: 3
p.000003:
p.000003: fine and who will collect. The Universlty of Guam Will not have the power or authority to police all research.
p.000003:
p.000003: Ms. Gregoria Smith testified in favor of Bill 347. She also submitted written testimony that states obtaining
p.000003: consents from participants are necessary in the practice of research to protect the rights of those who
p.000003: participates. Researchers must be trained; research, especially scientific research, requires special training.
p.000003:
p.000003: Ms. Debbie Quinata, a member of OPIR, Chamorro Nation, ancestral/original landowners. Ms. Quinata is opposed
p.000003: to Bill 347. Guam already has an IRB for grant applicant that review standards at the Guam Memorial Hospital.
p.000003: This bill will create more loopholes. Ms. Quinata also stated that all off-island researchers should share in
p.000003: the results of the national research and charge fees. Mechanisms should be in place to ask for accountability - what
p.000003: are they doing for our island and educating our students.
p.000003:
p.000003: Dr. Bert Weiderholt, physician /neurologist and professor of neuroscience at the University of California, San
p.000003: Diego. NIA (National Institutes of Aging) funded program project for 5 years to study disease on Guam. Dr.
p.000003: Wiederholt is in full support of Bill 347 and further supports Drs. Nededog and Camacho, Workman and Smith. He has
p.000003: conducted research in various states and it is very important to submit research project for local review, although
p.000003: not federally required. Dr. Weiderholt and the project he is now involved in on Guam, had no hesitation in
p.000003: submitting application for research to the University of Guam and the Guam Memorial Hospital - both were
p.000003: approved.
p.000003:
...

Searching for indicator coerced:

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p.000010: gmqprehensioq. The manner and context in which information is conveyed is as important as the information itself. Por
p.000010: example, presenting information in a disorganized and rapid fashion, allowing too little time for
p.000010: consideration or curtailing opportunities for questioning, all may adversely affect a subject's ability to make an
p.000010: informed choice.
p.000010: Because the subject's ability to understand is a function of intelligence, rationality, maturity and language, it is
p.000010: necessary to adapt the presentation of the information to the subject's capacities. Investigators are responsible for
p.000010: ascertaining that the subject has comprehended the information.
p.000010: Voluntaripess. This element of informed consent requires condlñinns feee of coercion and undue influence.
p.000010: tfndue Influence occurs through an offer of an excessive, unwarranted, inappropriate or improper reward or other
p.000010: overture in order to obtain compliance. Also, inducements that would ordinarily be acceptable may become
p.000010:
p.000010: hand, lt would seem that respect requires that prisoners and students not be depz'1ved of the
p.000010: oppoz•gun1t:y tO volunteer Com research. On t2ie otlter hand, under prison and classroom
p.000010: conAlelonu both may be subtly coerced or unduly influenced to engage in research acVivieies for which they uould
p.000010: not: otherwise volunteer.
p.000010:
p.000010: g. Beneflcsnce: Is a term often understood to cover acte of kindness or charity that go beyond etrict obligations. In
p.000010: tAis document, beneficence is understood in a stronger aense, as an obligation. Two general mles are complementary
p.000010: oxpreasione of beneficent actions in tAis sense: (1) do not harm and (2) maximize possible benefits and minimize
p.000010: possible barme.
p.000010: obligations of baneJ°1cence agdecrg bottt J.nd1v1dua1 Invas1z1ga€o=s and soc1et:y at: 1acqa,
p.000010: because tbey extand botb to particular research projects and to tAe entira Enterprise ef research. In the case of
p.000010: particular projects, investigators and
p.000010: archers of their lns€lVu€ions ara obllqeñ to give foretbouqhe en
p.000010: tbe maximization oZ benefits and the reduction of risk that night occur from the research investigation.
p.000010: A difficult atbical problem remains about research tbat present:s aore Than niniztal rlsk ulehouV
p.000010: lmeeñ£aea prospects ed d1 acrg bene€1c No the subgecca tnvo1ved. Soae bave acqued that auch resesrnh
p.000010: is inadmissible, while otAers have pointed eut tAat this liBit would rule out research promising great benefit to
p.000010: people in the future. As with all haFd cases, the different Glaims coYazed by the principle of beneZicencz -- benefits
p.000010: versus harms - may come into conflict and force difficulty choices.
p.000010:
p.000010: 3 . 7us8£ce • aaks Who ought No cacelve tJte bane61ts o:I eaawch and baar It:s burdens?
...

Searching for indicator religious:

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p.000002: 23 or recording is taking place, and information which has been
p.000002: 24 provided for specific purposes by an individual and which the
p.000002: 25 individual can reasonably expect will not be made public (for
p.000002:
p.000003: 3
p.000003:
p.000003:
p.000003: 1 example, medical records). Private information must be
p.000003: 2 individually identifiable in order for obtaining the information to
p.000003: 3 constitute research involving human subjects.
p.000003: 4 (g) 'Minimal risk’ means that the probability and magnitude of
p.000003: 5 harm or discomfort anticipated in the research are not greater in and of
p.000003: 6 themselves than those ordinarily encountered in daily Me or during the
p.000003: 7 performance of routine physical or psychological examination or tests.
p.000003: 8 Section 24102. Board; Terms; Appointment; Continuance;
p.000003: 9 Removal. Members of the Board shall be consistent with the
p.000003: 10 University of Guam’s Committee on Human Subjects and Research
p.000003: 11 which is: three (3) or four (4) professional research proficient experts
p.000003: 12 from the Urñversity of Guam; at least one (1) Guam commurñty
p.000003: 13 representative; at least one (1) local religious leader; and at least one (1)
p.000003: 14 licensed practlcing local medical doctor.
p.000003: 15 Section 24103. Purpose. The purpose of the Board is to
p.000003: 16 review, approve, require modifications to secure approval or
p.000003: 17 disapprove all research subject to regulation.
p.000003: 18 Section 24104. Powers. The Board shall have and exerclse
p.000003: 19 each and all of the following powers:
p.000003: 20 (a) review and have authority to approve, requlre
p.000003: 21 modifications to secure approval or disapprove all research
p.000003: 22 activities covered by the rules and regulations;
p.000003: 23 (b) require documentation of informed consent of all
p.000003: 24 human subjects participating in the research subject to regulation.
p.000003: 25 At the Board’s discretion, require additional irdormation be given
p.000003:
p.000004: 4
p.000004:
p.000004:
p.000004: 1 to the subjects which would add to the protection of the rights and
p.000004: 2 welfare of the subjects;
p.000004: 3 (c) notify the investigators and the institution in writing
...

p.000002: I-luiDan Sobjecti
p.000002: ;xles ofconduct ofio‹4al ind behavioml mear*h as adopted by the
p.000002: *ho ’cal Association APA since l9D
p.000002:
p.000002:
p.000002: £‹•s• NO NEED TO DUPMcxTs THsSs SXIST G R£VisW BOARus CY
p.000002: ESTABL@HING A NEW REViEW BOARD that has no gcarMse ofproviding equal quality reviews or poN#ômMÆWP kofoœml
p.000002: [DGCœmÆœlœHumanGJQeœæRmwam CHS§ VdM#AæmMmoñNH MbmÆÆœÆRwicwBomdÇRB)fo ufpRV*Aügom€onM
p.000002: Oic Pcop)¢ ofGuarn, arid wM continue to jxovide this protectian to tha Pe¢$ils of¢?uam if’pcmiibed to
p.000002: cantñtuc s¢zvtng the Peopk o£Guam as tfi¢y pesently do, This points in Ote direction of&e ncad Iboa major revision
p.000002: ofBill 0347 to i&atify the existing UOG Conuuittee for Human Subjea tit Research (DHSR) wäh ihn existing lOi
p.000002: polJcies and pœcednes ce tim desigantod Rexicw Board for all nacaicli
p.000002:
p.000002:
p.000002: A foi& xiufi‹ ncY z ev«ient as Review Beard will éivolm tin
p.000002: University ofGuam under M c‹; trol uidguideriee of flu UOG H ie
p.000002: proposed Bill f347 is c du dancy of tin existing official UOO resean2i nvq control body: the Committee for Hymn
p.000002: Subject ia Research (CHSR) which serve the mnununity ss in olficiai appointed
p.000002: co at UC L RATHER, I I› icve BILL 8347 SHOULD IDENTIFY THE UOG cOUMITTEB FOR HUMAN Su&ECT iH RRSEARCH
p.000002: (eHSR; AS THB DESiGHATBD REViEw
p.000002: BOARD £x el1 rescecli projects rehtcd to luimai subjects OH GUnM.
p.000002:
p.000002: Mmihos ofûzasc Rmrî< Boards
p.000002: The propoceö Bill 9347 ûJemi6cs t‹'Îcw baud mœnbezs tocceatc anew revicw body hut a'oidd agaÎn be
p.000002:
p.000002:
p.000002: - at tqast 1 tocal Religious icadnt
p.000002: - MJ4ast I tic-isodprecticing beat Mcdicd Doctor
p.000002: kertas at pzofo visors ocz sources where
p.000002:
p.000002:
p.000002: m equally I entativa body orprog›sdanaI zcseazchcrs, educators, and locd leaders. tn accordance wi&
p.000002: Oic Tnstitut Rtnriaw Baard Policies and Ptocc4urcs (4/j3/95), the Guazn McsnorialNospitaJ FRB is
p.000002:
p.000002:
p.000002:
p.000002:
p.000002:
p.000002:
p.000002:
p.000002:
p.000002:
p.000002: May 4, 1998
p.000002:
p.000002: SomarLea)IGq›abaua,PKD.
p.000002:
p.000002:
p.000002:
p.000002: k8 Isöve to Cmat•ıg a Guam kes4mch Rev›•w Board
p.000002:
p.000002:
p.000002:
p.000002: IkloqzCWm4m,AcdngIkmftheUOGGmdaüShod&Rxmm\;redddmoMWmçopyof
p.000002: ModmRofiD#]47.DhıwmıddvzymmfuflymdMwtcücw*dBwUOGpov#MddbwmmWmW directives ated to resrach conducted with mgard to hignm
p.000002: subjects. I am an active member of the Umwnityq(€mmmOoımn)MxomHmxnSujxEinEmwmdı(CHSR)md)mv4bamdncemy
p.000002:
p.000002:
p.000002: Sinm I am unabk due to sctıcöul•d ctassa atfJO0 to attmdtÎ\s Pub\îc I4csûng arı Bîll #347 on May 5. I woukt like to
p.000002: heve the following included in tlu docummts nr 1 testimonies tfut your C‹xnmittee eonskk•rs ec it m•ke deb mtions
p.000002: ebout dms Bill.
p.000002: Du lic tio of Exi t R B d
p.000002:
p.000002:
p.000002:
p.000002:
p.000002:
p.000002: I BELIEV£ THAT BILL #347 IS IMPORTANT BUT AS WORDED WIkL INTERFER WITH,
p.000002: COMPLICATE AND CREATE PROBLE IS IN THE HEEDED RESEARCH THAT INVOLVES GUAM
p.000002: AND THE PEOPLE OP GUAM. 1 agm hut it * iioportintio i4dress rescuth issues that might not be covewd undere›fistirig
p.000002: UO3, GMH or DOE peléics. However, Bill 4347. as wooded, appears to go beyond the întent of'tIzc iîxlezat guides kör
...

p.000010: needs funding and the creation of a new clerical staff position. Please include appropriate funding as this
p.000010: legislation goes forward.
p.000010: UOG has a fine record of grantsmanship and compliance with federal standards because it strives to meet rules and
p.000010: regulations through the policies set by Research Council and enforced by GS&R.
p.000010: The third issues I will briefly address is the concern that an added review process would cause delays that could
p.000010: hinder the excellent research that is pre”sentIy being conducted by undergraduate students in various programs.
p.000010: Undergraduate students only have one semester or fifteen weeks in which to complete their research projects. It is our
p.000010: desire to encourage undergraduate students to conduct research under the mentorship of their professors. Review
p.000010: processes take time to complete , but unusual delays could damage a student’s enthusiasm for the research project.
p.000010: ”the UOG's Committee on Human Subjects in
p.000010:
p.000010: GRRDURTE SCHOOL RND RESEflRCH DERN'S TESTIMONY, 1998
p.000010:
p.000010: Research is currently expediting the review process for undergraduate
p.000010: students who have limited weeks to complete research.
p.000010: Finally, I will state my concerns about the composition o1 the committee. Section 3 on page 4 states the proposed
p.000010: composition of the Guam Research Review Board. This entire section of Bill No. 347 should be deleted and replaced with
p.000010: the composition of the CHRS which is:
p.000010: 3 or 4 professional research proficient experts from UOG
p.000010: at least 1 Guam community representative at least 1 local religious leader
p.000010: at least 1 licensed practicing local medical doctor
p.000010: This composition allows the IRB to remain relatively free from political interference. The UOG President is kept
p.000010: informed of changes in the membership and may appoint qualifi a the CHSR when there are v
p.000010: s.
p.000010: et me assure you, senators, that I am willing to revise Bill No. 347 by working with you and your staff. We all need
p.000010: to work towards the protection of the citizens of Guam who agree to participate in research projects.
p.000010:
p.000010:
p.000010:
p.000010:
p.000010:
p.000010:
p.000010:
p.000010:
p.000010:
p.000010:
p.000010:
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p.000001: They have existed since 1982 and serve Guam by providing
p.000001:
p.000001: protection to human subjects in accordance with federal/local regulations in research.
p.000001:
p.000001: Suggested changes.
p.000001: Change the words “Creation of Guam Research Review Board” and replace with “The designation of the University
p.000001: of Guam's Committee on Human Subjects in Research as the Institutional Review Board or (IRB) for researchers and
p.000001: collaborators at the University and for researchers who are not under other IRBs.” Wherever the bill states “Guam
p.000001: Research Review Board” it should be replaced with “UOG's Committee on Human Subjects in Research”.
p.000001:
p.000001: As with Dr. Nededog comments, clerlcal staff need to be assigned to ensure that the functions of the Committee
p.000001: are carried out.
p.000001:
p.000001: Dr. Randall Workman, Professor of Sociology and Community Development at the University of Guam testified in support
p.000001: of the intent of Bill 347. His written testimony outlined his concerns which includes the importance of informed
p.000001: consent and assessment of risks and benefits. Further, the bill, as currently written, establishes unnecessary
p.000001: additional island wide IRB.
p.000001:
p.000001: Dr. Kyle Smith teaches psychology and research methods at the University of Guam and fully supports the call for all
p.000001: research conducted on Guam to undergo review. The bill, as in its existing form may produce some unnecessary affects
p.000001: on the training available for standards at the University of Guam and creates redundant delays. He supports the
p.000001: option to modify the bill to accommodate student and research projects. Dr.Smith believes that it was not the
p.000001: intent of the author to impede research projects. He will fully support the bill with modifications.
p.000001:
p.000001: Mr. Roy Adonay testified in support of Bill 347. Mr. Adonay expressed the need to review the are of fines and
p.000001: penalties and needs to be expanded. There is no indication as to who will monitor and
p.000001:
p.000001:
p.000003: 3
p.000003:
p.000003: fine and who will collect. The Universlty of Guam Will not have the power or authority to police all research.
p.000003:
p.000003: Ms. Gregoria Smith testified in favor of Bill 347. She also submitted written testimony that states obtaining
p.000003: consents from participants are necessary in the practice of research to protect the rights of those who
p.000003: participates. Researchers must be trained; research, especially scientific research, requires special training.
p.000003:
p.000003: Ms. Debbie Quinata, a member of OPIR, Chamorro Nation, ancestral/original landowners. Ms. Quinata is opposed
p.000003: to Bill 347. Guam already has an IRB for grant applicant that review standards at the Guam Memorial Hospital.
p.000003: This bill will create more loopholes. Ms. Quinata also stated that all off-island researchers should share in
p.000003: the results of the national research and charge fees. Mechanisms should be in place to ask for accountability - what
p.000003: are they doing for our island and educating our students.
p.000003:
p.000003: Dr. Bert Weiderholt, physician /neurologist and professor of neuroscience at the University of California, San
...

p.000010: whom wc will
p.000010: not be able to conduct our studies.
p.000010:
p.000010: This bill will objectify what some of us are doing in the nance of “Research”. It will make us accountable for what
p.000010: we do in its name and will enforce the standards that are recognized most anywhere else.
p.000010:
p.000010:
p.000010: Thank you for your kind attention.
p.000010:
p.000010: Gregoria Smith Community Psychologist Tel/ Fax ti49 7571
p.000010:
p.000010:
p.000010: o AERSMYOFGUAM “
p.000010: 1 BETSEDAT U H
p.000010: oiveiox or scCxOxLaLuEaGxEnxOvFioARTS &scSiECIfElcNcCsESa socs wonx
p.000010: TeTepNOl (07J) 735-2870 FW {6 '1) Kg
p.000010:
p.000010:
p.000010:
p.000010:
p.000010: rsou:
p.000010: The Fiono/able La\•tence F. ffaaperbayer
p.000010: Senator. Chair. 6ég\mt¥ee on Education
p.000010: Dr. Maiozs C. Ty«„AssL Professor, Psychology PHouS
p.000010: University df Gvc 'i
p.000010: Dr. Mary L Spec, Dean. College ofAns A S‹ñennee, UOG
p.000010: 671-475-2000 ‘.
p.000010:
p.000010: 8Tt7 25f
p.000010: Or. u8a-Katñpa Or¥ig. Chad. Committee on Human Research Subjects, UOG
p.000010:
p.000010:
p.000010: Bill No. 347, An Ais to Create a Revie\y Board fa Reviaw ond Approval of Research Cond‹zctgd on Guam with Regerd!to
p.000010: Human Subjects
p.000010: essage• , ' !
p.000010: '
p.000010: Dear Seriatpr Ka*p&bauer, .
p.000010: ‘ ’ “* .
p.000010: I write to urge you a lobby against Bill No. 347. I am a faculty mem6er of the University of Guam wbere i I am engaged
p.000010: in an activé program of research, as are many of my colleagues. Research is of ina•lnsic benefit té the commune (both
p.000010: here on Guam and elsewhcreJ and directly helps student learning. I take pridé in the Su *f 'r'rés aich that is
p.000010: being fostwed at the University of Guam and am puzzled by Bifl No. 347. The spirit ofth#. bifl'is fully appropriatwit
p.000010: is irdeed important to be concernaJ first far tke welfare of human subjects. gmt to pr.ott•ts human.subj what
p.000010: is puzzling to me is the need fo' sucb a i
p.000010: ! bill; es etaally one that danstralns research done at the University, since UOG already has a review
p.000010: process that very carefull:y monitor research. Some of the many reasons against this bill include: ,'
p.000010: \. Such a law would be largely unjsecedented. Virtually all jurisdictions in the US and many o
p.000010: countries allow universiii@ and hospiBls to administer research internally. Indeed; UOG alieady has ,
p.000010: an excelldnt instizuttonal. review panel, the Committee on f4uman Research Subjects.
p.000010: 2. Even the proposal of such a law is disturbing as it gives the appearance that our island’s govenment: (ails to
p.000010: understand (ñn,d japs fails zo value) research and the University.
p.000010:
p.000010: committee
p.000010:
p.000010: 4. The passage of such.q law Auld swipusly undermine the eParts of faculty to bring in research money, Which
p.000010: traditionally ñelps stlpport the lost institution. It also adds to.Guam’s already large bureauoacy.
p.000010: ' Thank you for your tims end your effons in ensuring thac this bill does not oass, o- at the very least ‹o. inane
p.000010: sure the bill is amen ded,to exempt any researdi conducted on Guam that ‹eceives approva( from UOG's existing internal
p.000010: C ?nmisee on F uman Research Subjects
p.000010:
p.000010:
p.000010:
p.000010:
p.000010:
p.000010:
p.000010: T0T9L P. 01
p.000010:
p.000010: Defînitions
...

p.000003: (5) Written procedures for ensuring prompt reporting to the IRB, appropriate institutional officials, and the
p.000003: department or agency head of (1) any unanticipated problems involving risks to subjects or others or any serious or
p.000003: continuing noncompliance with this policy or the requirements or determinations of the IRB and (ii) any
p.000003: suspension or termination of IRB approval.
p.000003: (c) to (g) [additional specifications and policy for assurances]
p.000003: (f) . . . Institutions UithOUt an approved assurance covering the research ahall certify within 3o days after receipt
p.000003: of a request for such a certification from the department or agency, that the application or proposal has been approved
p.000003: by the IRB. If the
p.000003:
p.000003:
p.000003: sact1on 1o2 De€1a1€1ons
p.000003: (a) Department or agency head . . .
p.000003: (b) Institution . . .
p.000003:
p.000003:
p.000003: (d) Hesearcfl means a systematic investigation, including research development, testing and evaluation, designed
p.000003: to develop or contribute to generalizable knowledge.
p.000003: (e) Aesearcb subject to regu2atlon, . . . encompass those research activities for which a federal department or agency
p.000003: has specific responsibility for regulating as a research activity. It does not include research activities which are
p.000003: incidentally regulated by a federal department or agency solely as part of the department's or agency's broader
p.000003: responsibility to regulate certain types of activities whether research or non-research in nature (e.g., Wage and
p.000003: Hour requirements administered by the Department of Labor).
p.000003: (f) Buman subject means a living individual about whom an investigator (whether professional pr student)
p.000003: conducting research obtains (1) data through intervention or interaction with the individual, or (2) identifiable
p.000003: private information. (]xterventlon and private information are given expanded definition)
p.000003:
p.000003:
p.000003: (h) IRB appz-ova-I ...
p.000003:
p.000003: (i) Blzimal rlsk means that the probability and magnitude of harm or discomfort anticipated in the research are not
p.000003: greater in and of themselves than those ordinarily encountered in daily life or during the performance of routine
p.000003: physical or psychological examinations or tests.
p.000003: (j) Certification means the official notification by the institution to the supporting department or agency, in
p.000003: accordance with the requirements of this policy, that a research project or activity involvinghuman subjects has been
p.000003: reviewed and approved by an IRB in accordance with an approved assurance.
p.000003:
p.000003:
p.000003:
p.000003:
p.000003:
p.000003:
p.000003: 3
p.000003:
p.000003: (b) Unless otherwise required . . . research activities in which the only involvement of human subjects will be in one
p.000003: or more of the foLloWing categories are exempt from this policy:
p.000003: (1) Research conducted in established or commonly accepted educational settings, involving normal educational
p.000003: practices, such as (i) research On regular and special education instructional strategies, or (ii)
p.000003: research on the effectiveness oY or the comparison among instructional techniques, curricula, or classroom
p.000003: management methods.
...

p.000010:
p.000010: the Institutional Review Board (IRB) for researchers and collaborators at the University and for researchers who are
p.000010: not under other lRBs." Wherever the bill states ”Guam Research Review Board” it should be replaced with "UOG's
p.000010: Committee on Human Subjects in Research.”
p.000010: Second, I wish to state that the role of the University of Guam in research is that of the state institution and, as
p.000010: such, it is appropriate that the IRB be housed in the Office of Graduate School and Research. However, GS&R has as its
p.000010: primary duty service to graduate students, and it is already overburdened with increases in the number of graduate
p.000010: students enrolling in courses, increases in the number of graduate programs since 1993, and increases in the number of
p.000010: qualified graduate faculty who seek answers to questions. In order to meet the stipulations of the legislation, GS&R
p.000010: needs funding and the creation of a new clerical staff position. Please include appropriate funding as this
p.000010: legislation goes forward.
p.000010: UOG has a fine record of grantsmanship and compliance with federal standards because it strives to meet rules and
p.000010: regulations through the policies set by Research Council and enforced by GS&R.
p.000010: The third issues I will briefly address is the concern that an added review process would cause delays that could
p.000010: hinder the excellent research that is pre”sentIy being conducted by undergraduate students in various programs.
p.000010: Undergraduate students only have one semester or fifteen weeks in which to complete their research projects. It is our
p.000010: desire to encourage undergraduate students to conduct research under the mentorship of their professors. Review
p.000010: processes take time to complete , but unusual delays could damage a student’s enthusiasm for the research project.
p.000010: ”the UOG's Committee on Human Subjects in
p.000010:
p.000010: GRRDURTE SCHOOL RND RESEflRCH DERN'S TESTIMONY, 1998
p.000010:
p.000010: Research is currently expediting the review process for undergraduate
p.000010: students who have limited weeks to complete research.
p.000010: Finally, I will state my concerns about the composition o1 the committee. Section 3 on page 4 states the proposed
p.000010: composition of the Guam Research Review Board. This entire section of Bill No. 347 should be deleted and replaced with
p.000010: the composition of the CHRS which is:
p.000010: 3 or 4 professional research proficient experts from UOG
p.000010: at least 1 Guam community representative at least 1 local religious leader
p.000010: at least 1 licensed practicing local medical doctor
p.000010: This composition allows the IRB to remain relatively free from political interference. The UOG President is kept
p.000010: informed of changes in the membership and may appoint qualifi a the CHSR when there are v
p.000010: s.
p.000010: et me assure you, senators, that I am willing to revise Bill No. 347 by working with you and your staff. We all need
p.000010: to work towards the protection of the citizens of Guam who agree to participate in research projects.
p.000010:
p.000010:
p.000010:
p.000010:
p.000010:
p.000010:
p.000010:
p.000010:
p.000010:
p.000010:
p.000010:
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p.000010: 18 representative, in accordance with, and to the extent required by
p.000010: 19 Board regulation.
p.000010: 20 (e) lrdormed consent will be appropriately documented,
p.000010: 21 in accordance with, and to the extent required by Board
p.000010: 22 regulation.
p.000010: 23 ( When appropriate, the research plan makes adequate
p.000010: 24 provision for monitoring the data collected to ensure the safety of
p.000010: 25 subjects.
p.000010:
p.000010:
p.000010: 1 (g) When appropriate, there are adequate provisions to
p.000010: 2 protect the privacy of subjects and to maintain the confidentiality
p.000010: 3 of data.
p.000010: 4 When some or all of the subjects are likely to be vulnerable
p.000010: 5 to coercion or undue influence, such as children, the elderly,
p.000010: 6 prisoners, pregnant women, mentally disabled persons or
p.000010: 7 economically or educatiOnally disadvantaged persons, additional
p.000010: 8 safeguards have been included in the research plans, procedures
p.000010: 9 or protocols to protect the rights and welfare of these subjects.
p.000010: 10 (h) Progress reports or thesis shall be made available to
p.000010: 11 subjects participating in the research as appropriate.
p.000010: 12 Section 24108. Grievance Procedure. lf application for
p.000010: 13 approval is denied for a research proposal, investigators may appeal to
p.000010: 14 the Dean of the Graduate School and Research. The Dean will appoint
p.000010: 15 an ad hoc committee for a second, independent review of the research
p.000010: 16 project. The findings of the ad hoc committee are to be presented to the
p.000010: 17 Committee on Human Subjects in Research no later than ninety (90)
p.000010: 18 days after receipt of grievance from the investigator, to determine the
p.000010: 19 final decision to approve or not to approve a research project.
p.000010: 20 Section 24109. Fines and Penalties. Upon determination of
p.000010: 21 the Review Board through the approved rules and regulations, any
...

p.000008: 14 economically or educationally disadvantaged persons;
p.000008: 15 (d) Informed consent will be sought from each prospective
p.000008: 16 subject or the subject's legally authorized representative, in
p.000008: 17 accordance with, and to the extent required by Board regulation.
p.000008: 18 (e) Informed consent will be appropriately documented, in
p.000008: 19 accordance with, and to the extent required by Board regulation.
p.000008: 20 (O When appropriate, the research plan makes adequate
p.000008: 21 provision for monitoring the data collected to ensure the safety of
p.000008: 22 subjects; and
p.000008: 23 (g) When appropriate, there are adequate provisions to protect
p.000008: 24 the privacy of subjects and to maintain the confidentiality of data.
p.000008: 25 When some or all of the subject are likely to be vulnerable to
p.000008: 26 coercion or undue influence, such as children, the elderly, prisoners,
p.000008: 27 pregnant women, mentally disabled persons or economically or
p.000008: 28 educationally disadvantaged persons, additional safeguards have
p.000008: 29 been included in the research plans, procedures or protocols to
p.000008: 30 protect the rights and welfare of these subjects.
p.000008: 31 §24108. Grievance Procedure. II application for approval is
p.000008: 32 denied for a research proposal, investigators may appeal to the
p.000008: 33 Dean of the Graduate School & Research. The Dean will appoint an
p.000008: 34 ad hoc committee for a second, independent review of the research
p.000008: 35 project. The findings of the ad hoc committee are presented to the
p.000008: 36 Research Review Committee no later than ninety (90) days after
p.000008: 37 receipt of grievance from investigator, to determine the final
p.000008: 38 decision to approve or not to approve a research project.
p.000008:
p.000008: 39 §24109. Fines and Penalties. Upon determination of
p.000008: 40 review board through the approved rules and regulations,
p.000008: the any
p.000008:
p.000009: 9
p.000009:
p.000009: investigator, research sponsor, or their agents, which conducts
p.000009: 2 research subject to regulation in violation of this chapter shall be
p.000009: 3 subject to a fine of One Thousand Dollars ($1,000.00) per each
p.000009: 4 violation and shall be prohibited from continuing and conducting
...

p.000002: defined in Section 102(e) must be reviewed and approved, in compliance with Sections 101,102, ana rod through 117 Of
p.000002: this policy, by an institutional review board (IRB) that operates in accordance witA the pertinent requirements of this
p.000002: policy.
p.000002:
p.000002:
p.000002:
p.000002:
p.000002:
p.000002:
p.000002: 1.18 Børtør (Witb Patitøts or Oients)
p.000002:
p.000002:
p.000002:
p.000002:
p.000002:
p.000002: splay (Warse Staødøxii 1•I7. bluliipi» Refer-i-
p.000002:
p.000002:
p.000002:
p.000002:
p.000002:
p.000002:
p.000002:
p.000002:
p.000002:
p.000002:
p.000002:
p.000002:
p.000002:
p.000002:
p.000002:
p.000002:
p.000002:
p.000002:
p.000002:
p.000002:
p.000002:
p.000002:
p.000002: llTAirŁPsüyRaąuaBorS iæ
p.000002:
p.000002: certification is not submitted within these time limits, the application or proposal may be returned to the
p.000002: institution. (Approved by the Office of Hanagement and Budget under Control Nuatbec 9999-O02 0. )
p.000002: 8ac21one xo4 •arougb 106 [Reaez-vedj
p.000002: Backlog 1o7 ZRB aaabexsb1p
p.000002: a) Each IRB shall have at least five members, with varying backgrounds to promote complete and adequate review of
p.000002: research activities commonly conducted by tRe institution. In addition to possessing the professional competence
p.000002: necessary to review specific research activities, the IRB shall be able to ascertain the acceptability of
p.000002: proposed research in terms of institutional commitments and regulations, applicable law, and standards of
p.000002: professional conduct and practice.
p.000002: b) Every nondiscriminatory effort will be made to ensure that no IRB consists entirely of men or entirely of women.
p.000002: c) Each IRB ehall include at least one member whose primary concerns are in scientific areas and at least one member
p.000002: whose primary concerns are in nonscientific areas.
p.000002: d) Each IRB shall include at least one msmbsr who is not otherwise affiliated with the institution and who is not
p.000002: part of the immediate #amily of a person who is affiliated with the institution.
p.000002: e) NO ORB may have a member participate in review of any project in whicA the membsr has a conflicting interest,
p.000002: except to provide information.
p.000002: f) An IRB may, in its discretion, invite individuals with eompetence in special areas to assist in the review of
p.000002: issues which require expertise beyond or in addition to that available on the IRB. These individuals say not vote with
p.000002: the IRB.
p.000002: 8ec€1oa 1os IeB €uac€1ona and opeg a €1ons. Each IRB shall:
p.000002: a) POllow written procedures;
p.000002: b) Rxcep£ when an expedieed review procedure in used review proposed research at
p.000002: convened meetings at which a majority of the members of the IRB are present, including at lease one member whose
p.000002: primary concerns are in nonscientific areas. In order for the research to be approved, it shall receive the approval
p.000002: of a majority of those members present at the meeting.
p.000002:
p.000005: 5
p.000005:
p.000005: Section 109 IRB Review of Research.
p.000005: a) An IRB shall review and have authority to approve, require modifications in (to secure approval), or disapprove all
p.000005: research activities.
p.000005: b) An IRB shall require that information given to subjects as part of informed consent is in accordance with
...

p.000005: reviewersmay not disapprove the research•
p.000005:
p.000005:
p.000005:
p.000005: a) To approve research covered by this policy the IRB shall determine that all of the following requirements are
p.000005: satisfied:
p.000005: 1 • Risks to subjects are minimized.
p.000005: 2. Risks to subjects are reasonable in relation to anticipated benefits. The IRB should not consider possible
p.000005: long-range effects of applying knowledge gained in The research (foe example, the peesible effecrt:s og
p.000005: I:he research on public policy) as among thoae research risks that fall within the purview of its responsibility.
p.000005: 3. Selection of subjects is equitable.
p.000005: 4. Informed consent will be sought from each prospsctive subject or the subject's legally authorized.
p.000005: 5. Informed consent will be appropriately documented.
p.000005: 6. When appropriate, the research plan makes adequate provision for monitoring the data collected to ensure the safety
p.000005: of subjects.
p.000005: 7. There are adequate provisions to protect the privacy of subjects and to maintain the confidentiality of data.
p.000005: b) When some or all of the subjects are likely to be vulnerable to coercion or undue influence, such as children,
p.000005: prisoners, pregnant women, mentally disabled persona, or econoaicallY or educationally disadvantaged persons,
p.000005: additional safeguards have been included in the study to protect tAe rights and welfare of tRese subjects.
p.000005:
p.000005:
p.000005: Research covered by this policy that has been approved by ah IRB may be subject to further appropriate review by
p.000005: officials of the institution.
p.000005:
p.000005: 8•C*1O» 113 6UfipaO81OO or ¢eza1:aa61on OC Zea &ppg'Ova1.
p.000005:
p.000005: An IRB shall have autAoritY to suspend or terminate approval of research that is not being conducted in accordance with
p.000005: the IRB's requirements or that has been associated witA unexpected serious harm to subjects.
p.000005:
p.000005: Bec21oo 114 coopaxa€1ve Raseacaa.
p.000005:
p.000005: Cooperative research projects are those projects covered by this policy which involve more than one institution. In
p.000005: the conduct of cooperative research projects, each institution is responsible for safeguarding the rights and welfare
p.000005: of husmn subjects and for complying with this policy.
p.000005:
p.000005: An institution participating in a cooperative project may enter into a joint review arrangement, rely upon the review
p.000005: of another qualified ZRB, or nake similar arrangement:a for avoi‹:ling duplication of
p.000005: effort.
p.000005: sactioo us zRe xecora•.
p.000005: An IRB, shall prepare and maintain adequate documentation of IRB activities, including the following:
...

p.000010: off-island institution that does not have its own or other access to a Gtiam based irb. This is based on the idea
p.000010: that the legislative intent is to mandate that any research study involving human subjects has at least one
p.000010: on-island review. If that is the intent, then Guam has a ready mechanism in the form of the UOG CHRS to
p.000010: ensure that all of the following federal requirements are satisfied by any research covered by this law:
p.000010:
p.000010: 1. Risks to subjects are minimized.
p.000010: 2. Risks to subjects am reasonable in relation to anticipated benefits.
p.000010: 3. Selection of subjects is equitable.
p.000010: 4. Informed consent will be sought from each prospective subject or the subject's legally authorized .
p.000010: 5. Informed consent will be appropriately documented.
p.000010: 6. When appropriate, the research plan makes adequate provision for monitoring the data collected to ensure the
p.000010: safety of subjects.
p.000010: 7. Thème are adequate provisions to protect the privacy of subjects and to maintain the confidentiality of
p.000010:
p.000010: 8. When some or all of the subjects are likely to be vulnerable to coercion or undue inBuence, such as children,
p.000010: prisoners, pregnant women, mentally disabled persons, or economimlly or educationally disadvantaged persons, additional
p.000010: safeguards have been included in the study to pixitcct tlu rights and welfare of these subjects.
p.000010: I-However, as currently written, B’ 47 establishes an unnecessary additional‘
p.000010: Moreover, it includes a section 24102. Bonr- me; ppoin end Mntinnancp Renal. which is a confusing listing
p.000010: of membership, and does not fit the federal guidelines for irb stricture. For example, why only include the Director
p.000010: of DPHSS or his/her designee, and not the director of MHSA, DDPR, DOE, or the new agency for disabilities; and why is
p.000010: it so heavily weighted with people having no expertise in research or any academic science† What is the purpose of
p.000010: including an odd assemblage of persons — who may not have the skill and luiowledge for reviewing technical
p.000010: methodologies to ensure informed consent and procedures to handle any risks involved? Within the federal policy for
p.000010: irb’s it states:
p.000010:
p.000010: SOURCE’ Fedeml Rcgjstu June l8 199lJegu1atio«s •ffwtive xc is jeer j Section 107 IRB membership.
p.000010: a) Each IRB shall have at least five memberi with varying backgrounds to promote complete and adequate
p.000010: review of research activities commonly conducted by the institution. In addition to pouessing the
p.000010: professional competence necessary to review specific reseamh activities the IRB shall be able to ascertain
p.000010: the acceptability of proposed research in terms of institutional commitments and regulations, applicable
p.000010: law, and standards of professional conduct and practice.
p.000010: b) Every nondiscriminatory effort will be made to ensure that no IRB consists entirely of men or
p.000010: entirely of women.
p.000010: c) Each IRB shall include at least one member whose primary concerns are in scientific areas and at least one member
p.000010: whose primary concerns are in nonscientific areas.
p.000010: d) Each IRB shall include at least one member who is not otherwise affiliated with the institution and who is not part
p.000010: of the immediate family of a person who is afliliated with the institution.
p.000010: e) No IRB may have a member participate in review of any project in which the member has a conflicting interest,
p.000010: except to provide information.
p.000010: f) An IRB may, in its discretion, invite individuals with competence in special areas to assist in the review
p.000010: of issues which require expertise beyond or in addition to that available on the IRB. These individuals may not vote
p.000010: with the IRB.
p.000010:
p.000010:
p.000010: I recommend tire following changes be made to Bill No. 347 In Section 1. Legislative Findings
p.000010: Replace the second sentence on lines 7-10 which reads: “It further finds thai the creation of a review board is the
p.000010: appropriate body to review proposals, plans, procedures and protocols for research involving human subjects and to
p.000010: approve or disapprove the same.”
p.000010: With: “It further finds that there are institutional review boards on Guam +rbirfi con[omi. to federal guidelines for
p.000010: such entities which are the appropriate bodies to review proposals, plans, procedures and protocols for research
p.000010: involving human subjects and to approve or disapprove the came."
p.000010:
p.000010: Insert into the second paragraph on lines 11-15 an additional condition confronting Guam, so it reads:
p.000010: “Further more, the legislature finds that on occassions human research conducted on Guam does not always acquire
...

Searching for indicator minor:

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p.000005: rights and welfare of subjects.
p.000005: c) An IRB shall require documentation of informed consent.
p.000005: d) An IRB shall notify investigators and the institution in writing of its decision to approve or disapprove the
p.000005: proposed research activity, or of modifications required to secure IRB approval of the research activity.
p.000005: e) An IRB shall conduct continuing review of research covered by this policy at intervals appropriate to the degree of
p.000005: risk, but nOt less than once per year, and shall have authority to observe or have a third party observe the consent
p.000005: process and the research.
p.000005: 8ec€1on 11O Bs$seé1•ad z'•e1ew' pgocaduzeg fog' m €a1O 3c1odo of
p.000005: zogeaacb fgsoo1a1ag no aoaa Oban a1a3ma1 g'1o$t, aoQ Coz' a1zzot cbaBgeo
p.000005:
p.000005: a) In the Federal Register, a list of categories of research that may be reviewed by the IRB through an expedited
p.000005: review procedure will be amended, as appropriate after consultation with other departments and agencies.
p.000005: b) An IRB may use the expedited review procedure to review
p.000005: 1. Some or all of the research appearing on the list and found by the reviewer(s) to involve no more than minimal
p.000005: risk.
p.000005: 2. Minor changes in previously approved research.
p.000005: Under an expedited review procedure, the review may be carried out by the IRB chairperson or by one or more experienced
p.000005: reviewers designated by the chairperson. Reviewers may exercise all of the authorities of the IRB except that the
p.000005: reviewersmay not disapprove the research•
p.000005:
p.000005:
p.000005:
p.000005: a) To approve research covered by this policy the IRB shall determine that all of the following requirements are
p.000005: satisfied:
p.000005: 1 • Risks to subjects are minimized.
p.000005: 2. Risks to subjects are reasonable in relation to anticipated benefits. The IRB should not consider possible
p.000005: long-range effects of applying knowledge gained in The research (foe example, the peesible effecrt:s og
p.000005: I:he research on public policy) as among thoae research risks that fall within the purview of its responsibility.
p.000005: 3. Selection of subjects is equitable.
p.000005: 4. Informed consent will be sought from each prospsctive subject or the subject's legally authorized.
p.000005: 5. Informed consent will be appropriately documented.
p.000005: 6. When appropriate, the research plan makes adequate provision for monitoring the data collected to ensure the safety
p.000005: of subjects.
p.000005: 7. There are adequate provisions to protect the privacy of subjects and to maintain the confidentiality of data.
...

Searching for indicator education:

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p.000002: 77-GtJAv
p.000002:
p.000002:
p.000002: MINA'BENTE KUATTRO NA LIHESLATURAN GUAHAN
p.000002: 1998 (SECOND) Regular Session
p.000002:
p.000002: CERTIFICATION OF PASSAGE OF AN ACT TO I GA’LAHEN G LIAHAN
p.000002:
p.000002: This is to certify that Substitute Bill No. 347 (COR), “AN ACT TO ADD CHAPTER 24 TO DIVISION 3 OF TITLE
p.000002: 17 OF TI-IE GUAM CODE ANNOTATED, RELATIVE TO DESIGNATING UOG'S COMMITTEE ON HUMAN SUBJECTS IN
p.000002: RESEARCH AS THE INSTITUTIONAL REVIEW BOARD FOR REVIEW AND APPROVAL OF RESEARCH CONDUCTED ON GUAM WITH
p.000002: REGARD TO I-HUMAN SUBJECTS,” returned without
p.000002: approval of I Maga"lahen Gradx, was reconsidered by I Liheslaturan Cuahan and after such consideration, did
p.000002: agree, on the 30“ day of December, 1998, to pass said bill notwithstanding the veto of i
p.000002: Maga’lahen Citrix by a vote teen (14) members.
p.000002:
p.000002:
p.000002:
p.000002:
p.000002:
p.000002:
p.000002: Atteste
p.000002:
p.000002:
p.000002: ANNE M. WN
p.000002: enator and Legislative Secretary
p.000002: AN 0ON
p.000002: R. UNPINGCO
p.000002: Speaker
p.000002:
p.000002:
p.000002:
p.000002:
p.000002:
p.000002:
p.000002:
p.000002:
p.000002:
p.000002: Assistant Staff Officer
p.000002: Maga’lahi’s Office
p.000002:
p.000002:
p.000002:
p.000002:
p.000002:
p.000002:
p.000002:
p.000002:
p.000002:
p.000002:
p.000002:
p.000002: Public Law No. 2 4=32Q
p.000002:
p.000002:
p.000002: MINA’ BENTE KUATTnO NA LIHESLATURAN GUAHAN
p.000002: 1997 (First) Regular Session
p.000002:
p.000002: Bill No. 347 (COR)
p.000002: As substituted by the Committee on Education and as amended on the Floor
p.000002:
p.000002: Introduced by: L. A. Leon Guerrero
p.000002: W.B.S.M. Flores
p.000002: T. C. Ada
p.000002: F. B. Aguon, Jr.
p.000002: A. C. Blaz
p.000002: J.M.S. Brown Felix P. Camacho
p.000002: Francisco P. Camacho
p.000002: M. C. Charfauros
p.000002: E. J. Cruz Mark Forbes
p.000002: L. F. Kasperbauer
p.000002: A. C. Lamorena, V
p.000002: C. A. Leon Guerrero
p.000002: V. C. Pangelinan
p.000002: J. C. Salas
p.000002: A.L.G. Santos
p.000002: F. E. Santos
p.000002: A. R. Unpingco
p.000002: J. T. Won Pat
p.000002:
p.000002: AN ACT TO ADD CHAPTER 24 TO DIVISION 3 OF TITLE 17 OF THE GUAM CODE ANNOTATED, RELATIVE TO
p.000002: DESIGNATING UOG'S COMMITTEE ON HUMAN SUBJECTS IN RESEARCH AS THE INSTITUTIONAL
p.000002: REVIEW BOARD FOIt REVIEW AND APPROVAL OF RESEARCH CONDUCTED ON GUAM WITH REGARD TO HUMAN
p.000002: SUBJECTS.
p.000002:
p.000002:
p.000002:
p.000002:
p.000002:
p.000002:
p.000002: 1 BE IT ENACTED BY THE PEOPLE OF GUAM:
p.000002: 2 Section 1. Legislative Findings. Liheslaturan Guahan finds that
p.000002: 3 research studies involving human subjects are conducted on Guam, and
p.000002: 4 realizes a need to protect the rights of persons participating in human
p.000002: 5 research projects through a review of research proposals, plans, procedures
p.000002: 6 and protocols. It further finds that designation of the University of Guam’s
p.000002: 7 (“UOG's”) Committee on Human Subjects in Research as the InstitlltlOTlal
...

p.000012: 9 other accommodations necessary to assist with the function of
p.000012: 10 processing applications. This appropriation shall continue until
p.000012: 11 expended for the operations and purposes specified herein.”
p.000012:
p.000012:
p.000012:
p.000012:
p.000012:
p.000012:
p.000012:
p.000012:
p.000012:
p.000012:
p.000012:
p.000012:
p.000012:
p.000012:
p.000012:
p.000012:
p.000012:
p.000012:
p.000012:
p.000012:
p.000013: 13
p.000013:
p.000013:
p.000013: Tw ñHTY YOU Ft4 , UAN PEG ISLATURE
p.000013: COMMITTEE OU Eii cATIOts
p.000013:
p.000013:
p.000013:
p.000013:
p.000013:
p.000013:
p.000013:
p.000013: La*vzence F.
p.000013: Kasperbauer
p.000013: c1 r*'
p.000013:
p.000013: Senator
p.000013: Sal as
p.000013:
p.000013:
p.000013:
p.000013: UnpiNgCO
p.000013:
p.000013: Menu:or
p.000013: ThomasC.
p.000013: Ana
p.000013:
p.000013: "enatc r
p.000013: Franh B.
p.000013: Aguon
p.000013:
p.000013: he' a to r Elizabeth Barrett- Aiiaerson
p.000013:
p.000013: Vice peaker
p.000013:
p.000013:
p.000013:
p.000013:
p.000013:
p.000013: JoaoneM.S.
p.000013:
p.000013:
p.000013: Senaor feHxé CamacBo
p.000013:
p.000013:
p.000013: CamacHo
p.000013:
p.000013:
p.000013: Ed wardo d.
p.000013:
p.000013:
p.000013:
p.000013: ForDes
p.000013:
p.000013:
p.000013: Angel L.G.
p.000013: Santos
p.000013:
p.000013:
p.000013: Judith
p.000013: ifon Pat-
p.000013: Borja
p.000013: October 22, 1998
p.000013:
p.000013:
p.000013: The Honorable Antonio R. Unpingco Speaker, 24t h te am Legislature Hagdtña, Guam
p.000013: via: Committee on Rules Dear Mr. Speaker:
p.000013: The Committee on Education to which was referred Bill No. 347 (COR): “AN ACT TO ADD CHAPTER 24,
p.000013: DIYISION 3. 17 GCC TO DEST GNA I E THE UT 1’.'*P-3IT Y OF Gt.'AM’S COM4IITTEE OH riMlLN SUEJ*C'TS
p.000013: P? RESFARCI-I IS THE INSTITUTIONAL REVIEIV BOARD FOR REVIEW AND APPROVAL OI RSA ?vFxCH
p.000013: CONDUCTED ON GUAM \VIT1I REGARD TO HU4IAN
p.000013: back u’ith the recommendation TO DO PASS Substitute Bill No. 347. Votes of the committee members are as follows:
p.000013: 7 To Pass
p.000013:
p.000013: Not To Pass
p.000013:
p.000013: To The Inactive File
p.000013:
p.000013: Abstained
p.000013:
p.000013:
p.000013:
p.000013:
p.000013:
p.000013:
p.000013:
p.000013:
p.000013: /\tiachmen ts
p.000013:
p.000013:
p.000013:
p.000013:
p.000013:
p.000013: Education is the lYayl
p.000013:
p.000013: TWEMTY-hOUKl. CUAM LkGISLATURZ
p.000013: COMMITTEE ON EDUCATION
p.000013:
p.000013:
p.000013:
p.000013:
p.000013:
p.000013:
p.000013: Se o etor Lawrence F. Kasperbauer
p.000013:
p.000013:
p.000013: October 22, 1998
p.000013:
p.000013:
p.000013: Se I-'at O r
p.000013: Jonn C.
p.000013: Sat as
p.000013:
p.000013:
p.000013: Antonio R.
p.000013:
p.000013:
p.000013: TO:
p.000013:
p.000013:
p.000013: All Members
p.000013: Committee on Education
p.000013:
p.000013:
p.000013:
p.000013:
p.000013: Se n ato r
p.000013: FROM: Chairman
p.000013: SUBJ: Voting Sheet
p.000013:
p.000013:
p.000013: Senate r
p.000013: Aguon
p.000013:
p.000013:
p.000013: £liznbetn Barrett- Anderson
p.000013:
p.000013: face Speup.000013: Blaz
p.000013:
p.000013: Joanne N.S.
p.000013: BFOW€
p.000013:
p.000013: S°-mo Felix P.
p.000013:
p.000013: Transmitted herewith is the voting sheet and committee report for Substitute Bill No. 347 (COR): “AN ACT TO
p.000013: ADD CHAPTER 24. DIVISION 3, 17 GCA TO DESIGNATE THE UNIVERSITY OF GUAM’S COMMITTEE ON HUMAN SUBJECTS IN RESEARCH
p.000013: AS THE INSTITUTIONAL REVIEW BOARD FOR REVIEW AND APPROVAL OF RESEARCH CONDUCTED ON GUAM WITH REGARD
p.000013: TO HUMAN SUBJECTS.”
p.000013: Your attention to this matter is greatly appreciated.
p.000013:
p.000013:
p.000013:
p.000013: Sincerely,
p.000013:
p.000013:
p.000013: F.
p.000013:
p.000013: Attachments
p.000013:
p.000013:
p.000013:
p.000013:
p.000013:
p.000013:
p.000013: Narn
p.000013:
p.000013:
p.000013:
p.000013:
p.000013:
p.000013:
p.000013:
p.000013:
p.000013:
p.000013:
p.000013:
p.000013: Education is the had I
p.000013:
p.000013: COMMITTEE ON EDUCATION
p.000013: TWENTY-FOURTH GUAM LEGISLATURE
p.000013: 155 I-tesler Street, Agana, Guam 96910
p.000013:
p.000013:
p.000013: Chairman: Senator Lawrence F. Kasperbauer Vice Chairman: Senator John C. Salas Ex-Officio Member: Speaker
p.000013: Antonio R. Unpingco
p.000013:
p.000013:
p.000013: VOTING SHEET ON:
p.000013:
p.000013: Substitute Bill No. 347 (COR): “AN ACT TO ADD CHAPTER 24, DIVISION 3, 17 GCA TO DESIGNATE THE UNIVERSITY OF GUAM’S
p.000013: COMMITTEE ON HUMAN SUBJECTS IN RESEARCH AS THE INSTITUTIONAL REVIEW BOARD FOR REVIEW AND APPROVAL OF RESEARCH
p.000013: CONDUCTED ON GUAM WITH REGARD TO HUMAN SUBJECTS.”
p.000013:
p.000013:
p.000013:
p.000013: COMMITTEE MEMBERS
p.000013:
p.000013: Sen. Lawrence F. Kasperbauer Sen. John C. Salas
p.000013: Spkr. Antonio R. Unpingco
p.000013: Ex-Officio Member
p.000013:
p.000013: Sen. Thomas C. Ada
p.000013: Member
p.000013:
p.000013: INITIAL
p.000013: TO PASS
p.000013: NOT TO PASS
p.000013: TO PLACE IN
p.000013: ABSTAIN INACTIVE FILE
p.000013:
p.000013: Sen. Frank B. Aguon, Jr.
p.000013: Member
p.000013:
p.000013: Sen. Anthony C. Blaz
p.000013:
p.000013: Member
p.000013:
p.000013: Sen. Joanne M.S. Brown
p.000013:
p.000013: Member
p.000013:
p.000013: Sen. Felix P. Camacho
p.000013:
p.000013: Member
p.000013:
p.000013: Sen. Francisco P. Camacho
p.000013:
p.000013: Member
p.000013:
p.000013: Sen. Edwardo J. Cruz
p.000013:
p.000013: Member
p.000013:
p.000013: Sen. Mark Forbes
p.000013: Member
p.000013:
p.000013: Sen. Angel L.G. Santos
p.000013: Member
p.000013:
p.000013: Sen. Judith Won Pat
p.000013:
p.000013: Member
p.000013:
p.000013: COMMITTEE REPOIJT COMMITTEE ON EDUCATION May 5, 1998
p.000013:
p.000013: Bill No. 347: AN ACT TO CREATE A REVIEW BOARD OF REVIEW AND APPROVAL OF RESEARCH CONDUCTED ON GUAM WITri nEcAnD To
p.000013: HuMAN SUBJECTS.
p.000013:
p.000013: Senadors present: Senator Larry Kasperbaur, Chairperson, Senator Lou Leon Guerrero, Senator Mark Charfauros
p.000013: and Senator Frank Camacho.
p.000013:
p.000013: Those present to testify were: Dr. Jose T. Nededog, President, University of Guam, Dr. Joyce Camacho, Dean of
p.000013: Graduate School and Research, University of Guam, Dr. Kyle Smith, Professor of Psychology, University of Guam, Dr.
p.000013: Randall L. Workman, Professor of Sociology, University of Guam, Gregoria Smith, Psychometrist, UOG /UCSD Research
p.000013: Project, Mr. Ray Adonay, Dr. Bert Weiderholt, Physician/ Neurologist, University of California-San Diego and
p.000013: Debbie Quinata.
p.000013:
p.000013: Those not present, but submitted written testimony were: Dr. John Steele, Dr. Marcus Tye, Asst. Professor,
p.000013: Psychology, University of Guam, Dr. Richard Colfax, Management & Marketing Chairperson, University of Guam,
p.000013: Dr. Seyda Turk Smith, Associate Professor, Psychology, University of Guam, Dr. Pamina J. Hofer, Clinical
p.000013: Neurolopsychologist and Guam Lytico and Bodig Association.
p.000013:
p.000013: Overview of Bill
p.000013:
p.000013: Senator Lou Leon Guerrero shared with the Committee members and the audience an overview of Bill 347.
p.000013:
p.000013: Bill 347 was drafted as a result of a public hearing conducted during the 23rd Guam Legislature when Senator Lou Leon
p.000013: Guerrero was Chairperson of Health, Welfare & Senior Citizens to discuss various
p.000013:
p.000013:
p.000001: 1
p.000001:
...

p.000003: not federally required. Dr. Weiderholt and the project he is now involved in on Guam, had no hesitation in
p.000003: submitting application for research to the University of Guam and the Guam Memorial Hospital - both were
p.000003: approved.
p.000003:
p.000003: Senator Charfauros supports research and Bill 347. He suggested various amendments to the bill: need
p.000003: rules/regulations, more liability for researchers, require license to practice, progress reports made available to
p.000003: public, increase fine to $10,000 for violation, commercial profits need to be shared with research subjects and no
p.000003: exploitation of research subjects.
p.000003:
p.000003:
p.000004: 4
p.000004:
p.000004: Senator Kasperbauer shared his concerns with exploited research subjects and need protection.
p.000004:
p.000004: Final gar
p.000004:
p.000004: Aauthor of Bill 347, Senator Lou Leon Guerrero gave final remarks. She welcomed any amendments to assure the intent
p.000004: of legislation is achieved - to protect human subjects. Although there are IRBs at Guam Memorial Hospital and
p.000004: the University of Guam, there is research being conducted that are not associated with these institutions.
p.000004: Therefore, we are not assured that the research subjects are protected. When discussing the bill with the
p.000004: representatives at the University of Guam, there was discussions to expand the exlsting Human Research Committee.
p.000004: The community needs to be part of the research conducted.
p.000004:
p.000004: Recommendation
p.000004: It 1s the recommendation of the Committee on Education TO DO PASS AS SUBSTITUTED BY THE AUTHOR BILL NO. 347, AN ACT TO
p.000004: ADD CHAPTER 24, DIVISION 3, 17 GCA TO DESIGNATE THE UNIVERSITY OF GUAM'S COMMITTEE ON HUMAN SUBJECTS IN RESEARCH AS
p.000004: THE INSTITUTIONAL REVIEW BOARD FOR REVIEW AND APPROVAL
p.000004:
p.000004:
p.000004:
p.000004:
p.000004:
p.000004:
p.000004:
p.000004:
p.000004:
p.000004:
p.000004:
p.000004:
p.000004:
p.000004:
p.000004:
p.000004: APR*
p.000004:
p.000004: MEMORANDUM
p.000004:
p.000004: TO: Chairman
p.000004: Commi e Education
p.000004:
p.000004: FROM: Chair
p.000004: Committee on Rules, Government Reform and Federal Affairs SUBJECT: Referral - Bill No. 347
p.000004: The above Bill is referred to your Committee as the principal committee. lt is recommended
p.000004: you schedule a public hearing at your earliest convenience.
p.000004:
p.000004: Thank you for your attention to this matter.
p.000004:
p.000004:
p.000004:
p.000004: MARK FORBES
p.000004:
p.000004:
p.000004: Attachment
p.000004:
p.000004: TWENTY-FOURTH GUAM LEGISLATURE
p.000004: 1997 lFirst) Regular Session
p.000004:
p.000004: Bill No. 347
p.000004: As substituted by the Author
p.000004: Introduced by: L. Leon Guerrero
p.000004: W.Flores T.Ada
p.000004:
p.000004: AN ACT TO ADD CHAPTER 24, DIVISION 3, 17 GCA TO CREATE A REVIEW BOARD FOR REVIEW
p.000004: AND APPROVAL OF RESEARCH CONDUCTED ON GUAM WITH REGARD TO HUMAN SUBJECTS.
p.000004:
p.000004: BE IT ENACTED ON BY THE PEOPLE OF THE TERRITORY O F GUAM:
p.000004: 3 Section 1. Legislative Findings. The legislature finds that
p.000004: 4 research studies involving human subjects are conducted on Guam
p.000004: arid realizes a need to protect the rights of persons participating in
p.000004: 6 human research projects through a review of research proposals,
p.000004: 7 plans, procedures and protocols. It further finds that the creation of
p.000004: 8 a review board is the appropriate body to review proposals, plans,
p.000004: 9 procedures and protocol for research involving human subjects and
p.000004: 10 to approve or disapprove the same.
...

p.000004: 6 behalf of a prospective subject to the subject’s participation in the
p.000004: 7 procedure(s) involved in the research.
p.000004: 8 (d) Research means a systematic investigation, including
p.000004: 9 research development, testing and evaluation, designed to develop
p.000004: 10 or contribute to the understanding of a particular condition or
p.000004: IJ generalized knowledge. Activities which meet this definition
p.000004: 12 constitute research for purposes of this policy, whether or not they
p.000004: t3 are conducted or supported under a program which is considered
p.000004: 14 research for other purposes. For example, some demonstration and
p.000004: 15 service programs may fall under this definition of research. Not
p.000004: 16 included in this definition are:
p.000004: 17 (1) Opinion polls or other similar investigations of the
p.000004: 18 human subjects' opinions or beliefs;
p.000004: 19 (2) Research conducted in established or commorily
p.000004: 20 accepted educational settings, involving normal
p.000004: 21 educational practices, such as (i) research on regular
p.000004: 22 and special education instructional strategies or (ii)
p.000004: 23 research on the effectiveness or the comparison among
p.000004: 24 instructional techniques, curricula or classroom
p.000004: 25 management methods;
p.000004: 26 (3) Research involving the use of educational tests
p.000004: 27 (cognitive, diagnostic, aptitude, achievement), survey
p.000004: 28 procedures, interview procedures or observation of
p.000004: 29 public behavior, unless: ;(i) information obtained is
p.000004: 30 recorded in such a manner that human subjects can be
p.000004: 31 identified, directly or through identifier's linked to the
p.000004: 32 subjects; and (ü) any disclosure of the human subject's
p.000004: 33 responses outside the research could reasonably place
p.000004: 34 the subject at risk of criminal or civil liability or be
p.000004: 35 damaging to the subject's financial standing,
p.000004: 36 employability or reputation;
...

p.000008: 34 ad hoc committee for a second, independent review of the research
p.000008: 35 project. The findings of the ad hoc committee are presented to the
p.000008: 36 Research Review Committee no later than ninety (90) days after
p.000008: 37 receipt of grievance from investigator, to determine the final
p.000008: 38 decision to approve or not to approve a research project.
p.000008:
p.000008: 39 §24109. Fines and Penalties. Upon determination of
p.000008: 40 review board through the approved rules and regulations,
p.000008: the any
p.000008:
p.000009: 9
p.000009:
p.000009: investigator, research sponsor, or their agents, which conducts
p.000009: 2 research subject to regulation in violation of this chapter shall be
p.000009: 3 subject to a fine of One Thousand Dollars ($1,000.00) per each
p.000009: 4 violation and shall be prohibited from continuing and conducting
p.000009: 5 human research studies for not less than 2 (two) years. “
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p.000010: 10
p.000010:
p.000010: University of Ruam
p.000010: Unibetsedåt Guahan
p.000010: OFFICE OF THE PRESIDENT
p.000010: UOG Station, Mangilao, Guain 96923
p.000010: Telephone: (671) 735-2990• Fax: (67 I) 734-2296
p.000010:
p.000010:
p.000010:
p.000010:
p.000010: May 5, 1998
p.000010: The Honorable Lawrence Kasperbauer Chairman, Committee on Education 24th Guam Legislature
p.000010: 155 Hessler Drive
p.000010: Agana, GU 96910
p.000010:
p.000010: Re: AN ACT TO CREATE A REVIEW BOARD FOR REVIEW AND APPROVAL OF RESEARCH CONDUCTED ON GUAM WITH REGARD TO
p.000010: HUMAN SUBJECTS.
p.000010: Dear Chairman Kasperbauer:
p.000010: I am here today to testify in support of Bill No. 347. This bill proposes to create a Guam Research Review Board
p.000010: for review and approval of research conducted on Guam with regard to human subjects. University
p.000010: administrators and faculty agree that any research on our island must undergo one review process.
p.000010: However, since the Guam Research Review Board would be a dnplication of the University of Guam’s Committee on Human
p.000010: Subjects in Researeh (CHSR), I iecommcnd that CHSR, under the Office of Graduate School and Research, be
p.000010: designated as the Institutional Review Board (IRB) for researchers and collaborators at the University and for
p.000010: researchers who are not under other IRBs.
p.000010:
p.000010: lt is noted that theie is no mention of additional financial or human resources to accomplish the
p.000010: numerous tasks as specified in the bill. At the present time, Graduate School and Research has only
p.000010: three employees listed in its staffing pattern, and each of these employees has a clearly defined job
p.000010: description and delineated tasks. To comply with the bill’s proposed tasks, it is essential to add one clerical
p.000010: staff position and funding for a computer, office fumiture, and supplies. In addition, funds would
p.000010: be needed for advertising or informing the community about the Committee on Human Subjects in Research
p.000010: to assure that researchers submit research proposals for review.
p.000010: Sincerely,
p.000010:
p.000010:
p.000010: Jose T. Nededog
p.000010:
p.000010: JOHN C. STEELE, M.D., FRCP(C)
p.000010: NEUROLOGIST
p.000010: FELLOW, AMERICAN COLLEGE OF PHYSICIANS
p.000010:
p.000010:
p.000010: May 11, 1998
p.000010:
p.000010: Senator Lawrence F. Kasperbauer Chairman, Committee on Education Twenty-Fourth Guam Legislature
p.000010:
p.000010: Dear Dr. Kasperbauer
p.000010:
p.000010:
p.000010: TePFax: (671) 828-30¢)0
p.000010:
p.000010: I am writing to provide testimony about Bill 347 to “create a review board for review and approval of research
p.000010: conducted on Guam with regard to human subjects”.
p.000010:
p.000010: I agree with the intent of the Bill but I have concerns about the mechanism it proposes to achieve the intent. It is a
p.000010: bill which proposes a “ fox to guard the hen house”
p.000010:
p.000010: That intent of bill 347 is to be certain that all medical research on Guam is reviewed and approved by a Committee
p.000010: which will assure protection of human subjects.
p.000010:
p.000010: In October 1995 at a Legislative Oversight Hearing about lytico-bodig research on Guam which was chaired by Senator
p.000010: Leon Guerrero all participants, including myself agreed that such review and approval was desireable.
p.000010:
p.000010: After that Oversight Hearing, Dr. Ulla Craig and her medical research associate Dr. Wigbert Wiederhoh composed this
p.000010: Bill at the request of Senator Lou Leon Guerrero. However many of us disagreed that the authority of this process
p.000010: should rest in Dr. Craig’s Division at the University of Guam, since she and Dr. Wiederholt were pursuing their own
p.000010: exclusive human subject studies of lytico-bodig there. We felt there would be a conflict of interest and that putting
p.000010: the authority with them could jeopordize similar and competing studies by myself and other scienticists wishing to
p.000010: conduct research on Guam.
p.000010:
p.000010: Senator Leon Guerrero understood that and set the Bill aside.
p.000010:
...

p.000010: the authority for reviewing and approving research involving human subjects remains with the (established) GMH IRB and
p.000010: UOG Human Subjects Committee. To ensure protection for human subjects, I recommend that you and your Committee mandate
p.000010: prior approval of all human subject research by one or other Committee, subject to the fines and penalties of Section
p.000010: 24109, if investigators fail to comply.
p.000010:
p.000010: Your favorable decision of these recommendations will ensure fairness in research and avoid the possability of
p.000010: discrimination against my studies by Drs. Craig and Wiederholt, and members of the UOG Graduate School.
p.000010:
p.000010: I thank you.
p.000010:
p.000010:
p.000010: John C. Steele MD Neurologist
p.000010:
p.000010: Madeleine Z. Bordallo, President of the Guam Lytico & Bodig Association Norbert Perez, President of the Republic of
p.000010: Guahan
p.000010: Tyrone Taitano, Chairman GMH IRB
p.000010: Professor John Hardy, Professor of Pharmacology Mayo Clinic Jacksonville
p.000010: Professor Teepu Siddique, Director Neurogenetics Laboratory, Nothwestem University Professor Nicholas Wood, Department
p.000010: of Genetics, National Hospital Queen Square Professor Patrick McGeer, Kinsmen Laboraotory of Neurological research,
p.000010: Vancouver
p.000010: Dr. Marcelle Morrison-Bogorad, Associate Director of Neuroscienc and Neurophysiology of Aging Program, National
p.000010: Institute of Aging
p.000010:
p.000010: z•.O. Box 4jia A/ana ‹fi an• 96932
p.000010: . • • 4 7- 294
p.000010:
p.000010:
p.000010:
p.000010: Senator La me F. Kaperbauer
p.000010: Chat*-man, Committee on Education
p.000010: 2 15-A Chat an Santo Papa, Suite SOG F Ada's Professfionat 6.omme.rcial Center Agana, Guam g6932
p.000010: Deer SenatorK perbauer,
p.000010: Thsnk you for licltlng comments and view s o£the Guam L'ytICO and Bodig
p.000010: Assop.000010:
p.000010: Mnivcrsi¿y o£ G amp be and approva
p.000010: regard to humn subj ”
p.000010: of nesea•-ch conducted on Guam wit+r-”“ " ”””"" “"“" ”
p.000010: We agree thai cl\ research I+waiving human p•bjt cts should be reviewed b'y a htaman
p.000010:
p.000010: stiLjec-cs committee arid thai oIl investigo*or
p.000010: w-qui••ed to ave approval J’or thefr studies
p.000010: We have a ni mber of' specify c concerns abou
p.000010: you and you committee.
p.000010: 1.
p.000010: can ducting such I-esearch
p.000010:
p.000010: Bilf 34-7 which we u/ish to share with
p.000010:
p.000010: pa g nrese
p.000010: GusmiMemomat
p.000010:
p.000010: hoossppiitaal a g rreeccoommmmeended
p.000010: bg/ Federal IRB
p.000010: egu
p.000010: amons. 7ts state+tes also foltow
p.000010: guideline pertaining
p.000010:
p.000010:
p.000010: WO
p.000010:
p.000010: z. We have speci6c infie.rest•
p.000010: patients we
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p.000010: 3.
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p.000010: We recommend that tHe e Eng 1RBs w Gh
p.000010: v boarp.000010:
p.000010: the advantages tHat you to see In Che new r
p.000010: ia m& posMbm Men me hop e you TH Wedd
p.000010: we heve raised.
p.000010: Thank you foe consulting n e and Ore Guard
p.000010: preser,r ciii t o clamp the co•@r '• co ana B•dig .Bssociazion in t1'sis
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p.000010:
p.000010: New d!cs› i‹ say, the ultimate benefactors of the rcsu1ts of one's
p.000010: schs I +‘l) eLfortS are neither the conductor of the reseai ch although he n*>l ^* ñ‹ ‹›?,iiized by his
p.000010: pecrs in one w ay or anotliei’ nn' ltte assistants vl r* o idc so-called leg v ork for the researcher.
p.000010: The real benefactors arc 1)1OS £ is hose qualilJ of lii iiig will be made bettcr by such a
p.000010: disct4\ cry and the young i1i‹jtiisitive minds who will push off from where
p.000010: WC I C‹It c, either to affirms or hegaie eat findings. The scholars and
p.000010:
p.000010: stakeholders in this deliberatlon today must then, recognize that it is' the community at large and humanity in
p.000010: general who would benefit from the results. l8 ordei to do this we must all safeguard the quality of researches
p.000010: performed here and that they be done in the strictest ethical standards that show respect to those people without
p.000010: whom wc will
p.000010: not be able to conduct our studies.
p.000010:
p.000010: This bill will objectify what some of us are doing in the nance of “Research”. It will make us accountable for what
p.000010: we do in its name and will enforce the standards that are recognized most anywhere else.
p.000010:
p.000010:
p.000010: Thank you for your kind attention.
p.000010:
p.000010: Gregoria Smith Community Psychologist Tel/ Fax ti49 7571
p.000010:
p.000010:
p.000010: o AERSMYOFGUAM “
p.000010: 1 BETSEDAT U H
p.000010: oiveiox or scCxOxLaLuEaGxEnxOvFioARTS &scSiECIfElcNcCsESa socs wonx
p.000010: TeTepNOl (07J) 735-2870 FW {6 '1) Kg
p.000010:
p.000010:
p.000010:
p.000010:
p.000010: rsou:
p.000010: The Fiono/able La\•tence F. ffaaperbayer
p.000010: Senator. Chair. 6ég\mt¥ee on Education
p.000010: Dr. Maiozs C. Ty«„AssL Professor, Psychology PHouS
p.000010: University df Gvc 'i
p.000010: Dr. Mary L Spec, Dean. College ofAns A S‹ñennee, UOG
p.000010: 671-475-2000 ‘.
p.000010:
p.000010: 8Tt7 25f
p.000010: Or. u8a-Katñpa Or¥ig. Chad. Committee on Human Research Subjects, UOG
p.000010:
p.000010:
p.000010: Bill No. 347, An Ais to Create a Revie\y Board fa Reviaw ond Approval of Research Cond‹zctgd on Guam with Regerd!to
p.000010: Human Subjects
p.000010: essage• , ' !
p.000010: '
p.000010: Dear Seriatpr Ka*p&bauer, .
p.000010: ‘ ’ “* .
p.000010: I write to urge you a lobby against Bill No. 347. I am a faculty mem6er of the University of Guam wbere i I am engaged
p.000010: in an activé program of research, as are many of my colleagues. Research is of ina•lnsic benefit té the commune (both
p.000010: here on Guam and elsewhcreJ and directly helps student learning. I take pridé in the Su *f 'r'rés aich that is
p.000010: being fostwed at the University of Guam and am puzzled by Bifl No. 347. The spirit ofth#. bifl'is fully appropriatwit
p.000010: is irdeed important to be concernaJ first far tke welfare of human subjects. gmt to pr.ott•ts human.subj what
p.000010: is puzzling to me is the need fo' sucb a i
p.000010: ! bill; es etaally one that danstralns research done at the University, since UOG already has a review
p.000010: process that very carefull:y monitor research. Some of the many reasons against this bill include: ,'
p.000010: \. Such a law would be largely unjsecedented. Virtually all jurisdictions in the US and many o
p.000010: countries allow universiii@ and hospiBls to administer research internally. Indeed; UOG alieady has ,
...

p.000010: RescamK THE PEOPLE OF GUAM ARE SWERBLT PRO1ECTbD BT THE BXiSTINO REVIEW BOARDS when arch0 proesued tbrougit
p.000010: &cni.
p.000010: m ei rd Board. GUAM FiEEDS TO HAVE THS UOtS
p.000010: E FOR H IN RESEARCH (CHSR) DESIGNATED BY TH6 GUAM
p.000010: LEGISLATURE AS THE REVIEW BODY POR nLL RESEARCH RELATED TO HU$4AN SUBJEC
p.000010: nuraces r;mcz or cm. ,tin uoc rai‹i« in r«›«i»ma«trms t»ma
p.000010:
p.000010:
p.000010: Todoto,
p.000010:
p.000010:
p.000010:
p.000010: . I STD * URG8 YOLI AND YOUR COI fdITTEE ON EDUCATfOX TC RS- CONMDBIT TIIBp ARGUMENTS RSGABOING B!LL #34?.
p.000010: URG6 TI4B COMMI B TO Mt)VB THAT BILk C347 \JND5RGO SERIOUS REVJfiION SO THAT JT WILL EI POWER MD EU 7POR7 THE
p.000010: UOG COMMTTTg£ FOCI HUMAN 3U0JECT IN RESSAItCI4
p.000010: (cusp›'• ›h ‹»•=a•t /›g voc gait•ie u«t »« M due cvAu zzssAecn ›‹Evisw aoARo FOR IfUMAN SUB48 CTS.
p.000010: Dankoto Na Si Yu’os \4a’ese for tire opportupity to voice en opinion repealing whx Bill ¥347 should be
p.000010:
p.000010: —1998 (fi: 49HN FRON ABS
p.000010: P. 81
p.000010:
p.000010: NI RSITY OF GuAM
p.000010: NI ETSEDAT GLAHAN
p.000010: P6YCHOLOGY PROGRAM
p.000010: ŒVT9ION OF 8OCIAL/BENAVFORAL 9ŒENCEB SOCtAL YORK
p.000010: eyda 7Qck Smith, Ph. D.
p.000010: C )O i3t&tort, zhao, 9 28
p.000010: Tei«t›t›e»e. (671) 7eS-ze»i F•«: {871) 7e4-5zs«
p.000010: e-hill Ttsmilhfluog9 edu
p.000010:
p.000010:
p.000010: Sejjator Lawfenee F. Kasperbauer
p.000010:
p.000010: Twenty-fourth Gtiam Legiolatgre Committee on Education
p.000010: Reference : Bill #34s Relaäve to Creafing a Guani Research Review Board
p.000010: As a researcfiez ans an eduœtox teachîng zeseacch stethodotogy and mtpefv’‘iaing undergraduate research at
p.000010: the University of Guari, I finally oppooe tp the mtablislurient of a new "Guam heseamh Review Board"
p.000010: that will oversea all research conducted on Guam This will make undergraduate march impossible to
p.000010: cenduct and will deprive UOG stpdents of valuabl!e.reseamh experience. I would like to state some of œy
p.000010:
p.000010: 1. And rmearch thatis cnndncted at the UOG is being feviewed - and will
p.000010:
p.000010: tînae
p.000010: Subjects
p.000010: by the University's Committee on Human to æsure ’the pmtection of the rights ef petaons
p.000010: Under the present system,
p.000010: undergraduate teseacdiers working under faculty supervision can design, submit for review, and conduct a
p.000010: study within one semcster. Such research which typically is noninvasive and straightforward - needs only
p.000010: an expedited review, and the approval takee approximately 7-8 It will be impossible t;D Ôt
p.000010: another review by another Reseæch Review
p.000010:
p.000010: 2. Given that all Undergraduate research is reviewed by the University’s Committee on Human Research
p.000010: Subjects, the duplication of this process ses unneœssary and redundont The Univenity’s review
p.000010: boacd han a gœd öack æœzd aztd has been able to zeview æsearch applicaôons anü protect the Rights of human
p.000010: subjefls euccessfully.
p.000010:
...

p.000010:
p.000010: urk Smith, IPh. D.
p.000010:
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p.000010: TOTFIL P. BZ
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p.000010:
p.000010:
p.000010:
p.000010: ETHICAL PRINCIPLES AND GUIDELINES FOR TI-BE PROTECTION OF HUMAN SUBJECTS
p.000010: OF RESEARCH
p.000010: A Summary of the Belmont Report
p.000010: sha nat:ional coeaisalon ccc sha P 'o*ec¢1ozt of Buzaao Bub§ ects o2 Biomedical fi Behavioral
p.000010: Research
p.000010:
p.000010:
p.000010:
p.000010:
p.000010: The following consists of quoted excerpts. A copy of the complete report is available in eha £11se of ehe Joe
p.000010: cormie€ae cor tiuaan Reseaccn Subjseen , Gratiuazs gchoo1 and Reeaat-ch O££lce .
p.000010:
p.000010:
p.000010: {NTRODU ION
p.000010:
p.000010: Scientific research has produced substantial social benefits.
p.000010: It has also posed some troubling ethical questions.
p.000010: Since 194], various codes £or the proper and responsible conduct of human experimentation in medical research have been
p.000010: adopted. These are the Nuremberg Code of 1947, the Helsinki Declaration of 1964 (revised i975), and the 1971
p.000010: Guidelines (codi#ied into Federal Regulations in 1974) issued by the U.S. Department of Health, Education, and
p.000010: Welfare. Codes for the conduct of social and behaVioral research have also been adopted, by the American Psychological
p.000010: Association, 1973.
p.000010: Three principles, or general prescriptive judgments, that are relevant to research involving human subjects are
p.000010: identified in these statements. These should assist scientists, subjects, reviewers and interested citizens to
p.000010: understand the ethical issues inherent io research involving human subjects.
p.000010: mis report consists of a distinction between research and practice, a discussion of the three basic ethical
p.000010: principles, and remarks about the application of these principles.
p.000010:
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p.000010: 2. Asses#eent of Aisks and ]exeflts• presents botA an opportunity and a responsibility to gatAer systematic
p.000010: and comprehensive information about proposed resesrcA, including alternative ways of obtaining tAe benefits
p.000010: sougAt in tAe zssearsA. Pos fibe lnves€1gacoz', IN la a aeans jzo exax£na obefibac tbe puopoaaA
p.000010: research is properly deslgned. Por a review ooemittee, lt is a matAod for determining wAetAertée risAs to sub3ectsara
p.000010: justified. The cert "r1.ak" refers I:o a posslbill£y thai harm may comer •
p.000010: £0 Includes re£arence botL to tha chance (probab111t:y) of nxparlenclnq a hara and
p.000010: the sevarlty (gaqnit:ude) of the envlalonad Aarm. Tñe term "benefit" is used to refer to aometAing of
...

p.000003: conducting research obtains (1) data through intervention or interaction with the individual, or (2) identifiable
p.000003: private information. (]xterventlon and private information are given expanded definition)
p.000003:
p.000003:
p.000003: (h) IRB appz-ova-I ...
p.000003:
p.000003: (i) Blzimal rlsk means that the probability and magnitude of harm or discomfort anticipated in the research are not
p.000003: greater in and of themselves than those ordinarily encountered in daily life or during the performance of routine
p.000003: physical or psychological examinations or tests.
p.000003: (j) Certification means the official notification by the institution to the supporting department or agency, in
p.000003: accordance with the requirements of this policy, that a research project or activity involvinghuman subjects has been
p.000003: reviewed and approved by an IRB in accordance with an approved assurance.
p.000003:
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p.000003:
p.000003: (b) Unless otherwise required . . . research activities in which the only involvement of human subjects will be in one
p.000003: or more of the foLloWing categories are exempt from this policy:
p.000003: (1) Research conducted in established or commonly accepted educational settings, involving normal educational
p.000003: practices, such as (i) research On regular and special education instructional strategies, or (ii)
p.000003: research on the effectiveness oY or the comparison among instructional techniques, curricula, or classroom
p.000003: management methods.
p.000003: (2) Research involving the use of educational tests (cognitive, diagnostic, aptitude, achievement), survey
p.000003: procedures or observation of public behavior, unless:
p.000003: (i) Information obtained is recorded in such a manner that human subjects can be iaent:if1e‹t, directly
p.000003: or through identifiers linked to the subjects; and (ii) any disclosure of the human subjects' responses outside
p.000003: the research could reasonably place the subjects at risk of criminal or civil liability or be damaging tO the
p.000003: subjects' financial standing, employability, or reputation.
p.000003: (3) Research [under 101(b)(2)] that is not exempt under paragraph (b)(2) of this section, if: (i) ... subjects are
p.000003: elected or appointed public officials or candidates for public office; or (ii) federal statute(s) require(s)
p.000003: without exception that the confidentiality of the personally identifiable information will be maintained
p.000003: throughout the research and thereafter.
p.000003: (4) Research, involving the collection or study Of existing data, documents, records, pathological specimens, or
p.000003: diagnostic specimens, if these sources are publicly available or if the information is recorded by the investigator in
p.000003: such a manner that subjects cannot be identified, directly or through identifiers linked to the subjects.
...

p.000005: involve human suh3eHs In the researcht I:he research afraid fl.ref be reviewed and approved by an IRB,
p.000005: as provided In this policy.
p.000005: Bec€1oa 120 Bea1ua61•a aaA d1apoa1€1on
p.000005: pcoposala €ou xeeaazcb •o b• coaauc•e4
p.000005:
p.000005: The department or agency head will evaluate all applications and proposals involving human subjects submitted to the
p.000005: department or agency
p.000005: 8ac€1oa 121 [Reserved]
p.000005: seoa£on xzz Ose o€ s•d•xa1 €uo4a.
p.000005: Pederal funds administered by a department or agency may not be 4zpendmd for research involving human subjects
p.000005: unless the requirements of this policy have been satisYiud.
p.000005: Bacg1oa 123 Bnz'1g' €•zmñDab1oO of z'eaaag'cb guppozfi I Bva1tza€1oo oC app11oaC1oaa aod pxopoaals.
p.000005: a) The department or agency head nay require that department or agency support for any project to be terminated or
p.000005: suspended when the department or agency head Sinds an institution has materially failed to comply with the terms of
p.000005: this policy.
p.000005: sa«g1oa 12« cooa181o¥ta1 Zae appg'o 1.
p.000005: The department or agency head may impose additional conditions prior to or at the time of approval when in the judgment
p.000005: of the department or agency head additional conditions are necessary.
p.000005:
p.000005:
p.000005:
p.000005:
p.000005:
p.000005:
p.000010: 10
p.000010:
p.000010: t estimony recommyyding changes to Bill 347 Profsof Smiology and Commuiñty De*el°i*i&t
p.000010: College of Agriculture & Life Scit•-, U£Ki
p.000010:
p.000010:
p.000010: Greetings to Senator Kasperbauer, members of the Committee On Education, and other attendees to today’s Public
p.000010: Hearing. I speak on the subject of Bill 347 drawing from my experience of 20 years conducting research involving human
p.000010: subjects on Guam and in Micronesia, and my tenure with the University’s Committee on I-luman Research Subjects since
p.000010: it’s inception in 1982.
p.000010: I strongly support the intent of Bill 347 that any research study involving the participation of citizens and residents
p.000010: of Guam should be required to have at least one review by an appropriately constituted institutional review board
p.000010: established on Guam
p.000010: Scientific research has produced substantial social benefits, yet has also posed some troubling ethical queitions.
p.000010: Since 1945, various codes for the proper and responsible conduct of human experimentation in medical research hsve
p.000010: been adopted. Basic principles of research involving human subjects developed by these codes have been summarized in
p.000010: the Belmont Report, by The National Commission for the Protection of Human Subjects of Biomedical & Behavioral
p.000010: Research, U.S. Department of Health, Education and Welfare (Published: April 18, 1979). I note this an‹ attach a
p.000010: summary of it for you to clarify the ethical issues inherent in research involving human subjects. The essential heart
p.000010: of concern is
p.000010: Respect for Persons: the idea that individuals are capable of deliberation about personal goals and of acting under
p.000010: the direction of such deliberation. To respect autonomy is to give weight to a persons’ considered opinions and
p.000010: choices. To show lack of respect for an autonomous agent is to deny an individual the freedom to ad on those considered
p.000010: judgements, or to withhold information necessary to make a considered judgement Respect for persons demands that
p.000010: subjects enter into the research voluntarily and with adequate information.
p.000010: Applications of the general principles to the conduct of research leads to consideration of the following requirements:
p.000010: 1. I o ed C t: requires that subjects, to the degree that they are capable, be given the opportunity to
p.000010: choose what shall or shall not happen to them, and 2.
p.000010: Aices e o presents both an opportunity and a responsibility. Many kinds
p.000010: of possible harms and benefits need to be taken into account. There are, for example, risks of psychological harm,
p.000010: physical harm, legal harm, social harm and economic harm and the corresponding benefits. Risk can perhaps never be
...

p.000010: requirements of this law, the University of Unani ’s tnstitutional review board drill provide zi appropriate review
p.000010: for the purposes of this law.”
p.000010:
p.000010:
p.000010: This makts apparent the need to change the titre of the law to be:
p.000010: AN ACT TO ADD CHAPTER 24, DIVISION 3, 17 GCA TO REQUIRE AT TEAS' ONE REV W AND APPROVAL OF ANY RESEARCH
p.000010: CONDUCTcD ON GrAM WrrH REGARD TO BUMAN SUBJECTS BY A GUAM-BASED INSTITUTIONAL REVIEW BOARD
p.000010:
p.000010: Finally, Delete section 24102. Board; Terms; Appointment; Continuance; Removal., Page 4 lines 19 through 40.
p.000010:
p.000010:
p.000010:
p.000010:
p.000010:
p.000010:
p.000010:
p.000010:
p.000010:
p.000010:
p.000010: Greetings to Senator Kasperbauer and other senators!
p.000010:
p.000010: I am also here today to testify that Bill No. 347 must be revised before it is forwarded to the full body of the 24th
p.000010: Guam Legislature.
p.000010: There are four reasons for the revisions that I wish to address: 1) duplication of the existing review process; 2) the
p.000010: role of the University of Guam in research; 3) delays in conducting research; and 4) the composition of the committee.
p.000010: Let me begin by discussing duplication of the existing review process and suggesting a change in the legislation. The
p.000010: University of Guam's Committee on Human Subjects in Research (CHSR) has existed since 1982 and its members actively
p.000010: serve the citizens of Guam by providing protection. Members review 20 to 30 research proposals per year; these are
p.000010: submitted by faculty conducting research on human subjects, by graduate students conducting thesis research in the
p.000010: Department of Education and other agencies, and by undergraduate students conducting research in Guam's classrooms.
p.000010: Those participating in the research are adequately protected in accordance with the U.S. federal and local regulations
p.000010: related to human subjects in research.
p.000010: The change we are suggesting is that the ”creation of the Guam Research Review Board” be replaced with ”the designation
p.000010: of the University of Guam's Committee on Human Subjects in Research as
p.000010:
p.000010: GRRDURTE SCHOOL RND RESEARCH DERN‘S TESTI I'HONY, 1998
p.000010:
p.000010: the Institutional Review Board (IRB) for researchers and collaborators at the University and for researchers who are
p.000010: not under other lRBs." Wherever the bill states ”Guam Research Review Board” it should be replaced with "UOG's
p.000010: Committee on Human Subjects in Research.”
p.000010: Second, I wish to state that the role of the University of Guam in research is that of the state institution and, as
p.000010: such, it is appropriate that the IRB be housed in the Office of Graduate School and Research. However, GS&R has as its
p.000010: primary duty service to graduate students, and it is already overburdened with increases in the number of graduate
p.000010: students enrolling in courses, increases in the number of graduate programs since 1993, and increases in the number of
p.000010: qualified graduate faculty who seek answers to questions. In order to meet the stipulations of the legislation, GS&R
p.000010: needs funding and the creation of a new clerical staff position. Please include appropriate funding as this
p.000010: legislation goes forward.
p.000010: UOG has a fine record of grantsmanship and compliance with federal standards because it strives to meet rules and
p.000010: regulations through the policies set by Research Council and enforced by GS&R.
...

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p.000004:
p.000004: 1 (b) Investigator means any individual, public or private entity
p.000004: 2 or agency engaged in or purposing to engage in research subject to
p.000004: 3 regulation;
p.000004: 4 (c) Legally authorized representative means an individual or
p.000004: 5 judicial or other body authorized under applicable law to consent on
p.000004: 6 behalf of a prospective subject to the subject’s participation in the
p.000004: 7 procedure(s) involved in the research.
p.000004: 8 (d) Research means a systematic investigation, including
p.000004: 9 research development, testing and evaluation, designed to develop
p.000004: 10 or contribute to the understanding of a particular condition or
p.000004: IJ generalized knowledge. Activities which meet this definition
p.000004: 12 constitute research for purposes of this policy, whether or not they
p.000004: t3 are conducted or supported under a program which is considered
p.000004: 14 research for other purposes. For example, some demonstration and
p.000004: 15 service programs may fall under this definition of research. Not
p.000004: 16 included in this definition are:
p.000004: 17 (1) Opinion polls or other similar investigations of the
p.000004: 18 human subjects' opinions or beliefs;
p.000004: 19 (2) Research conducted in established or commorily
p.000004: 20 accepted educational settings, involving normal
p.000004: 21 educational practices, such as (i) research on regular
p.000004: 22 and special education instructional strategies or (ii)
p.000004: 23 research on the effectiveness or the comparison among
p.000004: 24 instructional techniques, curricula or classroom
p.000004: 25 management methods;
p.000004: 26 (3) Research involving the use of educational tests
p.000004: 27 (cognitive, diagnostic, aptitude, achievement), survey
p.000004: 28 procedures, interview procedures or observation of
p.000004: 29 public behavior, unless: ;(i) information obtained is
p.000004: 30 recorded in such a manner that human subjects can be
p.000004: 31 identified, directly or through identifier's linked to the
p.000004: 32 subjects; and (ü) any disclosure of the human subject's
p.000004: 33 responses outside the research could reasonably place
p.000004: 34 the subject at risk of criminal or civil liability or be
p.000004: 35 damaging to the subject's financial standing,
p.000004: 36 employability or reputation;
p.000004: 37 (4) Research involving the use of educational tests
p.000004: 38 (cognitive, diagnostic, aptitude, achievement), survey
p.000004: 39 procedures or observation or public behavior that is not
p.000004: 40 exempted under paragraph (d)(2) of this section, if: (i)
p.000004:
p.000002: 2
p.000002:
p.000002:
p.000002:
p.000002:
p.000002:
p.000002:
p.000002:
p.000002:
p.000002:
p.000002:
p.000002:
p.000002:
p.000002:
p.000002:
p.000002: • UOO Ouidt inns rcgardmg the “Ethical Principles wxl Guidelines for the Protection
p.000002: ofHwnan 5 objects of Research"
p.000002: - GMH Insti» poiul R« io Bard Policies *od Pr»cc«u cs ef13/9i3
p.000002: - Applicabb I sdemt R orii (1974 end hta) as issoed by the U.S. Oepartment of
p.000002: Heelth, Edu pgon, nid Welhre
p.000002: • Applicable i:gntioos of flu Office Hi Rotcction from Resee*h Risks (OPRR),
p.000002: N#Æm@knÿmhofHnü#Depmmœ#ofIoü1mdHmnanSwüA
p.000002: £pÿmbkçpAdm#ofWcUSPoÆxdDmçhJmWümaémÇD%
p.000002:
p.000002: Protection c
p.000002: - Applicable
p.000002: Any::rican
p.000002: I-luiDan Sobjecti
p.000002: ;xles ofconduct ofio‹4al ind behavioml mear*h as adopted by the
p.000002: *ho ’cal Association APA since l9D
p.000002:
p.000002:
p.000002: £‹•s• NO NEED TO DUPMcxTs THsSs SXIST G R£VisW BOARus CY
p.000002: ESTABL@HING A NEW REViEW BOARD that has no gcarMse ofproviding equal quality reviews or poN#ômMÆWP kofoœml
p.000002: [DGCœmÆœlœHumanGJQeœæRmwam CHS§ VdM#AæmMmoñNH MbmÆÆœÆRwicwBomdÇRB)fo ufpRV*Aügom€onM
p.000002: Oic Pcop)¢ ofGuarn, arid wM continue to jxovide this protectian to tha Pe¢$ils of¢?uam if’pcmiibed to
...

p.000010:
p.000010: Going tir ougl review boards and obtain ing consent horn participants are pi'ocesses that are necessary in
p.000010: the practice of research, a practicc that has come ft out past histories of uHkiowing subjects being
p.000010: 9J *had I› haunted b› experiiiients, set jects who have appeared its filnls and )f1nted m‹di:‹ v ithout their
p.000010: consent I !ook at this bill as not
p.000010: '* °e "' i °' that » ould haiiipei any pi ospcctive rcscai cher but one
p.000010: int°n ticd Io p i’o t ec t t lie rigli ts of t most ii ho Jia rticip;i tc.
p.000010:
p.000010: 1 belleve thai a iiong these rights are tint 11ie researcher be triliiicd in
p.000010: Conductin’g a xoJ ei in estigation Of thai he/she be super vised by
p.000010:
p.000010:
p.000010: someone or agency ’who' ’is kno 1 dgeable on ethica c'onduct of researchers. Being a doctor, teacher or a
p.000010: social worker, for instance, does not always mean a pel son can conduct research. One may be a gon d, honest,
p.000010: knowledgeable doctor / teacher but a poor or inept researcher. Reseai ch, espccially scientific research, requires
p.000010: special training in many skills among which is imdcrstanding the language of statistics and a knowledge of the
p.000010: various steps one follows in
p.000010: adIi4inistei’ing the project. If it is complex, it might 1 equire knowledge of thc l’oject’s algorithm,
p.000010: requiring, decision-making in every step of the way. This is why most researches are conducted under the auspices of
p.000010: eiilicr the federal government, educational lnstitutions or foundations Who conduct training courses for the
p.000010: discipline of research.
p.000010:
p.000010: Ttaining for research includes aniong otl er things, luiowledge and explication of the “iucthodology” beirg proposed
p.000010: that would fit the stateil objectives of the project. One can not just think of soitiething and say tte wants to do
p.000010: research on it. Onc has to ha› e hypothèses and sky how tte/she is going to prove that his Results ai c going to
p.000010: make a SlÇI11f)caol difference front what e assortie tO be normal in the general sc)ieiiie c›f thitigs. The
p.000010: tests have to bc riq•orous so thal the results can witlistand the scrutiny of other scientlsts who are coiiducting
p.000010: related studios. For there is a socicty of scholars to whoui ose communicates and s)iares knowlcdge with One hope›
p.000010: iiiat the results Of one’s studies won id l earl to a different wa of loOklng at something whether it is a
p.000010: discale, specie in nature or the Relationship 21T1Ong categories or concepts l’e are familial with
p.000010:
p.000010: New d!cs› i‹ say, the ultimate benefactors of the rcsu1ts of one's
p.000010: schs I +‘l) eLfortS are neither the conductor of the reseai ch although he n*>l ^* ñ‹ ‹›?,iiized by his
p.000010: pecrs in one w ay or anotliei’ nn' ltte assistants vl r* o idc so-called leg v ork for the researcher.
p.000010: The real benefactors arc 1)1OS £ is hose qualilJ of lii iiig will be made bettcr by such a
p.000010: disct4\ cry and the young i1i‹jtiisitive minds who will push off from where
p.000010: WC I C‹It c, either to affirms or hegaie eat findings. The scholars and
p.000010:
p.000010: stakeholders in this deliberatlon today must then, recognize that it is' the community at large and humanity in
...

p.000010: Under the present system,
p.000010: undergraduate teseacdiers working under faculty supervision can design, submit for review, and conduct a
p.000010: study within one semcster. Such research which typically is noninvasive and straightforward - needs only
p.000010: an expedited review, and the approval takee approximately 7-8 It will be impossible t;D Ôt
p.000010: another review by another Reseæch Review
p.000010:
p.000010: 2. Given that all Undergraduate research is reviewed by the University’s Committee on Human Research
p.000010: Subjects, the duplication of this process ses unneœssary and redundont The Univenity’s review
p.000010: boacd han a gœd öack æœzd aztd has been able to zeview æsearch applicaôons anü protect the Rights of human
p.000010: subjefls euccessfully.
p.000010:
p.000010: Undergraduate reseafAi is an integral part of the cgmculum cif the UOG Paychofogy Progr- AU psychology dasses
p.000010: have a reseœch œsy›anent. Students learn to evaluate research and develop researplt propo At
p.000010: least' hàb of the students
p.000010:
p.000010: BJ:49Rm FRDM Sx SW
p.000010: TQ 475Z000 P. OZ
p.000010:
p.000010:
p.000010:
p.000010:
p.000010:
p.000010:
p.000010:
p.000010: !' to have ext ve æsearcli trai›ning and those who have hande-
p.000010: . research Experience have advanÏage river other appiicanW It is critical our stiidents '
p.000010: ciontinue to cpndiicl undergraduate research that
p.000010: ' their learñing experience imd in reases their educational
p.000010:
p.000010:
p.000010:
p.000010:
p.000010:
p.000010: urk Smith, IPh. D.
p.000010:
p.000010:
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p.000010:
p.000010:
p.000010: TOTFIL P. BZ
p.000010:
p.000010:
p.000010:
p.000010:
p.000010: ETHICAL PRINCIPLES AND GUIDELINES FOR TI-BE PROTECTION OF HUMAN SUBJECTS
p.000010: OF RESEARCH
p.000010: A Summary of the Belmont Report
p.000010: sha nat:ional coeaisalon ccc sha P 'o*ec¢1ozt of Buzaao Bub§ ects o2 Biomedical fi Behavioral
p.000010: Research
p.000010:
p.000010:
p.000010:
p.000010:
p.000010: The following consists of quoted excerpts. A copy of the complete report is available in eha £11se of ehe Joe
p.000010: cormie€ae cor tiuaan Reseaccn Subjseen , Gratiuazs gchoo1 and Reeaat-ch O££lce .
p.000010:
p.000010:
p.000010: {NTRODU ION
p.000010:
p.000010: Scientific research has produced substantial social benefits.
p.000010: It has also posed some troubling ethical questions.
p.000010: Since 194], various codes £or the proper and responsible conduct of human experimentation in medical research have been
p.000010: adopted. These are the Nuremberg Code of 1947, the Helsinki Declaration of 1964 (revised i975), and the 1971
...

p.000003: incidentally regulated by a federal department or agency solely as part of the department's or agency's broader
p.000003: responsibility to regulate certain types of activities whether research or non-research in nature (e.g., Wage and
p.000003: Hour requirements administered by the Department of Labor).
p.000003: (f) Buman subject means a living individual about whom an investigator (whether professional pr student)
p.000003: conducting research obtains (1) data through intervention or interaction with the individual, or (2) identifiable
p.000003: private information. (]xterventlon and private information are given expanded definition)
p.000003:
p.000003:
p.000003: (h) IRB appz-ova-I ...
p.000003:
p.000003: (i) Blzimal rlsk means that the probability and magnitude of harm or discomfort anticipated in the research are not
p.000003: greater in and of themselves than those ordinarily encountered in daily life or during the performance of routine
p.000003: physical or psychological examinations or tests.
p.000003: (j) Certification means the official notification by the institution to the supporting department or agency, in
p.000003: accordance with the requirements of this policy, that a research project or activity involvinghuman subjects has been
p.000003: reviewed and approved by an IRB in accordance with an approved assurance.
p.000003:
p.000003:
p.000003:
p.000003:
p.000003:
p.000003:
p.000003: 3
p.000003:
p.000003: (b) Unless otherwise required . . . research activities in which the only involvement of human subjects will be in one
p.000003: or more of the foLloWing categories are exempt from this policy:
p.000003: (1) Research conducted in established or commonly accepted educational settings, involving normal educational
p.000003: practices, such as (i) research On regular and special education instructional strategies, or (ii)
p.000003: research on the effectiveness oY or the comparison among instructional techniques, curricula, or classroom
p.000003: management methods.
p.000003: (2) Research involving the use of educational tests (cognitive, diagnostic, aptitude, achievement), survey
p.000003: procedures or observation of public behavior, unless:
p.000003: (i) Information obtained is recorded in such a manner that human subjects can be iaent:if1e‹t, directly
p.000003: or through identifiers linked to the subjects; and (ii) any disclosure of the human subjects' responses outside
p.000003: the research could reasonably place the subjects at risk of criminal or civil liability or be damaging tO the
p.000003: subjects' financial standing, employability, or reputation.
p.000003: (3) Research [under 101(b)(2)] that is not exempt under paragraph (b)(2) of this section, if: (i) ... subjects are
p.000003: elected or appointed public officials or candidates for public office; or (ii) federal statute(s) require(s)
p.000003: without exception that the confidentiality of the personally identifiable information will be maintained
p.000003: throughout the research and thereafter.
p.000003: (4) Research, involving the collection or study Of existing data, documents, records, pathological specimens, or
p.000003: diagnostic specimens, if these sources are publicly available or if the information is recorded by the investigator in
p.000003: such a manner that subjects cannot be identified, directly or through identifiers linked to the subjects.
p.000003: (5) Research and demonstration projects... which are designed to study, evaluate or otherwise examine: (i) Public
p.000003: benefit or service programs; (ii) procedures for obtaining benefits or services under those programs; (iii) possible
p.000003: changes in or alternatives to those programs ...(iv) possible changes in methods or ... payment ... or services under
p.000003: those programs.
...

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p.000006: 19 (7) an explanation of whom to contact for answers
p.000006: 20 to pertinent questions about the research and research
p.000006: 21 subject’s rights, and whom to contact in the event of a
p.000006: 22 research-related injury to the subject; and
p.000006: 23 (8) a statement that participation is
p.000006: voluntary,
p.000006: 24 refusal to participate will involve no penalty or loss of
p.000006: '5 benefits to which the subject is otherwise entitled, and the
p.000006:
p.000007: 7
p.000007:
p.000007:
p.000007:
p.000001: 1
p.000002: 2
p.000003: 3
p.000004: 4
p.000005: 5
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p.000007: 7
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p.000011: 11
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p.000014: 14
p.000015: 15
p.000016: 16
p.000017: 17
p.000018: 18
p.000019: 19
p.000020: 20
p.000021: 21
p.000022: 22
p.000023: 23
p.000024: 24
p.000024: -'5
p.000024: subject may discontinue participation at any time without penalty OF lOsS of benefits to which the
p.000024: subject is otherwise entitled.
p.000024: (b) Additional Elements of Informed Consent.
p.000024: When appropriate, the Board may require that one (1) or more of the following elements of
p.000024: information shall also be provided to each subject:
p.000024: (1) a statement that the particular treatment or procedure may involve risks to the subject, or
p.000024: to the embryo or fetus, if the subject is or may become pregnant, which are currently urrforeseeable;
p.000024: (2) anticipated circumstances under which the subject's participation may be terminated by an
p.000024: investigator without regard to the subject’s consent;
p.000024: (3) any additional cost to the subject that may result from participation in the research;
p.000024: (4) the consequences of a subject's decision to withdraw from the research and
p.000024: procedures for orderly termination of participation by the subject;
p.000024: (5) a statement that significant new findings developed during the course of the
p.000024: research which may relate to the subject's willingness to continue participation will be provided to the
p.000024: subject; and
p.000024: (6) the approximate number of subjects involved in
p.000024: the study.
p.000024:
p.000008: 8
p.000008:
p.000008:
p.000008: i (c) The Board may approve a consent procedure which
p.000008: 2 does not include, or which alters, some or all of the elements of
p.000008: 3 irdormed consent set forth above, or waive the requirements to
p.000008: 4 obtain informed consent; provided, that the Board finds and
p.000008: 5 documents that:
...

p.000005: 38 explanation as to whether any medical treatments are
p.000005: 39 available if injury occurs and, if so, what it consist of or
p.000005: 40 whether further information my be obtained;
p.000005:
p.000005: t (7) An explanation of whom to contact for answers to
p.000005: 2 pertinent questions about the research and research
p.000005: 3 subject's rights, and whom to contact in the event of a
p.000005: 4 research-related injury to the subject; and
p.000005: 5 (8) A statement that participation is voluntary, refusal to
p.000005: 6 participate will involve no penalty or loss of benefits to
p.000005: 7 which the subject is otherwise entitled and the subject
p.000005: 8 may discontinue participation at any time without
p.000005: 9 penalty or loss of benefits to which the subject is
p.000005: to otherwise entitled.
p.000005: i1 (b) Additional Elements of Informed Consent. When
p.000005: 12 appropriate, the Board may require that one (1) or more of the
p.000005: 13 following elements of information shall also be provided to each
p.000005: 14 subject;
p.000005: 15 (1) A statement that the particular treatment or procedure
p.000005: 16 may involve risks to the subject (or to the embryo or
p.000005: 17 fetus, if the subject is or may become pregnant) which
p.000005: 18 are currently unforeseeable;
p.000005: 19 (2) Anticipated circumstances under which the subject's
p.000005: 20 participation may be terminated by an investigator
p.000005: 21 without regard to the subject's consent;
p.000005: 22 (3) Any additional cost to the subject that may result from
p.000005: 23 participation in the research;
p.000005: 24 (4) The consequences of a subject's decision to withdraw
p.000005: 25 from the research and procedures for orderly
p.000005: 26 termination of participation by the subject;
p.000005: 27 (5) A statement that significant new findings developed
p.000005: 28 during the course of the research which may relate to
p.000005: 29 the subject's willingness to continue participation will
p.000005: 30 be provided to the subject; and
p.000005: 31 (6) The approximate number of subjects involved in the
p.000005: 32 study.
p.000005: 33 (c) The Board may approve a consent procedure which does not
p.000005: 34 include, or which alters, some or all of the elements of informed
...

Searching for indicator employees:

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p.000009:
p.000009:
p.000009:
p.000009:
p.000009:
p.000009:
p.000009:
p.000009:
p.000010: 10
p.000010:
p.000010: University of Ruam
p.000010: Unibetsedåt Guahan
p.000010: OFFICE OF THE PRESIDENT
p.000010: UOG Station, Mangilao, Guain 96923
p.000010: Telephone: (671) 735-2990• Fax: (67 I) 734-2296
p.000010:
p.000010:
p.000010:
p.000010:
p.000010: May 5, 1998
p.000010: The Honorable Lawrence Kasperbauer Chairman, Committee on Education 24th Guam Legislature
p.000010: 155 Hessler Drive
p.000010: Agana, GU 96910
p.000010:
p.000010: Re: AN ACT TO CREATE A REVIEW BOARD FOR REVIEW AND APPROVAL OF RESEARCH CONDUCTED ON GUAM WITH REGARD TO
p.000010: HUMAN SUBJECTS.
p.000010: Dear Chairman Kasperbauer:
p.000010: I am here today to testify in support of Bill No. 347. This bill proposes to create a Guam Research Review Board
p.000010: for review and approval of research conducted on Guam with regard to human subjects. University
p.000010: administrators and faculty agree that any research on our island must undergo one review process.
p.000010: However, since the Guam Research Review Board would be a dnplication of the University of Guam’s Committee on Human
p.000010: Subjects in Researeh (CHSR), I iecommcnd that CHSR, under the Office of Graduate School and Research, be
p.000010: designated as the Institutional Review Board (IRB) for researchers and collaborators at the University and for
p.000010: researchers who are not under other IRBs.
p.000010:
p.000010: lt is noted that theie is no mention of additional financial or human resources to accomplish the
p.000010: numerous tasks as specified in the bill. At the present time, Graduate School and Research has only
p.000010: three employees listed in its staffing pattern, and each of these employees has a clearly defined job
p.000010: description and delineated tasks. To comply with the bill’s proposed tasks, it is essential to add one clerical
p.000010: staff position and funding for a computer, office fumiture, and supplies. In addition, funds would
p.000010: be needed for advertising or informing the community about the Committee on Human Subjects in Research
p.000010: to assure that researchers submit research proposals for review.
p.000010: Sincerely,
p.000010:
p.000010:
p.000010: Jose T. Nededog
p.000010:
p.000010: JOHN C. STEELE, M.D., FRCP(C)
p.000010: NEUROLOGIST
p.000010: FELLOW, AMERICAN COLLEGE OF PHYSICIANS
p.000010:
p.000010:
p.000010: May 11, 1998
p.000010:
p.000010: Senator Lawrence F. Kasperbauer Chairman, Committee on Education Twenty-Fourth Guam Legislature
p.000010:
p.000010: Dear Dr. Kasperbauer
p.000010:
p.000010:
p.000010: TePFax: (671) 828-30¢)0
p.000010:
p.000010: I am writing to provide testimony about Bill 347 to “create a review board for review and approval of research
p.000010: conducted on Guam with regard to human subjects”.
p.000010:
p.000010: I agree with the intent of the Bill but I have concerns about the mechanism it proposes to achieve the intent. It is a
p.000010: bill which proposes a “ fox to guard the hen house”
p.000010:
p.000010: That intent of bill 347 is to be certain that all medical research on Guam is reviewed and approved by a Committee
p.000010: which will assure protection of human subjects.
p.000010:
p.000010: In October 1995 at a Legislative Oversight Hearing about lytico-bodig research on Guam which was chaired by Senator
...

Searching for indicator opinion:

(return to top)
p.000004: 20 add Chapter 24 to read as follows:
p.000004: 2T “Chapter 24
p.000004: 22 §24101. Definitions. As used in this chapter:
p.000004: 23 (a) Board means the Guam Research Review Board;
p.000004:
p.000004: 1 (b) Investigator means any individual, public or private entity
p.000004: 2 or agency engaged in or purposing to engage in research subject to
p.000004: 3 regulation;
p.000004: 4 (c) Legally authorized representative means an individual or
p.000004: 5 judicial or other body authorized under applicable law to consent on
p.000004: 6 behalf of a prospective subject to the subject’s participation in the
p.000004: 7 procedure(s) involved in the research.
p.000004: 8 (d) Research means a systematic investigation, including
p.000004: 9 research development, testing and evaluation, designed to develop
p.000004: 10 or contribute to the understanding of a particular condition or
p.000004: IJ generalized knowledge. Activities which meet this definition
p.000004: 12 constitute research for purposes of this policy, whether or not they
p.000004: t3 are conducted or supported under a program which is considered
p.000004: 14 research for other purposes. For example, some demonstration and
p.000004: 15 service programs may fall under this definition of research. Not
p.000004: 16 included in this definition are:
p.000004: 17 (1) Opinion polls or other similar investigations of the
p.000004: 18 human subjects' opinions or beliefs;
p.000004: 19 (2) Research conducted in established or commorily
p.000004: 20 accepted educational settings, involving normal
p.000004: 21 educational practices, such as (i) research on regular
p.000004: 22 and special education instructional strategies or (ii)
p.000004: 23 research on the effectiveness or the comparison among
p.000004: 24 instructional techniques, curricula or classroom
p.000004: 25 management methods;
p.000004: 26 (3) Research involving the use of educational tests
p.000004: 27 (cognitive, diagnostic, aptitude, achievement), survey
p.000004: 28 procedures, interview procedures or observation of
p.000004: 29 public behavior, unless: ;(i) information obtained is
p.000004: 30 recorded in such a manner that human subjects can be
p.000004: 31 identified, directly or through identifier's linked to the
p.000004: 32 subjects; and (ü) any disclosure of the human subject's
...

p.000010:
p.000010: - } I4o§pitd Administrator
p.000010: - &e Prmfdo t ofMcdicat 5Bg
p.000010: ° Department of Surgery of Medicine
p.000010:
p.000010:
p.000010: : ! «siiy'o for Human Sub ‹a a Rc«a ch (SSR) tcpres••t•a u AND has standing
p.000010: pttlicics ltiat empower the IRB to requmt and ébtain relevant inputs from
p.000010:
p.000010: Existing Review Boards do not need to be Duplicated
p.000010: BiJl ¥347 prepmm the licafion elite misting ah pioccssu and proccdums #ial we conducted by t}n
p.000010: UO'£i Committee for Human Subject in Receamli (CHsg) and M Guem Memeñel jjQpit4l IfMtitotioff4l Review Board(IRB) fer
p.000010: RescamK THE PEOPLE OF GUAM ARE SWERBLT PRO1ECTbD BT THE BXiSTINO REVIEW BOARDS when arch0 proesued tbrougit
p.000010: &cni.
p.000010: m ei rd Board. GUAM FiEEDS TO HAVE THS UOtS
p.000010: E FOR H IN RESEARCH (CHSR) DESIGNATED BY TH6 GUAM
p.000010: LEGISLATURE AS THE REVIEW BODY POR nLL RESEARCH RELATED TO HU$4AN SUBJEC
p.000010: nuraces r;mcz or cm. ,tin uoc rai‹i« in r«›«i»ma«trms t»ma
p.000010:
p.000010:
p.000010: Todoto,
p.000010:
p.000010:
p.000010:
p.000010: . I STD * URG8 YOLI AND YOUR COI fdITTEE ON EDUCATfOX TC RS- CONMDBIT TIIBp ARGUMENTS RSGABOING B!LL #34?.
p.000010: URG6 TI4B COMMI B TO Mt)VB THAT BILk C347 \JND5RGO SERIOUS REVJfiION SO THAT JT WILL EI POWER MD EU 7POR7 THE
p.000010: UOG COMMTTTg£ FOCI HUMAN 3U0JECT IN RESSAItCI4
p.000010: (cusp›'• ›h ‹»•=a•t /›g voc gait•ie u«t »« M due cvAu zzssAecn ›‹Evisw aoARo FOR IfUMAN SUB48 CTS.
p.000010: Dankoto Na Si Yu’os \4a’ese for tire opportupity to voice en opinion repealing whx Bill ¥347 should be
p.000010:
p.000010: —1998 (fi: 49HN FRON ABS
p.000010: P. 81
p.000010:
p.000010: NI RSITY OF GuAM
p.000010: NI ETSEDAT GLAHAN
p.000010: P6YCHOLOGY PROGRAM
p.000010: ŒVT9ION OF 8OCIAL/BENAVFORAL 9ŒENCEB SOCtAL YORK
p.000010: eyda 7Qck Smith, Ph. D.
p.000010: C )O i3t&tort, zhao, 9 28
p.000010: Tei«t›t›e»e. (671) 7eS-ze»i F•«: {871) 7e4-5zs«
p.000010: e-hill Ttsmilhfluog9 edu
p.000010:
p.000010:
p.000010: Sejjator Lawfenee F. Kasperbauer
p.000010:
p.000010: Twenty-fourth Gtiam Legiolatgre Committee on Education
p.000010: Reference : Bill #34s Relaäve to Creafing a Guani Research Review Board
p.000010: As a researcfiez ans an eduœtox teachîng zeseacch stethodotogy and mtpefv’‘iaing undergraduate research at
p.000010: the University of Guari, I finally oppooe tp the mtablislurient of a new "Guam heseamh Review Board"
p.000010: that will oversea all research conducted on Guam This will make undergraduate march impossible to
p.000010: cenduct and will deprive UOG stpdents of valuabl!e.reseamh experience. I would like to state some of œy
p.000010:
p.000010: 1. And rmearch thatis cnndncted at the UOG is being feviewed - and will
p.000010:
p.000010: tînae
p.000010: Subjects
p.000010: by the University's Committee on Human to æsure ’the pmtection of the rights ef petaons
p.000010: Under the present system,
p.000010: undergraduate teseacdiers working under faculty supervision can design, submit for review, and conduct a
p.000010: study within one semcster. Such research which typically is noninvasive and straightforward - needs only
...

Economic / Economic/Poverty

Searching for indicator poor:

(return to top)
p.000010: As an associate professor at the University of Guam for 25 years, I have done social science reseai‘ch on the cultice
p.000010: of the peoples of the Western Pacific. These past few years, I have researched On the Meaning of Illness and
p.000010: Coming with ALS and Parkinsonisin Dementia, Sioce they involve human su ejects, all of thc researches treat I
p.000010: have done had to go through institutional review boards of New York Universi) , UOG, or of the Federal agencies for
p.000010: whom I performed the studies and who fended the studies.
p.000010:
p.000010: Going tir ougl review boards and obtain ing consent horn participants are pi'ocesses that are necessary in
p.000010: the practice of research, a practicc that has come ft out past histories of uHkiowing subjects being
p.000010: 9J *had I› haunted b› experiiiients, set jects who have appeared its filnls and )f1nted m‹di:‹ v ithout their
p.000010: consent I !ook at this bill as not
p.000010: '* °e "' i °' that » ould haiiipei any pi ospcctive rcscai cher but one
p.000010: int°n ticd Io p i’o t ec t t lie rigli ts of t most ii ho Jia rticip;i tc.
p.000010:
p.000010: 1 belleve thai a iiong these rights are tint 11ie researcher be triliiicd in
p.000010: Conductin’g a xoJ ei in estigation Of thai he/she be super vised by
p.000010:
p.000010:
p.000010: someone or agency ’who' ’is kno 1 dgeable on ethica c'onduct of researchers. Being a doctor, teacher or a
p.000010: social worker, for instance, does not always mean a pel son can conduct research. One may be a gon d, honest,
p.000010: knowledgeable doctor / teacher but a poor or inept researcher. Reseai ch, espccially scientific research, requires
p.000010: special training in many skills among which is imdcrstanding the language of statistics and a knowledge of the
p.000010: various steps one follows in
p.000010: adIi4inistei’ing the project. If it is complex, it might 1 equire knowledge of thc l’oject’s algorithm,
p.000010: requiring, decision-making in every step of the way. This is why most researches are conducted under the auspices of
p.000010: eiilicr the federal government, educational lnstitutions or foundations Who conduct training courses for the
p.000010: discipline of research.
p.000010:
p.000010: Ttaining for research includes aniong otl er things, luiowledge and explication of the “iucthodology” beirg proposed
p.000010: that would fit the stateil objectives of the project. One can not just think of soitiething and say tte wants to do
p.000010: research on it. Onc has to ha› e hypothèses and sky how tte/she is going to prove that his Results ai c going to
p.000010: make a SlÇI11f)caol difference front what e assortie tO be normal in the general sc)ieiiie c›f thitigs. The
p.000010: tests have to bc riq•orous so thal the results can witlistand the scrutiny of other scientlsts who are coiiducting
p.000010: related studios. For there is a socicty of scholars to whoui ose communicates and s)iares knowlcdge with One hope›
p.000010: iiiat the results Of one’s studies won id l earl to a different wa of loOklng at something whether it is a
p.000010: discale, specie in nature or the Relationship 21T1Ong categories or concepts l’e are familial with
p.000010:
p.000010: New d!cs› i‹ say, the ultimate benefactors of the rcsu1ts of one's
...

General/Other / Diminished Autonomy

Searching for indicator diminished:

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p.000010:
p.000010:
p.000010:
p.000010:
p.000010:
p.000010:
p.000003: 3
p.000003:
p.000003: A. gouodazlea Ba*veea 9xac6ica aoa aaseazca
p.000003: It is important to distinguish between biomedical and behavioral research, on the one hand, and the practice oY
p.000003: accepted therapy on the other, in order to know what activities ougAt to undergo review for the protection of human
p.000003: subjects oZ research. The distinction between research and practice Ls blurred partly because both often occur together
p.000003: (as in resesrcfi dea[gned to evaluate a therapy).
p.000003: The term "practice" refers to interventions tbat are designed BOlely to *nhance the well-being of an Individual patient
p.000003: or client and that have a reasonable expectation of success. By contrast, tAe term "research" designates an
p.000003: activity designed to test an hypothesis, permit conclusions to be drawn, and/or develop and contribute to knowledge
p.000003: (expressed, for example, in tAeoriss, principles, statements of relationship, and descriptive summary). Research and
p.000003: practice may be carried on together when research
p.000003: 1s designed to evaluate the safsty and efficacy of a therapy. Tbis need not cause any confusion regarding whether or
p.000003: not the activity requires review; the general rule is that if there is any element of research, that activity should
p.000003: undergo rsview for tAe protection of human subjects.
p.000003:
p.000003: g. Basio gtbical Principles
p.000003: z. Respect for Persons• incorporates at least two ethical convictions; first, that individuals should be treatad
p.000003: as autonomous agents, and second, that persons with diminished autonomy are entitled to protection. The
p.000003: principle thus divides into two separate moral requirements: the requirement to acknowledge autonomy and the
p.000003: requirement to protect tAose witA diNinished 6UtOüOWy.
p.000003: An autonomous person is an individual capable of dellberation aboulz personal goals and oC act;£ng under
p.000003: tbe 41xec€1on oC atzch dellberacion • To respect autonomy is €o glva weight: go autonomous
p.000003: persons' considered opinions and choices. Fo show lack of respect
p.000003: for an autonomous agent is to repudiate that person's considered
p.000003:
p.000003: judgements considered
p.000003: eo deny an indlvidual the freedom eo act on those
p.000003: judgements, or to withholdinformation necessary to make
p.000003: a considered judgement.
p.000003: The capacity for self-determination matures during an individual's like, and some individuals lose this capacity
p.000003: wholly or in part because of illness, mental disability, or oircumstancea that severely restrict liberty. Respect for
...

General/Other / Impaired Autonomy

Searching for indicator autonomy:

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p.000010:
p.000010:
p.000010:
p.000003: 3
p.000003:
p.000003: A. gouodazlea Ba*veea 9xac6ica aoa aaseazca
p.000003: It is important to distinguish between biomedical and behavioral research, on the one hand, and the practice oY
p.000003: accepted therapy on the other, in order to know what activities ougAt to undergo review for the protection of human
p.000003: subjects oZ research. The distinction between research and practice Ls blurred partly because both often occur together
p.000003: (as in resesrcfi dea[gned to evaluate a therapy).
p.000003: The term "practice" refers to interventions tbat are designed BOlely to *nhance the well-being of an Individual patient
p.000003: or client and that have a reasonable expectation of success. By contrast, tAe term "research" designates an
p.000003: activity designed to test an hypothesis, permit conclusions to be drawn, and/or develop and contribute to knowledge
p.000003: (expressed, for example, in tAeoriss, principles, statements of relationship, and descriptive summary). Research and
p.000003: practice may be carried on together when research
p.000003: 1s designed to evaluate the safsty and efficacy of a therapy. Tbis need not cause any confusion regarding whether or
p.000003: not the activity requires review; the general rule is that if there is any element of research, that activity should
p.000003: undergo rsview for tAe protection of human subjects.
p.000003:
p.000003: g. Basio gtbical Principles
p.000003: z. Respect for Persons• incorporates at least two ethical convictions; first, that individuals should be treatad
p.000003: as autonomous agents, and second, that persons with diminished autonomy are entitled to protection. The
p.000003: principle thus divides into two separate moral requirements: the requirement to acknowledge autonomy and the
p.000003: requirement to protect tAose witA diNinished 6UtOüOWy.
p.000003: An autonomous person is an individual capable of dellberation aboulz personal goals and oC act;£ng under
p.000003: tbe 41xec€1on oC atzch dellberacion • To respect autonomy is €o glva weight: go autonomous
p.000003: persons' considered opinions and choices. Fo show lack of respect
p.000003: for an autonomous agent is to repudiate that person's considered
p.000003:
p.000003: judgements considered
p.000003: eo deny an indlvidual the freedom eo act on those
p.000003: judgements, or to withholdinformation necessary to make
p.000003: a considered judgement.
p.000003: The capacity for self-determination matures during an individual's like, and some individuals lose this capacity
p.000003: wholly or in part because of illness, mental disability, or oircumstancea that severely restrict liberty. Respect for
p.000003: tAe immature and the incapacitated may require protecting them as they matura or while they are incapacitated.
p.000003: Respect Yor persons demands that subjects enter into the
p.000003: research voluntarily and with adequate information. In eome situations, however, application of the principle is
p.000003: not obvious. The involvement of prisoners, at one extreme, or of students in more normal circumstances, provide
p.000003: instructive examples. On the one
p.000003:
p.000003:
p.000003:
p.000003:
p.000003:
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p.000003:
p.000003:
p.000003:
p.000003:
p.000003:
p.000003:
p.000003:
p.000003:
p.000003:
p.000003: 1•26 Accum ia Reports te Payars aad
p.000003:
p.000003:
...

p.000010: Hearing. I speak on the subject of Bill 347 drawing from my experience of 20 years conducting research involving human
p.000010: subjects on Guam and in Micronesia, and my tenure with the University’s Committee on I-luman Research Subjects since
p.000010: it’s inception in 1982.
p.000010: I strongly support the intent of Bill 347 that any research study involving the participation of citizens and residents
p.000010: of Guam should be required to have at least one review by an appropriately constituted institutional review board
p.000010: established on Guam
p.000010: Scientific research has produced substantial social benefits, yet has also posed some troubling ethical queitions.
p.000010: Since 1945, various codes for the proper and responsible conduct of human experimentation in medical research hsve
p.000010: been adopted. Basic principles of research involving human subjects developed by these codes have been summarized in
p.000010: the Belmont Report, by The National Commission for the Protection of Human Subjects of Biomedical & Behavioral
p.000010: Research, U.S. Department of Health, Education and Welfare (Published: April 18, 1979). I note this an‹ attach a
p.000010: summary of it for you to clarify the ethical issues inherent in research involving human subjects. The essential heart
p.000010: of concern is
p.000010: Respect for Persons: the idea that individuals are capable of deliberation about personal goals and of acting under
p.000010: the direction of such deliberation. To respect autonomy is to give weight to a persons’ considered opinions and
p.000010: choices. To show lack of respect for an autonomous agent is to deny an individual the freedom to ad on those considered
p.000010: judgements, or to withhold information necessary to make a considered judgement Respect for persons demands that
p.000010: subjects enter into the research voluntarily and with adequate information.
p.000010: Applications of the general principles to the conduct of research leads to consideration of the following requirements:
p.000010: 1. I o ed C t: requires that subjects, to the degree that they are capable, be given the opportunity to
p.000010: choose what shall or shall not happen to them, and 2.
p.000010: Aices e o presents both an opportunity and a responsibility. Many kinds
p.000010: of possible harms and benefits need to be taken into account. There are, for example, risks of psychological harm,
p.000010: physical harm, legal harm, social harm and economic harm and the corresponding benefits. Risk can perhaps never be
p.000010: entirely eliminated, but it can often be reduced by careful attention to alternative procedures.
p.000010:
p.000010: The University of Guam’s Human Research Subjects Committee, an irb meeting the appropriate federal guidelines, has more
p.000010: than adequately carried out this responsibility for research involving or associated with UOG faculty or students. I
p.000010: have attached a copy of their guidelines to investigators. In recent years and with the assistance of UOG faculty the
...

General/Other / Incapacitated

Searching for indicator incapacitated:

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p.000003: principle thus divides into two separate moral requirements: the requirement to acknowledge autonomy and the
p.000003: requirement to protect tAose witA diNinished 6UtOüOWy.
p.000003: An autonomous person is an individual capable of dellberation aboulz personal goals and oC act;£ng under
p.000003: tbe 41xec€1on oC atzch dellberacion • To respect autonomy is €o glva weight: go autonomous
p.000003: persons' considered opinions and choices. Fo show lack of respect
p.000003: for an autonomous agent is to repudiate that person's considered
p.000003:
p.000003: judgements considered
p.000003: eo deny an indlvidual the freedom eo act on those
p.000003: judgements, or to withholdinformation necessary to make
p.000003: a considered judgement.
p.000003: The capacity for self-determination matures during an individual's like, and some individuals lose this capacity
p.000003: wholly or in part because of illness, mental disability, or oircumstancea that severely restrict liberty. Respect for
p.000003: tAe immature and the incapacitated may require protecting them as they matura or while they are incapacitated.
p.000003: Respect Yor persons demands that subjects enter into the
p.000003: research voluntarily and with adequate information. In eome situations, however, application of the principle is
p.000003: not obvious. The involvement of prisoners, at one extreme, or of students in more normal circumstances, provide
p.000003: instructive examples. On the one
p.000003:
p.000003:
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p.000003:
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p.000003: 1•26 Accum ia Reports te Payars aad
p.000003:
p.000003:
p.000003: i=m 4i ‹r mice preri appii=nk, in «k=«iy
p.000003:
p.000003: L27 Referrals nod Fees
p.000003:
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p.000003:
p.000003:
p.000003: 2•02 Competence sod Appropriate thee of
p.000003: 107 Obsolete 7mts aad Ouutet•d
p.000003:
p.000003:
p.000003:
p.000003:
p.000003:
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p.000003:
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p.000003: Smmnœm
p.000003:
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p.000003:
p.000003: 3. Ai• ' aad Otbcr
p.000003: c tafezaœts
p.000003: 3.01 Pab jamœ
p.000003: aazœia«smt " yæ j»ofœ‹œd m. p‹aöuœ.e
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p.000003:
p.000003:
p.000003: 4Jf1 Stracauñag tbe Brlatienship)
p.000003:
...

General/Other / Public Emergency

Searching for indicator emergency:

(return to top)
p.000008: 23 to the subject;
p.000008: 24 (2) the walver or alteration will nof adversely affect
p.000008: 25 the rights and welfare of the subject;
p.000008:
p.000009: 9
p.000009:
p.000009:
p.000009: 1 (3) the research could not practically be carried
p.000009: out
p.000009: 2 without the waiver or alteration; and
p.000009: 3 (4) whenever appropriate, the subjects will
p.000009: be
p.000009: 4 provided with additional and pertinent information after
p.000009: 5 participation.
p.000009: 6 (e) The informed consent requirements are not intended to
p.000009: 7 preempt any applicable Federal, state or local laws which require
p.000009: 8 additional information to be disclosed in order for informed
p.000009: 9 consent to be legally effective.
p.000009: 10 (9 Nothing in this Section is intended to limit
p.000009: the
p.000009: 11 authority of a physician to provide emergency medical care, to the
p.000009: 12 extent the physician is permitted to do so under applicable
p.000009: 13 Federal, state, or territorial law.
p.000009: 14 Section 24107. Criteria for Board Approval of Research.
p.000009: 15 In order to approve research subject to regulation, the Board shall
p.000009: 16 determine that all the following requirements are satisfied:
p.000009: 17 (a) Risks to subject are minimized: (i) by
p.000009: using
p.000009: 18 procedures which are consistent with sound research design and
p.000009: 19 which do nof unnecessarily expose subject’s to rlsk; and (ii)
p.000009: 20 whenever appropriate by using procedures akeady being
p.000009: 21 performed on the subjects for diagnostic or treatment purposes.
p.000009: 22 (b) Risks to subject are reasonable in relation
p.000009: to
p.000009: 23 anticipated benefits, if any, to subjects and the importance of the
p.000009: 24 knowledge that may reasonably be expected to result. In
p.000009: 25 evaluating risks and beneflts, the Board should consider only
p.000009:
p.000010: 10
p.000010:
p.000010:
p.000010: those risks and benefits that may result from the research, as
p.000010: 2 distinguished from risks and benefits of therapies subject would
...

p.000007: 11 consent set forth in this section, or waive the requirements to obtain
p.000007: 12 informed consent provided that the Board finds and documents that:
p.000007: 13 (1) The research involves no more than minimal risk to the
p.000007: i4 subject;
p.000007: 15 (2) The waiver or alteration will not adversely affect the
p.000007: 16 rights and welfare of the subject;
p.000007: (3) The research could not practically be carried out
p.000007: 18 without the waiver or alteration; and
p.000007: 19 (4) Whenever appropriate, the subjects will be provided
p.000007: 20 with additional and pertinent information after
p.000007: 21 participation.
p.000007: 22 (e) The informed consent requirements are not intended to
p.000007: 23 preempt any applicable federal, state or local laws which require
p.000007: 24 additional information to be disclosed in order for informed consent
p.000007: 25 to be legally effective; and
p.000007: 26 (I) Nothing in this section is intended to limit the authority of a
p.000007: 27 physician to provide emergency medical care, to the extent the
p.000007: 28 physician is permitted to do so under applicable federal, state, or
p.000007: 29 territorial law.
p.000007: 30 §24107. Criteria for Board Approval of Research. In order to
p.000007: 31 approve research subject to regulation, the Board shall determine
p.000007: 32 that all the following requirements are satisfied:
p.000007: 33 (a) Risks to subject are minimized: (i) by using procedures
p.000007: 34 which are consistent with sound research design and which do not
p.000007: 35 unnecessarily expose subject's to risk; and (ii) whenever appropriate
p.000007: 36 by using procedures already being performed on the subjects for
p.000007: 37 diagnostic or treatment purposes;
p.000007: 38 (b) Risks to subject are reasonable in relation to anticipated
p.000007: 39 benefits, if any, to subjects and the importance of the knowledge that
p.000007: 40 may reasonably be expected to result. In evaluating risks and
p.000007:
p.000008: 8
p.000008:
p.000008: benefits, the Board should consider only those risks and benefits that
p.000008: 2 may result from the research (as distinguished from risks and
p.000008: 3 benefits of therapies subject would receive even if not participating
p.000008: 4 in the research). The Board should not consider possible long range
p.000008: 5 effects of applying knowledge gained in the research (for example,
p.000008: 6 the possible effects of the research on public poñcy) as among those
p.000008: 7 research risks that fall within the purview of its responsibility;
...

General/Other / Relationship to Authority

Searching for indicator authority:

(return to top)
p.000003: 5 harm or discomfort anticipated in the research are not greater in and of
p.000003: 6 themselves than those ordinarily encountered in daily Me or during the
p.000003: 7 performance of routine physical or psychological examination or tests.
p.000003: 8 Section 24102. Board; Terms; Appointment; Continuance;
p.000003: 9 Removal. Members of the Board shall be consistent with the
p.000003: 10 University of Guam’s Committee on Human Subjects and Research
p.000003: 11 which is: three (3) or four (4) professional research proficient experts
p.000003: 12 from the Urñversity of Guam; at least one (1) Guam commurñty
p.000003: 13 representative; at least one (1) local religious leader; and at least one (1)
p.000003: 14 licensed practlcing local medical doctor.
p.000003: 15 Section 24103. Purpose. The purpose of the Board is to
p.000003: 16 review, approve, require modifications to secure approval or
p.000003: 17 disapprove all research subject to regulation.
p.000003: 18 Section 24104. Powers. The Board shall have and exerclse
p.000003: 19 each and all of the following powers:
p.000003: 20 (a) review and have authority to approve, requlre
p.000003: 21 modifications to secure approval or disapprove all research
p.000003: 22 activities covered by the rules and regulations;
p.000003: 23 (b) require documentation of informed consent of all
p.000003: 24 human subjects participating in the research subject to regulation.
p.000003: 25 At the Board’s discretion, require additional irdormation be given
p.000003:
p.000004: 4
p.000004:
p.000004:
p.000004: 1 to the subjects which would add to the protection of the rights and
p.000004: 2 welfare of the subjects;
p.000004: 3 (c) notify the investigators and the institution in writing
p.000004: 4 of its decision to approve or disapprove the proposed research
p.000004: 5 activity, or of modifications required to secure approval of the
p.000004: 6 research activity. If the Board decides to disapprove a research
p.000004: 7 activity, it shall include in its written notification a statement of
p.000004: 8 the reasons for lts decision and give the investigator an
p.000004: 9 opportunity to respond in person or in writing;
p.000004: 10 (d) conduct continuing review of research subject to
p.000004: 11 regulation at intervals appropriate to the degree of risk, but not
p.000004: 12 less than once per year and shall have authority to observe or have
p.000004: 13 a third party observe and consent to the process and the research;
p.000004: 14 and
p.000004: 15 (e) to disapprove research subject to regulation which had
p.000004: 16 been previously approved.
p.000004: 17 Section 24105. Duties of Investigators. The
p.000004: 18 proposals, plans, procedures and protocols for all proposed research
p.000004: 19 subject to regulation shall be submitted to the Board for review,
p.000004: 20 approval, modification or dlsapproval. No research subject to
p.000004: 21 regulation shall be conducted without Board approval. The plans,
p.000004: 22 procedures and protocols for all research subject to regulation which is
p.000004: 23 being conducted at the time of the enactment of this legislation shall be
p.000004: 24 submitted to the Board for review, approval, modification or
p.000004: 25 disapproval within thirty (30) days of this bill becoming law. Research
p.000004:
p.000004:
p.000004: i subject to regulation which is being conducted at the time of the
p.000004: 2 enactment or this legislation may continue pending Board action.
p.000004: 3 Section 24106. General Requirements for Informed Consent.
...

p.000008: 22 (1) the research involves no more than minimal risk
p.000008: 23 to the subject;
p.000008: 24 (2) the walver or alteration will nof adversely affect
p.000008: 25 the rights and welfare of the subject;
p.000008:
p.000009: 9
p.000009:
p.000009:
p.000009: 1 (3) the research could not practically be carried
p.000009: out
p.000009: 2 without the waiver or alteration; and
p.000009: 3 (4) whenever appropriate, the subjects will
p.000009: be
p.000009: 4 provided with additional and pertinent information after
p.000009: 5 participation.
p.000009: 6 (e) The informed consent requirements are not intended to
p.000009: 7 preempt any applicable Federal, state or local laws which require
p.000009: 8 additional information to be disclosed in order for informed
p.000009: 9 consent to be legally effective.
p.000009: 10 (9 Nothing in this Section is intended to limit
p.000009: the
p.000009: 11 authority of a physician to provide emergency medical care, to the
p.000009: 12 extent the physician is permitted to do so under applicable
p.000009: 13 Federal, state, or territorial law.
p.000009: 14 Section 24107. Criteria for Board Approval of Research.
p.000009: 15 In order to approve research subject to regulation, the Board shall
p.000009: 16 determine that all the following requirements are satisfied:
p.000009: 17 (a) Risks to subject are minimized: (i) by
p.000009: using
p.000009: 18 procedures which are consistent with sound research design and
p.000009: 19 which do nof unnecessarily expose subject’s to rlsk; and (ii)
p.000009: 20 whenever appropriate by using procedures akeady being
p.000009: 21 performed on the subjects for diagnostic or treatment purposes.
p.000009: 22 (b) Risks to subject are reasonable in relation
p.000009: to
p.000009: 23 anticipated benefits, if any, to subjects and the importance of the
p.000009: 24 knowledge that may reasonably be expected to result. In
p.000009: 25 evaluating risks and beneflts, the Board should consider only
p.000009:
p.000010: 10
p.000010:
p.000010:
p.000010: those risks and benefits that may result from the research, as
...

p.000001: Research Review Board” it should be replaced with “UOG's Committee on Human Subjects in Research”.
p.000001:
p.000001: As with Dr. Nededog comments, clerlcal staff need to be assigned to ensure that the functions of the Committee
p.000001: are carried out.
p.000001:
p.000001: Dr. Randall Workman, Professor of Sociology and Community Development at the University of Guam testified in support
p.000001: of the intent of Bill 347. His written testimony outlined his concerns which includes the importance of informed
p.000001: consent and assessment of risks and benefits. Further, the bill, as currently written, establishes unnecessary
p.000001: additional island wide IRB.
p.000001:
p.000001: Dr. Kyle Smith teaches psychology and research methods at the University of Guam and fully supports the call for all
p.000001: research conducted on Guam to undergo review. The bill, as in its existing form may produce some unnecessary affects
p.000001: on the training available for standards at the University of Guam and creates redundant delays. He supports the
p.000001: option to modify the bill to accommodate student and research projects. Dr.Smith believes that it was not the
p.000001: intent of the author to impede research projects. He will fully support the bill with modifications.
p.000001:
p.000001: Mr. Roy Adonay testified in support of Bill 347. Mr. Adonay expressed the need to review the are of fines and
p.000001: penalties and needs to be expanded. There is no indication as to who will monitor and
p.000001:
p.000001:
p.000003: 3
p.000003:
p.000003: fine and who will collect. The Universlty of Guam Will not have the power or authority to police all research.
p.000003:
p.000003: Ms. Gregoria Smith testified in favor of Bill 347. She also submitted written testimony that states obtaining
p.000003: consents from participants are necessary in the practice of research to protect the rights of those who
p.000003: participates. Researchers must be trained; research, especially scientific research, requires special training.
p.000003:
p.000003: Ms. Debbie Quinata, a member of OPIR, Chamorro Nation, ancestral/original landowners. Ms. Quinata is opposed
p.000003: to Bill 347. Guam already has an IRB for grant applicant that review standards at the Guam Memorial Hospital.
p.000003: This bill will create more loopholes. Ms. Quinata also stated that all off-island researchers should share in
p.000003: the results of the national research and charge fees. Mechanisms should be in place to ask for accountability - what
p.000003: are they doing for our island and educating our students.
p.000003:
p.000003: Dr. Bert Weiderholt, physician /neurologist and professor of neuroscience at the University of California, San
p.000003: Diego. NIA (National Institutes of Aging) funded program project for 5 years to study disease on Guam. Dr.
p.000003: Wiederholt is in full support of Bill 347 and further supports Drs. Nededog and Camacho, Workman and Smith. He has
p.000003: conducted research in various states and it is very important to submit research project for local review, although
p.000003: not federally required. Dr. Weiderholt and the project he is now involved in on Guam, had no hesitation in
p.000003: submitting application for research to the University of Guam and the Guam Memorial Hospital - both were
p.000003: approved.
...

p.000002: 26 (1) member of the clergy; the Director of the Department of Public
p.000002: 27 Health and Social Services or his/her designee; two (2) community
p.000002: 28 representatives recommended by the Mayor's Council; and an
p.000002: 29 attorney licensed to practice in the Territory of Guam. Members of
p.000002: 30 the Board shall be appointed by the President of the University of
p.000002: 31 Guam. The Board shall be appointed for a three (3) year term. The
p.000002: 32 President of the University of Guam may remove any member from
p.000002: 33 the Board for the neglect of any duty required by law, for
p.000002: 34 incompetence, for improper and unprofessional conduct or for
p.000002: 35 violation of Board rules and regulations. Four (4) members shall
p.000002: 36 constitute a quorum of the Board for the transaction of business. The
p.000002: 37 Board shall adopt rules and regulations in accordance with existing
p.000002: 38 federal law, if applicable and the Administrative Adjudication Act,
p.000002: 39 governing the conduct of its affairs and exercise of its powers within
p.000002: 40 ninety (90) days of enactment of this law.
p.000002:
p.000004: 4
p.000004:
p.000004: 1 §24103. Purpose. The purpose of the Board is to review,
p.000004: 2 approve, require modifications to secure approval or disapprove all
p.000004: 3 research subject to regulation.
p.000004: 4 §24104. Powers. The Board shall have and exercise each and
p.000004: 5 all of the following powers:
p.000004: (a) Review and have authority to approve, require
p.000004: 7 modifications to secure approval or disapprove all research
p.000004: 8 activities covered by the rules and regulations.
p.000004: 9 (b) Require documentation of informed consent of all human
p.000004: 10 subjects participating in the research subject to regulation. At the
p.000004: 11 Board's discretion, require additional information be given to the
p.000004: 12 subjects which would add to the protection of the rights and welfare
p.000004: 13 of the subjects;
p.000004: 14 (c) Notify the investigators and the institution in writing of its
p.000004: 15 decision to approve or disapprove the proposed research activity, or
p.000004: 16 of modifications required to secure approval of the research activity.
p.000004: 17 If the Board decides to disapprove a research activity, it shall include
p.000004: 18 in its written notification a statement of the reasons for its decision
p.000004: 19 and give the investigator an opportunity to respond in person or in
p.000004: 20 writing;
p.000004: 21 (d) Conduct continuing review of research subject to regulation
p.000004: 22 at intervals appropriate to the degree of risk, but not less than once
p.000004: 23 per year and shall have authority to observe or have a third party
p.000004: 24 observe and consent to the process and the research; and
p.000004: 25 (e) To disapprove research subject to regulation which had
p.000004: 26 been previously approved.
p.000004: 27 §24105. Dufies of Investigators. The proposals, plans,
p.000004: 28 procedures and protocols for all proposed research subject to
p.000004: 29 regulation shall be submitted to the Board for review, approval,
p.000004: 30 modification, or disapproval. No research subject to regulation shall
p.000004: 31 be conducted without Board approval. The plans, procedures and
p.000004: 32 protocols for all research subject to regulation which is being
p.000004: 33 conducted at the time of the enactment of this legislation shall be
p.000004: 34 submitted to the Board for review, approval, modification or
p.000004: 35 disapproval within thirty (30) days of this bill becoming law.
p.000004: 36 Research subject to regulation which is being conducted at the time
p.000004:
p.000004: 37 of the enactment of this leglslation
p.000004: 38 action.
p.000004: may continue pending Board
p.000004: 39 §24106. General Requirements for Informed Consent. No
p.000004: 40 investigator may involve a human being in research subject to
p.000004:
p.000005: 5
p.000005:
p.000005: regulation unless the investigator has obtained the legally effective
...

p.000007: 10 not include, or which alters, some or all of the elements of informed
p.000007: 11 consent set forth in this section, or waive the requirements to obtain
p.000007: 12 informed consent provided that the Board finds and documents that:
p.000007: 13 (1) The research involves no more than minimal risk to the
p.000007: i4 subject;
p.000007: 15 (2) The waiver or alteration will not adversely affect the
p.000007: 16 rights and welfare of the subject;
p.000007: (3) The research could not practically be carried out
p.000007: 18 without the waiver or alteration; and
p.000007: 19 (4) Whenever appropriate, the subjects will be provided
p.000007: 20 with additional and pertinent information after
p.000007: 21 participation.
p.000007: 22 (e) The informed consent requirements are not intended to
p.000007: 23 preempt any applicable federal, state or local laws which require
p.000007: 24 additional information to be disclosed in order for informed consent
p.000007: 25 to be legally effective; and
p.000007: 26 (I) Nothing in this section is intended to limit the authority of a
p.000007: 27 physician to provide emergency medical care, to the extent the
p.000007: 28 physician is permitted to do so under applicable federal, state, or
p.000007: 29 territorial law.
p.000007: 30 §24107. Criteria for Board Approval of Research. In order to
p.000007: 31 approve research subject to regulation, the Board shall determine
p.000007: 32 that all the following requirements are satisfied:
p.000007: 33 (a) Risks to subject are minimized: (i) by using procedures
p.000007: 34 which are consistent with sound research design and which do not
p.000007: 35 unnecessarily expose subject's to risk; and (ii) whenever appropriate
p.000007: 36 by using procedures already being performed on the subjects for
p.000007: 37 diagnostic or treatment purposes;
p.000007: 38 (b) Risks to subject are reasonable in relation to anticipated
p.000007: 39 benefits, if any, to subjects and the importance of the knowledge that
p.000007: 40 may reasonably be expected to result. In evaluating risks and
p.000007:
p.000008: 8
p.000008:
p.000008: benefits, the Board should consider only those risks and benefits that
p.000008: 2 may result from the research (as distinguished from risks and
p.000008: 3 benefits of therapies subject would receive even if not participating
p.000008: 4 in the research). The Board should not consider possible long range
p.000008: 5 effects of applying knowledge gained in the research (for example,
p.000008: 6 the possible effects of the research on public poñcy) as among those
...

p.000010: be needed for advertising or informing the community about the Committee on Human Subjects in Research
p.000010: to assure that researchers submit research proposals for review.
p.000010: Sincerely,
p.000010:
p.000010:
p.000010: Jose T. Nededog
p.000010:
p.000010: JOHN C. STEELE, M.D., FRCP(C)
p.000010: NEUROLOGIST
p.000010: FELLOW, AMERICAN COLLEGE OF PHYSICIANS
p.000010:
p.000010:
p.000010: May 11, 1998
p.000010:
p.000010: Senator Lawrence F. Kasperbauer Chairman, Committee on Education Twenty-Fourth Guam Legislature
p.000010:
p.000010: Dear Dr. Kasperbauer
p.000010:
p.000010:
p.000010: TePFax: (671) 828-30¢)0
p.000010:
p.000010: I am writing to provide testimony about Bill 347 to “create a review board for review and approval of research
p.000010: conducted on Guam with regard to human subjects”.
p.000010:
p.000010: I agree with the intent of the Bill but I have concerns about the mechanism it proposes to achieve the intent. It is a
p.000010: bill which proposes a “ fox to guard the hen house”
p.000010:
p.000010: That intent of bill 347 is to be certain that all medical research on Guam is reviewed and approved by a Committee
p.000010: which will assure protection of human subjects.
p.000010:
p.000010: In October 1995 at a Legislative Oversight Hearing about lytico-bodig research on Guam which was chaired by Senator
p.000010: Leon Guerrero all participants, including myself agreed that such review and approval was desireable.
p.000010:
p.000010: After that Oversight Hearing, Dr. Ulla Craig and her medical research associate Dr. Wigbert Wiederhoh composed this
p.000010: Bill at the request of Senator Lou Leon Guerrero. However many of us disagreed that the authority of this process
p.000010: should rest in Dr. Craig’s Division at the University of Guam, since she and Dr. Wiederholt were pursuing their own
p.000010: exclusive human subject studies of lytico-bodig there. We felt there would be a conflict of interest and that putting
p.000010: the authority with them could jeopordize similar and competing studies by myself and other scienticists wishing to
p.000010: conduct research on Guam.
p.000010:
p.000010: Senator Leon Guerrero understood that and set the Bill aside.
p.000010:
p.000010: However, because we agreed that peer review of research was necessary, after the 1995 Oversight Hearing the Hospital
p.000010: formed an Institutional Review Board (IRB) to review research
p.000010: proposals concerned with human subjects. This Hospital Committee meets regularly and it follows Federal guideleines. It
p.000010: is chaired by the GMH Administrator and constituted by members from the Hospital staff and community. The IRB reviews
p.000010: and approves all research conducted under its auspices, including my own.
p.000010:
p.000010:
p.000010:
p.000010:
p.000010:
p.000010:
p.000010: HCR 18 118 • Umatac, Guam 96g18 • E- Mail: JSTEELE@K UEN1 OS•GUAM•NET
p.000010:
p.000010: As the competition to find the cause of lytico-bodig mounts between teams led by Dr. Wiederholt and myself, Senator
p.000010: Leon Guerrero is introducing the original Bill which Drs Craig and Wiederholt developed in 1995. Because she is a
p.000010: member of theé Community Advisory Committee and therefore likely to be biased in theé favor, I understand the Bill is
p.000010: being introduced under your auspices. It is cosponsored by Senator Ada but Senator Flores has recently withdrawn his
p.000010: support for it.
p.000010:
p.000010: Bill 347 proposes another Committee to review research involving human subjects. Although it will be constituted by a
p.000010: representative from the GMH IRB and University of Guam Human Subjects Committee, it will supercede the authority of
p.000010: each and both. Furthermore it places authority for research involving human subjects into the hands of the UOG
p.000010: Graduate School, of which Drs. Craig and Wiederholt are a part. It vests medical research decision making at the
p.000010: University and there is little question but that the authority of section 24105 will be used to restrict and perhaps
p.000010: end studies of lytico-bodig by myself and my colleagues, Professors John Hardy, geneticist at Mayo Clinic, Teepu
p.000010: Siddique, molecular geneticist at Northwestern University, Nicholas Wood geneticist at the National Hospital, London
p.000010: UK, and Patrrick McGeer, immunopathologist at the University of British Columbia.
p.000010:
p.000010: To ensure fairness and to avoid discrimination against our studies by Drs. Craig and Wiederholt, I am requesting that
p.000010: the authority for reviewing and approving research involving human subjects remains with the (established) GMH IRB and
p.000010: UOG Human Subjects Committee. To ensure protection for human subjects, I recommend that you and your Committee mandate
p.000010: prior approval of all human subject research by one or other Committee, subject to the fines and penalties of Section
p.000010: 24109, if investigators fail to comply.
p.000010:
p.000010: Your favorable decision of these recommendations will ensure fairness in research and avoid the possability of
p.000010: discrimination against my studies by Drs. Craig and Wiederholt, and members of the UOG Graduate School.
p.000010:
p.000010: I thank you.
p.000010:
p.000010:
p.000010: John C. Steele MD Neurologist
p.000010:
p.000010: Madeleine Z. Bordallo, President of the Guam Lytico & Bodig Association Norbert Perez, President of the Republic of
p.000010: Guahan
p.000010: Tyrone Taitano, Chairman GMH IRB
p.000010: Professor John Hardy, Professor of Pharmacology Mayo Clinic Jacksonville
p.000010: Professor Teepu Siddique, Director Neurogenetics Laboratory, Nothwestem University Professor Nicholas Wood, Department
p.000010: of Genetics, National Hospital Queen Square Professor Patrick McGeer, Kinsmen Laboraotory of Neurological research,
p.000010: Vancouver
p.000010: Dr. Marcelle Morrison-Bogorad, Associate Director of Neuroscienc and Neurophysiology of Aging Program, National
p.000010: Institute of Aging
p.000010:
p.000010: z•.O. Box 4jia A/ana ‹fi an• 96932
p.000010: . • • 4 7- 294
p.000010:
p.000010:
p.000010:
p.000010: Senator La me F. Kaperbauer
p.000010: Chat*-man, Committee on Education
p.000010: 2 15-A Chat an Santo Papa, Suite SOG F Ada's Professfionat 6.omme.rcial Center Agana, Guam g6932
...

p.000002: professional conduct and practice.
p.000002: b) Every nondiscriminatory effort will be made to ensure that no IRB consists entirely of men or entirely of women.
p.000002: c) Each IRB ehall include at least one member whose primary concerns are in scientific areas and at least one member
p.000002: whose primary concerns are in nonscientific areas.
p.000002: d) Each IRB shall include at least one msmbsr who is not otherwise affiliated with the institution and who is not
p.000002: part of the immediate #amily of a person who is affiliated with the institution.
p.000002: e) NO ORB may have a member participate in review of any project in whicA the membsr has a conflicting interest,
p.000002: except to provide information.
p.000002: f) An IRB may, in its discretion, invite individuals with eompetence in special areas to assist in the review of
p.000002: issues which require expertise beyond or in addition to that available on the IRB. These individuals say not vote with
p.000002: the IRB.
p.000002: 8ec€1oa 1os IeB €uac€1ona and opeg a €1ons. Each IRB shall:
p.000002: a) POllow written procedures;
p.000002: b) Rxcep£ when an expedieed review procedure in used review proposed research at
p.000002: convened meetings at which a majority of the members of the IRB are present, including at lease one member whose
p.000002: primary concerns are in nonscientific areas. In order for the research to be approved, it shall receive the approval
p.000002: of a majority of those members present at the meeting.
p.000002:
p.000005: 5
p.000005:
p.000005: Section 109 IRB Review of Research.
p.000005: a) An IRB shall review and have authority to approve, require modifications in (to secure approval), or disapprove all
p.000005: research activities.
p.000005: b) An IRB shall require that information given to subjects as part of informed consent is in accordance with
p.000005: Section.116. The IRB may require that information, in addition to that specifically mentioned in Section.116,
p.000005: be given to the subjects when in the IRB's judgment the information would meaningfully add to the protection of the
p.000005: rights and welfare of subjects.
p.000005: c) An IRB shall require documentation of informed consent.
p.000005: d) An IRB shall notify investigators and the institution in writing of its decision to approve or disapprove the
p.000005: proposed research activity, or of modifications required to secure IRB approval of the research activity.
p.000005: e) An IRB shall conduct continuing review of research covered by this policy at intervals appropriate to the degree of
p.000005: risk, but nOt less than once per year, and shall have authority to observe or have a third party observe the consent
p.000005: process and the research.
p.000005: 8ec€1on 11O Bs$seé1•ad z'•e1ew' pgocaduzeg fog' m €a1O 3c1odo of
p.000005: zogeaacb fgsoo1a1ag no aoaa Oban a1a3ma1 g'1o$t, aoQ Coz' a1zzot cbaBgeo
p.000005:
p.000005: a) In the Federal Register, a list of categories of research that may be reviewed by the IRB through an expedited
p.000005: review procedure will be amended, as appropriate after consultation with other departments and agencies.
p.000005: b) An IRB may use the expedited review procedure to review
p.000005: 1. Some or all of the research appearing on the list and found by the reviewer(s) to involve no more than minimal
p.000005: risk.
p.000005: 2. Minor changes in previously approved research.
p.000005: Under an expedited review procedure, the review may be carried out by the IRB chairperson or by one or more experienced
p.000005: reviewers designated by the chairperson. Reviewers may exercise all of the authorities of the IRB except that the
p.000005: reviewersmay not disapprove the research•
p.000005:
p.000005:
p.000005:
p.000005: a) To approve research covered by this policy the IRB shall determine that all of the following requirements are
p.000005: satisfied:
p.000005: 1 • Risks to subjects are minimized.
p.000005: 2. Risks to subjects are reasonable in relation to anticipated benefits. The IRB should not consider possible
p.000005: long-range effects of applying knowledge gained in The research (foe example, the peesible effecrt:s og
p.000005: I:he research on public policy) as among thoae research risks that fall within the purview of its responsibility.
...

General/Other / Undue Influence

Searching for indicator undue influence:

(return to top)
p.000008: populations such as children,
p.000008: 13 prisoners, pregnant woman, persons with disabilities, the elderly, or
p.000008: 14 economically or educationally disadvantaged persons;
p.000008: 15 (d) Informed consent will be sought from each prospective
p.000008: 16 subject or the subject's legally authorized representative, in
p.000008: 17 accordance with, and to the extent required by Board regulation.
p.000008: 18 (e) Informed consent will be appropriately documented, in
p.000008: 19 accordance with, and to the extent required by Board regulation.
p.000008: 20 (O When appropriate, the research plan makes adequate
p.000008: 21 provision for monitoring the data collected to ensure the safety of
p.000008: 22 subjects; and
p.000008: 23 (g) When appropriate, there are adequate provisions to protect
p.000008: 24 the privacy of subjects and to maintain the confidentiality of data.
p.000008: 25 When some or all of the subject are likely to be vulnerable to
p.000008: 26 coercion or undue influence, such as children, the elderly, prisoners,
p.000008: 27 pregnant women, mentally disabled persons or economically or
p.000008: 28 educationally disadvantaged persons, additional safeguards have
p.000008: 29 been included in the research plans, procedures or protocols to
p.000008: 30 protect the rights and welfare of these subjects.
p.000008: 31 §24108. Grievance Procedure. II application for approval is
p.000008: 32 denied for a research proposal, investigators may appeal to the
p.000008: 33 Dean of the Graduate School & Research. The Dean will appoint an
p.000008: 34 ad hoc committee for a second, independent review of the research
p.000008: 35 project. The findings of the ad hoc committee are presented to the
p.000008: 36 Research Review Committee no later than ninety (90) days after
p.000008: 37 receipt of grievance from investigator, to determine the final
p.000008: 38 decision to approve or not to approve a research project.
p.000008:
p.000008: 39 §24109. Fines and Penalties. Upon determination of
p.000008: 40 review board through the approved rules and regulations,
p.000008: the any
p.000008:
p.000009: 9
p.000009:
...

p.000010:
p.000010: 2. Be given an explanation of the procedures to be followed in the research study, and drugs or device to be
p.000010: used.
p.000010:
p.000010: 3. Be given a description of any possible discomfort and risks reasonably to be expected from a research
p.000010: procedure, if applicable.
p.000010:
p.000010: 4. Be given an explanation of any benefits to the subject reasonably to be expected from the research
p.000010: procedure, if applicable.
p.000010:
p.000010: 5. Be given a disclosure of any appropriate alternative procedures, drugs, or devices that might be advantages
p.000010: to the subject, and their relative riiks and benefits.
p.000010:
p.000010: 6. Be informed of the avenues of medical treatment, if any, available to the subject after the experiment if
p.000010: complications should arise.
p.000010:
p.000010: 7. Be given an opportunity to ask any questions concerning the experiment or the procedures involved.
p.000010:
p.000010: 8. Be instructed that consent to participate in the research study may be withdrawn at any time, and the
p.000010: subject may discontinue participation in the research study without prejudice.
p.000010:
p.000010: 9. Be given a copy of a signed and dated written consent form when one is required.
p.000010:
p.000010: 10. Be given the opportunity to decide to consent or not to consent to participate in a research study without
p.000010: the intervention of any element of force, fraud, deceit, duress, coercion, or undue influence on the subject’s
p.000010: decision.
p.000010:
p.000010: If you have a question regarding the research study, the researcher or other research personnel will be glad to answer
p.000010: them. You may seek information from the UOG Committee for Human Research Subjects—established for the protection of
p.000010: participants in research projects—by calling 735-2173 (UOG Graduate School & Research) from 8 am to 5 pm, Monday
p.000010: through Friday, or by writing to the above address.
p.000010:
p.000010:
p.000010:
p.000010:
p.000010:
p.000010:
p.000010:
p.000010:
p.000010:
p.000010:
p.000010:
p.000010:
p.000010:
p.000010:
p.000010:
p.000010:
p.000010:
p.000010:
p.000010:
p.000010:
p.000010:
p.000010: LWRapxHorRAz*
p.000010: Iotbetrwork-rstain‹Iactivitinc,ps élogistsrccpct
p.000010: tbnrightsofoth‹ssuzbaIdyabics,a0iu•d•c, aPiai«*¥t*•l
p.000010: zrfzom tbczr
p.000010: II) XOQ¥ls¢ZtAñndtiOn
p.000010: to tbcir wozk•ccIazcd activitisc. jn ogist• d* no* mgagc ia uafatr dt¥cztistinatizsl baBcd oo ggndgf,
p.000010: dbaicity, naziazd origg rali8ioo, mud " takon. dI*- abifity,zocirxxx›naazicstuus,or•aybactz h7k•'•
p.000010: L11 S••••* Barassa«at
p.000010: (a)PcyckoIogisudozzotozga$sta bazaua›ant Smud barassa›p.000010: szxsvcrbd condzact tbat is sex in aauzrc• that ia ooauexJm with tlzc ” 's activities sr
p.000010:
p.000010:
p.000010:
p.000010:
p.000010:
p.000010: L17 !fp!tRdsMossiñp*
p.000010:
p.000010:
p.000010:
p.000010: upmthnoincetiicofciichpimccdi•gi aliens. ,nupnrvism,or caichpartici
p.000010: £'cy-
p.000010: Ofotbcf app infomMliot£. cltologigts mugtal g7s
...

p.000005: Under an expedited review procedure, the review may be carried out by the IRB chairperson or by one or more experienced
p.000005: reviewers designated by the chairperson. Reviewers may exercise all of the authorities of the IRB except that the
p.000005: reviewersmay not disapprove the research•
p.000005:
p.000005:
p.000005:
p.000005: a) To approve research covered by this policy the IRB shall determine that all of the following requirements are
p.000005: satisfied:
p.000005: 1 • Risks to subjects are minimized.
p.000005: 2. Risks to subjects are reasonable in relation to anticipated benefits. The IRB should not consider possible
p.000005: long-range effects of applying knowledge gained in The research (foe example, the peesible effecrt:s og
p.000005: I:he research on public policy) as among thoae research risks that fall within the purview of its responsibility.
p.000005: 3. Selection of subjects is equitable.
p.000005: 4. Informed consent will be sought from each prospsctive subject or the subject's legally authorized.
p.000005: 5. Informed consent will be appropriately documented.
p.000005: 6. When appropriate, the research plan makes adequate provision for monitoring the data collected to ensure the safety
p.000005: of subjects.
p.000005: 7. There are adequate provisions to protect the privacy of subjects and to maintain the confidentiality of data.
p.000005: b) When some or all of the subjects are likely to be vulnerable to coercion or undue influence, such as children,
p.000005: prisoners, pregnant women, mentally disabled persona, or econoaicallY or educationally disadvantaged persons,
p.000005: additional safeguards have been included in the study to protect tAe rights and welfare of tRese subjects.
p.000005:
p.000005:
p.000005: Research covered by this policy that has been approved by ah IRB may be subject to further appropriate review by
p.000005: officials of the institution.
p.000005:
p.000005: 8•C*1O» 113 6UfipaO81OO or ¢eza1:aa61on OC Zea &ppg'Ova1.
p.000005:
p.000005: An IRB shall have autAoritY to suspend or terminate approval of research that is not being conducted in accordance with
p.000005: the IRB's requirements or that has been associated witA unexpected serious harm to subjects.
p.000005:
p.000005: Bec21oo 114 coopaxa€1ve Raseacaa.
p.000005:
p.000005: Cooperative research projects are those projects covered by this policy which involve more than one institution. In
p.000005: the conduct of cooperative research projects, each institution is responsible for safeguarding the rights and welfare
p.000005: of husmn subjects and for complying with this policy.
p.000005:
p.000005: An institution participating in a cooperative project may enter into a joint review arrangement, rely upon the review
p.000005: of another qualified ZRB, or nake similar arrangement:a for avoi‹:ling duplication of
p.000005: effort.
p.000005: sactioo us zRe xecora•.
p.000005: An IRB, shall prepare and maintain adequate documentation of IRB activities, including the following:
p.000005: 1. Copies of all research proposals reviewed.
p.000005: 2. of IRB meetings
p.000005: s. Records of continuing review activities.
p.000005: 4. Copies of all correspondence.
p.000005: 5. A list of IRB members.
p.000005: 6. Writ:I:en procedures for the ZRB .
p.000005:
p.000005:
p.000005: An investigator shall seeE such consent only under circumstances that provide the prospective subject or the
p.000005: representative sufficient opportunity to consider whether or not to participate and that minimize the possibility of
p.000005: coercion or undue influence. The information that is given to the subject or the representative shall be in language
p.000005: understandable to the subject or the representative.
p.000005: a) Basic elements of informed consent
p.000005: 1. A statement that the study involves research, an explanation of the purposes of the research and the expected
p.000005: duratiOn of the subject's participation, a description of the procedures to be followed, and identification of any
p.000005: procedures which are experimental,
p.000005:
p.000005: 2. A description of any reasonably foreseeable risks or discomforts to the subject,
p.000005:
p.000005: 3 . A description of any benefits to the subject or to others which may reasonably bm expected from the research;
p.000005: 4. A disclosure of appropriate alternative procedures or courses of treatment, if any;
p.000005: 5. & statement describing the extent, if any,
p.000005: to which confidentiality of records identifying the subject will be maintained;
p.000005: 6. An explanation as to whether any compensation and
p.000005: an explanatioñ as to whether any medical treatments are available lf injury occura and, if so, what they consist of, or
p.000005: where further information xay be obtained,
p.000005: 7. An explanation of whom to contact for answers to pertinent questions;
p.000005: 8. A statement that participati on is voluntary, refusal to participate will involve no penalty or loss of benefits to
p.000005: which the subject is otherwise entitled, and the subject say discontinue participation at any time.
p.000005: b) When appropriate, one or more of the following elements of information shall also be provided to each subject:
p.000005: 1. L statement that the particular treatment or procedure may involve rieks;
...

General/Other / belmont

Searching for indicator belmont:

(return to top)
p.000010: subjefls euccessfully.
p.000010:
p.000010: Undergraduate reseafAi is an integral part of the cgmculum cif the UOG Paychofogy Progr- AU psychology dasses
p.000010: have a reseœch œsy›anent. Students learn to evaluate research and develop researplt propo At
p.000010: least' hàb of the students
p.000010:
p.000010: BJ:49Rm FRDM Sx SW
p.000010: TQ 475Z000 P. OZ
p.000010:
p.000010:
p.000010:
p.000010:
p.000010:
p.000010:
p.000010:
p.000010: !' to have ext ve æsearcli trai›ning and those who have hande-
p.000010: . research Experience have advanÏage river other appiicanW It is critical our stiidents '
p.000010: ciontinue to cpndiicl undergraduate research that
p.000010: ' their learñing experience imd in reases their educational
p.000010:
p.000010:
p.000010:
p.000010:
p.000010:
p.000010: urk Smith, IPh. D.
p.000010:
p.000010:
p.000010:
p.000010:
p.000010:
p.000010:
p.000010:
p.000010:
p.000010:
p.000010:
p.000010:
p.000010:
p.000010:
p.000010:
p.000010:
p.000010:
p.000010:
p.000010:
p.000010:
p.000010:
p.000010:
p.000010:
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p.000010:
p.000010:
p.000010:
p.000010:
p.000010:
p.000010:
p.000010:
p.000010:
p.000010: TOTFIL P. BZ
p.000010:
p.000010:
p.000010:
p.000010:
p.000010: ETHICAL PRINCIPLES AND GUIDELINES FOR TI-BE PROTECTION OF HUMAN SUBJECTS
p.000010: OF RESEARCH
p.000010: A Summary of the Belmont Report
p.000010: sha nat:ional coeaisalon ccc sha P 'o*ec¢1ozt of Buzaao Bub§ ects o2 Biomedical fi Behavioral
p.000010: Research
p.000010:
p.000010:
p.000010:
p.000010:
p.000010: The following consists of quoted excerpts. A copy of the complete report is available in eha £11se of ehe Joe
p.000010: cormie€ae cor tiuaan Reseaccn Subjseen , Gratiuazs gchoo1 and Reeaat-ch O££lce .
p.000010:
p.000010:
p.000010: {NTRODU ION
p.000010:
p.000010: Scientific research has produced substantial social benefits.
p.000010: It has also posed some troubling ethical questions.
p.000010: Since 194], various codes £or the proper and responsible conduct of human experimentation in medical research have been
p.000010: adopted. These are the Nuremberg Code of 1947, the Helsinki Declaration of 1964 (revised i975), and the 1971
p.000010: Guidelines (codi#ied into Federal Regulations in 1974) issued by the U.S. Department of Health, Education, and
p.000010: Welfare. Codes for the conduct of social and behaVioral research have also been adopted, by the American Psychological
p.000010: Association, 1973.
p.000010: Three principles, or general prescriptive judgments, that are relevant to research involving human subjects are
p.000010: identified in these statements. These should assist scientists, subjects, reviewers and interested citizens to
p.000010: understand the ethical issues inherent io research involving human subjects.
p.000010: mis report consists of a distinction between research and practice, a discussion of the three basic ethical
p.000010: principles, and remarks about the application of these principles.
p.000010:
p.000010:
p.000010:
p.000010:
p.000010:
p.000010:
p.000010:
...

p.000005: suspended when the department or agency head Sinds an institution has materially failed to comply with the terms of
p.000005: this policy.
p.000005: sa«g1oa 12« cooa181o¥ta1 Zae appg'o 1.
p.000005: The department or agency head may impose additional conditions prior to or at the time of approval when in the judgment
p.000005: of the department or agency head additional conditions are necessary.
p.000005:
p.000005:
p.000005:
p.000005:
p.000005:
p.000005:
p.000010: 10
p.000010:
p.000010: t estimony recommyyding changes to Bill 347 Profsof Smiology and Commuiñty De*el°i*i&t
p.000010: College of Agriculture & Life Scit•-, U£Ki
p.000010:
p.000010:
p.000010: Greetings to Senator Kasperbauer, members of the Committee On Education, and other attendees to today’s Public
p.000010: Hearing. I speak on the subject of Bill 347 drawing from my experience of 20 years conducting research involving human
p.000010: subjects on Guam and in Micronesia, and my tenure with the University’s Committee on I-luman Research Subjects since
p.000010: it’s inception in 1982.
p.000010: I strongly support the intent of Bill 347 that any research study involving the participation of citizens and residents
p.000010: of Guam should be required to have at least one review by an appropriately constituted institutional review board
p.000010: established on Guam
p.000010: Scientific research has produced substantial social benefits, yet has also posed some troubling ethical queitions.
p.000010: Since 1945, various codes for the proper and responsible conduct of human experimentation in medical research hsve
p.000010: been adopted. Basic principles of research involving human subjects developed by these codes have been summarized in
p.000010: the Belmont Report, by The National Commission for the Protection of Human Subjects of Biomedical & Behavioral
p.000010: Research, U.S. Department of Health, Education and Welfare (Published: April 18, 1979). I note this an‹ attach a
p.000010: summary of it for you to clarify the ethical issues inherent in research involving human subjects. The essential heart
p.000010: of concern is
p.000010: Respect for Persons: the idea that individuals are capable of deliberation about personal goals and of acting under
p.000010: the direction of such deliberation. To respect autonomy is to give weight to a persons’ considered opinions and
p.000010: choices. To show lack of respect for an autonomous agent is to deny an individual the freedom to ad on those considered
p.000010: judgements, or to withhold information necessary to make a considered judgement Respect for persons demands that
p.000010: subjects enter into the research voluntarily and with adequate information.
p.000010: Applications of the general principles to the conduct of research leads to consideration of the following requirements:
p.000010: 1. I o ed C t: requires that subjects, to the degree that they are capable, be given the opportunity to
p.000010: choose what shall or shall not happen to them, and 2.
p.000010: Aices e o presents both an opportunity and a responsibility. Many kinds
p.000010: of possible harms and benefits need to be taken into account. There are, for example, risks of psychological harm,
...

General/Other / common rule

Searching for indicator common rule:

(return to top)
p.000003: such a manner that subjects cannot be identified, directly or through identifiers linked to the subjects.
p.000003: (5) Research and demonstration projects... which are designed to study, evaluate or otherwise examine: (i) Public
p.000003: benefit or service programs; (ii) procedures for obtaining benefits or services under those programs; (iii) possible
p.000003: changes in or alternatives to those programs ...(iv) possible changes in methods or ... payment ... or services under
p.000003: those programs.
p.000003: (6) Taste and food quality evaluation and consumer acceptance studies, (i) if wholesome foods without additives are
p.000003: consumed or (ii) if a food is consumed that contains a food ingredient at or below the level and for a use found to be
p.000003: safe, or agricultural chsrical or environmental contaminant at or below the level found to be aafe, by the Food
p.000003: and Drug Administration or approved by the Environmental Protection Agency or the Food Safety and Inspection Service
p.000003: of the USDA.
p.000002: 2
p.000002:
p.000002: UxSVBeszzg or auazg
p.000002: tJDlBsKsBaAz ouaanx
p.000002: COMMITTEE on IlTJhfWf RZSZAItCIE SUBJECTS
p.000002: RESEARCH COUNCIL GRADUATE SCHOOL & RESEARCH
p.000002:
p.000002:
p.000002:
p.000002: SOURCE: Pederg} Reqister, Jupg 18, 1991 (Regq}atioqs effective Augugt 19, 1991)
p.000002:
p.000002:
p.000002: "This document sets forth a common Federal Poliwy for the Protection of Human Subjects accepted by the office
p.000002: of Science aod TacRoology Pollwy and promulgated in regulation by each of the listed Departments and Agencies.•
p.000002: Each of these Departments and Agencies have adopted the common rule as regulations for the protection of human subjects
p.000002: involved in research conducted or funded by the following:
p.000002: Cs Depactzsenc o£ hgu1cu1cure› Dapaztaian€ o£ znecgy; mac1ona1 Aeronautics and Spaoe Adm£n1e€cac1ozt›
p.000002: Dapaz-haiarzc oC Coaaaocce; Conauaiou product Sa£ecy Cozam1ee ton; InVecna€1one1 Deva1ogxaan€ Coopora¢1oa
p.000002: kgency; urgency Com IncecnahLonaL Deea1o$man€; Depactaian€ of Bous1ng aztd Ocban Davalogaaanc;
p.000002: Depaccmenc o£ 6uac1ce› Depaz-ba›nnc oC De£anee; Depaz€a›anc o£ 6duoac1on; Depaz-beanjr o£ ve€aran
p.000002: ACCa1ce;
p.000002:
p.000002:
p.000002:
p.000002:
p.000002: 8ecc1on for g'o abas doea fib1a po11oy app1g's
p.000002:
p.000002: (a) . . . this policy applies to all research involving human subjects conducted, supported or otherwise subject to
p.000002: regulation by any federal department or agency which takes appropriate administrative action to make the
p.000002: policy applicable to such research. . . . It also includes research conducted, supported, or otherwise subject to
p.000002: regulation by the federal government outside the United States.
p.000002:
p.000002: (2) Research that is neither conducted nor supported by a federal department or agensy but is subject to regulation as
p.000002: defined in Section 102(e) must be reviewed and approved, in compliance with Sections 101,102, ana rod through 117 Of
p.000002: this policy, by an institutional review board (IRB) that operates in accordance witA the pertinent requirements of this
p.000002: policy.
p.000002:
p.000002:
p.000002:
p.000002:
p.000002:
p.000002:
p.000002: 1.18 Børtør (Witb Patitøts or Oients)
p.000002:
p.000002:
p.000002:
p.000002:
p.000002:
p.000002: splay (Warse Staødøxii 1•I7. bluliipi» Refer-i-
p.000002:
...

General/Other / declaration of helsinki

Searching for indicator helsinki:

(return to top)
p.000010: ' their learñing experience imd in reases their educational
p.000010:
p.000010:
p.000010:
p.000010:
p.000010:
p.000010: urk Smith, IPh. D.
p.000010:
p.000010:
p.000010:
p.000010:
p.000010:
p.000010:
p.000010:
p.000010:
p.000010:
p.000010:
p.000010:
p.000010:
p.000010:
p.000010:
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p.000010:
p.000010:
p.000010:
p.000010:
p.000010:
p.000010:
p.000010:
p.000010:
p.000010:
p.000010:
p.000010:
p.000010:
p.000010:
p.000010:
p.000010:
p.000010:
p.000010:
p.000010:
p.000010:
p.000010:
p.000010:
p.000010:
p.000010:
p.000010:
p.000010:
p.000010: TOTFIL P. BZ
p.000010:
p.000010:
p.000010:
p.000010:
p.000010: ETHICAL PRINCIPLES AND GUIDELINES FOR TI-BE PROTECTION OF HUMAN SUBJECTS
p.000010: OF RESEARCH
p.000010: A Summary of the Belmont Report
p.000010: sha nat:ional coeaisalon ccc sha P 'o*ec¢1ozt of Buzaao Bub§ ects o2 Biomedical fi Behavioral
p.000010: Research
p.000010:
p.000010:
p.000010:
p.000010:
p.000010: The following consists of quoted excerpts. A copy of the complete report is available in eha £11se of ehe Joe
p.000010: cormie€ae cor tiuaan Reseaccn Subjseen , Gratiuazs gchoo1 and Reeaat-ch O££lce .
p.000010:
p.000010:
p.000010: {NTRODU ION
p.000010:
p.000010: Scientific research has produced substantial social benefits.
p.000010: It has also posed some troubling ethical questions.
p.000010: Since 194], various codes £or the proper and responsible conduct of human experimentation in medical research have been
p.000010: adopted. These are the Nuremberg Code of 1947, the Helsinki Declaration of 1964 (revised i975), and the 1971
p.000010: Guidelines (codi#ied into Federal Regulations in 1974) issued by the U.S. Department of Health, Education, and
p.000010: Welfare. Codes for the conduct of social and behaVioral research have also been adopted, by the American Psychological
p.000010: Association, 1973.
p.000010: Three principles, or general prescriptive judgments, that are relevant to research involving human subjects are
p.000010: identified in these statements. These should assist scientists, subjects, reviewers and interested citizens to
p.000010: understand the ethical issues inherent io research involving human subjects.
p.000010: mis report consists of a distinction between research and practice, a discussion of the three basic ethical
p.000010: principles, and remarks about the application of these principles.
p.000010:
p.000010:
p.000010:
p.000010:
p.000010:
p.000010:
p.000010:
p.000010:
p.000010:
p.000010:
p.000010: 2. Asses#eent of Aisks and ]exeflts• presents botA an opportunity and a responsibility to gatAer systematic
p.000010: and comprehensive information about proposed resesrcA, including alternative ways of obtaining tAe benefits
p.000010: sougAt in tAe zssearsA. Pos fibe lnves€1gacoz', IN la a aeans jzo exax£na obefibac tbe puopoaaA
p.000010: research is properly deslgned. Por a review ooemittee, lt is a matAod for determining wAetAertée risAs to sub3ectsara
p.000010: justified. The cert "r1.ak" refers I:o a posslbill£y thai harm may comer •
p.000010: £0 Includes re£arence botL to tha chance (probab111t:y) of nxparlenclnq a hara and
...

Orphaned Trigger Words

p.000002: V. C. Pangelinan
p.000002: J. C. Salas
p.000002: A.L.G. Santos
p.000002: F. E. Santos
p.000002: A. R. Unpingco
p.000002: J. T. Won Pat
p.000002:
p.000002: AN ACT TO ADD CHAPTER 24 TO DIVISION 3 OF TITLE 17 OF THE GUAM CODE ANNOTATED, RELATIVE TO
p.000002: DESIGNATING UOG'S COMMITTEE ON HUMAN SUBJECTS IN RESEARCH AS THE INSTITUTIONAL
p.000002: REVIEW BOARD FOIt REVIEW AND APPROVAL OF RESEARCH CONDUCTED ON GUAM WITH REGARD TO HUMAN
p.000002: SUBJECTS.
p.000002:
p.000002:
p.000002:
p.000002:
p.000002:
p.000002:
p.000002: 1 BE IT ENACTED BY THE PEOPLE OF GUAM:
p.000002: 2 Section 1. Legislative Findings. Liheslaturan Guahan finds that
p.000002: 3 research studies involving human subjects are conducted on Guam, and
p.000002: 4 realizes a need to protect the rights of persons participating in human
p.000002: 5 research projects through a review of research proposals, plans, procedures
p.000002: 6 and protocols. It further finds that designation of the University of Guam’s
p.000002: 7 (“UOG's”) Committee on Human Subjects in Research as the InstitlltlOTlal
p.000002: 8 Review Board (“IRB”) for researchers and collaborators at University of Guam
p.000002: 9 and for researchers who are not under other IRB's is the appropriate body to
p.000002: 10 review proposals, plans, procedures and protocol for research involving
p.000002: 11 human subjects and to approve or disapprove the same.
p.000002: 12 Furthermore, I Liheslaturan Guahan finds that human research conducted
p.000002: 13 on Guam do Sof always acquire informed consent from persons participating
p.000002: 14 in the programs, and that there is a need to regulate and mandate informed
p.000002: 15 consents to ensure that those persons participating are adequately informed.
p.000002: 16 The Review Board will be under the auspices of UOG as it has been
p.000002: 17 identified as the suitable entity under the direction of the Graduate School
p.000002: 18 and Research Department.
p.000002: 19 Section 2. Chapter 24 is hereby added to Division 3 of Title 17 of the
p.000002: 20 Guam Code Annotated to read as follows:
p.000002: 21 “CHAPTER 24.
p.000002: 22 Section 24101. Definitions. As used in this Chapter:
p.000002: 23 (a) ’Board’ means the Guam Research Review Board.
p.000002:
p.000002:
p.000002: 2
p.000002:
p.000002:
p.000002: 1 (b) ’Investigator’ means any individual, public or private entity,
p.000002: 2 or agency engaged in or purposing to engage in research subject to
p.000002: 3 regulation.
p.000002: 4 (c) ’Legally’ authorized representative means an individual or
p.000002: 5 judicial or other body authorized under applicable law to consent on
p.000002: 6 behalf of a prospective subject to the subject's participation in the
p.000002: 7 procedure(s) involved in the research.
p.000002: 8 (d) ’Research’ as defined in the Federal Register, §102
p.000002: 9 Definitions.
p.000002: 10 (e) ’Research’ subject to regulation means research involving
p.000002: 11 human subjects.
p.000002: 12 (f) 'Human subjects’ means a living individual about whom an
p.000002: 13 investigator conducting research obtains:
p.000002: 14 (1) Data Through Intervention or Interaction with the
p.000002: 15 Individual. Intervention includes both
p.000002: physical
p.000002: 16 procedures by which data are gathered and manipulations of the
p.000002: 17 subject or the subject's environment that are performed for
p.000002: 18 research purposes. Interaction includes communication or
p.000002: 19 interpersonal contact between investigator and subject.
p.000002: 20 (2) Identifiable Private Information. Private irJormation
p.000002: 21 may include information about behavior that occurs in a context
p.000002: 22 in which an individual can reasonably expect that no observation
p.000002: 23 or recording is taking place, and information which has been ...

p.000004: 23 representative:
p.000004: 24 (1) a statement that the study involves research, an
p.000004: 25 explanation of the purpose of the research and the expected
p.000004:
p.000006: 6
p.000006:
p.000006:
p.000006: 1 duration of the subject’s participation, description of the
p.000006: 2 procedures to be followed and identification of any
p.000006: 3 procedures which are experimental;
p.000006: 4 (2) a description of any reasonably foreseeable risk
p.000006: 5 or discomforts to the subject;
p.000006: 6 (3) a description of any benefits to the subject or to
p.000006: 7 others which may reasonably be expected from the research;
p.000006: 8 (4) a disclosure of appropriate
p.000006: alternative
p.000006: 9 procedures or courses or treatment, if any, that might be
p.000006: 10 advantageous to the subject;
p.000006: 11 (5) a statement describing the extent, if any,
p.000006: to
p.000006: 12 which confidentiality of records identifying the subject will
p.000006: 13 be maintained;
p.000006: 14 (6) for research involving more than minimal risk,
p.000006: 15 an explanation as to whether any compensation and an
p.000006: 16 explanation as to whether any medical treatments are
p.000006: 17 available if injury occurs, and, if so, what it consists of or
p.000006: 18 whether further information may be obtained;
p.000006: 19 (7) an explanation of whom to contact for answers
p.000006: 20 to pertinent questions about the research and research
p.000006: 21 subject’s rights, and whom to contact in the event of a
p.000006: 22 research-related injury to the subject; and
p.000006: 23 (8) a statement that participation is
p.000006: voluntary,
p.000006: 24 refusal to participate will involve no penalty or loss of
p.000006: '5 benefits to which the subject is otherwise entitled, and the
p.000006:
p.000007: 7
p.000007:
p.000007:
p.000007:
p.000001: 1
p.000002: 2
p.000003: 3
p.000004: 4
p.000005: 5
p.000006: 6
p.000007: 7
p.000008: 8
p.000009: 9
p.000010: 10
p.000011: 11
p.000012: 12
p.000013: 13
p.000014: 14
p.000015: 15
p.000016: 16
p.000017: 17
p.000018: 18
p.000019: 19
p.000020: 20
p.000021: 21
p.000022: 22
p.000023: 23
p.000024: 24
p.000024: -'5
p.000024: subject may discontinue participation at any time without penalty OF lOsS of benefits to which the
p.000024: subject is otherwise entitled. ...

p.000008: 2 does not include, or which alters, some or all of the elements of
p.000008: 3 irdormed consent set forth above, or waive the requirements to
p.000008: 4 obtain informed consent; provided, that the Board finds and
p.000008: 5 documents that:
p.000008: 6 (1) the research or demonstration project is to be
p.000008: 7 conducted by, or subject to, the approval of Federal, state,
p.000008: 8 territorial or local government officials, and is designed to
p.000008: 9 study, evaluate or otherwise examine: (i) public benefit of
p.000008: 10 service programs; (ii) procedures for obtaining benefits or
p.000008: 11 services under those programs; (iii) possible changes and/ or
p.000008: 12 alternatives to those programs or procedures; or (iv) possible
p.000008: 13 changes in methods or levels of payments for benefits or
p.000008: 14 services under those programs; and
p.000008: 15 (2) the research could not practically be carried out
p.000008: 16 without the waiver or alteration.
p.000008: 17 (d) The Board may approve a consent procedure which
p.000008: 18 does not include, or which alters, some or all of the elements of
p.000008: 19 informed consent set forth in this Section, or waives the
p.000008: 20 requirements to obtain informed consent; provided, that the Board
p.000008: 21 finds and documents that:
p.000008: 22 (1) the research involves no more than minimal risk
p.000008: 23 to the subject;
p.000008: 24 (2) the walver or alteration will nof adversely affect
p.000008: 25 the rights and welfare of the subject;
p.000008:
p.000009: 9
p.000009:
p.000009:
p.000009: 1 (3) the research could not practically be carried
p.000009: out
p.000009: 2 without the waiver or alteration; and
p.000009: 3 (4) whenever appropriate, the subjects will
p.000009: be
p.000009: 4 provided with additional and pertinent information after
p.000009: 5 participation.
p.000009: 6 (e) The informed consent requirements are not intended to
p.000009: 7 preempt any applicable Federal, state or local laws which require
p.000009: 8 additional information to be disclosed in order for informed
p.000009: 9 consent to be legally effective.
p.000009: 10 (9 Nothing in this Section is intended to limit
p.000009: the ...

p.000013:
p.000013: Bill No. 347: AN ACT TO CREATE A REVIEW BOARD OF REVIEW AND APPROVAL OF RESEARCH CONDUCTED ON GUAM WITri nEcAnD To
p.000013: HuMAN SUBJECTS.
p.000013:
p.000013: Senadors present: Senator Larry Kasperbaur, Chairperson, Senator Lou Leon Guerrero, Senator Mark Charfauros
p.000013: and Senator Frank Camacho.
p.000013:
p.000013: Those present to testify were: Dr. Jose T. Nededog, President, University of Guam, Dr. Joyce Camacho, Dean of
p.000013: Graduate School and Research, University of Guam, Dr. Kyle Smith, Professor of Psychology, University of Guam, Dr.
p.000013: Randall L. Workman, Professor of Sociology, University of Guam, Gregoria Smith, Psychometrist, UOG /UCSD Research
p.000013: Project, Mr. Ray Adonay, Dr. Bert Weiderholt, Physician/ Neurologist, University of California-San Diego and
p.000013: Debbie Quinata.
p.000013:
p.000013: Those not present, but submitted written testimony were: Dr. John Steele, Dr. Marcus Tye, Asst. Professor,
p.000013: Psychology, University of Guam, Dr. Richard Colfax, Management & Marketing Chairperson, University of Guam,
p.000013: Dr. Seyda Turk Smith, Associate Professor, Psychology, University of Guam, Dr. Pamina J. Hofer, Clinical
p.000013: Neurolopsychologist and Guam Lytico and Bodig Association.
p.000013:
p.000013: Overview of Bill
p.000013:
p.000013: Senator Lou Leon Guerrero shared with the Committee members and the audience an overview of Bill 347.
p.000013:
p.000013: Bill 347 was drafted as a result of a public hearing conducted during the 23rd Guam Legislature when Senator Lou Leon
p.000013: Guerrero was Chairperson of Health, Welfare & Senior Citizens to discuss various
p.000013:
p.000013:
p.000001: 1
p.000001:
p.000001: research done on Guam. There was a public outcry on how we protect human subjects for research. The University of
p.000001: Guam has a review board, as well as the Guam Memorial Hospital. However, Bill 347 will set forth rules and
p.000001: regulations to assure that people are protected with informed consent. All research studies and methodologies must
p.000001: go through a review process.
p.000001: Oral Testimonies
p.000001:
p.000001: Dr. Jose Nededog, President, University of Guam presented his oral testimony in support of Bill 347. He indicated
p.000001: that this bill can act as an umbrella for various research done on Guam. His concern was that the present staff is
p.000001: overtasked and the bill should be modified to include support - a clerk and supporting equipment.
p.000001:
p.000001: Dr. Joyce Camacho, Acting Dean for Graduate School and Research submitted oral testimony to support Bill 347. Her
p.000001: concerns include (1) duplicatlon of existing review; (2) the role of University of Guam in research; (3) delays in
p.000001: conducting research; and (4) composition of Committee members as stated in the proposed legislation.
p.000001:
p.000001: Dr. Camacho gave some background information on the existing research board: The Research Council is comprised
p.000001: of the Dean of Graduate School and Research, Dean of Learning Resources, Directors of Research Institute,
p.000001: Associate Dean of Agriculture Experiment Studies and elected faculty from the five (5) academic colleges with an
p.000001: ex-officio representative to the Council of Undergraduate Research.
p.000001:
p.000001: The Council meets bimonthly to discuss relevant research issues. Their tasks include development, review and
p.000001: enforcement of research policy at the University of Guam. One of the standing committees of the Research Council
p.000001: is the Committee on Human Subjects in Research. They are tasked with reviewing and approving or disapproving of
p.000001: research proposals that involve human subjects.
p.000001: They have existed since 1982 and serve Guam by providing
p.000001: ...

p.000004: The above Bill is referred to your Committee as the principal committee. lt is recommended
p.000004: you schedule a public hearing at your earliest convenience.
p.000004:
p.000004: Thank you for your attention to this matter.
p.000004:
p.000004:
p.000004:
p.000004: MARK FORBES
p.000004:
p.000004:
p.000004: Attachment
p.000004:
p.000004: TWENTY-FOURTH GUAM LEGISLATURE
p.000004: 1997 lFirst) Regular Session
p.000004:
p.000004: Bill No. 347
p.000004: As substituted by the Author
p.000004: Introduced by: L. Leon Guerrero
p.000004: W.Flores T.Ada
p.000004:
p.000004: AN ACT TO ADD CHAPTER 24, DIVISION 3, 17 GCA TO CREATE A REVIEW BOARD FOR REVIEW
p.000004: AND APPROVAL OF RESEARCH CONDUCTED ON GUAM WITH REGARD TO HUMAN SUBJECTS.
p.000004:
p.000004: BE IT ENACTED ON BY THE PEOPLE OF THE TERRITORY O F GUAM:
p.000004: 3 Section 1. Legislative Findings. The legislature finds that
p.000004: 4 research studies involving human subjects are conducted on Guam
p.000004: arid realizes a need to protect the rights of persons participating in
p.000004: 6 human research projects through a review of research proposals,
p.000004: 7 plans, procedures and protocols. It further finds that the creation of
p.000004: 8 a review board is the appropriate body to review proposals, plans,
p.000004: 9 procedures and protocol for research involving human subjects and
p.000004: 10 to approve or disapprove the same.
p.000004: Furthermore, the legislature finds that human research
p.000004: 12 conducted on Guam do not always acquire informed consent from
p.000004: 13 persons participating in the programs and that there is a need to
p.000004: 14 regulate and mandate informed consents to ensure that those
p.000004: 15 persons participating are adequately informed.
p.000004: 16 The review board will be under the auspices of the University
p.000004: 17 of Guam as it has been identified as the suitable entity under the
p.000004: 18 direction of the Graduate School and Research Department.
p.000004: 19 Section 2. Division 3 of Title 17 GCA, is hereby amended to
p.000004: 20 add Chapter 24 to read as follows:
p.000004: 2T “Chapter 24
p.000004: 22 §24101. Definitions. As used in this chapter:
p.000004: 23 (a) Board means the Guam Research Review Board;
p.000004:
p.000004: 1 (b) Investigator means any individual, public or private entity
p.000004: 2 or agency engaged in or purposing to engage in research subject to
p.000004: 3 regulation;
p.000004: 4 (c) Legally authorized representative means an individual or
p.000004: 5 judicial or other body authorized under applicable law to consent on
p.000004: 6 behalf of a prospective subject to the subject’s participation in the
p.000004: 7 procedure(s) involved in the research.
p.000004: 8 (d) Research means a systematic investigation, including
p.000004: 9 research development, testing and evaluation, designed to develop
p.000004: 10 or contribute to the understanding of a particular condition or ...

p.000002: 33 human subjects.
p.000002: 34 (0 Human sub jects means a living individual about whom an
p.000002: 35 investigator conducting research obtains
p.000002: 36 (1) Data through intervention or interaction with the
p.000002: 37 individual. Intervention includes both physical
p.000002: 38 procedures by which data are gathered and
p.000002: 39 manipulations of the subject or the subject's
p.000002: 40 environment that are performed for research purposes.
p.000002:
p.000002: 1 Interaction includes communication or interpersonal
p.000002: 2 contact between investigator and subject.
p.000002: 3 (2) Identifiable private information. Private information
p.000002: 4 may include information about behavior that occurs in a
p.000002: 5 context in which an individual can reasonably expect
p.000002: that no observation or recording is taking place, and
p.000002: 7 information which has been provided for specific
p.000002: purposes by an individual and which the individual can
p.000002: 9 reasonably expect will not be made public (for example,
p.000002: 10 a medical records). Private information must be
p.000002: 11 individually identifiable in order for obtaining the
p.000002: 12 information to constitute research involving human
p.000002: 13 subjects.
p.000002: 14 (g) Mioirnl risk means that the probability and magnitude of
p.000002: 15 harm or discomfort anticipated in the research are not grater in and
p.000002: 16 of themselves than those ordinarily encountered in daily life or
p.000002: 17 during the performance of routine physical or psychological
p.000002: 18 examination or tests.
p.000002: 19 §24102. Board; Terms; Appointment; Continuance; Removal.
p.000002: 20 There is created a seven (7) member ”Guam Research Review Board"
p.000002: 21 under the direction of the Office of the Graduate School and
p.000002: 22 Research at the University of Guam. Members of the Board shall be
p.000002: 23 comprised of representatives of the following: one (1) member from
p.000002: 24 the Guam Memorial Hospital Institutional Review Board; one (1)
p.000002: 25 member from the University of Guam Institutional Review Board;
p.000002: 26 (1) member of the clergy; the Director of the Department of Public
p.000002: 27 Health and Social Services or his/her designee; two (2) community
p.000002: 28 representatives recommended by the Mayor's Council; and an
p.000002: 29 attorney licensed to practice in the Territory of Guam. Members of
p.000002: 30 the Board shall be appointed by the President of the University of
p.000002: 31 Guam. The Board shall be appointed for a three (3) year term. The
p.000002: 32 President of the University of Guam may remove any member from
p.000002: 33 the Board for the neglect of any duty required by law, for
p.000002: 34 incompetence, for improper and unprofessional conduct or for
p.000002: 35 violation of Board rules and regulations. Four (4) members shall
p.000002: 36 constitute a quorum of the Board for the transaction of business. The ...

p.000005: 18 following information shall be provided to each human subject or the
p.000005: 19 subject's legally authorized representative:
p.000005: 20 (1) A statement that the study involves research, an
p.000005: 21 explanation of the purpose of the research and the
p.000005: 22 expected duration of the subject's participation,
p.000005: 23 description of the procedures to be followed, and
p.000005: 24 identification of any procedures which are
p.000005: 25 experimental;
p.000005: 26 (2) A description of any reasonably foreseeable risk or
p.000005: 27 discomforts to the subject;
p.000005: 28 (3) A description of any benefits to the subject or to others
p.000005: 29 which may reasonably be expected from the research;
p.000005: 30 (4) A disclosure of appropriate alternative procedures or
p.000005: 31 courses or treatment, if any, that might be
p.000005: 32 advantageous to the subject;
p.000005: 33 (5) A statement describing the extent, if any, to which
p.000005: 34 confidentiality of records identifying the subject will be
p.000005: 35 maintained;
p.000005: 36 (6) For research involving more than minimal risk, an
p.000005: 37 explanation as to whether any compensation and an
p.000005: 38 explanation as to whether any medical treatments are
p.000005: 39 available if injury occurs and, if so, what it consist of or
p.000005: 40 whether further information my be obtained;
p.000005:
p.000005: t (7) An explanation of whom to contact for answers to
p.000005: 2 pertinent questions about the research and research
p.000005: 3 subject's rights, and whom to contact in the event of a
p.000005: 4 research-related injury to the subject; and
p.000005: 5 (8) A statement that participation is voluntary, refusal to
p.000005: 6 participate will involve no penalty or loss of benefits to
p.000005: 7 which the subject is otherwise entitled and the subject
p.000005: 8 may discontinue participation at any time without
p.000005: 9 penalty or loss of benefits to which the subject is
p.000005: to otherwise entitled.
p.000005: i1 (b) Additional Elements of Informed Consent. When
p.000005: 12 appropriate, the Board may require that one (1) or more of the
p.000005: 13 following elements of information shall also be provided to each
p.000005: 14 subject;
p.000005: 15 (1) A statement that the particular treatment or procedure ...

p.000010: understand (ñn,d japs fails zo value) research and the University.
p.000010:
p.000010: committee
p.000010:
p.000010: 4. The passage of such.q law Auld swipusly undermine the eParts of faculty to bring in research money, Which
p.000010: traditionally ñelps stlpport the lost institution. It also adds to.Guam’s already large bureauoacy.
p.000010: ' Thank you for your tims end your effons in ensuring thac this bill does not oass, o- at the very least ‹o. inane
p.000010: sure the bill is amen ded,to exempt any researdi conducted on Guam that ‹eceives approva( from UOG's existing internal
p.000010: C ?nmisee on F uman Research Subjects
p.000010:
p.000010:
p.000010:
p.000010:
p.000010:
p.000010:
p.000010: T0T9L P. 01
p.000010:
p.000010: Defînitions
p.000010: Raaaaæh n›aane a imæô$ation, indrding raceamh development, testirig and æaluat›on, des ned to
p.000010: or œntñbuta æ eabb
p.000010:
p.000010: Raaaarah subted to reqylaéon encompass those research aoi¥ities lbr which a f¥deral department or agency has specific
p.000010: recporaibiity for regulating as a research a¢tMty. It does not include re6earcfj actMtbs whiQi are ir¥fidentally
p.000010: regubtnd by a federal deparbnent or agency sdely as part of the depar¥nent's or agency's broader responsibility to
p.000010: regulate certain types of activitBs whatfer faseaich or non-research m nature (e.g., Waga/Hour fequi/ements
p.000010:
p.000010: Human suh]aotrfieans a flVirig individual about whom an irnestigator (whether professional or students coriducgng
p.000010: researdl olzlaxis (1) data through intervenron or interaction with the indfvtduaI, or
p.000010: (2) identfffable private information.
p.000010:
p.000010: Minimal fisk means that the probability and magnitude of harm or discomfort anécipatadin tha research are not greater
p.000010: in arid of themselves than those ordinarily encountered in daily life or duñng the performanm of rouine physical or
p.000010: psychological exarninarorn or tests.
p.000010:
p.000010: Cerffffcadon means the oflïcial notîÏîœtion by the institution tg the suppoitirig depar¥mnt or agancy, in acœidanœ with
p.000010: the reguiremerits ofthis polîcy, that a reseerÖj project or actfvity involving human subjeÖs has been ravîewed ard
p.000010: approvæl by an IRB in accordanca with an approved aesuranœ.
p.000010:
p.000010: Purpose
p.000010: The CHRS evaluates the level of risk to human subjects, ‹ecommends procedural steps to minimize risk9, and provides
p.000010: certification as needed by 0›e researcher. It does not judge research design nor recommend methodological
p.000010: alternatives. Under federal regulations, the CHRS is charged with safeguarding the rights and wellbre of humans
p.000010: involved, and must determine:
p.000010: • whe0ier öle nghte and woffaæ of the humane involved in research will be
p.000010: adequately protacted, and
p.000010: • wfiather legally affbcth/e infbfmed conaent of gll humane to be eollcitad will be obtained with adequate reCorde
p.000010: maintained (request CHR6 Informed Content Guidelines, Form B and C).
p.000010: Prccedures
p.000010: 1. Obtain an appliméon fix CHRS review (Form A) lion tf›e UOG O8‹a of t›e G/aduata School and Research.
p.000010: lnclt¥Ja copies eg 6s pr0jaO pRzpoBal, ag consent forms, and gummary sajpts of varbal and/or video instrudbns to ba
p.000010: depleted to sub}ecB.
p.000010:
p.000010: 2. Maintaif\ worI‹ing contad with the CHRS Ckair during the review process, and provde supplemental
p.000010: infbrmaéon as requesBd by the -nmidno or stAu\it a feplytD $ugpe9ted ¢x›nsaetations.
p.000010: 3. If approVed, rœeœÖ\ pfajeds may Iæ monb ad by One CHRS æ nædal to ensure due process and
p.000010:
p.000010: Appendix o
p.000010:
p.000010:
p.000010:
p.000010:
p.000010: UNIVERSITY OF GUAM
p.000010: Committee on Human Research Subjects Office of the Graduate School and Research
p.000010:
p.000010: RESEARCH SUBJECT’S BILL OF RIGHTS
p.000010:
p.000010: Any person who is requested to consent to participate as a subject in a research project, or who is requested to
p.000010: consent on behalf of another, has the right to:
p.000010:
p.000010: 1. Be informed of the nature and purpose of the experiment.
p.000010:
p.000010: 2. Be given an explanation of the procedures to be followed in the research study, and drugs or device to be
p.000010: used.
p.000010:
p.000010: 3. Be given a description of any possible discomfort and risks reasonably to be expected from a research
p.000010: procedure, if applicable.
p.000010:
p.000010: 4. Be given an explanation of any benefits to the subject reasonably to be expected from the research
p.000010: procedure, if applicable.
p.000010:
p.000010: 5. Be given a disclosure of any appropriate alternative procedures, drugs, or devices that might be advantages
p.000010: to the subject, and their relative riiks and benefits.
p.000010:
p.000010: 6. Be informed of the avenues of medical treatment, if any, available to the subject after the experiment if
p.000010: complications should arise.
p.000010:
p.000010: 7. Be given an opportunity to ask any questions concerning the experiment or the procedures involved.
p.000010:
p.000010: 8. Be instructed that consent to participate in the research study may be withdrawn at any time, and the
p.000010: subject may discontinue participation in the research study without prejudice.
p.000010:
p.000010: 9. Be given a copy of a signed and dated written consent form when one is required.
p.000010:
p.000010: 10. Be given the opportunity to decide to consent or not to consent to participate in a research study without ...

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p.000010: aim poblicauors They atce *. ,
p.000010: hoping inom‹ni'idaatnti Principle C: Professional and
p.000010: =*'°' ° Scitntific Respeocibility .
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p.000010: welfare sn4 protection uf the iad vi4uah and groups witb whom joyd›oIogists wurk. It is tba ñdividud rnspomibility
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p.000010: mivingumemicalcoumofmimlndmy becomidued byeuﬁcsbodisinimupreﬁngmeﬁlhiulsmrds. The Ethical Sundads set fmh
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p.000010: Association, 1973.
p.000010: Three principles, or general prescriptive judgments, that are relevant to research involving human subjects are
p.000010: identified in these statements. These should assist scientists, subjects, reviewers and interested citizens to
p.000010: understand the ethical issues inherent io research involving human subjects.
p.000010: mis report consists of a distinction between research and practice, a discussion of the three basic ethical
p.000010: principles, and remarks about the application of these principles.
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p.000010: 2. Asses#eent of Aisks and ]exeflts• presents botA an opportunity and a responsibility to gatAer systematic
p.000010: and comprehensive information about proposed resesrcA, including alternative ways of obtaining tAe benefits
p.000010: sougAt in tAe zssearsA. Pos fibe lnves€1gacoz', IN la a aeans jzo exax£na obefibac tbe puopoaaA
p.000010: research is properly deslgned. Por a review ooemittee, lt is a matAod for determining wAetAertée risAs to sub3ectsara
p.000010: justified. The cert "r1.ak" refers I:o a posslbill£y thai harm may comer •
p.000010: £0 Includes re£arence botL to tha chance (probab111t:y) of nxparlenclnq a hara and
p.000010: the sevarlty (gaqnit:ude) of the envlalonad Aarm. Tñe term "benefit" is used to refer to aometAing of
p.000010: poaitiva value re1at:ad No health, educat:ion, knmledge, or oel£ara. OnllXe "risk," "benefit" does not
p.000010: mzpress probabilities. Risk Ls properly
p.000010: conWas2ed No p obab1111$y oC banag1fis , and baneC1ga az'a pz'opac1y
p.000010: contrasted witA harms eat:Rer than risks of barm. IUxk/benefit asaeaeaant:a ma concacned x1ttt tha
p.000010: pcobab111€1ee and eagn1'budea oC poaa1b1e bazzas and an€1c1patad bane€1ts.
p.000010: Xany k1nda oC posa1b1e ba:raa and benaC1fis naed to ba taken Info account. There are, €oc axaap1e,
p.000010: c¿aka oC paycboloq1ca1 baza, phye1ca1 bazm, legal bazm, social bazza and econaalc bazm and tbe
p.000010: corresponding benefits. Rlsk can perhaps never ba entirely eliminated, but it can often be reduced by careful
p.000010: attention to aTcernat:1ve procedures .
p.000010:
p.000010:
p.000010:
p.000010: Applications of the general
p.000010: research leads to considerat:ion of
p.000010:
p.000010: principles to the conduct of the following requirements:
p.000010:
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p.000010: z • zn z'ozaed Consent •
p.000010: re irea that subjects, to tAa degree
p.000010: that they are capable, be given the opportunity to choose wAat
p.000010:
p.000010: shall er shall not happen to them. There tAat the consent process can
p.000010: ia widespread agreement
p.000010: eon4sainlnq three
p.000010: elements - information, comprehension and vo1un€aclneaa.
p.000010: In1 **ien- Most codes of research establish specific Items for disclosure intended to assure that aubjects are
p.000010: given su££iulene 1nroraat:ion. These It:ema generally Include: tha raneareh procedure, their purposes, risks
p.000010: and anticipated benefits, alternative procedures (where therapy is involved), and a statement oC€aclng the
p.000010: eubJ eel Cha oppocfiun1 €y e aak gues£1ono and to alt araw at any Time froa the
p.000010: raseaech. AddlLional 1.been have been proposed, including how subjects sre selected, tAe person responsible
p.000010: for the research, *tc.
p.000010: However, a listing of items does not clarify waYs for judging how much and what sOFt Of infOrmation should be provided.
p.000010: It may be cba€ a aeandacd oC ^€he z'eaaonab1e vo1un2eec" shou16 be Co11oued:
p.000010:
p.000010:
p.000010: risk and the voluntary nature of participation.
p.000010: Information about risks ehould never be withheld for tAe purpose of eliciting the cooperation of subjects, and truthful
p.000010: answers should always be given to direct questions about tAe research.
p.000010: gmqprehensioq. The manner and context in which information is conveyed is as important as the information itself. Por
p.000010: example, presenting information in a disorganized and rapid fashion, allowing too little time for ...

p.000010: possible barme.
p.000010: obligations of baneJ°1cence agdecrg bottt J.nd1v1dua1 Invas1z1ga€o=s and soc1et:y at: 1acqa,
p.000010: because tbey extand botb to particular research projects and to tAe entira Enterprise ef research. In the case of
p.000010: particular projects, investigators and
p.000010: archers of their lns€lVu€ions ara obllqeñ to give foretbouqhe en
p.000010: tbe maximization oZ benefits and the reduction of risk that night occur from the research investigation.
p.000010: A difficult atbical problem remains about research tbat present:s aore Than niniztal rlsk ulehouV
p.000010: lmeeñ£aea prospects ed d1 acrg bene€1c No the subgecca tnvo1ved. Soae bave acqued that auch resesrnh
p.000010: is inadmissible, while otAers have pointed eut tAat this liBit would rule out research promising great benefit to
p.000010: people in the future. As with all haFd cases, the different Glaims coYazed by the principle of beneZicencz -- benefits
p.000010: versus harms - may come into conflict and force difficulty choices.
p.000010:
p.000010: 3 . 7us8£ce • aaks Who ought No cacelve tJte bane61ts o:I eaawch and baar It:s burdens?
p.000010: This 1s a questlon of "far.mass In distribution" or " what is deserved." An injustice occurs
p.000010: wAen some benefit to which a person is *ntitled is denisd without good reason or when aoue burden 1s Imposed
p.000010: unduly.
p.000010:
p.000010:
p.000010: settings) are being systematically selected or excluded cimply because of thair eaay availabi¥iey, their
p.000010: compromised posit:ion, or their mezipulability, rather than for reasons directly related to the problem being
p.000010: studied. Justice demands both tbat research not provide advantages only to certain persons or groups, and that such
p.000010: research should not fail to direct bonegits toward those involved.
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p.000003: 3
p.000003:
p.000003: A. gouodazlea Ba*veea 9xac6ica aoa aaseazca
p.000003: It is important to distinguish between biomedical and behavioral research, on the one hand, and the practice oY
p.000003: accepted therapy on the other, in order to know what activities ougAt to undergo review for the protection of human
p.000003: subjects oZ research. The distinction between research and practice Ls blurred partly because both often occur together
p.000003: (as in resesrcfi dea[gned to evaluate a therapy).
p.000003: The term "practice" refers to interventions tbat are designed BOlely to *nhance the well-being of an Individual patient
p.000003: or client and that have a reasonable expectation of success. By contrast, tAe term "research" designates an
p.000003: activity designed to test an hypothesis, permit conclusions to be drawn, and/or develop and contribute to knowledge
p.000003: (expressed, for example, in tAeoriss, principles, statements of relationship, and descriptive summary). Research and
p.000003: practice may be carried on together when research
p.000003: 1s designed to evaluate the safsty and efficacy of a therapy. Tbis need not cause any confusion regarding whether or
p.000003: not the activity requires review; the general rule is that if there is any element of research, that activity should
p.000003: undergo rsview for tAe protection of human subjects.
p.000003:
p.000003: g. Basio gtbical Principles ...

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p.000003: I¥ycbologists ia¥c masonzbk xinnnzms to kznordl
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p.000003: . *^ortt **^*IfYt*aI^I^ oft!^iz W napsycbologtctis a›sazafawbez ra
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p.000003: UNfVZR9fTY OF G£tÆM
p.000003: UNIBE¥9Ü@AT GUANAN
p.000003: mæænzsœæaacgszææczs
p.000003:
p.000003:
p.000003: TO: Principal Invastigato‹s/Researcher at UOG
p.000003: FROM: UOG Committee on Human Research Subjects (CHRS) SUBJECT: Institutional Reytew Assuring
p.000003: Human Rights of Subjects
p.000003:
p.000003:
p.000003: This memo descrlbes poBsy and æview ctf\arîa for O'ie protection of human subjects involyed in projects œnductad
p.000003: at, aPonaored by, or aI'/iliated with the University of Guam, regardless of the absenœ or prœenœ of support, and
p.000003: ægardless of who elæ may have rm/iewed jfiern. Research projets (whether ptolëssional g¿_gggjggg Oiat obtain (a)
p.000003: data through infsîactian with irdiyîduaB, or (b) identifiable pñvate informaëon are subject to review. ÆI
p.000003: such projeœ must feœive pñor exemption or approæl fiom the CHRS, which sewes as gie University’s lnsëtuëonal
p.000003: Reyiew Boaid in œmplianœ with fedeial policy eatabliahed by the U.S. Oflîœ of Söenœ and Technology. Your
p.000003: understanding of thèse regulations is important for the Unh/eisity's adhereriæ to fsdeial policy on this topic, and
p.000003: for your own fiabilité assumed in the pæformanœ ofreseamh and #aining prof
p.000003: Each of thèse federal deparbnenfs and agencjes have adopted ö›ese regulations for the
p.000003: protection of human subjects irivoI›/ed in research œnducted or funded by the following:
p.000003: US Department of Agñadture; Department of Ene‹gy; National Aeronautics and Space Administraëon; Departmœt
p.000003: of Commerce; Consurner P‹odud Safety Commission; International Development Coopera0on Agericy; Agency
p.000003: for International Deælopment; Department of Housing and Urban Development; Deparbnent of Justice; Deparbnent
p.000003: of
p.000003: , Department of Eduœtion; Department of Vejgian Alfaiæ; Environmental Protection
p.000003: Agency; National Scienœ Foundatlan; Department of Health and Human Seiviœs; Deparbnent of Transponalfon. ...

p.000003: (a) Each institution engaged in research which is covered by this policy and which is conducted or supported by a
p.000003: federal department or agency shall provide written assurance satisfactory to the department or agency head that it will
p.000003: comply witA the requirements set forth in this policy. In lieu of requiring submission of an assurance, appropriate for
p.000003: the research in question, on file with the Office for Protection from Research Risks, RHS, and approved for federal
p.000003: wide use by that office.
p.000003: (b) Departments and agencies will conduct or support researeA covered by this policy pnly if the institution has an
p.000003: assurance
p.000003: approvea aa provided by this section, and only t§ the institution
p.000003: chas lfled co The departztene or agency head thai I:he research
p.000003: has been reviewed and approved by an xRB provided for in the assurance, and will be subject
p.000003: to continuing review by the IRB. Assurances applicable to federally supported or conducted research shall at a minimum
p.000003: include:
p.000003: (1) A statement ofprincipals governing the institution in the discharge of its responsibilities for protecting the
p.000003: rights and welfare of human subjects of research conducted at or sponsored by tAe institution, reqardlpss o w et e
p.000003: the peseqpch js subject to federql peoulation.
p.000003: (2) Designation of one or more IRBs estab1iah•d in accordance with the requirements of this policy, and for which
p.000003: provisions are made for peetiqg space and suf#iciept staf#„tp suDoort the IRB•s review and record keeDino duties.
p.000003: (3) L list of IRB members identified by name, earned degrees, representative capacity; . . . . sufficient to describe
p.000003: each members chief anticipated contributions . . .
p.000003: (4) Written procedures which the IRB will follow . . .
p.000003: (5) Written procedures for ensuring prompt reporting to the IRB, appropriate institutional officials, and the
p.000003: department or agency head of (1) any unanticipated problems involving risks to subjects or others or any serious or
p.000003: continuing noncompliance with this policy or the requirements or determinations of the IRB and (ii) any
p.000003: suspension or termination of IRB approval.
p.000003: (c) to (g) [additional specifications and policy for assurances]
p.000003: (f) . . . Institutions UithOUt an approved assurance covering the research ahall certify within 3o days after receipt
p.000003: of a request for such a certification from the department or agency, that the application or proposal has been approved
p.000003: by the IRB. If the
p.000003:
p.000003:
p.000003: sact1on 1o2 De€1a1€1ons
p.000003: (a) Department or agency head . . .
p.000003: (b) Institution . . .
p.000003:
p.000003:
p.000003: (d) Hesearcfl means a systematic investigation, including research development, testing and evaluation, designed
p.000003: to develop or contribute to generalizable knowledge.
p.000003: (e) Aesearcb subject to regu2atlon, . . . encompass those research activities for which a federal department or agency
p.000003: has specific responsibility for regulating as a research activity. It does not include research activities which are
p.000003: incidentally regulated by a federal department or agency solely as part of the department's or agency's broader
p.000003: responsibility to regulate certain types of activities whether research or non-research in nature (e.g., Wage and
p.000003: Hour requirements administered by the Department of Labor). ...

p.000005: a) Basic elements of informed consent
p.000005: 1. A statement that the study involves research, an explanation of the purposes of the research and the expected
p.000005: duratiOn of the subject's participation, a description of the procedures to be followed, and identification of any
p.000005: procedures which are experimental,
p.000005:
p.000005: 2. A description of any reasonably foreseeable risks or discomforts to the subject,
p.000005:
p.000005: 3 . A description of any benefits to the subject or to others which may reasonably bm expected from the research;
p.000005: 4. A disclosure of appropriate alternative procedures or courses of treatment, if any;
p.000005: 5. & statement describing the extent, if any,
p.000005: to which confidentiality of records identifying the subject will be maintained;
p.000005: 6. An explanation as to whether any compensation and
p.000005: an explanatioñ as to whether any medical treatments are available lf injury occura and, if so, what they consist of, or
p.000005: where further information xay be obtained,
p.000005: 7. An explanation of whom to contact for answers to pertinent questions;
p.000005: 8. A statement that participati on is voluntary, refusal to participate will involve no penalty or loss of benefits to
p.000005: which the subject is otherwise entitled, and the subject say discontinue participation at any time.
p.000005: b) When appropriate, one or more of the following elements of information shall also be provided to each subject:
p.000005: 1. L statement that the particular treatment or procedure may involve rieks;
p.000005: 2. Anticipated circumstances under which the subject's participation may be terminated;
p.000005: 3. Any additional costs tO the subject;
p.000005: 4. TAe consequences of a subject's decision to withdraw. 8ectie# 117. Documantatio# of Informed consent,
p.000005: a) Informed consent shall be documented by the use of written consent form approved by the IRB and signed by the
p.000005: subject or the subject's legally authorized representative. A copy shall be given to the person signing the form.
p.000005:
p.000005: ) ° -Y waive the requirement for the investigator to obtain a signed consent form for some or all subjects if it
p.000005: finds either:
p.000005: 1. That the only record linking the subject and the research would be tAe consent document and the principal risk
p.000005: would be potential harm resulting from a breach of confidentiality.
p.000005:
p.000005: 2. That the research presents no more tAan minimal risk of harm to subjects and involves no procedures for which
p.000005: written consent is normally required.
p.000005: 8ec€1oa 118 kpp11caC1oss aod puopoaala 1acjc:Log QeI1o12e p1aaa gon
p.000005: 1aooloamaaC g£ aua a •ubJec2fi•
p.000005:
p.000005:
p.000005:
p.000005: In the event research is undertaken without the intention of involving human subjects, but it is later proposed to
p.000005: involve human suh3eHs In the researcht I:he research afraid fl.ref be reviewed and approved by an IRB,
p.000005: as provided In this policy.
p.000005: Bec€1oa 120 Bea1ua61•a aaA d1apoa1€1on
p.000005: pcoposala €ou xeeaazcb •o b• coaauc•e4
p.000005:
p.000005: The department or agency head will evaluate all applications and proposals involving human subjects submitted to the
p.000005: department or agency
p.000005: 8ac€1oa 121 [Reserved]
p.000005: seoa£on xzz Ose o€ s•d•xa1 €uo4a.
p.000005: Pederal funds administered by a department or agency may not be 4zpendmd for research involving human subjects
p.000005: unless the requirements of this policy have been satisYiud.
p.000005: Bacg1oa 123 Bnz'1g' €•zmñDab1oO of z'eaaag'cb guppozfi I Bva1tza€1oo oC app11oaC1oaa aod pxopoaals.
p.000005: a) The department or agency head nay require that department or agency support for any project to be terminated or
p.000005: suspended when the department or agency head Sinds an institution has materially failed to comply with the terms of
p.000005: this policy.
p.000005: sa«g1oa 12« cooa181o¥ta1 Zae appg'o 1.
p.000005: The department or agency head may impose additional conditions prior to or at the time of approval when in the judgment
p.000005: of the department or agency head additional conditions are necessary.
p.000005:
p.000005:
p.000005:
p.000005:
p.000005:
p.000005:
p.000010: 10
p.000010: ...

p.000010: physical harm, legal harm, social harm and economic harm and the corresponding benefits. Risk can perhaps never be
p.000010: entirely eliminated, but it can often be reduced by careful attention to alternative procedures.
p.000010:
p.000010: The University of Guam’s Human Research Subjects Committee, an irb meeting the appropriate federal guidelines, has more
p.000010: than adequately carried out this responsibility for research involving or associated with UOG faculty or students. I
p.000010: have attached a copy of their guidelines to investigators. In recent years and with the assistance of UOG faculty the
p.000010: Guam Memorial Hospital has established a similar irb for research within its facility, or in association with its
p.000010: personnel and medical staA The purpose is to comply with federal regulation for grant funding:
p.000010: SOURCE- Federal Register June l8. 199} (ReguÍations effective Aupust I9. 1991j Secfion 103
p.000010: Assuring
p.000010: compliance with this policy-research conducted or supported by any federal department or agency.
p.000010: (a) Each institution engaged in resmrch which is covered by this policy and which is conducted or supported
p.000010: by a federal department or agency shall provide written assurance satisfactory to the department or agency
p.000010:
p.000010: head that it will comply with the requéements sa forth in this policy. In lieu of requiring submission of an
p.000010: assurance, appropriate for the resmrch in question, on tile with the 0&ce for Protection om Rep.000010: and approved for federal wide use by that o&cc.
p.000010:
p.000010: Through this federal mandate, the UOG HRSC has become involved with numerous research projects conducted on-island by
p.000010: other universities and research institutions from off-island. I have attached a summary for your clarification. As
p.000010: this federal policy dictates:
p.000010:
p.000010: Resenrck Cooperative resmrch projects am those projects coveimi by this policy whicit involve morn M one institution.
p.000010: In the conduct of cooperative imnrcli projects, ibStitutj‹n iS responsible for safeguarding
p.000010: the rights and welfare of human subjects and for complying with tbis g0liTy. An instittlti0A participating in a
p.000010: cmpciative project may enter into a joint review arrangement, fuly upon the review of another qualified IRB, or make
p.000010: similar arrangeinmts for avoiding duplication of effort.
p.000010:
p.000010: Unfortunately, this is not required for the island territory of Guam, rather it only becomes mandated between
p.000010: institutions. Thus it is possible for federally funded research projects from off-island institutions, to go through
p.000010: or affiliate with a Guam instituüon not covered b its own irb and OG or GMH (e g., a private
p.000010: medical clinic, Naval Hospital, or DPHSS, MHSA, DPR, etc.) AND THEY CAN CHOOSE NOT TO HAVE A GUAM BASED IRB
p.000010:
p.000010: Yet, the UOG CHRS, a Guam based irb, is very capable of handling these few occassional cases which may arise in any
p.000010: given year, and has the developed organizational mechanisms to efficiently and effectively process such cases. The UOG
p.000010: CHRS can fully achieve the intent of Bill 347, minimize and avoid any delay or obstruction that could adversely affect ...

p.000010: except to provide information.
p.000010: f) An IRB may, in its discretion, invite individuals with competence in special areas to assist in the review
p.000010: of issues which require expertise beyond or in addition to that available on the IRB. These individuals may not vote
p.000010: with the IRB.
p.000010:
p.000010:
p.000010: I recommend tire following changes be made to Bill No. 347 In Section 1. Legislative Findings
p.000010: Replace the second sentence on lines 7-10 which reads: “It further finds thai the creation of a review board is the
p.000010: appropriate body to review proposals, plans, procedures and protocols for research involving human subjects and to
p.000010: approve or disapprove the same.”
p.000010: With: “It further finds that there are institutional review boards on Guam +rbirfi con[omi. to federal guidelines for
p.000010: such entities which are the appropriate bodies to review proposals, plans, procedures and protocols for research
p.000010: involving human subjects and to approve or disapprove the came."
p.000010:
p.000010: Insert into the second paragraph on lines 11-15 an additional condition confronting Guam, so it reads:
p.000010: “Further more, the legislature finds that on occassions human research conducted on Guam does not always acquire
p.000010: informed consent fiom persons participating in the programs, thai come research although hnving obtained off-island
p.000010: irb reverts fail to take into eonsoiñeration uni‹tue islnnd cultural rind socinf condifions that confound or negnte nn
p.000010: indiviJunl’s ability to makea eonsiilered iudeement iibout fiber oartitiontton , and that there is a need to
p.000010: regulate and mandate informed consent to ensure that those persons participating are adequately informed.”
p.000010:
p.000010: Replace the third paragraph lines 16-18 to read:
p.000010: “In the case +rhere an investigator, entity, or agency engaged in research subject to regulation does not have nor isa
p.000010: iliated with an appropriately constituted institutioiml review board on Guam so they can confomi to the
p.000010: requirements of this law, the University of Unani ’s tnstitutional review board drill provide zi appropriate review
p.000010: for the purposes of this law.”
p.000010:
p.000010:
p.000010: This makts apparent the need to change the titre of the law to be:
p.000010: AN ACT TO ADD CHAPTER 24, DIVISION 3, 17 GCA TO REQUIRE AT TEAS' ONE REV W AND APPROVAL OF ANY RESEARCH
p.000010: CONDUCTcD ON GrAM WrrH REGARD TO BUMAN SUBJECTS BY A GUAM-BASED INSTITUTIONAL REVIEW BOARD
p.000010:
p.000010: Finally, Delete section 24102. Board; Terms; Appointment; Continuance; Removal., Page 4 lines 19 through 40.
p.000010:
p.000010:
p.000010:
p.000010:
p.000010:
p.000010:
p.000010:
p.000010:
p.000010:
p.000010:
p.000010: Greetings to Senator Kasperbauer and other senators!
p.000010:
p.000010: I am also here today to testify that Bill No. 347 must be revised before it is forwarded to the full body of the 24th
p.000010: Guam Legislature.
p.000010: There are four reasons for the revisions that I wish to address: 1) duplication of the existing review process; 2) the
p.000010: role of the University of Guam in research; 3) delays in conducting research; and 4) the composition of the committee.
p.000010: Let me begin by discussing duplication of the existing review process and suggesting a change in the legislation. The
p.000010: University of Guam's Committee on Human Subjects in Research (CHSR) has existed since 1982 and its members actively ...

Appendix

Indicator List

Indicator	Vulnerability
access	Access to Social Goods
authority	Relationship to Authority
autonomy	Impaired Autonomy
belmont	belmont
children	Child
coerced	Presence of Coercion
cognitive	Cognitive Impairment
common rule	common rule
criminal	criminal
diminished	Diminished Autonomy
disability	Mentally Disabled
disabled	Mentally Disabled
drug	Drug Usage
education	education
educational	education
elderly	Elderly
embryo	embryo
emergency	Public Emergency
employees	employees
family	Motherhood/Family
fetus	Fetus/Neonate
helsinki	declaration of helsinki
illness	Physically Disabled
incapacitated	Incapacitated
influence	Drug Usage
job	Occupation
language	Linguistic Proficiency
liberty	Incarcerated
mentally	Mentally Disabled
minor	Youth/Minors
nation	stateless persons
opinion	philosophical differences/differences of opinion
party	political affiliation
police	Police Officer
political	political affiliation
poor	Economic/Poverty
pregnant	Pregnant
prison	Incarcerated
prisoners	Criminal Convictions
religious	Religion
std	sexually transmitted disases
student	Student
undue influence	Undue Influence
vulnerable	vulnerable
women	Women

Indicator Peers (Indicators in Same Vulnerability)

Indicator	Peers
disability	['disabled', 'mentally']
disabled	['mentally', 'disability']
drug	['influence']
education	['educational']
educational	['education']
influence	['drug']
liberty	['prison']
mentally	['disabled', 'disability']
party	['political']
political	['party']
prison	['liberty']

Trigger Words

capacity

coercion

consent

cultural

harm

justice

protect

protection

risk

self-determination

volunteer

welfare

Applicable Type / Vulnerability / Indicator Overlay for this Input

Vulnerability Type	Vulnerability	Indicator	# Matches
Political	Criminal Convictions	prisoners	8
Political	criminal	criminal	2
Political	political affiliation	party	3
Political	political affiliation	political	2
Political	stateless persons	nation	1
Political	vulnerable	vulnerable	6
Health	Cognitive Impairment	cognitive	4
Health	Drug Usage	drug	3
Health	Drug Usage	influence	4
Health	Mentally Disabled	disabled	4
Health	Mentally Disabled	mentally	4
Health	Mentally Disabled	disability	1
Health	Motherhood/Family	family	1
Health	Physically Disabled	illness	2
Health	Pregnant	pregnant	8
Health	sexually transmitted disases	std	1
Social	Access to Social Goods	access	1
Social	Child	children	6
Social	Elderly	elderly	4
Social	Fetus/Neonate	fetus	2
Social	Incarcerated	liberty	1
Social	Incarcerated	prison	1
Social	Linguistic Proficiency	language	7
Social	Occupation	job	1
Social	Police Officer	police	1
Social	Presence of Coercion	coerced	1
Social	Religion	religious	3
Social	Student	student	4
Social	Women	women	6
Social	Youth/Minors	minor	1
Social	education	education	21
Social	education	educational	9
Social	embryo	embryo	2
Social	employees	employees	2
Social	philosophical differences/differences of opinion	opinion	2
Economic	Economic/Poverty	poor	1
General/Other	Diminished Autonomy	diminished	1
General/Other	Impaired Autonomy	autonomy	4
General/Other	Incapacitated	incapacitated	2
General/Other	Public Emergency	emergency	2
General/Other	Relationship to Authority	authority	15
General/Other	Undue Influence	undue influence	4
General/Other	belmont	belmont	2
General/Other	common rule	common rule	1
General/Other	declaration of helsinki	helsinki	1

Public Law 24-326

Applicable Type / Vulnerability / Indicator Overlay for this Input

Political / Criminal Convictions

Political / criminal

Political / political affiliation

Political / stateless persons

Political / vulnerable

Health / Cognitive Impairment

Health / Drug Usage

Health / Mentally Disabled

Health / Motherhood/Family

Health / Physically Disabled

Health / Pregnant

Health / sexually transmitted disases

Social / Access to Social Goods

Social / Child

Social / Elderly

Social / Fetus/Neonate

Social / Incarcerated

Social / Linguistic Proficiency

Social / Occupation

Social / Police Officer

Social / Presence of Coercion

Social / Religion

Social / Student

Social / Women

Social / Youth/Minors

Social / education

Social / embryo

Social / employees

Social / philosophical differences/differences of opinion

Economic / Economic/Poverty

General/Other / Diminished Autonomy

General/Other / Impaired Autonomy

General/Other / Incapacitated

General/Other / Public Emergency

General/Other / Relationship to Authority

General/Other / Undue Influence

General/Other / belmont

General/Other / common rule

General/Other / declaration of helsinki

Orphaned Trigger Words

Appendix

Indicator List

Indicator Peers (Indicators in Same Vulnerability)

Trigger Words

Applicable Type / Vulnerability / Indicator Overlay for this Input