79C3C34C52B45572883A05D425EB0F82
EPA Order 1000.17A
https://www.leaux.net/URLS/General/2016_policy_order_revision_6-10-16.pdf
http://leaux.net/URLS/ConvertAPI Text Files/DFEC34DC1A1EC7B84030B7631FE2B124.en.txt
Examining the file media/Synopses/DFEC34DC1A1EC7B84030B7631FE2B124.html:
This file was generated: 2020-12-01 05:26:06
| Indicators in focus are typically shown highlighted in yellow; |
Peer Indicators (that share the same Vulnerability association) are shown highlighted in pink; |
"Outside" Indicators (those that do NOT share the same Vulnerability association) are shown highlighted in green; |
Trigger Words/Phrases are shown highlighted in gray. |
Link to Orphaned Trigger Words (Appendix (Indicator List, Indicator Peers, Trigger Words, Type/Vulnerability/Indicator Overlay)
Applicable Type / Vulnerability / Indicator Overlay for this Input
Health / Drug Usage
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p.000001: Conducted or Supported Research, approved May 27, 2011 and amended on July 27, 2011.
p.000001:
p.000001: 2. Applicability
p.000001: This Order applies to all research involving human subjects conducted or supported by EPA and covered by 40 CFR Part
p.000001: 26. It also addresses the oversight process for research involving human subjects that is exempt from 40 CFR Part 26.
p.000001: Furthermore all other EPA policies and other official EPA actions involving EPA conducted or supported research with
p.000001: human subjects shall cross-reference or include this Order.
p.000001:
p.000001:
p.000001: 3. Definitions
p.000001: A. Research. Research means a systematic investigation, including research, development, testing, and evaluation
p.000001: designed to develop or contribute to generalizable knowledge. Note that some demonstration and service programs may
p.000001: include research activities. [40 CFR 26.102(d)].
p.000001: B. Human subject means a living individual about whom an investigator (whether professional or student) conducting
p.000001: research obtains (1) data through intervention or interaction with the individual or (2) identifiable private
p.000001: information. [40 CFR 26.102 (f)]
p.000001: C. Exempt research. Research studies that may be found to be exempt are identified in 40 CFR 26.101(b). An example of
p.000001: such exempt research is that involving the analysis of existing research materials if they are publicly available or
p.000001: recorded in a manner such that the subjects cannot be identified.
p.000001:
p.000001: 1
p.000001:
p.000001: D. Intentional exposure research. Research involving intentional exposure of a human subject means a study of a
p.000001: substance in which the exposure to the substance experienced by a human subject participating in the study would not
p.000001: have occurred but for the human subject’s participation in the study. [40 CFR 26.202(a)]
p.000001: E. Observational research. Observational research means any human research that does not meet the definition of
p.000001: research involving intentional exposure of a human subject in 40 CFR 26.202(a). [40 CFR 26.302]
p.000001: F. Observational Human Exposure Studies. As defined in Scientific and Ethical Approaches for Observational Exposure
p.000001: Studies (SEAOES), observational human exposure studies are studies that involve the collection of environmental
p.000001: samples, data, and information from study participants in their everyday environments as they go about their normal
p.000001: activities. They involve neither the deliberate exposure of participants nor the control of environmental conditions in
p.000001: a way that impacts the participants’ naturally occurring exposures (SEAOES, pp. 7-8).
p.000001:
p.000001:
p.000001: 4. Policy
p.000001: In dealing with human subjects research it is EPA policy that:
p.000001: A. All research shall comply with 40 CFR Part 26 and with this Order.
p.000001: B. All human observational exposure studies conducted or supported by EPA will adhere to the principles set forth in
p.000001: SEAOES.
p.000001: C. All human subjects research conducted or supported by EPA must either be approved or be acknowledged as exempt
p.000001: research by the EPA Human Subjects Research Review Official (HSRRO) before any work involving human subjects research
p.000001: can begin. Approval will be given only to research that complies with subsections 4.A. and B. above. Preliminary review
p.000001: by the HSRRO can be requested for any research project, contract, grant application, cooperative agreement, cooperative
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Social / Police Officer
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p.000001: F. Observational Human Exposure Studies. As defined in Scientific and Ethical Approaches for Observational Exposure
p.000001: Studies (SEAOES), observational human exposure studies are studies that involve the collection of environmental
p.000001: samples, data, and information from study participants in their everyday environments as they go about their normal
p.000001: activities. They involve neither the deliberate exposure of participants nor the control of environmental conditions in
p.000001: a way that impacts the participants’ naturally occurring exposures (SEAOES, pp. 7-8).
p.000001:
p.000001:
p.000001: 4. Policy
p.000001: In dealing with human subjects research it is EPA policy that:
p.000001: A. All research shall comply with 40 CFR Part 26 and with this Order.
p.000001: B. All human observational exposure studies conducted or supported by EPA will adhere to the principles set forth in
p.000001: SEAOES.
p.000001: C. All human subjects research conducted or supported by EPA must either be approved or be acknowledged as exempt
p.000001: research by the EPA Human Subjects Research Review Official (HSRRO) before any work involving human subjects research
p.000001: can begin. Approval will be given only to research that complies with subsections 4.A. and B. above. Preliminary review
p.000001: by the HSRRO can be requested for any research project, contract, grant application, cooperative agreement, cooperative
p.000001: research and development agreement (CRADA), interagency agreement or any formal agreement involving EPA support of such
p.000001: studies. However, preliminary review is not required for any project, and if provided does not substitute for approval
p.000001: following IRB review.
p.000001: D. In laboratories/centers/offices/regions where there is a HSRRO-approved Human Subjects Officer (HSO), projects must
p.000001: first be reviewed by the on-site HSO before projects are presented to the HSRRO. In absence of an HSO, projects must be
p.000001: submitted directly to the HSRRO.
p.000001: E. Any solicitation issued by an EPA office or department for research involving human subjects shall require
p.000001: compliance with this order and 40 CFR Part 26.
p.000001: F. This policy extends to all EPA employees, regardless of the location of the employee or the human subjects
p.000001: research activity. This policy, however, does not affect any foreign laws or regulations which may otherwise be
p.000001: applicable and which provide additional protections to human subjects of research (40 CFR 26.101 (g)). Procedures
p.000001: followed in
p.000001:
p.000002: 2
p.000002:
p.000002: foreign countries to protect human research subjects may differ from those set forth in 40 CFR Part 26. See section 40
p.000002: CFR 26.101(h) for information about research involving human subjects that is performed in foreign countries.
p.000002:
p.000002: 5. Requirements
p.000002: Research involving human subjects provides important medical and scientific benefits to individuals and to society. The
p.000002: need for this research does not, however, outweigh the need to protect individual rights and interests.
p.000002: To obtain approval or a concurrence of exemption by the HSRRO, researchers must submit the IRB-approved research
p.000002: package or documentation of exemption, including evidence of IRB approval and any correspondence between the IRB and
p.000002: the researchers.
p.000002: Researchers must also provide evidence of a Federalwide Assurance (FWA) on file with the U.S. Department of Health and
...
p.000002: will advise the institution or organization on the process for obtaining an assurance from HHS or another source. For
p.000002: EPA investigators, no proof of assurance is required (EPA is covered by FWA #12755).
p.000002:
p.000002: 6. Responsibilities
p.000002: All EPA employees, contractors, grant recipients, and parties to other EPA agreements share the responsibility to
p.000002: protect the rights and welfare of human research subjects.
p.000002: A. Principal Investigator. The Principal Investigator, as the person directly implementing the research, has specific
p.000002: responsibilities related to that research project. These responsibilities include:
p.000002:
p.000002: 1. Complying with this Order, 40 CFR Part 26 and other applicable policies and regulations.
p.000002:
p.000002: 2. Ensuring the rights and welfare of subjects are protected.
p.000002:
p.000002: 3. Submitting all necessary documents to the IRB and making all appropriate modifications as required by the IRB.
p.000002:
p.000002: 4. Notifying EPA and the HSRRO (and HSO where applicable) of IRB suspension or termination of the research, of
p.000002: Unanticipated Problems Involving Risk to Subjects or Others (UPIRSO) that the IRB deems reportable, and any event that
p.000002: is significant enough to result in the removal of a subject from the study. In addition,
p.000002:
p.000002:
p.000002:
p.000003: 3
p.000003:
p.000003: for grantees of EPA, the PI must notify his/her Project Officer (described below) promptly, according to the terms
p.000003: specified by the IRB of record for the project.
p.000003:
p.000003: B. Human Subjects Research Review Official (HSRRO). The HSRRO is responsible for reviewing all EPA conducted or
p.000003: supported research studies involving human subjects. The HSRRO determines compliance with this Order and reviews all
p.000003: EPA conducted or supported research studies involving human subjects covered by 40 CFR Part 26. The outcome of HSRRO
p.000003: review will be in writing. Ordinarily, the HSRRO’s decision is expected in 30 days or fewer.
p.000003:
p.000003: 1. The HSRRO may withhold approval of any proposal if it does not adequately protect the rights and welfare of human
p.000003: subjects. The HSRRO will provide a written explanation to the requestor for such withholding. Such letter will contain
p.000003: an explanation of the applicable appeal rights. The Principal Investigator (PI) may revise the proposal to address the
p.000003: concerns of the HSRRO and resubmit the proposal. The decision to withhold approval may be appealed as set out below.
p.000003:
p.000003: 2. Studies that have been suspended or terminated by an IRB are automatically suspended or terminated by the EPA.
p.000003: a.The HSRRO also has the authority to suspend or terminate any study (i) if it is found to be in material noncompliance
p.000003: with the assurance or with the IRB approved methods and procedures; (ii) if the assurance is withdrawn by the approving
p.000003: organization; (iii) if there is good reason to believe that the rights and welfare of the human research subjects are
p.000003: not being adequately protected; or (iv) if there has been unexpected serious harm to one or more human subjects.
p.000003:
p.000003: b. If a non-EPA institution is involved, the HSRRO informs the Human Subjects Officer and/or the Project Officer (or
p.000003: equivalent) in writing of the reason for the suspension or termination. If the study has been suspended, the suspension
p.000003: shall remain in effect until the deficiencies have been corrected and the HSRRO has approved resumption of work.
p.000003: Decisions to suspend or terminate a study may be appealed as set out in subsection 6.E. below. Studies affected by a
p.000003: suspension or termination shall remain in suspended or terminated status pending conclusion of the appeal.
p.000003:
p.000003: 3. The HSRRO may establish and maintain an appropriate group or groups to advise and assist him/her in carrying out
p.000003: these responsibilities.
p.000003:
p.000003:
p.000003:
p.000003:
p.000003:
p.000004: 4
p.000004:
p.000004: C. Human Subjects Officer (HSO)
p.000004: 1. Some laboratories/centers/offices/regions have a Human Subjects Officer (HSO). Generally, the HSO should serve as
p.000004: a liaison for the HSRRO, laboratory/center/office/regional senior management, Project Officers, and researchers
p.000004: regarding human subjects research.
p.000004:
p.000004: 2. The HSO may provide advice, recommendations, and information to the HSRRO and laboratory/center/office/region
p.000004: senior management on human subjects research related issues within the laboratory/center/office/region. The HSO may
p.000004: also help to ensure that researchers meet regulatory requirements by facilitating and coordinating researcher and staff
p.000004: education and training in HSR.
p.000004:
p.000004: 3. The HSO may also assist researchers and Project Officers regarding the preparation and review of research projects
p.000004: for oversight by IRBs and the HSRRO. After appropriate training and approval by the HSRRO, the HSO may also make
p.000004: determinations that a project does not constitute human subjects research.
p.000004:
p.000004: D. EPA Program Office, Regional Office, Project Officer
p.000004: 1. The EPA program or regional office that conducts or supports research covered by this Order is responsible for
p.000004: compliance with it. In the first instance the office will decide whether the project involves “research” and “human
p.000004: subjects” as per
p.000004: 3.A. and 3.B. above and hence is subject to this Order. While the HSO is authorized to make the determination of what
p.000004: constitutes human subjects research once he or she is approved by the HSRRO, a courtesy consultation with the HSRRO is
p.000004: available upon request. Each research project will have a Project Officer from or reporting to the responsible office.
p.000004:
p.000004: 2. The program or regional office supporting extramural research involving human research subjects is responsible for
p.000004: notifying the EPA Award Official/Contracting Officer that human subjects are involved.
p.000004:
p.000004: 3. The Project Officer is responsible, inter alia, for monitoring the conduct of the study for compliance with the
p.000004: agreed upon procedures and methods for the protection of the rights and welfare of human subjects. Such monitoring may
p.000004: involve various management techniques such as site visits, review of documentation and communication with the
p.000004: researchers. Should the Project Officer discover material noncompliance with the assurance or with the IRB approved
p.000004: methods and procedures, the Project Officer shall notify his/her management, the Award Official/Contracting Officer
p.000004: (when applicable) and the HSRRO at once.
p.000004:
p.000005: 5
p.000005:
p.000005: E. EPA Award Official/Contracting Officer
p.000005: 1. The EPA Award Official/Contracting Officer is responsible for including with the contract, grant, cooperative
p.000005: agreement, CRADA or other formal agreement, except interagency agreements, a programmatic or administrative term or
p.000005: condition requiring compliance with EPA’s regulations, policies and procedures for the protection of human research
p.000005: subjects as described or referenced in this Order. For interagency agreements, he/she is responsible for including a
p.000005: clause or special condition requiring protection of human research subjects as per their own version of the Common
p.000005: Rule. Should the department or agency not be a signatory to the Common Rule, the clause or special condition will
p.000005: require compliance with EPA’s regulations, policies, and procedures as described or referenced in this Order.
p.000005:
p.000005: 2. The Award Official/Contracting Officer will immediately notify the institution in writing when a study is
p.000005: terminated or suspended and include in such notification a statement of the basis for the termination or suspension.
p.000005:
p.000005: F. The Administrator
p.000005: 1. If an institution or individual wishes to appeal the withholding of approval for a new study or activity in a
p.000005: study (paragraph 6.B.(1)), the suspension of a study because of deficiencies (paragraph 6.B. (2)) or the termination of
p.000005: a study because of deficiencies (paragraph 6.B.(2)), the institution may do so by delivering a written appeal within
p.000005: thirty (30) days of the date of receipt of notification of the action to the Administrator or his/her designee, U.S.
p.000005: Environmental Protection Agency, Washington, DC 20460. The appeal shall set forth in detail the decision being appealed
p.000005: and the basis of the appeal and may include supporting materials.
p.000005:
p.000005: 2. The Administrator or his/her designee will respond in writing within thirty (30) days of receipt of the appeal,
p.000005: which time can be extended for good cause by the Administrator or his/her designee.
p.000005:
p.000005: 7. Saving Provision
p.000005: Any and all modifications to 40 CFR Part 26 will automatically become part of this Order on the effective date of such
p.000005: modifications.
p.000005:
p.000005: 8. Supersession
p.000005: This Order supersedes EPA Order 1000.17 A1 Policy and Procedures on Protection of Human Research Subjects in EPA
p.000005: Conducted or Supported Research, approved May 27, 2011 and amended on July 27, 2011.
p.000005:
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p.000006:
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p.000006:
p.000006:
p.000006: What Did You Think?
p.000006:
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Social / Student
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p.000001:
p.000001:
p.000001:
p.000001:
p.000001:
p.000001: Classification No.: 1000.17A Approval Date: 06/15/2016
p.000001:
p.000001: Policy and Procedures on Protection of Human Subjects in EPA Conducted or Supported Research
p.000001:
p.000001: 1. Purpose
p.000001: The purpose of this document is to establish Environmental Protection Agency (EPA) procedures and responsibilities for
p.000001: implementing the requirements set forth in Title 40 Code of Federal Regulations (CFR) Part 26.
p.000001: This Order supersedes EPA Order 1000.17 A1 Policy and Procedures on Protection of Human Research Subjects in EPA
p.000001: Conducted or Supported Research, approved May 27, 2011 and amended on July 27, 2011.
p.000001:
p.000001: 2. Applicability
p.000001: This Order applies to all research involving human subjects conducted or supported by EPA and covered by 40 CFR Part
p.000001: 26. It also addresses the oversight process for research involving human subjects that is exempt from 40 CFR Part 26.
p.000001: Furthermore all other EPA policies and other official EPA actions involving EPA conducted or supported research with
p.000001: human subjects shall cross-reference or include this Order.
p.000001:
p.000001:
p.000001: 3. Definitions
p.000001: A. Research. Research means a systematic investigation, including research, development, testing, and evaluation
p.000001: designed to develop or contribute to generalizable knowledge. Note that some demonstration and service programs may
p.000001: include research activities. [40 CFR 26.102(d)].
p.000001: B. Human subject means a living individual about whom an investigator (whether professional or student) conducting
p.000001: research obtains (1) data through intervention or interaction with the individual or (2) identifiable private
p.000001: information. [40 CFR 26.102 (f)]
p.000001: C. Exempt research. Research studies that may be found to be exempt are identified in 40 CFR 26.101(b). An example of
p.000001: such exempt research is that involving the analysis of existing research materials if they are publicly available or
p.000001: recorded in a manner such that the subjects cannot be identified.
p.000001:
p.000001: 1
p.000001:
p.000001: D. Intentional exposure research. Research involving intentional exposure of a human subject means a study of a
p.000001: substance in which the exposure to the substance experienced by a human subject participating in the study would not
p.000001: have occurred but for the human subject’s participation in the study. [40 CFR 26.202(a)]
p.000001: E. Observational research. Observational research means any human research that does not meet the definition of
p.000001: research involving intentional exposure of a human subject in 40 CFR 26.202(a). [40 CFR 26.302]
p.000001: F. Observational Human Exposure Studies. As defined in Scientific and Ethical Approaches for Observational Exposure
p.000001: Studies (SEAOES), observational human exposure studies are studies that involve the collection of environmental
p.000001: samples, data, and information from study participants in their everyday environments as they go about their normal
p.000001: activities. They involve neither the deliberate exposure of participants nor the control of environmental conditions in
p.000001: a way that impacts the participants’ naturally occurring exposures (SEAOES, pp. 7-8).
p.000001:
p.000001:
p.000001: 4. Policy
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Social / education
Searching for indicator education:
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p.000003:
p.000003: b. If a non-EPA institution is involved, the HSRRO informs the Human Subjects Officer and/or the Project Officer (or
p.000003: equivalent) in writing of the reason for the suspension or termination. If the study has been suspended, the suspension
p.000003: shall remain in effect until the deficiencies have been corrected and the HSRRO has approved resumption of work.
p.000003: Decisions to suspend or terminate a study may be appealed as set out in subsection 6.E. below. Studies affected by a
p.000003: suspension or termination shall remain in suspended or terminated status pending conclusion of the appeal.
p.000003:
p.000003: 3. The HSRRO may establish and maintain an appropriate group or groups to advise and assist him/her in carrying out
p.000003: these responsibilities.
p.000003:
p.000003:
p.000003:
p.000003:
p.000003:
p.000004: 4
p.000004:
p.000004: C. Human Subjects Officer (HSO)
p.000004: 1. Some laboratories/centers/offices/regions have a Human Subjects Officer (HSO). Generally, the HSO should serve as
p.000004: a liaison for the HSRRO, laboratory/center/office/regional senior management, Project Officers, and researchers
p.000004: regarding human subjects research.
p.000004:
p.000004: 2. The HSO may provide advice, recommendations, and information to the HSRRO and laboratory/center/office/region
p.000004: senior management on human subjects research related issues within the laboratory/center/office/region. The HSO may
p.000004: also help to ensure that researchers meet regulatory requirements by facilitating and coordinating researcher and staff
p.000004: education and training in HSR.
p.000004:
p.000004: 3. The HSO may also assist researchers and Project Officers regarding the preparation and review of research projects
p.000004: for oversight by IRBs and the HSRRO. After appropriate training and approval by the HSRRO, the HSO may also make
p.000004: determinations that a project does not constitute human subjects research.
p.000004:
p.000004: D. EPA Program Office, Regional Office, Project Officer
p.000004: 1. The EPA program or regional office that conducts or supports research covered by this Order is responsible for
p.000004: compliance with it. In the first instance the office will decide whether the project involves “research” and “human
p.000004: subjects” as per
p.000004: 3.A. and 3.B. above and hence is subject to this Order. While the HSO is authorized to make the determination of what
p.000004: constitutes human subjects research once he or she is approved by the HSRRO, a courtesy consultation with the HSRRO is
p.000004: available upon request. Each research project will have a Project Officer from or reporting to the responsible office.
p.000004:
p.000004: 2. The program or regional office supporting extramural research involving human research subjects is responsible for
p.000004: notifying the EPA Award Official/Contracting Officer that human subjects are involved.
p.000004:
p.000004: 3. The Project Officer is responsible, inter alia, for monitoring the conduct of the study for compliance with the
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Social / employees
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p.000001: a way that impacts the participants’ naturally occurring exposures (SEAOES, pp. 7-8).
p.000001:
p.000001:
p.000001: 4. Policy
p.000001: In dealing with human subjects research it is EPA policy that:
p.000001: A. All research shall comply with 40 CFR Part 26 and with this Order.
p.000001: B. All human observational exposure studies conducted or supported by EPA will adhere to the principles set forth in
p.000001: SEAOES.
p.000001: C. All human subjects research conducted or supported by EPA must either be approved or be acknowledged as exempt
p.000001: research by the EPA Human Subjects Research Review Official (HSRRO) before any work involving human subjects research
p.000001: can begin. Approval will be given only to research that complies with subsections 4.A. and B. above. Preliminary review
p.000001: by the HSRRO can be requested for any research project, contract, grant application, cooperative agreement, cooperative
p.000001: research and development agreement (CRADA), interagency agreement or any formal agreement involving EPA support of such
p.000001: studies. However, preliminary review is not required for any project, and if provided does not substitute for approval
p.000001: following IRB review.
p.000001: D. In laboratories/centers/offices/regions where there is a HSRRO-approved Human Subjects Officer (HSO), projects must
p.000001: first be reviewed by the on-site HSO before projects are presented to the HSRRO. In absence of an HSO, projects must be
p.000001: submitted directly to the HSRRO.
p.000001: E. Any solicitation issued by an EPA office or department for research involving human subjects shall require
p.000001: compliance with this order and 40 CFR Part 26.
p.000001: F. This policy extends to all EPA employees, regardless of the location of the employee or the human subjects
p.000001: research activity. This policy, however, does not affect any foreign laws or regulations which may otherwise be
p.000001: applicable and which provide additional protections to human subjects of research (40 CFR 26.101 (g)). Procedures
p.000001: followed in
p.000001:
p.000002: 2
p.000002:
p.000002: foreign countries to protect human research subjects may differ from those set forth in 40 CFR Part 26. See section 40
p.000002: CFR 26.101(h) for information about research involving human subjects that is performed in foreign countries.
p.000002:
p.000002: 5. Requirements
p.000002: Research involving human subjects provides important medical and scientific benefits to individuals and to society. The
p.000002: need for this research does not, however, outweigh the need to protect individual rights and interests.
p.000002: To obtain approval or a concurrence of exemption by the HSRRO, researchers must submit the IRB-approved research
p.000002: package or documentation of exemption, including evidence of IRB approval and any correspondence between the IRB and
p.000002: the researchers.
p.000002: Researchers must also provide evidence of a Federalwide Assurance (FWA) on file with the U.S. Department of Health and
p.000002: Human Services (HHS) or other agency that their institution or organization will comply with regulatory provisions in
p.000002: the Common Rule (codified by EPA at 40 CFR 26, Part A). In special circumstances where there is no such assurance, EPA
p.000002: will advise the institution or organization on the process for obtaining an assurance from HHS or another source. For
p.000002: EPA investigators, no proof of assurance is required (EPA is covered by FWA #12755).
p.000002:
p.000002: 6. Responsibilities
p.000002: All EPA employees, contractors, grant recipients, and parties to other EPA agreements share the responsibility to
p.000002: protect the rights and welfare of human research subjects.
p.000002: A. Principal Investigator. The Principal Investigator, as the person directly implementing the research, has specific
p.000002: responsibilities related to that research project. These responsibilities include:
p.000002:
p.000002: 1. Complying with this Order, 40 CFR Part 26 and other applicable policies and regulations.
p.000002:
p.000002: 2. Ensuring the rights and welfare of subjects are protected.
p.000002:
p.000002: 3. Submitting all necessary documents to the IRB and making all appropriate modifications as required by the IRB.
p.000002:
p.000002: 4. Notifying EPA and the HSRRO (and HSO where applicable) of IRB suspension or termination of the research, of
p.000002: Unanticipated Problems Involving Risk to Subjects or Others (UPIRSO) that the IRB deems reportable, and any event that
p.000002: is significant enough to result in the removal of a subject from the study. In addition,
p.000002:
p.000002:
p.000002:
p.000003: 3
p.000003:
p.000003: for grantees of EPA, the PI must notify his/her Project Officer (described below) promptly, according to the terms
p.000003: specified by the IRB of record for the project.
p.000003:
p.000003: B. Human Subjects Research Review Official (HSRRO). The HSRRO is responsible for reviewing all EPA conducted or
p.000003: supported research studies involving human subjects. The HSRRO determines compliance with this Order and reviews all
...
General/Other / Relationship to Authority
Searching for indicator authority:
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p.000002: Unanticipated Problems Involving Risk to Subjects or Others (UPIRSO) that the IRB deems reportable, and any event that
p.000002: is significant enough to result in the removal of a subject from the study. In addition,
p.000002:
p.000002:
p.000002:
p.000003: 3
p.000003:
p.000003: for grantees of EPA, the PI must notify his/her Project Officer (described below) promptly, according to the terms
p.000003: specified by the IRB of record for the project.
p.000003:
p.000003: B. Human Subjects Research Review Official (HSRRO). The HSRRO is responsible for reviewing all EPA conducted or
p.000003: supported research studies involving human subjects. The HSRRO determines compliance with this Order and reviews all
p.000003: EPA conducted or supported research studies involving human subjects covered by 40 CFR Part 26. The outcome of HSRRO
p.000003: review will be in writing. Ordinarily, the HSRRO’s decision is expected in 30 days or fewer.
p.000003:
p.000003: 1. The HSRRO may withhold approval of any proposal if it does not adequately protect the rights and welfare of human
p.000003: subjects. The HSRRO will provide a written explanation to the requestor for such withholding. Such letter will contain
p.000003: an explanation of the applicable appeal rights. The Principal Investigator (PI) may revise the proposal to address the
p.000003: concerns of the HSRRO and resubmit the proposal. The decision to withhold approval may be appealed as set out below.
p.000003:
p.000003: 2. Studies that have been suspended or terminated by an IRB are automatically suspended or terminated by the EPA.
p.000003: a.The HSRRO also has the authority to suspend or terminate any study (i) if it is found to be in material noncompliance
p.000003: with the assurance or with the IRB approved methods and procedures; (ii) if the assurance is withdrawn by the approving
p.000003: organization; (iii) if there is good reason to believe that the rights and welfare of the human research subjects are
p.000003: not being adequately protected; or (iv) if there has been unexpected serious harm to one or more human subjects.
p.000003:
p.000003: b. If a non-EPA institution is involved, the HSRRO informs the Human Subjects Officer and/or the Project Officer (or
p.000003: equivalent) in writing of the reason for the suspension or termination. If the study has been suspended, the suspension
p.000003: shall remain in effect until the deficiencies have been corrected and the HSRRO has approved resumption of work.
p.000003: Decisions to suspend or terminate a study may be appealed as set out in subsection 6.E. below. Studies affected by a
p.000003: suspension or termination shall remain in suspended or terminated status pending conclusion of the appeal.
p.000003:
p.000003: 3. The HSRRO may establish and maintain an appropriate group or groups to advise and assist him/her in carrying out
p.000003: these responsibilities.
p.000003:
p.000003:
p.000003:
p.000003:
p.000003:
p.000004: 4
p.000004:
p.000004: C. Human Subjects Officer (HSO)
p.000004: 1. Some laboratories/centers/offices/regions have a Human Subjects Officer (HSO). Generally, the HSO should serve as
...
General/Other / common rule
Searching for indicator commonXrule:
(return to top)
p.000001: E. Any solicitation issued by an EPA office or department for research involving human subjects shall require
p.000001: compliance with this order and 40 CFR Part 26.
p.000001: F. This policy extends to all EPA employees, regardless of the location of the employee or the human subjects
p.000001: research activity. This policy, however, does not affect any foreign laws or regulations which may otherwise be
p.000001: applicable and which provide additional protections to human subjects of research (40 CFR 26.101 (g)). Procedures
p.000001: followed in
p.000001:
p.000002: 2
p.000002:
p.000002: foreign countries to protect human research subjects may differ from those set forth in 40 CFR Part 26. See section 40
p.000002: CFR 26.101(h) for information about research involving human subjects that is performed in foreign countries.
p.000002:
p.000002: 5. Requirements
p.000002: Research involving human subjects provides important medical and scientific benefits to individuals and to society. The
p.000002: need for this research does not, however, outweigh the need to protect individual rights and interests.
p.000002: To obtain approval or a concurrence of exemption by the HSRRO, researchers must submit the IRB-approved research
p.000002: package or documentation of exemption, including evidence of IRB approval and any correspondence between the IRB and
p.000002: the researchers.
p.000002: Researchers must also provide evidence of a Federalwide Assurance (FWA) on file with the U.S. Department of Health and
p.000002: Human Services (HHS) or other agency that their institution or organization will comply with regulatory provisions in
p.000002: the Common Rule (codified by EPA at 40 CFR 26, Part A). In special circumstances where there is no such assurance, EPA
p.000002: will advise the institution or organization on the process for obtaining an assurance from HHS or another source. For
p.000002: EPA investigators, no proof of assurance is required (EPA is covered by FWA #12755).
p.000002:
p.000002: 6. Responsibilities
p.000002: All EPA employees, contractors, grant recipients, and parties to other EPA agreements share the responsibility to
p.000002: protect the rights and welfare of human research subjects.
p.000002: A. Principal Investigator. The Principal Investigator, as the person directly implementing the research, has specific
p.000002: responsibilities related to that research project. These responsibilities include:
p.000002:
p.000002: 1. Complying with this Order, 40 CFR Part 26 and other applicable policies and regulations.
p.000002:
p.000002: 2. Ensuring the rights and welfare of subjects are protected.
p.000002:
p.000002: 3. Submitting all necessary documents to the IRB and making all appropriate modifications as required by the IRB.
p.000002:
p.000002: 4. Notifying EPA and the HSRRO (and HSO where applicable) of IRB suspension or termination of the research, of
p.000002: Unanticipated Problems Involving Risk to Subjects or Others (UPIRSO) that the IRB deems reportable, and any event that
p.000002: is significant enough to result in the removal of a subject from the study. In addition,
p.000002:
p.000002:
p.000002:
p.000003: 3
p.000003:
...
p.000004: agreed upon procedures and methods for the protection of the rights and welfare of human subjects. Such monitoring may
p.000004: involve various management techniques such as site visits, review of documentation and communication with the
p.000004: researchers. Should the Project Officer discover material noncompliance with the assurance or with the IRB approved
p.000004: methods and procedures, the Project Officer shall notify his/her management, the Award Official/Contracting Officer
p.000004: (when applicable) and the HSRRO at once.
p.000004:
p.000005: 5
p.000005:
p.000005: E. EPA Award Official/Contracting Officer
p.000005: 1. The EPA Award Official/Contracting Officer is responsible for including with the contract, grant, cooperative
p.000005: agreement, CRADA or other formal agreement, except interagency agreements, a programmatic or administrative term or
p.000005: condition requiring compliance with EPA’s regulations, policies and procedures for the protection of human research
p.000005: subjects as described or referenced in this Order. For interagency agreements, he/she is responsible for including a
p.000005: clause or special condition requiring protection of human research subjects as per their own version of the Common
p.000005: Rule. Should the department or agency not be a signatory to the Common Rule, the clause or special condition will
p.000005: require compliance with EPA’s regulations, policies, and procedures as described or referenced in this Order.
p.000005:
p.000005: 2. The Award Official/Contracting Officer will immediately notify the institution in writing when a study is
p.000005: terminated or suspended and include in such notification a statement of the basis for the termination or suspension.
p.000005:
p.000005: F. The Administrator
p.000005: 1. If an institution or individual wishes to appeal the withholding of approval for a new study or activity in a
p.000005: study (paragraph 6.B.(1)), the suspension of a study because of deficiencies (paragraph 6.B. (2)) or the termination of
p.000005: a study because of deficiencies (paragraph 6.B.(2)), the institution may do so by delivering a written appeal within
p.000005: thirty (30) days of the date of receipt of notification of the action to the Administrator or his/her designee, U.S.
p.000005: Environmental Protection Agency, Washington, DC 20460. The appeal shall set forth in detail the decision being appealed
p.000005: and the basis of the appeal and may include supporting materials.
p.000005:
p.000005: 2. The Administrator or his/her designee will respond in writing within thirty (30) days of receipt of the appeal,
p.000005: which time can be extended for good cause by the Administrator or his/her designee.
p.000005:
p.000005: 7. Saving Provision
p.000005: Any and all modifications to 40 CFR Part 26 will automatically become part of this Order on the effective date of such
p.000005: modifications.
p.000005:
p.000005: 8. Supersession
p.000005: This Order supersedes EPA Order 1000.17 A1 Policy and Procedures on Protection of Human Research Subjects in EPA
...
Orphaned Trigger Words
p.000005: Environmental Protection Agency, Washington, DC 20460. The appeal shall set forth in detail the decision being appealed
p.000005: and the basis of the appeal and may include supporting materials.
p.000005:
p.000005: 2. The Administrator or his/her designee will respond in writing within thirty (30) days of receipt of the appeal,
p.000005: which time can be extended for good cause by the Administrator or his/her designee.
p.000005:
p.000005: 7. Saving Provision
p.000005: Any and all modifications to 40 CFR Part 26 will automatically become part of this Order on the effective date of such
p.000005: modifications.
p.000005:
p.000005: 8. Supersession
p.000005: This Order supersedes EPA Order 1000.17 A1 Policy and Procedures on Protection of Human Research Subjects in EPA
p.000005: Conducted or Supported Research, approved May 27, 2011 and amended on July 27, 2011.
p.000005:
p.000006: 6
p.000006:
p.000006:
p.000006:
p.000006:
p.000006:
p.000006:
p.000006:
p.000006:
p.000006:
p.000006:
p.000006:
p.000006: What Did You Think?
p.000006:
p.000006:
p.000006: We strive to constantly provide the highest level of value for you. Please take a few minutes to tell us about your
p.000006: experience using this product.
p.000006:
p.000006: To be taken to a short consumer satisfaction survey, please click here or copy and paste the following URL into your
p.000006: browser:
p.000006:
p.000006: https://www.surveymonkey.com/r/OSAconsumerfdbck? product=Policy_Procedures_Protection_Human_Subjects_EPA
p.000006: Conducted_Supported_Research
p.000006:
p.000006: Thank you for your feedback.
p.000006:
p.000006:
p.000006: Sincerely,
p.000006:
p.000006: Office of the Science Advisor
...
Appendix
Indicator List
| Indicator | Vulnerability |
|---|
| authority | Relationship to Authority |
| commonXrule | common rule |
| education | education |
| employees | employees |
| officer | Police Officer |
| student | Student |
| substance | Drug Usage |
Indicator Peers (Indicators in Same Vulnerability)
Trigger Words
harm
protect
protection
risk
welfare
Applicable Type / Vulnerability / Indicator Overlay for this Input