CARL T.C. GUTIERREZ
GOVERNOR  OF- GUAM




JAØO48B
The  Honorable  Antonio  R.  Unpingco Speaker
Mina'Bente   Kufittro   na   Liheslaturan   Guåhan T wenty-Fourth    Guam   Legislature
Guam   Legislature   Temporary   Building
155   healer   Street Hagåtña,   Guam     96910

Dear   Speaker   Unpingco:

Enclosed   please   find   Substitute   Bill   No.   347   (COR),   "AN   ACT   TO   A D D CHAPTER  24 TO DIVISION  3 
OF TITLE 17 OF THE GUAM CODE ANNOTATED, RELATIVE  TO DESIGNATING  UOG'S  COMMITTEE  ON HUMAN  SUBJECTS  IN RESEARCH  AS 
 THE  INSTITUTIONAL  REVIEW  BOARD  FOR  REVIEW  AND APPROVAL OF RESEARCH CONDUCTED ON GUAM WìTH REGARD TO HUMAN
SUBJECTS",     which     was    vetoed     and    subsequently    overridden    by    i Liheslatura.    This    
legislation    is    now    designated    as    Public     Law     No. 2 4 - 3 2 6.

Very   truly   yours,



Car1 T.  C.  Gutierrez
I   Maga'lahen   Guåhan Governor   of   Guam

Attach ment:           copy   attached   for   signed   bill   or   overridden   bill original   attached   for   
vetoed   bill

cc:       The  Honorable  Joanne  M.  S.  Brown Legislative    Secretary






Ricardo I. Bordallc Governor’s Complex  •  Post Office  Box 2950, Agana, Guam 96912  •  (671)472-8931  •  Fax (6Z1)4 
77-GtJAv


MINA'BENTE KUATTRO NA  LIHESLATURAN GUAHAN
1998 (SECOND) Regular Session

CERTIFICATION OF PASSAGE OF AN ACT TO I       GA’LAHEN  G LIAHAN

This is to certify  that Substitute  Bill  No. 347 (COR),  “AN  ACT TO ADD CHAPTER  24 TO DIVISION   3   OF   TITLE   
17   OF   TI-IE   GUAM   CODE   ANNOTATED,   RELATIVE   TO DESIGNATING  UOG'S COMMITTEE  ON  HUMAN  SUBJECTS  IN  
RESEARCH  AS  THE INSTITUTIONAL   REVIEW   BOARD  FOR  REVIEW   AND  APPROVAL  OF  RESEARCH CONDUCTED  ON  GUAM  WITH  
REGARD  TO  I-HUMAN  SUBJECTS,”  returned  without
approval of  I Maga"lahen  Gradx, was reconsidered  by  I Liheslaturan  Cuahan  and  after such consideration,   did    
agree,   on   the   30“   day    of    December,   1998,   to    pass   said    bill notwithstanding the veto of i 
Maga’lahen Citrix by a vote             teen (14) members.






Atteste


ANNE M.               WN
enator and Legislative  Secretary
AN   0ON
R. UNPINGCO
Speaker









Assistant Staff Officer
Maga’lahi’s  Office











Public Law No.          2 4=32Q


MINA’ BENTE KUATTnO NA LIHESLATURAN  GUAHAN
1997 (First) Regular Session

Bill No. 347 (COR)
As substituted  by  the Committee on Education and as amended on the Floor

Introduced  by:                                                               L.  A. Leon Guerrero
W.B.S.M. Flores
T. C.  Ada                               
F. B. Aguon, Jr.
A. C.  Blaz
J.M.S. Brown Felix P. Camacho
Francisco P.  Camacho
M. C.  Charfauros
E. J. Cruz Mark Forbes
L.  F. Kasperbauer
A.  C.  Lamorena,  V
C.  A.  Leon Guerrero
V.  C.  Pangelinan
J. C.  Salas
A.L.G. Santos
F. E. Santos
A.  R.  Unpingco
J. T. Won Pat

AN ACT TO ADD CHAPTER  24 TO  DIVISION  3 OF TITLE  17  OF  THE  GUAM   CODE   ANNOTATED, RELATIVE         TO         
DESIGNATING          UOG'S COMMITTEE      ON      HUMAN      SUBJECTS      IN RESEARCH   AS   THE   INSTITUTIONAL   
REVIEW BOARD    FOIt    REVIEW    AND     APPROVAL    OF RESEARCH    CONDUCTED     ON    GUAM    WITH REGARD TO HUMAN 
SUBJECTS.






1                   BE   IT   ENACTED BY THE PEOPLE OF GUAM:
2                  Section 1.   Legislative Findings.          Liheslaturan    Guahan    finds     that
3      research   studies   involving   human   subjects   are   conducted   on   Guam,   and
4      realizes   a   need   to   protect   the   rights   of   persons   participating   in   human
5      research  projects  through  a  review  of  research  proposals,  plans,  procedures
6      and  protocols.    It  further  finds  that  designation  of  the  University  of  Guam’s
7      (“UOG's”)  Committee   on  Human  Subjects  in  Research  as  the  InstitlltlOTlal
8      Review Board (“IRB”) for researchers  and collaborators  at University  of Guam
9      and for researchers  who  are  not  under  other  IRB's  is  the  appropriate  body  to
10      review   proposals,   plans,   procedures   and   protocol   for   research   involving
11      human subjects and to approve or disapprove  the same.
12                  Furthermore,  I Liheslaturan Guahan finds that human research conducted
13      on  Guam do Sof  always  acquire  informed  consent  from persons  participating
14      in   the  programs,  and  that  there  is  a  need  to  regulate  and  mandate  informed
15      consents to ensure that those persons participating  are adequately informed.
16                  The  Review  Board  will  be  under  the  auspices  of  UOG    as  it  has  been
17      identified  as  the  suitable  entity  under  the  direction  of  the  Graduate  School
18      and Research Department.
19                   Section 2.   Chapter  24  is  hereby  added  to  Division  3  of  Title  17  of  the
20      Guam Code Annotated to read as follows:
21                                                               “CHAPTER 24.
22                  Section 24101.      Definitions.           As used in this Chapter:
23                              (a)      ’Board’ means the Guam Research Review Board.


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1                               (b)      ’Investigator’  means  any  individual,  public  or  private  entity,
2                  or  agency  engaged  in  or  purposing   to  engage  in  research  subject   to
3                  regulation.
4                              (c)       ’Legally’  authorized  representative  means  an  individual  or
5                  judicial  or  other  body  authorized  under  applicable  law  to  consent  on
6                  behalf   of   a   prospective   subject   to   the   subject's   participation   in   the
7                  procedure(s)  involved in the research.
8                              (d)      ’Research’     as     defined     in     the     Federal     Register,     §102
9                  Definitions.
10                              (e)       ’Research’   subject   to   regulation   means   research   involving
11                  human subjects.
12                              (f)       'Human  subjects’  means  a  living  individual  about  whom  an
13                  investigator conducting  research obtains:
14                                          (1)       Data  Through   Intervention   or  Interaction   with   the
15                              Individual.                        Intervention       includes       both       
physical
16                              procedures  by  which  data  are  gathered  and  manipulations  of  the
17                              subject    or   the   subject's    environment    that    are   performed    for
18                              research    purposes.        Interaction    includes    communication    or
19                              interpersonal contact between investigator and subject.
20                                          (2)       Identifiable  Private Information.  Private   irJormation
21                               may    include  information  about  behavior  that  occurs  in  a  context
22                              in  which  an individual  can reasonably  expect  that  no  observation
23                              or  recording   is   taking   place,   and  information   which   has   been
24                              provided  for  specific  purposes  by  an  individual   and  which  the
25                              individual   can  reasonably   expect   will   not  be  made  public  (for

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

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


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

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1                                     duration   of   the   subject’s   participation,   description   of   the
2                                     procedures    to    be    followed    and    identification    of    any
3                                  procedures  which are experimental;
4                                                (2)       a  description  of  any  reasonably  foreseeable  risk
5                                     or discomforts  to the subject;
6                                           (3)       a  description  of  any  benefits  to  the  subject  or  to
7                                      others which may reasonably be expected from the research;
8                                                (4)       a       disclosure       of       appropriate       
alternative
9                                     procedures  or  courses  or  treatment,  if   any,  that  might  be
10                                    advantageous  to the subject;
11                                                (5)       a   statement    describing    the   extent,   if   any,   
to
12                                     which  confidentiality  of  records  identifying  the  subject  will
13                                     be maintained;
14                                                (6)      for  research  involving  more  than  minimal  risk,
15                                     an  explanation   as   to   whether   any   compensation   and   an
16                                     explanation    as    to   whether    any   medical    treatments    are
17                                      available  if  injury  occurs,  and,  if  so,  what  it  consists  of  or
18                                      whether further information may be obtained;
19                                              (7)       an  explanation  of  whom  to  contact  for  answers
20                                     to   pertinent    questions    about    the   research   and   research
21                                     subject’s   rights,   and   whom   to   contact   in   the   event   of   a
22                                     research-related injury  to the subject; and
23                                                (8)       a    statement     that    participation    is    
voluntary,
24                                     refusal   to   participate   will   involve   no   penalty   or   loss   of
'5                                     benefits  to  which  the  subject  is  otherwise  entitled,  and  the

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subject  may  discontinue  participation  at  any  time  without penalty  OF  lOsS  of  benefits  to  which  the  
subject  is  otherwise entitled.
(b)      Additional  Elements  of Informed  Consent.
When  appropriate,   the  Board  may  require  that  one  (1)  or more   of   the   following   elements   of   
information   shall   also   be provided to each subject:
(1)       a   statement    that    the   particular    treatment    or procedure may  involve risks  to the subject, or 
to the embryo or fetus, if  the subject is or may become pregnant,  which are currently  urrforeseeable;
(2)      anticipated     circumstances     under     which     the subject's participation  may  be terminated  by  an 
investigator without  regard to the subject’s consent;
(3)       any  additional cost  to the subject  that may  result from participation in the research;
(4)       the    consequences    of    a    subject's    decision    to withdraw   from   the   research   and   
procedures   for   orderly termination  of participation by the subject;
(5)      a     statement     that     significant     new     findings developed   during   the  course   of   the  
research   which   may relate  to  the  subject's  willingness  to  continue  participation will be provided to the 
subject; and
(6)      the  approximate  number  of  subjects  involved  in
the study.

8


i                                  (c)      The  Board  may  approve  a  consent  procedure  which
2                           does  not  include,  or  which  alters,  some  or  all  of  the  elements  of
3                         irdormed  consent  set  forth  above,  or  waive  the  requirements  to
4                           obtain   informed   consent;   provided,   that   the   Board   finds   and
5                          documents that:
6                                             (1)      the  research  or  demonstration   project   is  to  be
7                                    conducted  by,  or  subject  to,  the  approval  of  Federal,  state,
8              territorial  or  local  government  officials,  and  is  designed  to
9                                    study,  evaluate  or  otherwise  examine:    (i)  public  benefit  of
10                                     service  programs;  (ii)  procedures  for  obtaining  benefits  or
11                                     services under  those programs; (iii) possible changes  and/ or
12                                     alternatives  to those programs or procedures; or (iv) possible
13                                     changes  in  methods  or  levels  of  payments  for  benefits  or
14                                     services under those programs; and
15                                                (2)      the  research  could  not  practically  be  carried  out
16                                     without the waiver or alteration.
17                                     (d)      The  Board  may  approve  a  consent  procedure  which
18                           does  not  include,  or  which  alters,  some  or  all  of  the  elements  of
19                           informed    consent    set    forth   in   this   Section,    or    waives    the
20                         requirements  to obtain informed consent; provided,  that the Board
21                           finds and documents that:
22                                                (1)      the research involves no more  than minimal risk
23                                    to the subject;
24                                                (2)      the  walver  or  alteration  will nof  adversely  affect
25                                     the rights and welfare of the subject;

9


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

10


those  risks   and  benefits   that  may   result  from  the  research,   as
2                           distinguished  from  risks  and  benefits  of  therapies  subject  would
3                          receive even if not participating  in the research.   The Board should
4                           not  consider  possible  long  range  effects  of  applying  knowledge
5                           gained  in  the  research  (for  example,  the  possible  effects  of  the
6                           research  on public  policy)  as  among  those  research  risks  that  fall
7                          within the purview  of lts responsibility.
8                                     (c)      Selection  of  the  subjects  is  equitable.    In  making  this
9                          assessment  the Board should take into account  the purposes of  the
10                          research    and   the   setting    in    which    the    research    would    be
11                           conducted   and  should   be  particularly   cognizant   of   the  special
12                           problems  that  research  involving  vulnerable  populations,  such  as
13                           children,  prisoners,   pregnant   woman,  persons   with  dlsabilities,
14                           the   elderly,   or   economically    or   educationally    disadvantaged
15                           persons.
16                                     (d)      Informed     consent      will     be     sought     from     each
17                           prospective      subject      or      the      subject’s      legally      authorized
18                           representative, in accordance  with,  and  to  the  extent  required  by
19                          Board regulation.
20                                     (e)      lrdormed  consent   will  be  appropriately   documented,
21                           in    accordance    with,    and    to    the    extent    required    by    Board
22                           regulation.
23                                    (          When  appropriate,  the  research  plan  makes  adequate
24                           provision for monitoring  the data collected  to ensure  the safety  of
25                          subjects.


1                                     (g)      When  appropriate,   there  are  adequate  provisions   to
2                             protect  the privacy  of  subjects  and to maintain  the confidentiality
3                          of data.
4                                           When  some  or  all  of  the  subjects  are likely  to be  vulnerable
5                          to   coercion   or   undue   influence,   such   as   children,   the   elderly,
6                             prisoners,    pregnant    women,    mentally    disabled    persons    or
7                          economically  or  educatiOnally  disadvantaged  persons,  additional
8                          safeguards  have  been  included  in  the  research  plans,  procedures
9                             or protocols to protect  the rights and welfare of these subjects.
10                                          (h)      Progress  reports  or  thesis  shall  be  made  available  to
11                               subjects participating in the research as appropriate.
12                              Section 24108.      Grievance Procedure.          lf        application       for
13                  approval is denied  for  a research proposal,  investigators  may appeal  to
14                  the Dean of  the Graduate  School  and Research.   The Dean will appoint
15                  an  ad hoc  committee  for  a  second,  independent  review  of  the  research
16                  project.   The findings of  the ad hoc committee  are to be presented  to the
17                  Committee  on  Human  Subjects  in  Research  no  later  than  ninety  (90)
18                  days  after  receipt  of  grievance  from  the  investigator,  to  determine  the
19                  final decision to approve or not to approve a research project.
20                              Section 24109.      Fines and Penalties.      Upon    determination     of
21                the  Review  Board  through   the  approved   rules  and  regulations,   any
22                  investigator,  research  sponsor  or  their  agents,  which  conducts  research
23               subject  to regulation in violation of this Chapter shall be subject  to a fine
24                  of  One  Thousand  Dollars  ($1,000.00)  per  each  violation,  and  shall  be


12


1                  prohibited  from continuing  and conducting  human research  studies  for
2                  not less than two (2) years.
3                            The  Dean  of  the  Graduate  School  and  Research  shall  refer  any
4                  cases   determined   by   the   Review   Board   as   a   valid   violation   to   the
5                  Attorney General's Office for investigation and prosecution.
6                              Section 24110.      Appropriation:    Authorization.    There               is
7                  hereby  appropriated  from  the  General  Fund  a  total  of  Forty  Thousand
8                 Dollars  ($40,000.00)  for  the  purpose  of  hiring  one  (1)  clerical  staff  and
9                  other    accommodations   necessary    to    assist    with    the    function    of
10                  processing     applications.     This     appropriation     shall    continue     until
11                  expended  for the operations and purposes specified herein.”




















13


Tw ñHTY  YOU Ft4   ,      UAN  PEG ISLATURE
COMMITTEE  OU  Eii    cATIOts







La*vzence F.
Kasperbauer
c1 r*'

Senator
Sal as



UnpiNgCO

Menu:or
ThomasC.
Ana

"enatc r
Franh  B.
Aguon

he' a to r Elizabeth Barrett- Aiiaerson

Vice     peaker





JoaoneM.S.


Senaor feHxé CamacBo


CamacHo


Ed wardo d.



ForDes


Angel L.G.
Santos


Judith
ifon Pat-
Borja
October 22, 1998


The Honorable Antonio R. Unpingco Speaker, 24t   h te   am Legislature Hagdtña, Guam
via:  Committee  on Rules Dear Mr. Speaker:
The  Committee  on  Education  to  which  was  referred  Bill  No.  347  (COR):  “AN  ACT  TO ADD  CHAPTER  24,  
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?    RESFARCI-I      IS    THE INSTITUTIONAL  REVIEIV  BOARD  FOR REVIEW  AND  APPROVAL  OI   RSA   ?vFxCH 
CONDUCTED   ON  GUAM  \VIT1I  REGARD  TO  HU4IAN
back u’ith the recommendation TO DO PASS Substitute Bill No. 347. Votes of the committee members are as follows:
7      To Pass

             Not To Pass

             To The Inactive File

             Abstained








/\tiachmen ts





Education  is  the  lYayl

TWEMTY-hOUKl. CUAM LkGISLATURZ
COMMITTEE  ON EDUCATION






Se o etor Lawrence  F. Kasperbauer


October 22, 1998


Se I-'at O r
Jonn  C.
Sat as


Antonio  R.


TO:


All Members
Committee on Education




Se n ato  r
FROM:           Chairman
SUBJ:             Voting Sheet


Senate r
Aguon


£liznbetn Barrett- Anderson

face Speu<er AnthonyC.
Blaz

Joanne  N.S.
BFOW€

S°-mo Felix P.

Transmitted  herewith  is the  voting  sheet  and  committee  report  for Substitute  Bill  No.  347 (COR): “AN  ACT TO 
ADD CHAPTER  24. DIVISION  3, 17 GCA TO DESIGNATE  THE UNIVERSITY  OF GUAM’S COMMITTEE  ON HUMAN  SUBJECTS  IN RESEARCH 
 AS THE   INSTITUTIONAL   REVIEW   BOARD   FOR   REVIEW   AND   APPROVAL   OF RESEARCH CONDUCTED  ON GUAM WITH REGARD 
TO HUMAN SUBJECTS.”
Your attention to this matter is greatly appreciated.



Sincerely,


F.

Attachments






Narn











Education is  the had  I

COMMITTEE ON EDUCATION
TWENTY-FOURTH  GUAM LEGISLATURE
155 I-tesler Street, Agana, Guam 96910


Chairman:  Senator Lawrence F. Kasperbauer      Vice Chairman:  Senator John C. Salas Ex-Officio Member:  Speaker 
Antonio R. Unpingco


VOTING SHEET ON:

Substitute Bill No. 347 (COR): “AN ACT TO ADD CHAPTER 24, DIVISION 3, 17 GCA TO DESIGNATE THE UNIVERSITY OF GUAM’S 
COMMITTEE ON HUMAN SUBJECTS IN RESEARCH AS THE INSTITUTIONAL  REVIEW BOARD FOR REVIEW AND APPROVAL OF RESEARCH 
CONDUCTED ON GUAM WITH REGARD TO HUMAN SUBJECTS.”



COMMITTEE MEMBERS

Sen. Lawrence F.  Kasperbauer Sen. John C.  Salas
Spkr. Antonio R. Unpingco
Ex-Officio Member

Sen. Thomas C.  Ada
Member

INITIAL
TO PASS
NOT TO PASS
TO PLACE IN
ABSTAIN             INACTIVE FILE

Sen. Frank B.  Aguon, Jr.
Member

Sen. Anthony C. Blaz                                                                                                    
                                                                                   
Member

Sen. Joanne M.S. Brown                                                                                                  
                                                                                                        
Member

Sen. Felix P. Camacho                                                                                                   
                                                                                   
Member

Sen. Francisco P. Camacho                                                                                               
                                                                                                      
Member

Sen. Edwardo  J.  Cruz                                                                                                  
                                                             
Member

Sen. Mark Forbes
Member

Sen. Angel L.G. Santos                                                                                
Member

Sen. Judith Won Pat                                                                                                     
      
Member

COMMITTEE  REPOIJT COMMITTEE  ON  EDUCATION May  5, 1998

Bill No. 347:  AN ACT TO CREATE A REVIEW BOARD OF REVIEW AND APPROVAL OF RESEARCH CONDUCTED ON GUAM WITri nEcAnD To 
HuMAN SUBJECTS.

Senadors  present:   Senator Larry Kasperbaur,  Chairperson,  Senator Lou Leon  Guerrero,  Senator  Mark  Charfauros  
and Senator  Frank Camacho.

Those present  to testify  were:  Dr. Jose T. Nededog, President, University  of Guam, Dr.  Joyce Camacho,  Dean of 
Graduate  School and Research, University  of Guam, Dr. Kyle Smith, Professor  of Psychology, University of Guam, Dr. 
Randall L.  Workman,  Professor of  Sociology, University  of  Guam, Gregoria Smith, Psychometrist, UOG  /UCSD Research 
 Project, Mr. Ray  Adonay, Dr. Bert Weiderholt,  Physician/ Neurologist,  University  of California-San Diego  and  
Debbie Quinata.

Those not present, but submitted  written testimony  were:  Dr. John Steele, Dr.  Marcus Tye, Asst. Professor, 
Psychology, University  of Guam,  Dr.  Richard  Colfax,  Management  &  Marketing Chairperson,  University  of Guam, 
Dr. Seyda Turk Smith, Associate Professor, Psychology, University  of Guam, Dr. Pamina  J. Hofer, Clinical 
Neurolopsychologist and Guam Lytico and Bodig Association.

Overview  of  Bill

Senator  Lou Leon Guerrero shared with the Committee  members and the audience an overview of Bill 347.

Bill 347 was drafted as a result of a public hearing conducted during the 23rd Guam Legislature  when Senator Lou Leon 
Guerrero  was Chairperson  of  Health, Welfare & Senior Citizens to discuss various


1

research done on Guam.   There was a public outcry on how we protect human subjects for research.   The University  of 
Guam has a review board, as well as the Guam Memorial Hospital.   However, Bill 347 will set forth rules and 
regulations  to assure that people are protected  with informed consent.   All research studies and methodologies must  
go through a review process.
Oral  Testimonies

Dr.  Jose Nededog, President, University  of Guam presented  his oral testimony  in support of Bill 347.  He indicated 
that this bill can act as an umbrella for various research done on Guam.   His concern was that the present staff  is 
overtasked  and the bill should be modified to include support - a clerk and supporting equipment.

Dr. Joyce Camacho,  Acting  Dean for Graduate School and Research submitted oral testimony to support Bill 347.  Her 
concerns include (1) duplicatlon of existing review; (2) the role of University of Guam in research; (3) delays in 
conducting research; and (4) composition of Committee members as stated in the proposed legislation.

Dr. Camacho  gave some background  information  on  the existing research board:    The Research Council is comprised  
of  the Dean of Graduate  School  and Research, Dean of  Learning  Resources, Directors of Research  Institute, 
Associate Dean  of  Agriculture Experiment  Studies and elected faculty from the five (5) academic colleges  with an 
ex-officio  representative to the Council  of Undergraduate  Research.

The Council meets bimonthly to discuss relevant research issues. Their tasks include development, review and 
enforcement  of  research policy at the University  of Guam.  One of  the standing committees of  the Research Council 
is the Committee on Human Subjects in Research.   They are tasked with reviewing and approving or disapproving  of  
research proposals  that involve human subjects.
They have existed since 1982 and serve Guam by providing

protection to human subjects in accordance  with federal/local regulations  in research.

Suggested  changes.
Change  the  words  “Creation of Guam Research  Review  Board”  and replace  with  “The designation  of  the University 
 of Guam's Committee  on Human Subjects in Research as the Institutional Review  Board  or (IRB) for researchers  and 
collaborators  at  the University   and for researchers  who are not under other IRBs.” Wherever  the bill states “Guam 
Research Review Board” it should be replaced  with “UOG's Committee on Human Subjects in Research”.

As  with Dr.  Nededog comments, clerlcal staff need to be assigned  to ensure that  the functions  of  the Committee  
are carried out.

Dr. Randall Workman, Professor  of Sociology and Community Development  at the University  of Guam testified in support 
of  the intent of Bill 347.  His written testimony outlined his concerns which includes  the importance of informed 
consent and assessment  of risks and benefits.   Further, the bill, as currently  written, establishes unnecessary  
additional island wide IRB.

Dr.  Kyle Smith teaches psychology  and research methods at the University  of Guam and fully supports the call for all 
research conducted on Guam to undergo review.  The bill, as in its existing form may produce some unnecessary  affects 
on the training available for standards  at  the University  of Guam and creates redundant delays.  He supports the 
option to modify  the bill to accommodate  student  and research  projects.   Dr.Smith  believes  that it was not the 
intent  of  the author  to impede research projects.   He will fully support  the bill with modifications.

Mr. Roy Adonay testified in support of Bill 347.  Mr. Adonay expressed  the need to review the are of fines and 
penalties and needs to be expanded.  There is no indication as to who will monitor and


3

fine and who will collect.  The Universlty  of Guam Will not have the power or authority  to police all research.

Ms. Gregoria Smith testified in favor of Bill 347.   She also submitted written testimony  that states obtaining  
consents from participants are necessary  in the practice of research  to protect  the rights of  those who 
participates.   Researchers  must be trained; research, especially scientific  research, requires  special training.

Ms.   Debbie Quinata,  a member  of OPIR, Chamorro  Nation, ancestral/original landowners.   Ms.  Quinata is opposed  
to Bill 347. Guam  already  has an IRB for  grant  applicant  that  review  standards at  the Guam Memorial Hospital.   
This bill will create more loopholes.   Ms.  Quinata  also stated  that  all off-island  researchers should share in 
the results of  the national research and charge fees. Mechanisms  should be in place to ask for accountability - what  
are they doing for our island and educating our students.

Dr. Bert Weiderholt,  physician /neurologist  and professor of neuroscience  at  the University  of California, San 
Diego.   NIA (National Institutes of Aging) funded program project for 5 years to study disease on Guam.  Dr. 
Wiederholt is in full support of Bill 347 and further supports Drs. Nededog and Camacho,  Workman and Smith.   He  has 
conducted research in various states and it is very important  to submit  research project for local review, although 
not federally required.   Dr.  Weiderholt  and  the project he is now involved in on Guam, had no hesitation in 
submitting  application for research  to the University  of Guam and  the Guam Memorial Hospital  - both were  
approved.

Senator  Charfauros  supports research  and Bill 347.   He  suggested various amendments to the bill:  need 
rules/regulations, more liability for researchers, require license to practice, progress reports made available to 
public, increase fine to $10,000 for violation, commercial  profits need to be shared with research subjects and no 
exploitation  of  research  subjects.


4

Senator  Kasperbauer shared  his concerns with exploited  research subjects and  need protection.

Final    gar

Aauthor of Bill 347, Senator Lou Leon Guerrero gave final remarks. She welcomed  any amendments  to assure  the intent  
of legislation  is achieved -  to protect  human subjects.   Although  there are IRBs at Guam Memorial Hospital and  
the University  of Guam, there is research being conducted  that  are not  associated  with these institutions.   
Therefore,  we are not  assured  that  the research  subjects are protected.   When discussing the bill with the 
representatives at the University  of Guam, there  was discussions  to expand the exlsting Human Research Committee.   
The community needs to be part of  the research conducted.

Recommendation
It 1s the recommendation of the Committee on Education TO  DO PASS AS SUBSTITUTED BY THE AUTHOR BILL NO. 347, AN ACT TO 
ADD CHAPTER 24, DIVISION 3, 17 GCA TO DESIGNATE THE UNIVERSITY  OF GUAM'S  COMMITTEE ON HUMAN SUBJECTS IN RESEARCH AS 
THE INSTITUTIONAL  REVIEW BOARD FOR REVIEW AND APPROVAL















APR*

MEMORANDUM

TO:                   Chairman
Commi     e       Education

FROM:            Chair
Committee on Rules, Government  Reform and Federal Affairs SUBJECT:      Referral - Bill No. 347
The   above   Bill   is   referred   to   your   Committee   as   the   principal   committee.      lt   is recommended 
 you schedule a public hearing at your earliest convenience.

Thank you for your attention to this matter.



MARK FORBES


Attachment

TWENTY-FOURTH  GUAM LEGISLATURE
1997 lFirst) Regular Session

Bill No. 347
As substituted by the Author
Introduced by:                                                             L.  Leon Guerrero
W.Flores T.Ada

AN  ACT  TO  ADD  CHAPTER  24,  DIVISION  3,  17 GCA TO  CREATE A REVIEW BOARD FOR REVIEW
AND   APPROVAL  OF RESEARCH CONDUCTED ON GUAM WITH REGARD TO HUMAN SUBJECTS.

BE IT ENACTED  ON  BY  THE  PEOPLE  OF   THE  TERRITORY   O F GUAM:
3                  Section 1.       Legislative  Findings.    The  legislature  finds  that
4       research  studies  involving  human  subjects  are  conducted  on  Guam
arid realizes  a  need  to protect  the  rights  of  persons  participating  in
6       human  research   projects   through  a  review  of  research  proposals,
7      plans, procedures  and protocols.   It further  finds that  the creation  of
8      a review  board is the  appropriate  body  to  review  proposals,  plans,
9      procedures  and protocol  for research  involving  human  subjects  and
10      to approve or disapprove  the same.
Furthermore,     the    legislature    finds    that     human    research
12       conducted  on Guam  do not  always  acquire  informed  consent  from
13      persons  participating  in  the  programs  and  that   there  is  a  need  to
14      regulate   and   mandate   informed   consents   to   ensure   that    those
15       persons participating  are adequately  informed.
16                    The review  board  will be under  the  auspices  of  the  University
17      of  Guam  as  it  has  been  identified  as  the  suitable  entity  under  the
18       direction of  the Graduate  School and Research  Department.
19                    Section  2.   Division  3 of  Title  17 GCA,  is hereby  amended   to
20      add Chapter 24 to read as follows:
2T                                                                       “Chapter 24
22                    §24101.  Definitions.  As used in this chapter:
23                   (a)  Board   means  the Guam Research  Review  Board;

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

2














•      UOO Ouidt inns rcgardmg the “Ethical Principles wxl Guidelines for the Protection
ofHwnan 5 objects of Research"
-     GMH Insti» poiul R« io   Bard Policies *od Pr»cc«u cs ef13/9i3
-      Applicabb I sdemt R           orii (1974 end hta) as issoed by the U.S. Oepartment of
Heelth, Edu pgon, nid Welhre
•     Applicable i:gntioos of flu Office Hi Rotcction from Resee*h Risks (OPRR),
N#Æm@knÿmhofHnü#Depmmœ#ofIoü1mdHmnanSwüA
£pÿmbkçpAdm#ofWcUSPoÆxdDmçhJmWümaémÇD%

Protection c
-      Applicable
Any::rican
I-luiDan Sobjecti
;xles ofconduct ofio‹4al ind behavioml mear*h as adopted by the
*ho     ’cal Association   APA  since l9D


£‹•s•             NO NEED TO DUPMcxTs THsSs SXIST    G R£VisW BOARus CY
ESTABL@HING A NEW REViEW BOARD that has no gcarMse ofproviding equal quality reviews or poN#ômMÆWP  kofoœml    
[DGCœmÆœlœHumanGJQeœæRmwam CHS§ VdM#AæmMmoñNH   MbmÆÆœÆRwicwBomdÇRB)fo   ufpRV*Aügom€onM
Oic Pcop)¢ ofGuarn, arid wM continue to jxovide this protectian to tha Pe¢$ils of¢?uam if’pcmiibed to
cantñtuc s¢zvtng the Peopk o£Guam as tfi¢y pesently do, This points in Ote direction of&e ncad Iboa major revision 
ofBill 0347 to i&atify the existing UOG Conuuittee for Human Subjea tit Research (DHSR) wäh ihn existing lOi    
polJcies and pœcednes ce tim desigantod Rexicw Board for all nacaicli


A foi&     xiufi‹  ncY z  ev«ient as                                                    Review Beard will éivolm tin 
University ofGuam under M   c‹;  trol uidguideriee of flu UOG H                                                   ie 
proposed Bill f347 is c   du  dancy of tin existing official UOO resean2i nvq      control body: the Committee for Hymn 
Subject ia Research (CHSR) which serve the mnununity ss in olficiai appointed
co              at UC  L RATHER, I I›  icve BILL 8347 SHOULD IDENTIFY THE UOG cOUMITTEB FOR HUMAN Su&ECT iH RRSEARCH 
(eHSR; AS THB DESiGHATBD REViEw
BOARD £x el1 rescecli projects rehtcd to luimai subjects OH GUnM.

Mmihos ofûzasc Rmrî<    Boards
The propoceö Bill 9347 ûJemi6cs t‹'Îcw baud mœnbezs tocceatc anew revicw body hut a'oidd agaÎn be


-    at tqast 1 tocal Religious icadnt
-    MJ4ast I tic-isodprecticing beat Mcdicd Doctor
kertas at                                           pzofo          visors ocz sources where


m  equally I         entativa body orprog›sdanaI zcseazchcrs, educators, and locd leaders. tn accordance wi&
Oic Tnstitut         Rtnriaw Baard Policies and Ptocc4urcs (4/j3/95), the Guazn McsnorialNospitaJ FRB is









May 4, 1998

SomarLea)IGq›abaua,PKD.



k8                                Isöve to Cmat•ıg a Guam kes4mch Rev›•w Board



IkloqzCWm4m,AcdngIkmftheUOGGmdaüShod&Rxmm\;redddmoMWmçopyof 
ModmRofiD#]47.DhıwmıddvzymmfuflymdMwtcücw*dBwUOGpov#MddbwmmWmW directives ated to resrach conducted with mgard to hignm 
subjects. I am an active member of the Umwnityq(€mmmOoımn)MxomHmxnSujxEinEmwmdı(CHSR)md)mv4bamdncemy


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 
heve the following included in tlu docummts nr  1 testimonies tfut your C‹xnmittee eonskk•rs ec it m•ke deb  mtions 
ebout dms Bill.
Du  lic  tio   of Exi  t       R            B      d





I BELIEV£ THAT BILL #347 IS IMPORTANT BUT AS WORDED WIkL INTERFER WITH,
COMPLICATE AND CREATE PROBLE  IS IN THE HEEDED RESEARCH THAT INVOLVES GUAM
AND THE PEOPLE OP GUAM. 1 agm hut it *  iioportintio i4dress rescuth issues that might not be covewd undere›fistirig 
UO3, GMH or DOE peléics. However, Bill 4347. as wooded, appears to go beyond the întent of'tIzc iîxlezat guides kör 
zes‹=rcbî¢Iat¢dto aman ezhjccts. The People ofOuam and rescamh«cs


Guam Mortal Hospital lnstiniaoml Revitw Boatd (IRB  f‹a Research                 p

refuted to h     an «objects in resc*rA by tin U(Ki Commit oa Hub     suIie*s in Reseaiiti (C  tsR3 md
tin Ottgrrı    emonal Hmpital Institutionai Rcfiew Board (IRB) for Rcsearch. Thesc c3isting active Rtview

1                               the   human   subjects   are   elected   or   appointed   public
2                               Officials or candidates  for public office; or (ii) federal  or
3                              local  statute(s)   require(s)   without   exception   that   the
4                              confidentiality       of       the       personally       identifiable
5                               information  will be maintained  throughout  the research
6                           and  thereafter;
7                       (5)   Research,  involving  the collection  or  study  of  existing
8                           data,  documents,  records,  pathological   specimens,  or
9                            diagnostic   specimens,   if   these   sources   are   publicly
10                           available   or   if   the  information   is   reported   by   the
11                            investigator  in such  a  manner  that  subjects  cannot  be
12                             identified,   directly   or   through   identifiers    that    link
i3                            through the subject;
14                       (6)     Research    and   demonstration    projects   which   are
i5                           designed  to  study, evaluate,  or  otherwise  examine:  (i)
16                            public  benefits  or  service  programs;  (ii)  procedures  for
17                            obtalning benefits or services under  those  programs;  (ii)
18                            possible changes and/or alternatives  to those  programs
19                           or  procedures;  or  (iv)  possible  changes  in  methods  or
20                             levels of  payments  for  benefits  or  services  under  those
21                            programs; and
22                        (7)     Taste   and   food   quality   evaluation   and   consumer
23                           acceptance   studies,   (i)   if   wholesome   foods   without
24                            additives are consumed or (ii) if a  good is consumed  that
25                            contains a food ingredient at or below  the level an  for  a
26                             use   found   to   be   safe,   or   agricultural    chemical   or
27                            environmental  contaminant  at  or below  the level found
28                           to  be  safe,  by  the  Food  and  Drug  Administration  or
29                             approved  by  the  Environmental   Protection  Agency  or
30                             the Food Safety Inspection  Service  of  the  United States
31                             Department  of  Agriculture.
32               (e)   Research   subject  to  regulation     means  research  involving
33     human subjects.
34               (0  Human  sub jects   means a living individual  about whom an
35     investigator  conducting  research obtains
36                       (1)   Data   through   intervention   or   interaction   with   the
37                            individual.           Intervention    includes    both    physical
38                           procedures     by    which    data     are     gathered     and
39                            manipulations     of     the    subject     or     the     subject's
40                             environment  that are  performed  for  research  purposes.

1            Interaction   includes   communication   or   interpersonal
2            contact  between investigator  and subject.
3          (2) Identifiable  private  information.     Private  information
4             may include information about behavior that occurs in a
5                                    context   in  which  an  individual  can  reasonably   expect
that  no  observation  or  recording  is  taking  place,  and
7             information   which   has   been   provided   for   specific
purposes  by an individual  and  which  the individual  can
9            reasonably expect will not be made public (for  example,
10            a   medical   records).      Private   information    must    be
11                              individually   identifiable   in   order   for   obtaining   the
12                              information   to  constitute   research   involving   human
13                             subjects.
14                  (g)  Mioirnl  risk    means that  the probability  and  magnitude  of
15     harm or discomfort anticipated  in the research  are not grater  in and
16      of  themselves  than  those  ordinarily  encountered   in  daily  life   or
17     during   the   performance    of    routine    physical    or    psychological
18      examination  or  tests.
19                 §24102.    Board;  Terms;  Appointment;  Continuance;  Removal.
20      There is created a seven (7) member  ”Guam Research Review Board"
21      under   the  direction  of   the  Office   of   the   Graduate   School   and
22      Research at  the  University of Guam.   Members  of  the Board  shall be
23      comprised of  representatives of  the following:   one (1) member from
24      the Guam  Memorial  Hospital  Institutional  Review  Board;  one  (1)
25      member  from  the  University  of  Guam  Institutional  Review  Board;
26      (1) member  of  the clergy;   the  Director  of  the  Department  of  Public
27      Health  and Social  Services  or  his/her  designee;  two  (2)  community
28      representatives   recommended   by  the  Mayor's   Council;     and  an
29      attorney  licensed  to practice  in the Territory  of  Guam.  Members  of
30      the  Board  shall  be appointed  by the  President  of  the   University  of
31      Guam.  The Board shall be appointed  for a  three  (3) year term.    The
32      President of  the University of  Guam  may remove  any member  from
33      the   Board   for   the   neglect   of   any   duty   required   by   law,   for
34       incompetence,   for   improper   and   unprofessional   conduct   or   for
35      violation  of  Board  rules  and  regulations.     Four  (4)  members  shall
36       constitute a quorum of the Board for the transaction of business.  The
37      Board  shall adopt  rules and regulations  in accordance  with  existing
38      federal  law,  if  applicable  and  the  Administrative  Adjudication  Act,
39       governing  the conduct  of its affairs  and exercise  of its powers  within
40      ninety (90) days of enactment  of this law.

4

1       §24103.     Purpose.       The  purpose  of   the  Board  is  to  review,
2      approve,  require modifications  to secure approval  or disapprove  all
3      research  subject  to regulation.
4                  §24104.   Powers.    The Board  shall have  and exercise  each  and
5      all of  the following powers:
(a)        Review     and    have    authority     to    approve,     require
7      modifications    to   secure    approval    or    disapprove    all    research
8      activities covered by the rules and regulations.
9                (b)   Require  documentation  of  informed  consent  of  all  human
10       subjects  participating  in  the  research  subject  to  regulation.     At  the
11       Board's   discretion,  require  additional  information   be  given  to   the
12      subjects which would add to  the protection  of  the  rights and welfare
13      of the subjects;
14                    (c)  Notify the investigators  and  the institution in writing  of  its
15      decision  to approve or disapprove  the proposed  research  activity, or
16       of modifications required  to secure approval of  the research  activity.
17      If  the Board decides to disapprove a research activity,  it shall  include
18       in its written  notification  a statement  of  the reasons  for  its decision
19       and  give  the investigator  an opportunity  to respond  in  person  or  in
20       writing;
21                     (d) Conduct continuing review of research subject to regulation
22       at  intervals  appropriate  to the degree of  risk, but not  less than  once
23      per year  and  shall  have  authority  to  observe  or  have  a  third  party
24      observe and consent  to the process and the research; and
25                    (e)  To  disapprove   research   subject   to  regulation   which  had
26       been previously approved.
27                    §24105.      Dufies   of   Investigators.         The   proposals,    plans,
28       procedures   and   protocols   for   all   proposed   research    subject    to
29      regulation  shall  be  submitted  to  the  Board   for  review,   approval,
30      modification, or disapproval.   No  research subject  to regulation  shall
31       be conducted  without  Board  approval.    The  plans,  procedures  and
32       protocols   for   all   research   subject   to   regulation    which   is   being
33       conducted  at  the  time  of   the  enactment   of  this  legislation   shall  be
34      submitted   to   the   Board   for   review,   approval,    modification    or
35      disapproval   within   thirty   (30)   days  of   this   bill   becoming   law.
36      Research  subject  to regulation  which is being  conducted  at  the  time

37      of  the  enactment   of   this  leglslation
38      action.
may  continue   pending  Board
39                 §24106.    General  Requirements  for  Informed  Consent.      No
40     investigator   may   involve   a   human  being  in  research   subject   to

5

regulation  unless the investigator  has  obtained  the  legally  effective
2  informed  consent  of  the  subject  or  the  subject's  legally  authorized
representative.    An investigator  shall  seek  such  consent  only  under
4       circumstances     that     provide     the     prospective     subject     or     the
5  representative  sufficient  opportunity  to  consider  whether  or  not  to
6  participate   and  that   minimize  the  possibility  of  coercion  or  undue
7      influence.      The   information   that   is  given   to   the   subject   or   the
8      representative  shall  be in language  understandable  to  the  subject  or
9       the representative.  Unless otherwise  provided by law  or regulation,
10      no  informed   consent,   whether   oral  or   written,   may   include   any
11       exculpatory     language      through     which     the     subject     or     the
12      representative  is  made  to  waive  or  appear   to  waive   any  of   the
13      subject's    legal    rights,    or    releases    or    appears    to    release    the
14       investigator,  the research  sponsor,  if  different,  or  their  agents  from
15      liability for negligence;
16                    (a) Basic elements of Informed Consent.   Except  as provided  in
17       paragraphs  (c) or (d) of  this section,  in seeking  informed  consent  the
18       following information shall be provided to each human subject or  the
19      subject's  legally  authorized  representative:
20                               (1)   A   statement    that    the   study   involves    research,    an
21                                      explanation   of   the  purpose  of   the   research   and   the
22                                    expected    duration    of     the    subject's     participation,
23                                    description   of   the   procedures   to   be   followed,   and
24                                      identification      of      any      procedures      which      are
25                                      experimental;
26                               (2)  A description  of  any  reasonably   foreseeable   risk   or
27                                    discomforts  to the subject;
28                              (3) A description of  any benefits to the subject or  to others
29                                    which may reasonably be expected from the research;
30                              (4)  A disclosure  of  appropriate  alternative   procedures  or
31                                     courses    or    treatment,     if     any,     that     might     be
32                                      advantageous  to the subject;
33                              (5)  A statement   describing  the  extent,  if   any,  to  which
34                                    confidentiality of  records identifying  the  subject  will  be
35                                      maintained;
36                              (6)  For   research   involving  more  than   minimal   risk,  an
37                                    explanation   as  to  whether  any  compensation   and  an
38                                    explanation  as to  whether  any  medical  treatments  are
39                                    available if injury occurs and, if so, what  it consist of  or
40                                    whether further information my be obtained;

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

7

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

8

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

39                     §24109.       Fines  and   Penalties.     Upon   determination   of
40      review   board   through   the   approved   rules  and   regulations,
the any

9

investigator,   research   sponsor,   or   their   agents,    which   conducts
2      research  subject  to  regulation  in  violation  of  this  chapter  shall  be
3      subject   to  a  fine   of   One   Thousand   Dollars   ($1,000.00)   per   each
4       violation   and  shall  be  prohibited  from  continuing   and  conducting
5      human research studies for not less than 2 (two) years. “






























10

University of Ruam
Unibetsedåt Guahan
OFFICE OF THE PRESIDENT
UOG Station, Mangilao, Guain 96923
Telephone: (671) 735-2990• Fax: (67 I) 734-2296




May 5, 1998
The Honorable Lawrence Kasperbauer Chairman, Committee on Education 24th Guam Legislature
155 Hessler Drive
Agana, GU  96910

Re:       AN ACT TO CREATE A REVIEW BOARD FOR REVIEW AND    APPROVAL OF RESEARCH CONDUCTED ON GUAM WITH  REGARD TO 
HUMAN SUBJECTS.
Dear Chairman Kasperbauer:
I am here today to testify in support of Bill No. 347.   This bill  proposes  to create a Guam  Research  Review  Board 
for review  and  approval  of  research  conducted  on  Guam with  regard  to  human  subjects.    University  
administrators  and  faculty  agree  that  any research  on  our  island  must  undergo  one  review  process.    
However,  since  the  Guam Research Review Board would be a dnplication of the University of Guam’s Committee  on Human 
 Subjects  in  Researeh  (CHSR),  I  iecommcnd   that  CHSR,  under  the  Office  of Graduate School and Research, be 
designated as the Institutional  Review  Board  (IRB)  for researchers and collaborators at the University and for 
researchers  who are  not  under other IRBs.

lt is noted  that  theie  is  no  mention  of  additional  financial  or  human  resources  to accomplish  the  
numerous  tasks  as  specified  in  the  bill.    At  the  present  time,  Graduate School  and  Research  has only  
three  employees  listed  in  its  staffing  pattern,  and  each  of these employees has a clearly defined job 
description and delineated tasks.  To comply  with the bill’s proposed tasks, it is essential  to add one clerical  
staff  position  and  funding  for a computer,   office  fumiture,  and  supplies.     In  addition,   funds   would   
be   needed   for advertising  or  informing  the  community  about  the  Committee  on  Human   Subjects   in Research 
to assure that researchers submit research proposals for review.
Sincerely,


Jose T. Nededog

JOHN  C. STEELE,  M.D.,  FRCP(C)
NEUROLOGIST
FELLOW,  AMERICAN  COLLEGE OF PHYSICIANS


May 11, 1998

Senator Lawrence F. Kasperbauer Chairman, Committee on Education Twenty-Fourth Guam Legislature

Dear Dr. Kasperbauer


TePFax:  (671) 828-30¢)0

I am writing to provide testimony about Bill 347 to “create a review board for review and approval of research 
conducted on Guam with regard to human subjects”.

I agree with the intent of the Bill but I have concerns about the mechanism it proposes to achieve the intent. It is a 
bill which  proposes a “ fox to guard the hen house”

That intent of bill 347 is to be certain that all medical research on Guam is reviewed and approved by a Committee 
which will assure protection of human subjects.

In October 1995 at a Legislative Oversight Hearing about lytico-bodig research on Guam which was chaired by Senator 
Leon Guerrero all participants, including myself agreed that such review and approval was desireable.

After that Oversight Hearing, Dr. Ulla Craig and her medical research associate Dr. Wigbert Wiederhoh composed this 
Bill at the request of Senator Lou Leon Guerrero. However many of us disagreed that the authority of this process 
should rest in Dr. Craig’s Division at the University of Guam, since she and Dr. Wiederholt  were pursuing their own 
exclusive human subject studies of lytico-bodig there. We felt there would be a conflict of interest and that putting 
the authority with them could jeopordize similar and competing studies by myself and other scienticists wishing to 
conduct research on Guam.

Senator Leon Guerrero understood that and set the Bill aside.

However, because we agreed that peer review of research was necessary, after the 1995 Oversight Hearing the Hospital 
formed an Institutional Review Board (IRB) to review research
proposals concerned with human subjects. This Hospital Committee meets regularly and it follows Federal guideleines. It 
is chaired by the GMH Administrator  and constituted  by members from the Hospital staff and community. The IRB reviews 
and approves all research conducted under its auspices, including my own.






HCR 18 118 • Umatac, Guam 96g18   •    E- Mail:   JSTEELE@K UEN1 OS•GUAM•NET

As the competition to find the cause of lytico-bodig mounts between teams led by Dr. Wiederholt and myself,  Senator 
Leon Guerrero is introducing the original Bill which Drs Craig and Wiederholt developed in 1995. Because she is a 
member of theé Community Advisory Committee and therefore likely to be biased in theé favor, I understand the Bill is 
being introduced under  your auspices. It is cosponsored  by Senator Ada but Senator Flores has recently withdrawn his 
support for it.

Bill 347 proposes another Committee to review research involving human subjects. Although it will be constituted by a 
representative from the GMH IRB and University of Guam Human Subjects Committee, it will supercede the authority of 
each and both.  Furthermore it places authority for research involving human subjects into the hands of the UOG 
Graduate School, of which Drs. Craig and Wiederholt are a part. It vests medical research decision making at the 
University and there is little question but that the authority of section 24105 will be used to restrict and perhaps 
end studies of lytico-bodig by myself and my colleagues, Professors John Hardy, geneticist at Mayo Clinic, Teepu 
Siddique, molecular geneticist at Northwestern University, Nicholas Wood geneticist at the National Hospital, London 
UK, and Patrrick McGeer, immunopathologist at the University of British Columbia.

To ensure fairness and to avoid discrimination against our studies by Drs. Craig and Wiederholt,  I am requesting that 
the authority for reviewing and approving research involving human subjects remains with the (established) GMH IRB and 
UOG Human Subjects Committee. To ensure protection for human subjects, I recommend  that you and your Committee mandate 
prior approval of all human subject research by one or other Committee, subject to the fines and penalties of Section 
24109, if investigators fail to comply.

Your favorable decision of these recommendations will ensure fairness in research and avoid the possability of 
discrimination against my studies by Drs. Craig and Wiederholt, and members of the UOG Graduate School.

I thank you.


John C. Steele MD Neurologist

Madeleine Z. Bordallo, President of the Guam Lytico & Bodig Association Norbert Perez, President of the Republic of 
Guahan
Tyrone Taitano, Chairman GMH IRB
Professor John Hardy, Professor of Pharmacology Mayo Clinic Jacksonville
Professor Teepu Siddique, Director Neurogenetics Laboratory, Nothwestem University Professor Nicholas Wood, Department 
of Genetics, National Hospital Queen Square Professor Patrick McGeer,  Kinsmen Laboraotory of Neurological research, 
Vancouver
Dr. Marcelle Morrison-Bogorad, Associate Director of Neuroscienc and Neurophysiology of Aging Program, National 
Institute of Aging

z•.O.   Box      4jia  A/ana  ‹fi  an• 96932
.           •         •            4  7-  294



Senator La      me  F. Kaperbauer
Chat*-man, Committee on  Education
2 15-A Chat an Santo Papa, Suite SOG F Ada's Professfionat       6.omme.rcial Center Agana, Guam g6932
Deer SenatorK     perbauer,
Thsnk you for      licltlng comments and view s o£the Guam L'ytICO and Bodig
Asso<iatioz› abu  I “Bill luo. 34Y: relative co t he c••ation of a Review Boat eat: the

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Distinguished  Senadors,
Buenas yan hsfa adai.

My name is Gregoria Smith, ciirrcntly  servint  as the psychometrist  for the UOO/ UCSD Research project on Litigo and 
Bodlg Research.  I speak  in favor of the intent of Bill 347. First,  I wisli to commend  the introducers   of this 
bill as it is time to define what researcli  is on Guam, However,  I w'oiild  like to suggest that a corresponding  
mechanism  of iiT1   OSÍIig fines to violators   be included .   Whether the Attofney General’s officc should be the 
investigatiog   agency and wliere the
collecied  fines should go are issues that may be includcd as aiucndiiients.

As an associate  professor at the University  of Guam for 25 years, I have done social science reseai‘ch on the cultice 
 of  the  peoples  of the Western  Pacific. These past few years, I have researched On the  Meaning  of  Illness and 
Coming  with  ALS   and Parkinsonisin Dementia,    Sioce they  involve human  su ejects, all of thc researches  treat I 
 have done had to go through institutional  review  boards of  New York Universi) , UOG, or of the Federal agencies for 
whom I performed    the studies and who fended  the studies.

Going  tir ougl   review  boards and  obtain ing consent  horn participants are pi'ocesses  that  are necessary   in 
the practice of research, a practicc that has come ft out  past histories of uHkiowing  subjects being
9J    *had I›  haunted  b›  experiiiients, set jects  who have appeared  its filnls and )f1nted m‹di:‹  v ithout  their 
 consent    I !ook  at this bill as not
'*  °e    "' i     °'      that »  ould haiiipei  any  pi ospcctive rcscai cher but  one
int°n ticd  Io  p i’o t ec t  t lie  rigli ts of  t most  ii  ho  Jia rticip;i tc.

1  belleve  thai a iiong these rights are tint 11ie researcher  be triliiicd  in
Conductin’g  a  xoJ ei  in   estigation  Of  thai he/she be super vised  by


someone or agency  ’who'  ’is kno   1  dgeable on ethica  c'onduct  of researchers.   Being a doctor, teacher or a 
social  worker, for instance, does not  always mean a pel son can conduct research.   One may  be a gon d, honest,  
knowledgeable  doctor / teacher but a poor or inept researcher.  Reseai ch, espccially  scientific research, requires 
special training in many skills among  which is imdcrstanding  the language of statistics and a knowledge of the 
various steps one follows in
adIi4inistei’ing the project.  If it is complex, it might 1 equire knowledge of thc    l’oject’s  algorithm,   
requiring, decision-making in every  step of the way.   This is why most researches are conducted under the auspices of 
eiilicr the federal government,  educational  lnstitutions or foundations Who conduct  training courses  for the 
discipline of research.

Ttaining for research  includes aniong otl er things,  luiowledge and explication  of the “iucthodology” beirg proposed 
that would fit the stateil objectives of the project.  One can not just think of soitiething and say  tte wants to do 
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 
make a SlÇI11f)caol  difference  front  what     e assortie tO be  normal  in the general sc)ieiiie  c›f thitigs.  The 
tests have to bc riq•orous  so thal the results can witlistand  the scrutiny  of other scientlsts  who are coiiducting 
related studios.  For there is a socicty  of scholars to whoui ose communicates and s)iares  knowlcdge  with  One hope› 
iiiat the results Of one’s studies won id l earl to a different  wa    of  loOklng at something  whether it is a 
discale,   specie in  nature or the Relationship  21T1Ong  categories  or concepts   l’e  are familial with

New d!cs› i‹  say, the ultimate   benefactors of the rcsu1ts of one's
schs I +‘l)  eLfortS   are neither the conductor  of the reseai ch although  he n*>l   ^*   ñ‹ ‹›?,iiized  by  his 
pecrs  in one w ay  or anotliei’ nn' ltte assistants vl  r*      o   idc  so-called  leg v ork  for the researcher.  
The  real  benefactors arc 1)1OS £  is hose qualilJ of  lii iiig will  be  made  bettcr  by  such  a
disct4\ cry  and  the young  i1i‹jtiisitive minds  who  will push off from   where
WC I C‹It c,  either  to affirms  or hegaie eat  findings.  The scholars and

stakeholders   in this deliberatlon  today must then, recognize that it is' the community  at large and humanity in 
general who would benefit from the results. l8 ordei  to do this we must all safeguard  the quality of researches 
performed here and that they be done in the strictest ethical standards  that show respect  to those people without 
whom  wc will
not be able to conduct  our studies.

This bill  will objectify  what some of us are doing in the nance of “Research”.  It will make us accountable for what 
we do in its name and will enforce the standards that are recognized most anywhere else.


Thank you for your kind  attention.

Gregoria Smith Community Psychologist Tel/ Fax  ti49 7571


o AERSMYOFGUAM    “
1   BETSEDAT  U H
oiveiox or scCxOxLaLuEaGxEnxOvFioARTS &scSiECIfElcNcCsESa socs wonx
TeTepNOl (07J) 735-2870  FW {6 '1) Kg




rsou:
The Fiono/able La\•tence F. ffaaperbayer
Senator. Chair. 6ég\mt¥ee on Education
Dr. Maiozs C.  Ty«„AssL Professor, Psychology      PHouS
University df Gvc 'i
Dr. Mary L  Spec, Dean. College ofAns A S‹ñennee, UOG
671-475-2000         ‘.

8Tt7   25f
Or. u8a-Katñpa Or¥ig. Chad. Committee on Human Research Subjects, UOG


Bill No. 347, An Ais to Create a Revie\y Board fa Reviaw ond Approval of Research Cond‹zctgd on Guam with Regerd!to 
Human Subjects
   essage•              ,         '             !                                                                       
               '
Dear Seriatpr Ka*p&bauer,     .                                                                                         
      ‘  ’    “* .
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 
in an activé program of research, as are many of my colleagues. Research is of ina•lnsic  benefit té the commune (both 
here on Guam and elsewhcreJ and directly helps student learning. I take pridé in the Su        *f 'r'rés  aich that is 
being fostwed at the University of Guam and am puzzled by Bifl  No. 347. The spirit ofth#. bifl'is fully appropriatwit 
is irdeed important to be concernaJ first far tke  welfare of human subjects. gmt to pr.ott•ts human.subj        what 
is puzzling to me is the need fo' sucb a    i
! bill; es etaally one that danstralns research done at the University, since UOG already has a review
process that very carefull:y monitor research. Some of the many reasons against this bill include:              ,'
\. Such a law would be largely unjsecedented. Virtually all jurisdictions in the US and many o
countries allow universiii@ and hospiBls to administer research internally. Indeed; UOG   alieady has    ,
an excelldnt instizuttonal. review panel, the Committee on f4uman Research Subjects.
2. Even the proposal of such a law is disturbing as it gives the appearance that our island’s govenment: (ails to 
understand (ñn,d japs fails zo value) research and the University.

committee

4. The passage of such.q law Auld swipusly undermine the eParts of faculty to bring in research money, Which 
traditionally ñelps stlpport the lost institution. It also adds to.Guam’s already large bureauoacy.
'      Thank you for your tims end your effons in ensuring thac this bill does not oass, o- at the very least ‹o. inane 
sure the bill is amen ded,to exempt any researdi conducted on Guam that ‹eceives approva( from UOG's existing internal 
C  ?nmisee on F uman Research Subjects






T0T9L  P.  01

Defînitions
Raaaaæh  n›aane  a                  imæô$ation,  indrding  raceamh  development,  testirig  and  æaluat›on, des  ned to 
           or œntñbuta æ            eabb

Raaaarah subted to reqylaéon encompass those research aoi¥ities lbr which a f¥deral department or agency has specific 
recporaibiity for regulating as a research a¢tMty. It does not include re6earcfj actMtbs whiQi are ir¥fidentally 
regubtnd by a federal deparbnent or agency sdely as part of the depar¥nent's or agency's broader responsibility to 
regulate certain types of activitBs whatfer faseaich or non-research m nature (e.g., Waga/Hour fequi/ements

Human suh]aotrfieans a flVirig individual about whom an irnestigator (whether professional or students coriducgng 
researdl olzlaxis (1) data through intervenron or interaction with the indfvtduaI, or
(2) identfffable private information.

Minimal fisk means that the probability and magnitude of harm or discomfort anécipatadin tha research are not greater 
in arid of themselves than those ordinarily encountered in daily life or duñng the performanm of rouine physical or 
psychological exarninarorn or tests.

Cerffffcadon means the oflïcial notîÏîœtion by the institution tg the suppoitirig depar¥mnt or agancy, in acœidanœ with 
the reguiremerits ofthis polîcy, that a reseerÖj project or actfvity involving human subjeÖs has been ravîewed ard 
approvæl by an IRB in accordanca with an approved aesuranœ.

Purpose
The CHRS evaluates the level of risk to human subjects, ‹ecommends procedural steps to minimize  risk9,  and provides  
certification  as needed by 0›e researcher. It does not judge research design nor recommend methodological 
alternatives. Under federal regulations, the CHRS is charged with safeguarding  the rights and wellbre of humans  
involved,  and must determine:
•    whe0ier  öle nghte  and woffaæ  of  the  humane  involved  in research  will be
adequately protacted, and
•    wfiather legally affbcth/e infbfmed conaent of gll humane to be eollcitad will be obtained with adequate reCorde 
maintained (request CHR6 Informed Content Guidelines, Form B and C).
Prccedures
1.         Obtain an appliméon fix CHRS review (Form A) lion tf›e UOG O8‹a of  t›e G/aduata School and Research. 
lnclt¥Ja copies eg 6s  pr0jaO pRzpoBal, ag consent forms, and gummary sajpts of varbal and/or video instrudbns to ba 
depleted to sub}ecB.

2.         Maintaif\  worI‹ing contad with the CHRS Ckair during the review process, and provde supplemental
infbrmaéon as requesBd by the -nmidno or stAu\it a feplytD $ugpe9ted ¢x›nsaetations.
3.          If approVed, rœeœÖ\ pfajeds may Iæ monb  ad by One CHRS æ  nædal to ensure due process and

Appendix   o




UNIVERSITY  OF GUAM
Committee on Human Research Subjects Office of the Graduate School and Research

RESEARCH SUBJECT’S BILL OF RIGHTS

Any person who is requested to consent to participate as a subject in a research project, or who is requested to 
consent on behalf of another, has the right to:

1.         Be informed of the nature and purpose of the experiment.

2.         Be given an explanation of the procedures to be followed in the research study, and drugs or device to be 
used.

3.         Be given a description of any possible discomfort and risks reasonably to be expected from a research 
procedure, if applicable.

4.         Be given an explanation of any benefits to the subject reasonably to be expected from the research 
procedure, if applicable.

5.        Be given a disclosure of any appropriate alternative procedures, drugs, or devices that might be advantages 
to the subject, and their relative riiks and benefits.

6.        Be informed of the avenues of medical treatment, if any, available to the subject after the experiment if 
complications should arise.

7.         Be given an opportunity to ask any questions concerning the experiment or the procedures involved.

8.         Be instructed  that consent to participate in the research study may be withdrawn at any time, and the 
subject may discontinue participation in the research study without prejudice.

9.         Be given a copy of a signed and dated written consent form when one is required.

10.       Be given the opportunity to decide to consent or not to consent to participate in a research study without 
the intervention of any element of force, fraud, deceit, duress, coercion, or undue influence on the subject’s 
decision.

If you have a question regarding the research study, the researcher or other research personnel will be glad to answer 
them.  You may seek information from the UOG Committee for Human Research Subjects—established for the protection of 
participants in research projects—by calling 735-2173 (UOG Graduate School & Research) from 8 am to 5 pm, Monday 
through Friday, or by writing  to the above address.





















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GENEIGALPIUNCWLES

P's     ologixii  nriv•  t4 ataintais  hip                  0f
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*b•iz  p•rti••Ia   ¢ompcJci=ics  and hue  kmituians  of  tI‹ctc


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Bz<azablo-PriactpIcD •


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Wen“:ml:(«conduct as














nines. development of men!immanent:  conduct ingassasmmeducaumflcounsdingomniudmllcm- mlting  social intervention  
administration  andothcncfivi


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  ?       Tlluerewllsuehued m legal rather than exhical rules. However. compliance withorViol-lion of









2         ?  Introduction





mammammmmmw wmmmsmmwwmocmm
made-m naummmwm








Ethical Principles of   sychologists and Code of C  nduct

CONTENTS




TsmnBnm

a•<t DigaltY










6.t7  Hinlmlzi9g
















Aur Psr Ass

O LOGI CIATIOȘ












ICA1  ğ,//NCIPLES OF  ËS  CHO1OG/STş








-     } I4o§pitd Administrator
-     &e Prmfdo t ofMcdicat 5Bg
°                                Department of Surgery of Medicine


:       !          «siiy'o                           for Human Sub ‹a  a  Rc«a ch (SSR) tcpres••t•a  u AND has standing 
pttlicics ltiat empower the IRB to requmt and ébtain relevant inputs from

Existing Review Boards do not need to be Duplicated
BiJl ¥347 prepmm the      licafion elite misting ah                  pioccssu and proccdums #ial we conducted by t}n 
UO'£i Committee for Human Subject in Receamli (CHsg) and M  Guem Memeñel jjQpit4l IfMtitotioff4l Review Board(IRB) fer 
RescamK THE PEOPLE OF GUAM ARE SWERBLT PRO1ECTbD BT THE BXiSTINO REVIEW BOARDS when      arch0   proesued tbrougit 
&cni.
m ei                                     rd           Board. GUAM FiEEDS TO HAVE THS UOtS
E FOR H                               IN RESEARCH (CHSR) DESIGNATED BY TH6 GUAM
LEGISLATURE AS THE REVIEW BODY POR nLL RESEARCH RELATED TO HU$4AN SUBJEC
nuraces r;mcz or cm.            ,tin           uoc rai‹i« in  r«›«i»ma«trms t»ma


Todoto,



. I STD        * URG8 YOLI AND YOUR COI  fdITTEE ON EDUCATfOX TC  RS- CONMDBIT TIIBp ARGUMENTS RSGABOING B!LL #34?.   
URG6 TI4B COMMI      B TO Mt)VB THAT BILk C347 \JND5RGO SERIOUS REVJfiION SO THAT JT WILL EI  POWER MD  EU 7POR7 THE 
UOG COMMTTTg£ FOCI HUMAN 3U0JECT IN RESSAItCI4
(cusp›'• ›h ‹»•=a•t /›g voc    gait•ie u«t   »«        M  due cvAu zzssAecn ›‹Evisw aoARo FOR IfUMAN SUB48 CTS.
Dankoto Na Si Yu’os  \4a’ese  for tire opportupity to voice en opinion repealing whx Bill ¥347 should be

—1998  (fi: 49HN       FRON     ABS                                                                                     
                                          P.  81

NI     RSITY  OF GuAM
NI   ETSEDAT  GLAHAN
P6YCHOLOGY   PROGRAM
ŒVT9ION   OF   8OCIAL/BENAVFORAL   9ŒENCEB         SOCtAL   YORK
eyda 7Qck  Smith,  Ph. D.
C  )O i3t&tort, zhao,             9   28
Tei«t›t›e»e. (671) 7eS-ze»i   F•«: {871) 7e4-5zs«
e-hill  Ttsmilhfluog9         edu


Sejjator Lawfenee F. Kasperbauer

Twenty-fourth  Gtiam Legiolatgre Committee  on Education
Reference :   Bill #34s Relaäve to Creafing a Guani Research Review  Board
As  a  researcfiez  ans  an  eduœtox  teachîng  zeseacch  stethodotogy   and mtpefv’‘iaing  undergraduate  research  at 
 the  University  of  Guari,   I  finally oppooe  tp  the  mtablislurient  of  a  new  "Guam  heseamh   Review  Board" 
that  will  oversea  all  research  conducted  on  Guam        This  will   make undergraduate   march  impossible   to 
 cenduct   and   will  deprive   UOG stpdents of valuabl!e.reseamh experience.   I  would like to state  some  of œy

1.  And rmearch thatis cnndncted at the UOG is being  feviewed  -  and will

tînae
Subjects
by  the   University's   Committee   on   Human to  æsure  ’the pmtection   of   the   rights   ef   petaons
Under  the  present   system,
undergraduate teseacdiers  working  under  faculty supervision  can  design, submit  for  review,  and  conduct  a  
study  within  one  semcster.    Such research    which typically  is noninvasive  and  straightforward -  needs only 
an  expedited  review,  and  the  approval  takee  approximately  7-8               It will  be  impossible  t;D  Ôt  
another   review   by   another   Reseæch   Review

2.   Given that all Undergraduate  research  is reviewed  by  the  University’s Committee  on  Human Research  
Subjects,  the  duplication  of  this  process ses         unneœssary  and  redundont    The  Univenity’s  review  
boacd  han  a gœd öack æœzd  aztd  has  been  able  to  zeview  æsearch  applicaôons  anü protect  the Rights of  human 
subjefls euccessfully.

Undergraduate  reseafAi  is an integral part of  the cgmculum cif  the  UOG Paychofogy  Progr-   AU psychology  dasses  
have  a  reseœch  œsy›anent. Students  learn  to evaluate  research   and  develop  researplt  propo            At 
least'  hàb  of   the  students

BJ:49Rm  FRDM  Sx  SW
TQ             475Z000        P.  OZ







!'                          to  have ext       ve æsearcli  trai›ning  and  those  who  have  hande-
.               research Experience  have  advanÏage river  other  appiicanW  It is critical our   stiidents '  
ciontinue    to   cpndiicl    undergraduate    research    that
'                            their    learñing    experience   imd    in  reases    their     educational





urk Smith, IPh. D.








































TOTFIL   P.  BZ




ETHICAL  PRINCIPLES  AND GUIDELINES FOR  TI-BE PROTECTION  OF HUMAN SUBJECTS
OF RESEARCH
A  Summary  of the Belmont Report
sha   nat:ional  coeaisalon  ccc  sha  P 'o*ec¢1ozt  of  Buzaao  Bub§ ects  o2 Biomedical   fi     Behavioral   
Research




The following consists of quoted excerpts. A copy of the complete report is available   in  eha £11se  of   ehe  Joe   
cormie€ae  cor   tiuaan  Reseaccn  Subjseen ,   Gratiuazs gchoo1  and  Reeaat-ch  O££lce .


{NTRODU  ION

Scientific research has produced substantial social benefits.
It has also posed some troubling ethical questions.
Since 194], various codes £or the proper and responsible conduct of human experimentation in medical research have been 
adopted.  These  are the Nuremberg  Code of  1947,  the Helsinki Declaration  of  1964 (revised  i975),  and  the 1971 
Guidelines (codi#ied  into Federal Regulations in 1974) issued by the U.S. Department of Health, Education, and 
Welfare. Codes for the conduct of social and behaVioral research have also been adopted, by the American Psychological 
Association, 1973.
Three principles, or general prescriptive judgments, that are relevant to research involving human subjects are 
identified in these  statements.  These  should  assist  scientists,  subjects, reviewers and interested citizens to 
understand the ethical issues inherent io research involving human subjects.
mis  report consists of a distinction between research and practice, a discussion of the three basic ethical 
principles, and remarks about the application of these principles.










2.  Asses#eent  of Aisks  and ]exeflts•  presents  botA  an opportunity  and  a  responsibility  to  gatAer  systematic 
 and comprehensive  information  about  proposed  resesrcA,  including alternative ways of obtaining tAe benefits 
sougAt in tAe zssearsA. Pos    fibe  lnves€1gacoz',   IN  la   a  aeans  jzo  exax£na  obefibac  tbe   puopoaaA 
research is properly deslgned. Por a review ooemittee, lt is a matAod for determining wAetAertée risAs to sub3ectsara 
justified. The    cert   "r1.ak"   refers  I:o  a   posslbill£y   thai  harm  may   comer •
£0     Includes     re£arence     botL     to     tha     chance     (probab111t:y)     of nxparlenclnq   a  hara  and  
the   sevarlty   (gaqnit:ude)   of   the   envlalonad Aarm. Tñe term "benefit" is used to refer to aometAing of 
poaitiva value   re1at:ad   No   health,   educat:ion,    knmledge,   or  oel£ara.   OnllXe "risk," "benefit" does not 
mzpress probabilities. Risk Ls properly
conWas2ed  No  p   obab1111$y  oC  banag1fis ,   and  baneC1ga  az'a  pz'opac1y
contrasted witA harms eat:Rer than risks of barm. IUxk/benefit asaeaeaant:a   ma   concacned  x1ttt  tha   
pcobab111€1ee   and  eagn1'budea   oC poaa1b1e  bazzas  and  an€1c1patad  bane€1ts.
Xany  k1nda  oC  posa1b1e  ba:raa  and  benaC1fis  naed  to  ba  taken Info  account.  There  are,   €oc  axaap1e,  
c¿aka  oC  paycboloq1ca1 baza, phye1ca1  bazm,   legal  bazm,   social  bazza  and  econaalc  bazm  and  tbe 
corresponding  benefits.  Rlsk  can  perhaps  never  ba  entirely eliminated, but it can often be reduced by careful 
attention to aTcernat:1ve   procedures .



Applications of the general
research   leads  to   considerat:ion  of

principles to the conduct of the following requirements:


z •    zn z'ozaed     Consent •
re  irea that subjects, to tAa degree
that they are capable, be given the opportunity to choose wAat

shall er shall not happen to them. There tAat the consent process can
ia widespread agreement
eon4sainlnq    three
elements - information, comprehension and vo1un€aclneaa.
In1  **ien- Most codes of research establish specific Items for  disclosure  intended  to  assure  that  aubjects  are  
given su££iulene  1nroraat:ion.   These  It:ema  generally  Include:  tha raneareh procedure,  their  purposes,  risks  
and  anticipated  benefits, alternative procedures (where therapy is involved), and a statement oC€aclng    the     
eubJ eel     Cha    oppocfiun1 €y    e    aak    gues£1ono    and    to alt    araw  at   any  Time  froa  the  
raseaech.   AddlLional  1.been  have  been proposed,  including  how  subjects  sre  selected,  tAe  person responsible 
for the research, *tc.
However, a listing of items does not clarify waYs for judging how much and what sOFt Of infOrmation should be provided. 
It may be cba€  a  aeandacd  oC  ^€he  z'eaaonab1e  vo1un2eec"  shou16  be  Co11oued:


risk and the voluntary nature of participation.
Information about risks ehould never be withheld for tAe purpose of eliciting the cooperation of subjects, and truthful 
answers should always be given to direct questions about tAe research.
gmqprehensioq. The manner and context in which information is conveyed is as important as the information itself. Por 
example, presenting  information  in  a  disorganized  and  rapid  fashion, allowing  too  little  time  for  
consideration  or  curtailing opportunities for questioning, all may adversely affect a subject's ability to make an 
informed choice.
Because the subject's ability to understand is a function of intelligence, rationality, maturity and language, it is 
necessary to adapt the presentation of the information to the subject's capacities. Investigators are responsible for 
ascertaining that the subject has comprehended the information.
Voluntaripess. This  element of informed  consent requires condlñinns   feee  of  coercion   and   undue   influence.   
tfndue   Influence occurs through an offer of an excessive, unwarranted, inappropriate or improper reward or other 
overture in order to obtain compliance. Also, inducements that would ordinarily be acceptable may become

hand, lt would seem that respect requires that prisoners and students     not    be   depz'1ved    of     the     
oppoz•gun1t:y     tO     volunteer    Com research.   On   t2ie  otlter  hand,   under  prison  and classroom  
conAlelonu both may be subtly coerced or unduly influenced to engage in research   acVivieies   for  which  they  uould 
 not:  otherwise  volunteer.

g. Beneflcsnce: Is a term often understood to cover acte of kindness or charity that go beyond etrict obligations. In 
tAis document, beneficence is understood in a stronger aense, as an obligation. Two general mles are complementary 
oxpreasione of beneficent actions in tAis sense: (1) do not harm and (2) maximize possible benefits and minimize 
possible barme.
obligations  of       baneJ°1cence      agdecrg     bottt      J.nd1v1dua1 Invas1z1ga€o=s  and  soc1et:y  at:  1acqa,   
because  tbey  extand  botb  to particular  research projects and to tAe entira Enterprise ef research. In the case of 
particular projects, investigators and
archers   of  their   lns€lVu€ions   ara   obllqeñ   to   give  foretbouqhe   en
tbe maximization oZ benefits and the reduction of risk that night occur from the research investigation.
A difficult  atbical problem  remains  about research  tbat present:s   aore    Than   niniztal   rlsk   ulehouV    
lmeeñ£aea   prospects   ed d1  acrg  bene€1c  No  the   subgecca   tnvo1ved.   Soae  bave  acqued  that  auch resesrnh 
is inadmissible, while otAers have pointed eut tAat this liBit would rule out research promising great benefit to 
people in the future. As with all haFd cases, the different Glaims coYazed by the principle of beneZicencz -- benefits 
versus harms -  may come into conflict and force difficulty choices.

3 .   7us8£ce •  aaks  Who  ought  No  cacelve  tJte  bane61ts  o:I    eaawch and     baar     It:s     burdens?     
This     1s     a     questlon    of     "far.mass     In distribution" or " what is deserved." An injustice occurs 
wAen some benefit to which a person is *ntitled is denisd without good reason or   when  aoue  burden  1s   Imposed  
unduly.


settings) are being systematically selected or excluded cimply because  of  thair  eaay  availabi¥iey,   their  
compromised  posit:ion,   or their mezipulability, rather than for reasons directly related to the problem being 
studied. Justice demands both tbat research not provide advantages only to certain persons or groups, and that such 
research should not fail to direct bonegits toward those involved.






3

A.  gouodazlea  Ba*veea  9xac6ica  aoa  aaseazca
It  is  important  to  distinguish  between  biomedical  and behavioral research, on the one hand, and the practice oY 
accepted therapy on the other, in order to know what activities ougAt to undergo review for the protection of human 
subjects oZ research. The distinction between research and practice Ls blurred partly because both often occur together 
(as in resesrcfi dea[gned to evaluate a therapy).
The term "practice" refers to interventions tbat are designed BOlely to *nhance the well-being of an Individual patient 
or client and that have a reasonable expectation of success. By contrast, tAe term  "research"  designates  an  
activity  designed  to  test an hypothesis, permit conclusions to be drawn, and/or develop and contribute to knowledge 
(expressed,  for example,  in tAeoriss, principles, statements of relationship, and descriptive summary). Research  and 
 practice  may  be  carried  on  together  when  research
1s designed to evaluate the safsty and efficacy of a therapy. Tbis need not cause any confusion regarding whether or 
not the activity requires review; the general rule is that if there is any element of research, that activity should 
undergo rsview for tAe protection of human subjects.

g. Basio gtbical Principles
z. Respect for Persons• incorporates at least two ethical convictions;  first,  that  individuals  should  be  treatad  
as autonomous  agents,  and  second,  that  persons  with  diminished autonomy are entitled to protection. The 
principle thus divides into  two  separate  moral  requirements:  the  requirement  to acknowledge autonomy and the 
requirement to protect tAose witA diNinished 6UtOüOWy.
An autonomous person is an individual capable of dellberation aboulz   personal    goals   and   oC   act;£ng   under   
tbe    41xec€1on   oC   atzch dellberacion •   To  respect  autonomy   is    €o  glva  weight:  go  autonomous
persons' considered opinions and choices. Fo show lack of respect
for     an   autonomous   agent is to repudiate that person's considered

judgements considered
eo    deny   an   indlvidual   the   freedom   eo   act    on   those
judgements, or to withholdinformation necessary to make
a considered judgement.
The  capacity  for  self-determination  matures  during  an individual's like, and some individuals lose this capacity 
wholly or in part because of illness, mental disability, or oircumstancea that severely restrict liberty. Respect for 
tAe immature and the incapacitated may require protecting them as they matura or while they are incapacitated.
Respect Yor persons demands that subjects enter into the
research  voluntarily  and  with  adequate  information.  In  eome situations, however, application of the principle is 
not obvious. The involvement of prisoners, at one extreme, or of students in more normal circumstances, provide 
instructive examples. On the one















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TO:               Principal Invastigato‹s/Researcher at UOG
FROM:                    UOG Committee on Human Research Subjects (CHRS) SUBJECT:     Institutional Reytew Assuring 
Human Rights of Subjects


This memo  descrlbes  poBsy  and æview ctf\arîa  for O'ie protection  of human  subjects involyed in projects œnductad 
at, aPonaored by, or aI'/iliated with the University of Guam, regardless  of the absenœ or prœenœ of support, and 
ægardless of who elæ may have rm/iewed  jfiern. Research projets (whether  ptolëssional  g¿_gggjggg  Oiat obtain (a) 
data through  infsîactian  with  irdiyîduaB,  or  (b)  identifiable  pñvate  informaëon  are  subject  to review. ÆI 
such projeœ must feœive pñor exemption or approæl fiom the CHRS, which sewes  as  gie  University’s  lnsëtuëonal  
Reyiew  Boaid  in  œmplianœ  with  fedeial  policy eatabliahed  by the U.S. Oflîœ  of Söenœ and Technology.  Your 
understanding  of thèse regulations is important for the Unh/eisity's adhereriæ to fsdeial policy on this topic, and 
for your own fiabilité assumed in the pæformanœ ofreseamh and #aining prof
Each of thèse federal deparbnenfs and agencjes have adopted ö›ese regulations for the
protection of human subjects irivoI›/ed in research œnducted or funded by the following:
US  Department  of  Agñadture;  Department  of Ene‹gy;  National  Aeronautics  and  Space Administraëon;   Departmœt   
of   Commerce;   Consurner   P‹odud   Safety   Commission; International  Development  Coopera0on  Agericy;  Agency  
for  International  Deælopment; Department  of Housing  and Urban  Development;  Deparbnent  of Justice;  Deparbnent  
of
, Department of Eduœtion; Department of Vejgian Alfaiæ; Environmental Protection
Agency;  National  Scienœ  Foundatlan;   Department   of  Health  and  Human  Seiviœs; Deparbnent of Transponalfon.
Researchers  should  be  awaæ  of  other  regional  æview  boards  in  addition  to  Elle Unfærsity CHRS. The Guazi 
Memorial Hospital has an IRB for mœliœl æsearch on Guam.” Alao,  permit  reyiews  are  æquired  by  tf›e  Fæjerajed  
Statæ  of  Mioonesia,  with  similar législation being œnsdered by othœ Paöfîc laland entitles. The FSM has an 
eslablished deaiinghouse  pioceduæ Jbr anyone p«›posing ræearch in the areas of atchaeoloqy,  oial histDry,  SoÔaI 
CLlltufe,  Œ/stDm,  arls/cfalfs,  afŒliyal, political  histDfy,  or anything  to do with hietoric and culturat resounæs 
in the FSM.

To what does this policy apply†

Uni /ersity policy applies to all ‹eaærŒ iwoNing human subjects œnducted,  supported or o0›etwiæ subject to ægulaton by 
any federal department or aqency whidi takes appfopñate adminisbaöve action to make the policy applkable to suŒ 
research. lt also indudœ ‹œeaia œnduÖed, supported, or otherwise subject to regulalton by the federal govemrnent 
outside the United States. Research If›at is neîlher œnduöed nor suppo‹ted by a fède‹al deparbnent or agency but is 
subject to regulation  must be /eyiewed  and appnwed by an instîtutional
/eview board (IRB) 0›at operales in aa›o‹danos with the peitinœt ‹equî‹ements ofbiis policy.
Unless otherwise required, /eseatch actñ/iges wheie One only in ‹olvement of human subjects will be in one or more of 
the fdlowing ‹ategories  may be ezemptad or subjected  only to expedited reyiew prooedures as assessed from ‹he CHRS 
Reyiew Application:
(1) Research œnduond in establîdæd or commonly accepted eduœtîanal Settings, involving normal eduætîonal practî‹æs, 
such as (i) research on regular and apeôal eduœtion instrucôonal etrategîœ, or (ii) æseatoi on the eflbcbæneœ ofor the 
œmparîson among insbucêonal techniques, artîcula, or ciaasmom management rnethods.
(2) Research involving the uee of eduæôonal taets (cognitive, &ægriostic, aptitude,
-        ›hîevernent), sun/ey ptoœduæs or obseræêon of public behavÔr, unleæ:
(i) Irtfonœtîon obtained ia æœrded in such a manner Oæt human subjects can be dentilted, diieclfty or through 
dîdeennttiî55eerrs linked to the esub{edz; and gi) any diacbsuæ of the human subjects’ responses outside the            
 ould taasonably place the subjects at ñsk of cittiinal or civil febility or be damaging to the subjects’ financial

(3)ResemhndsæmWundwpsœgmPh2dRüeœRq1(#æ#aÆeœëœÆdor
appointed public oflîcials or mndidatea for public oflîce; or (i) fedeial statele(s)
information will be maîmained thtoughout tlæ æsearch and thereañer.
(4) Research involvîng the oolbctian or study of exîetîng data, dœxnerits, records. pathologîœl speörnens, or &ægnostîc 
specà'neiæ, if 0›eee eounæs are publîcly æailable or ifthe information is recordaf by0is itweati$ator in auofi a manner 
Oiat su#jéc/s cannot be kfentilied, directly or Oirough identifiers linked to tta subs
(5) Research and demonslratbn pro}ecB which aia designed to study, evaluate or otherwise examine:  #) Public beneE or 
ser¥ica pto$tams; (g) ptocedurea for obtaining benefits or eenfioae under Oiæe progærna; (A) poesble dænges in or 
alBmatîves to those p‹ogæms; or (iv) possible changea in methods, payment or senñces under thoee

(6) Taste and food quality evaluation and consumer aaxplarice sbzdie8, (i) if wholesome foods without addîtîves an  
œneumed or §§ ifa  food is œnsumed that œntains a food ingredîent at or bebw the Iesel and for a usa Jöund æ be safe, 
or agñcultuæl chemiœl or eiwironmental œri/aminant at or below gie lœel Iôund to be aafe, by the Food and Drug 
Adminia#atîon orappioved bythe Eiwironmental Protection Agency orthe Food Safaty and Inspectbn Service ofgie USDA.

8actioo  i03  Assuring  compliance  Pitt  this  policy--research
corductad or supported by aoy federal department or ageocy.
(a) Each institution engaged in research which is covered by this policy and which is conducted or supported by a 
federal department or agency shall provide written assurance satisfactory to the department or agency head that it will 
comply witA the requirements set forth in this policy. In lieu of requiring submission of an assurance, appropriate for 
the research in question, on file with the Office for Protection from Research Risks, RHS, and approved for federal 
wide use by that office.
(b) Departments and agencies will conduct or support researeA covered by this policy pnly if the institution has an 
assurance
approvea aa provided by this section, and only t§ the institution
chas               lfled   co The   departztene   or   agency   head   thai   I:he   research
has    been    reviewed   and   approved    by   an    xRB   provided    for    in   the assurance, and will be subject 
to continuing review by the IRB. Assurances applicable to federally supported or conducted research shall at a minimum 
include:
(1) A statement ofprincipals governing the institution in the discharge of its responsibilities for protecting the 
rights and welfare of human subjects of research conducted at or sponsored  by tAe  institution,  reqardlpss  o  w et e 
 the peseqpch js subject to federql peoulation.
(2) Designation of one or more IRBs estab1iah•d in accordance with the requirements of this policy, and for which 
provisions are made for peetiqg space and suf#iciept staf#„tp suDoort the IRB•s review and record keeDino duties.
(3) L list of IRB members identified by name, earned degrees, representative capacity; . . . . sufficient to describe 
each members chief anticipated contributions . . .
(4) Written procedures which the IRB will follow . . .
(5) Written procedures for ensuring prompt reporting to the IRB, appropriate institutional officials, and the 
department or agency head of (1) any unanticipated problems involving risks to subjects or others or any serious or 
continuing noncompliance  with  this  policy  or  the  requirements  or determinations  of  the  IRB  and  (ii)  any  
suspension  or termination of IRB approval.
(c) to (g) [additional specifications and policy for assurances]
(f) . . . Institutions UithOUt an approved assurance covering the research ahall certify within 3o days after receipt 
of a request for such a certification from the department or agency, that the application or proposal has been approved 
 by the IRB. If the


sact1on  1o2  De€1a1€1ons
(a) Department or agency head . . .
(b) Institution . . .


(d) Hesearcfl means a systematic investigation, including research development,  testing  and  evaluation,  designed  
to  develop  or contribute to generalizable knowledge.
(e) Aesearcb subject to regu2atlon, . . . encompass those research activities for which a federal department or agency 
has specific responsibility for regulating as a research activity. It does not include research activities which are 
incidentally regulated by a federal department or agency solely as part of the department's or agency's  broader  
responsibility  to regulate  certain  types  of activities whether research or non-research in nature (e.g., Wage and 
Hour requirements administered by the Department of Labor).
(f)  Buman  subject  means  a  living  individual  about  whom  an investigator (whether professional pr student) 
conducting research obtains (1) data through intervention  or interaction  with the individual, or (2) identifiable 
private information. (]xterventlon and private information are given expanded definition)


(h)    IRB    appz-ova-I   ...

(i) Blzimal rlsk means that the probability and magnitude of harm or discomfort anticipated in the research are not 
greater in and of themselves than those ordinarily  encountered  in daily life or during  the  performance  of  routine 
 physical  or  psychological examinations or tests.
(j)  Certification  means  the  official  notification  by  the institution to the supporting department or agency, in 
accordance with the requirements of this policy, that a research project or activity involvinghuman subjects has been 
reviewed and approved by an IRB in accordance with an approved assurance.






3

(b) Unless otherwise required . . .  research activities in which the only involvement of human subjects will be in one 
or more of the foLloWing categories are exempt from this policy:
(1) Research conducted in established or commonly accepted educational settings, involving normal educational 
practices, such  as  (i)  research  On  regular  and  special  education instructional   strategies,   or  (ii)  
research   on  the effectiveness  oY  or  the  comparison  among  instructional techniques, curricula, or classroom 
management methods.
(2)  Research  involving  the  use  of  educational  tests (cognitive,  diagnostic,  aptitude,  achievement),  survey 
procedures or observation of public behavior, unless:
(i) Information obtained is recorded in such a manner that human     subjects    can   be    iaent:if1e‹t,     directly 
    or    through identifiers linked to the subjects; and (ii) any disclosure of the human subjects' responses  outside 
the research  could reasonably place the subjects at risk of criminal or civil liability or be damaging tO the 
subjects' financial standing, employability, or reputation.
(3) Research [under 101(b)(2)] that is not exempt under paragraph (b)(2) of this section, if: (i) ... subjects are 
elected or appointed public officials or candidates for public office;  or  (ii)  federal  statute(s)  require(s)  
without exception  that  the  confidentiality  of  the  personally identifiable information will be maintained 
throughout the research and thereafter.
(4) Research, involving the collection or study Of existing data,  documents,  records,  pathological  specimens,  or 
diagnostic specimens, if these sources are publicly available or if the information is recorded by the investigator in 
such a manner that subjects cannot be identified,  directly or through identifiers linked to the subjects.
(5) Research and demonstration projects... which are designed to study, evaluate or otherwise examine: (i) Public 
benefit or service programs; (ii) procedures for obtaining benefits or services under those programs; (iii) possible 
changes in or alternatives to those programs ...(iv) possible changes in methods or ... payment ... or services under 
those programs.
(6) Taste and food quality evaluation and consumer acceptance studies, (i) if wholesome foods without additives are 
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 
safe, or agricultural chsrical or environmental contaminant at or below the  level  found  to  be  aafe,  by  the  Food 
 and  Drug Administration or approved by the Environmental Protection Agency or the Food Safety and Inspection Service 
of the USDA.
2

UxSVBeszzg  or   auazg
tJDlBsKsBaAz  ouaanx
COMMITTEE on IlTJhfWf RZSZAItCIE SUBJECTS
RESEARCH COUNCIL GRADUATE SCHOOL & RESEARCH



SOURCE: Pederg} Reqister, Jupg 18, 1991 (Regq}atioqs effective Augugt 19, 1991)


"This  document  sets  forth  a  common  Federal  Poliwy  for  the Protection of Human Subjects accepted by the office 
of Science aod TacRoology Pollwy and promulgated in regulation by each of the listed Departments and Agencies.•
Each of these Departments and Agencies have adopted the common rule as regulations for the protection of human subjects 
involved in research conducted or funded by the following:
Cs  Depactzsenc   o£  hgu1cu1cure›   Dapaztaian€   o£   znecgy;   mac1ona1  Aeronautics   and Spaoe Adm£n1e€cac1ozt›  
Dapaz-haiarzc  oC Coaaaocce;  Conauaiou product  Sa£ecy  Cozam1ee ton; InVecna€1one1    Deva1ogxaan€     Coopora¢1oa    
 kgency;     urgency     Com     IncecnahLonaL Deea1o$man€;  Depactaian€  of   Bous1ng  aztd Ocban  Davalogaaanc;  
Depaccmenc  o£  6uac1ce› Depaz-ba›nnc   oC  De£anee;   Depaz€a›anc   o£  6duoac1on;   Depaz-beanjr   o£  ve€aran  
ACCa1ce;




8ecc1on  for    g'o  abas  doea  fib1a  po11oy  app1g's

(a) . . . this policy applies to all research involving human subjects conducted, supported or otherwise subject to 
regulation by any  federal  department  or  agency  which  takes  appropriate administrative  action  to  make  the  
policy  applicable  to  such research.  . . .  It also includes research conducted, supported, or otherwise  subject to 
regulation  by the federal  government outside the United States.

(2) Research that is neither conducted nor supported by a federal department or agensy but is subject to regulation as 
defined in Section 102(e) must be reviewed and approved, in compliance with Sections 101,102, ana rod through 117 Of 
this policy, by an institutional review board (IRB) that operates in accordance witA the pertinent requirements of this 
policy.






1.18 Børtør (Witb Patitøts or Oients)





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llTAirŁPsüyRaąuaBorS  iæ

certification  is not submitted  within these time limits,  the application  or  proposal  may  be returned  to the  
institution. (Approved by the Office of Hanagement and Budget under Control Nuatbec  9999-O02 0. )
8ac21one   xo4  •arougb  106  [Reaez-vedj
Backlog   1o7 ZRB  aaabexsb1p
a) Each IRB shall have at least five  members,  with  varying backgrounds to promote complete and adequate review of 
research activities commonly conducted by tRe institution.  In addition to possessing the professional competence 
necessary to review specific research  activities,  the IRB shall  be able to ascertain  the acceptability  of  
proposed  research  in terms of  institutional commitments and regulations, applicable  law, and standards  of 
professional conduct and practice.
b)  Every nondiscriminatory effort will be made to ensure that no IRB consists entirely of men or entirely of women.
c)   Each IRB ehall include at least one member whose primary concerns are in scientific areas and at least one member 
whose primary concerns are in nonscientific areas.
d) Each IRB shall include at least one msmbsr who is not otherwise affiliated  with the institution  and who is not 
part of the immediate  #amily  of  a  person  who  is  affiliated  with  the institution.
e)  NO ORB may have a member participate in review of any project in whicA the membsr has a conflicting interest, 
except to provide information.
f)   An IRB may,  in its discretion,  invite individuals  with eompetence in special areas to assist in the review of 
issues which require expertise beyond or in addition to that available on the IRB.  These individuals say not vote with 
the IRB.
8ec€1oa  1os     IeB  €uac€1ona  and  opeg   a €1ons. Each  IRB  shall:
a)  POllow written procedures;
b)          Rxcep£    when    an     expedieed    review    procedure    in     used    review proposed research at 
convened meetings at which a majority of the members of the IRB are present, including at lease one member whose 
primary concerns are in nonscientific areas.  In order for the research  to be approved,  it shall receive the approval 
 of a majority of those members present at the meeting.

5

Section 109 IRB Review of Research.
a)  An IRB shall review and have authority to approve, require modifications in (to secure approval), or disapprove all 
research activities.
b) An IRB shall require that information given to subjects as part of informed consent is in accordance with 
Section.116.  The IRB may require  that  information,  in  addition  to  that  specifically mentioned in Section.116, 
be given to the subjects when in the IRB's judgment  the information  would  meaningfully  add to the protection of the 
rights and welfare of subjects.
c)  An IRB shall require documentation of informed consent.
d)   An IRB shall notify investigators  and the institution  in writing of its decision to approve or disapprove the 
proposed research activity, or of modifications  required to secure IRB approval of the research activity.
e)  An IRB shall conduct continuing review of research covered by this policy at intervals appropriate to the degree of 
risk, but nOt less than once per year, and shall have authority to observe or have a third party observe the consent 
process and the research.
8ec€1on    11O   Bs$seé1•ad   z'•e1ew'   pgocaduzeg    fog'   m    €a1O   3c1odo    of
zogeaacb  fgsoo1a1ag  no  aoaa  Oban  a1a3ma1  g'1o$t,   aoQ  Coz'  a1zzot  cbaBgeo

a)  In the Federal Register, a list of categories of research that may be reviewed by the IRB through an expedited 
review procedure will be amended, as appropriate after consultation  with other departments and agencies.
b)  An IRB may use the expedited review procedure to review
1.  Some or all of the research appearing on the list and found by the reviewer(s) to involve no more than minimal 
risk.
2.  Minor changes in previously approved research.
Under an expedited review procedure, the review may be carried out by the IRB chairperson or by one or more experienced 
reviewers designated by the chairperson.  Reviewers may exercise all of the authorities of the IRB except that the 
reviewersmay not disapprove the    research•



a)   To approve research covered  by this policy the IRB shall determine that all of the following requirements are 
satisfied:
1 •      Risks to subjects are minimized.
2.  Risks to subjects are reasonable in relation to anticipated benefits.  The IRB should not consider possible 
long-range effects of applying knowledge gained in   The  research   (foe  example,   the   peesible  effecrt:s  og   
I:he research on public policy) as among thoae research risks that fall within the purview of its responsibility.
3.  Selection of subjects is equitable.
4.  Informed consent will be sought from each prospsctive subject or the subject's legally authorized.
5.  Informed consent will be appropriately documented.
6.  When appropriate, the research plan makes adequate provision for monitoring the data collected to ensure the safety 
of subjects.
7.  There are adequate provisions to protect the privacy of subjects and to maintain the confidentiality of data.
b) When some or all of the subjects are likely to be vulnerable to coercion or undue influence, such as children, 
prisoners, pregnant women, mentally disabled persona, or econoaicallY or educationally disadvantaged persons, 
additional safeguards have been included in the study to protect tAe rights and welfare of tRese subjects.


Research covered by this policy that has been approved by ah IRB may be subject to further appropriate review by 
officials of the institution.

8•C*1O»   113    6UfipaO81OO   or     ¢eza1:aa61on   OC   Zea     &ppg'Ova1.

An IRB shall have autAoritY to suspend or terminate approval of research that is not being conducted in accordance with 
the IRB's requirements or that has been associated witA unexpected serious harm to subjects.

Bec21oo  114   coopaxa€1ve   Raseacaa.

Cooperative research projects are those projects covered by this policy which involve more than one institution.  In 
the conduct of cooperative research projects, each institution is responsible for safeguarding  the rights and welfare 
of husmn subjects and for complying with this policy.

An institution participating in a cooperative project may enter into a joint review arrangement, rely upon the review 
of another qualified      ZRB,      or      nake     similar     arrangement:a      for      avoi‹:ling duplication of 
effort.
sactioo us  zRe xecora•.
An IRB, shall prepare and maintain adequate documentation of IRB activities, including the following:
1.  Copies of all research proposals reviewed.
2.                         of IRB meetings
s.  Records of continuing review activities.
4.  Copies of all correspondence.
5.  A list of IRB members.
6.      Writ:I:en   procedures  for   the   ZRB .


An investigator shall seeE such consent only under circumstances that  provide  the  prospective  subject  or  the  
representative sufficient opportunity to consider whether or not to participate and that minimize the possibility of 
coercion or undue influence. The information that is given to the subject or the representative shall  be  in  language 
 understandable  to  the  subject  or  the representative.
a)  Basic elements of informed consent
1.  A statement that the study involves research, an explanation of the purposes of the research and the expected 
duratiOn of the subject's participation, a description of the procedures to be followed, and identification of any 
procedures which are experimental,

2.  A description of any reasonably foreseeable risks or discomforts to the subject,

3 .      A description of any benefits to the subject or to others which may reasonably bm expected from the research;
4.  A disclosure of appropriate alternative procedures or courses of treatment, if any;
5. &  statement describing the extent, if any,
to which confidentiality of records identifying the subject will be maintained;
6.  An explanation as to whether any compensation and
an explanatioñ as to whether any medical treatments are available lf injury occura and, if so, what they consist of, or 
where further information xay be obtained,
7. An explanation of whom to contact for answers to pertinent questions;
8.  A statement that participati on is voluntary, refusal to participate will involve no penalty or loss of benefits to 
which the subject is otherwise entitled, and the subject say discontinue participation at any time.
b)  When appropriate, one or more of the following elements of information shall also be provided to each subject:
1. L statement that the particular treatment or procedure may involve rieks;
2.  Anticipated circumstances under which the subject's participation may be terminated;
3.  Any additional costs tO the subject;
4.  TAe consequences of a subject's decision to withdraw. 8ectie# 117. Documantatio# of Informed consent,
a)  Informed consent shall be documented by the use of written consent form approved by the IRB and signed by the 
subject or the subject's legally authorized representative. A copy shall be given to the person signing the form.

)  °    -Y  waive the requirement for the investigator to obtain a signed consent form for some or all subjects if it 
finds either:
1.  That the only record linking the subject and the research would be tAe consent document and the principal risk 
would be potential harm resulting from a breach of confidentiality.

2.  That the research presents no more tAan minimal risk of harm to subjects and involves no procedures for which 
written consent is normally required.
8ec€1oa  118  kpp11caC1oss   aod   puopoaala   1acjc:Log  QeI1o12e   p1aaa   gon
1aooloamaaC  g£   aua   a  •ubJec2fi•



In the event research is undertaken without the intention of involving human subjects, but it is later proposed to 
involve human suh3eHs  In  the  researcht   I:he  research  afraid  fl.ref   be  reviewed  and approved   by  an   IRB, 
  as   provided   In   this  policy.
Bec€1oa     120     Bea1ua61•a     aaA     d1apoa1€1on
pcoposala   €ou  xeeaazcb  •o   b•   coaauc•e4

The department or agency head will evaluate all applications and proposals involving human subjects submitted to the 
department or agency
8ac€1oa  121  [Reserved]
seoa£on   xzz  Ose  o€  s•d•xa1  €uo4a.
Pederal funds administered by a department or agency may not be 4zpendmd  for  research  involving  human  subjects  
unless  the requirements of this policy have been satisYiud.
Bacg1oa  123  Bnz'1g'  €•zmñDab1oO  of   z'eaaag'cb   guppozfi I   Bva1tza€1oo  oC app11oaC1oaa  aod  pxopoaals.
a)  The department or agency head nay require that department or agency support for any project to be terminated or 
suspended when the department or agency head Sinds an institution has materially failed to comply with the terms of 
this policy.
sa«g1oa  12«  cooa181o¥ta1  Zae  appg'o    1.
The department or agency head may impose additional conditions prior to or at the time of approval when in the judgment 
of the department or agency head additional conditions are necessary.






10

t estimony recommyyding changes to  Bill 347                      Profsof Smiology and Commuiñty De*el°i*i&t
College of Agriculture & Life Scit•-, U£Ki


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

The University of Guam’s Human Research Subjects Committee, an irb meeting the appropriate federal guidelines, has more 
than adequately carried out this responsibility for research involving or associated  with UOG faculty or students. I 
have attached a copy of their guidelines to investigators. In recent years and with the assistance of UOG faculty the 
Guam Memorial Hospital has established  a similar irb for research  within its facility, or in association with its 
personnel and medical staA  The purpose is to comply with federal regulation for grant funding:
SOURCE-   Federal   Register    June   l8.  199}   (ReguÍations   effective   Aupust   I9.  1991j  Secfion  103  
Assuring
compliance  with this policy-research conducted or supported  by any federal  department or agency.
(a) Each institution engaged in resmrch which is covered by this policy and which is conducted or supported
by a federal department or agency shall provide written assurance satisfactory to the department  or agency

head that it will comply  with the requéements sa  forth in this policy. In lieu of requiring submission of an 
assurance,  appropriate  for the  resmrch  in question,  on tile with the 0&ce for Protection    om Re<a'ch Risks, HHS, 
and approved for federal wide use by that o&cc.

Through this federal mandate, the UOG HRSC has become involved with numerous research projects conducted on-island by 
other universities and research institutions from off-island. I have attached a summary for your clarification.  As 
this federal policy dictates:

Resenrck Cooperative resmrch projects am those projects coveimi by this policy whicit involve morn M one  institution.  
   In  the  conduct   of  cooperative  imnrcli  projects,            ibStitutj‹n  iS  responsible  for safeguarding  
the rights and  welfare  of human subjects and for complying  with tbis g0liTy.  An instittlti0A participating  in a 
cmpciative  project may enter into a joint review arrangement,  fuly upon the review of another qualified IRB, or make 
similar arrangeinmts for avoiding duplication of effort.

Unfortunately, this is not required for the island territory of Guam, rather it only becomes mandated  between 
institutions.  Thus it is possible for federally funded research projects from off-island institutions, to go through 
or affiliate with a Guam instituüon not covered b   its own irb and                          OG or GMH (e g., a private 
medical clinic, Naval Hospital, or DPHSS, MHSA, DPR, etc.) AND THEY CAN CHOOSE NOT TO HAVE A GUAM BASED IRB

Yet, the UOG CHRS, a Guam based irb, is very capable of handling these few occassional cases which may arise in any 
given year, and has the developed organizational mechanisms to efficiently and effectively process such cases. The UOG 
CHRS can fully achieve the intent of Bill 347, minimize and avoid any delay or obstruction that could adversely affect 
such research projects, and do this in a cost effective manner because it would fit within their normal  processing of 
on-island research studies. The UOG CHRS handles about 25-30 studies each year, most of these being Expedited/low risk 
studies by graduate and undergraduate students, with 3-4 major studies involving UOG faculty affiliated with local 
agencies (e.g., DPHSS, MHSA, etc.).
The UOG CHRS  is experienced  and can provide an on-island irb review service to any agency, private entity, or 
off-island institution that does not have its own or other access to a Gtiam based irb.  This  is  based  on  the  idea 
 that  the  legislative  intent  is to  mandate  that  any  research  study involving human subjects has at least one 
on-island  review. If that is the intent, then Guam has a ready  mechanism  in  the  form  of  the  UOG  CHRS  to  
ensure  that  all  of  the following  federal requirements are satisfied by any research covered by this law:

1.  Risks to subjects are minimized.
2.    Risks to subjects am reasonable in relation to anticipated benefits.
3.    Selection of subjects is equitable.
4.  Informed consent will be sought from each prospective   subject or the subject's legally authorized .
5.  Informed consent will be appropriately  documented.
6.  When appropriate, the research plan makes adequate provision for monitoring the data collected to ensure the  
safety of subjects.
7.  Thème are adequate provisions to protect the privacy of subjects and to maintain the confidentiality of

8.  When some or all of the subjects are likely to be vulnerable to coercion or undue inBuence, such as children, 
prisoners, pregnant women, mentally disabled persons, or economimlly or educationally disadvantaged persons, additional 
safeguards have been included in the study to pixitcct tlu rights and welfare of these subjects.
I-However, as currently written, B’     47 establishes an unnecessary additional‘
Moreover, it includes a section 24102. Bonr-         me;   ppoin    end  Mntinnancp Renal. which is a confusing listing 
of membership, and does not fit the federal guidelines for irb stricture.  For example, why only include the Director 
of DPHSS or his/her designee, and not the director of MHSA, DDPR, DOE, or the new agency for disabilities; and why is 
it so heavily weighted with  people having no expertise in research or any academic science† What is the purpose of 
including an odd assemblage of persons — who may not have the skill and luiowledge for reviewing technical 
methodologies to ensure informed consent and procedures to handle any risks involved? Within the federal policy for 
irb’s it states:

SOURCE’ Fedeml Rcgjstu June l8 199lJegu1atio«s •ffwtive xc       is  jeer j Section 107 IRB membership.
a) Each IRB  shall  have  at  least  five  memberi  with  varying  backgrounds  to  promote  complete  and adequate  
review  of  research  activities  commonly  conducted  by  the  institution.    In  addition  to pouessing  the  
professional  competence  necessary  to review  specific  reseamh  activities  the IRB shall   be  able  to  ascertain  
 the  acceptability   of  proposed   research   in  terms  of  institutional commitments and regulations, applicable 
law, and standards of professional conduct and practice.
b)   Every  nondiscriminatory  effort  will  be  made  to ensure  that  no IRB  consists  entirely  of  men  or 
entirely of women.
c)  Each IRB shall include at least one member whose primary concerns are in scientific areas and at least one member 
whose primary concerns are in nonscientific areas.
d)  Each IRB shall include at least one member who is not otherwise affiliated with the institution and who is not part 
of the immediate family of a person who is afliliated with the institution.
e)  No IRB may have a member participate in review of any project in which the member has a conflicting interest, 
except to provide information.
f)   An IRB may,  in  its discretion,  invite  individuals  with competence  in special  areas to assist  in the review 
of issues which require expertise beyond or in addition to that available on the IRB.  These individuals may not vote 
with the IRB.


I  recommend  tire following changes be made to Bill No. 347 In Section  1. Legislative Findings
Replace the second sentence on lines 7-10 which reads: “It further finds thai the creation of a review board is the 
appropriate body to review proposals, plans, procedures and protocols for research involving human subjects and to 
approve or disapprove the same.”
With: “It further finds that there are institutional review boards on Guam +rbirfi con[omi. to federal guidelines for 
such entities which are the appropriate bodies to review proposals, plans, procedures and protocols for research 
involving human subjects and to approve or disapprove the came."

Insert into the second paragraph on lines 11-15 an additional condition confronting Guam, so it reads:
“Further more, the legislature finds that on occassions human research conducted on Guam does not always acquire 
informed consent fiom persons participating in the programs, thai come research although  hnving obtained off-island 
irb reverts fail to take  into eonsoiñeration uni‹tue islnnd cultural rind socinf condifions that confound or negnte nn 
indiviJunl’s ability to makea    eonsiilered iudeement iibout fiber oartitiontton ,  and that there is a need to 
regulate and mandate informed consent to ensure that those persons participating are adequately informed.”

Replace the third paragraph lines 16-18 to read:
“In the case +rhere an investigator,  entity, or agency engaged in research subject to regulation does not have nor isa 
   iliated with an appropriately constituted institutioiml review board on Guam  so they can confomi to the 
requirements of this law, the University of Unani ’s tnstitutional review board drill provide   zi appropriate review 
for the purposes of this law.”


This makts apparent  the need to change the titre of the law to be:
AN ACT TO ADD CHAPTER 24, DIVISION 3, 17 GCA   TO REQUIRE AT TEAS'   ONE REV     W AND APPROVAL OF ANY RESEARCH 
CONDUCTcD ON GrAM WrrH REGARD TO BUMAN SUBJECTS BY A GUAM-BASED INSTITUTIONAL REVIEW BOARD

Finally, Delete section 24102. Board; Terms; Appointment; Continuance; Removal., Page 4 lines 19 through 40.










Greetings to Senator Kasperbauer and other senators!

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 
Guam Legislature.
There are four reasons for the revisions that I wish to address:  1) duplication of the existing review process; 2) the 
role of the University of Guam in research; 3) delays in conducting research; and 4)  the composition of the committee.
Let me begin by discussing duplication of the existing review process and suggesting a change in the legislation.   The 
University of Guam's Committee on Human Subjects in Research (CHSR) has existed since 1982 and its members actively 
serve the citizens of Guam by providing protection.   Members review 20 to 30 research proposals per year; these are 
submitted by faculty conducting research on human subjects, by graduate students conducting thesis research in the 
Department of Education and other agencies, and by undergraduate students conducting research in Guam's classrooms.  
Those participating in the research are adequately protected in accordance with the U.S. federal and local regulations 
related to human subjects in research.
The change we are suggesting is that the ”creation of the Guam Research Review Board” be replaced with ”the designation 
of the University of Guam's Committee on Human Subjects in Research as

GRRDURTE  SCHOOL  RND  RESEARCH  DERN‘S  TESTI I'HONY,  1998

the Institutional Review Board (IRB) for researchers and collaborators at the University and for researchers who are 
not under other lRBs." Wherever the bill states ”Guam Research Review Board” it should be replaced with "UOG's 
Committee on Human Subjects in Research.”
Second, I wish to state that the role of the University of Guam in research is that of the state institution and, as 
such, it is appropriate that the IRB be housed in the Office of Graduate School and Research. However, GS&R has as its 
primary duty service to graduate students, and it is already overburdened with increases in the number of graduate 
students enrolling in courses, increases in the number of graduate programs since 1993, and increases in the number of 
qualified graduate faculty who seek answers to questions.  In order to meet the stipulations of the legislation, GS&R 
needs funding and the creation of a new clerical staff position.  Please include appropriate funding as this 
legislation goes forward.
UOG has a fine record of grantsmanship and compliance with federal standards because it strives to meet rules and 
regulations through the policies set by Research Council and enforced by GS&R.
The third issues I will briefly address is the concern that an added review process would cause delays that could 
hinder the excellent research that is pre”sentIy being conducted by undergraduate students in various programs.  
Undergraduate students only have one semester or fifteen weeks in which to complete their research projects.  It is our 
desire to encourage undergraduate students to conduct research under the mentorship of their professors.  Review 
processes take time to complete , but unusual delays could damage a student’s enthusiasm for the research project.   
”the UOG's Committee on Human Subjects in

GRRDURTE  SCHOOL  RND  RESEflRCH  DERN'S  TESTIMONY,  1998

Research is currently expediting the review process for undergraduate
students who have limited weeks to complete research.
Finally, I will state my concerns about the composition o1 the committee.  Section 3 on page 4 states the proposed 
composition of the Guam Research Review Board.  This entire section of Bill No. 347 should be deleted and replaced with 
the composition of the CHRS which is:
3 or 4 professional research proficient experts from UOG
at least 1 Guam community representative at least 1 local religious leader
at least 1 licensed practicing local medical doctor
This composition allows the IRB to remain relatively free from political interference.  The UOG President is kept 
informed of changes in the membership and may appoint qualifi                     a the CHSR when there are v           
 s.
et me assure you, senators, that I am willing to revise Bill No. 347 by working with you and your staff.   We all need 
to work towards the protection of the citizens of Guam who agree to participate in research projects.











GRRDURTE  SCHOOL  fINB  RESERRCH  BERN‘S  TESTIMONY,  1998