[Name of Institution (note abbreviated name if it is referred to throughout the document)] supports the advancement of scientific knowledge through research. [Name of Institution] is grateful to individuals who choose to participate in such research and is committed to the protection of people who participate in research conducted by its staff or at its facility.
The following human research protection policies are hereby adopted and are immediately effective. This document will be updated and revised as necessary and will be reviewed annually in its entirety. [Name of Institution] will establish all procedures necessary to implement these policies.
I. Policies
A. Ethical Framework for Conducting Human Research
1.
All research involving human volunteers conducted by [Name of Institution] will be conducted ethically and in accordance with pertinent federal regulations and state laws regardless of source of funding.
2.
[Name of Institution] will enact all policies and procedures necessary to carry out its responsibilities and ensure ethical conduct of research.
3.
All research conducted by [Name of Institution] will be guided by the ethical principles for human research articulated in The Belmont Report: Ethical Principles and Guidelines for the Protection of Human Subjects of Research of the National
Commission for the Protection of Human Subjects of Biomedical and Behavioral
Research (The Belmont Report).
4.
All non-exempt human research conducted by [Name of Institution] will receive IRB approval before being initiated. [Name of Institution] will adhere to and comply with federal human research regulations at Code of Federal Regulations Title 45, Part 46
(45 CFR 46) as appropriate and applicable, and with all policies, procedures and requirements of the cognizant IRB.
5.
Where appropriate, [Name of Institution] will require adequate additional protections for fetuses, pregnant women, prisoners and children, per Subparts B, C and D of 45
CFR 46. [Name of Institution] will comply with additional protections required by the reviewing IRB.
Where appropriate, [Name of Institution] will require adequate additional protections for other classes of special populations, including but not limited to, decisionally impaired
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individuals, HIV-positive individuals, non-English-speaking individuals, or employees and students of [Name of Institution] who may participate as research subjects, in accordance with the criteria found at 45 CFR 46.111 and the federal guidelines for involvement of such individuals in research, and as required by the reviewing IRB. (
B. Operation of the Human Subject Protection Program
1.
[Name of Institution]
’s Signatory Official (SO) will have ultimate responsibility for ensuring ethical conduct of research involving humans.
2.
This SO will ensure the appointment of a Human Protections Administrator (HPA) to oversee the administration and daily operations of human subject protection matters including the implementation of these policies. The HPA should have demonstrated experience in human research protections, federal regulations and, when possible, research with humans. The HPA shall report to the SO for matters related to the protection of humans in research.
C. Authority of IRB(s)
1.
All human research conducted by [Name of Institution] will be in accordance with the decisions of the IRB(s) that review [Name of Institution]
’s research as well as that
IRB’s policies and procedures.
2.
The designated IRB(s) that review [Name of Institution]
’s research have the authority to 1) approve, 2) require modifications to secure approval, 3) disapprove, and 4) terminate or suspend all such research. All IRB decisions will be accepted as binding on [Name of Institution] and no human research will take place without documented
IRB approval.
3.
In addition, the designated IRB(s) have the authority to 1) require research progress reports, 2) audit and/or monitor the research, and 3) report suspensions, terminations and non-compliance to IRB officials, [Name of Institution] , and the federal government.
D. Training and Education
1.
All researchers and pertinent staff (including the HPA and SO) must receive initial and ongoing education in the general concepts of ethical conduct of research and the protections of humans in research. As appropriate to the organization, all researchers and pertinent staff must complete HIPAA training as it relates to the conduct of research.
2.
Only those researchers and study personnel who have completed all necessary training and who are qualified to perform the specific research interventions identified in the protocol may participate in the conduct of human research.
E. Research Compliance and Oversight
1.
[Name of Institution] will maintain and manage an oversight system to ensure that research by its staff or within its facility complies with the terms of the approved
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protocol, federal regulations and state law, IRB decisions and IRB policies and procedures.
2.
[Name of Institution] will conduct procedural and record keeping audits for the purpose of detecting, correcting and reporting (as required) administrative and/or material breaches in protecting the rights and welfare of humans in research.
A climate free of fear of sanction is required to foster appropriate reports and ensure a fair review of allegations of misconduct or noncompliance. Therefore, the identity of any individual who reports an incident of noncompliance will remain confidential and be protected from retaliation. Retaliation against good faith "whistle blowers" will not be tolerated at [Name of Institution]
F. Informed Consent
Informed consent will be obtained from all individuals enrolled in research. No investigator or staff person may enroll an individual into a research protocol without having obtained the informed consent of the subject or his/her legally authorized representative using an IRB-approved consent document. The only exception to this policy is for studies in which the cognizant IRB has waived the requirement for investigators to obtain signed consent or waived the informed consent process pursuant to federal regulations.
G. Adverse Events/Unanticipated Problems
All adverse events, both anticipated and unanticipated, and all unanticipated problems involving risk to research participants or others must be reported to the HPA. Adverse events and unanticipated problems should be reported to the cognizant IRB pursuant to that IRB’s policies and procedures.
H. Confidentiality of Persons Participating in Research
[Name of Institution] will ensure that information related to an individual’s participation in research is protected and maintained in a confidential manner. No such information will be released beyond the scope of the research staff, the IRB, sponsor, persons with financial oversight of research including billings and payments or the appropriate
Institutional officials without the individual’s permission, unless otherwise required by law or in response to emergent situations which require such disclosure to minimize harm to the research participant or others.
In some studies, information about the participant may remain confidential and not be disclosed even to the participant or may be disclosed to the participant only after some period of time. In such studies, the consent form will explain the confidentiality requirements to the research participant.
I. Document Retention
1.
[Name of Institution] requires investigators who conduct research at [Name of
Institution] to ensure that all research-related documents are maintained for the duration of the research study and after the study has been terminated as required by
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the applicable grant, contract, or local, state, or federal law or federal regulation. Such documents include, but are not limited to, copies of individual research protocols,
IRB decisions and correspondences, annual reports. All protocol and IRB-related records must be available for inspection in accordance with federal regulations.
HIPAA-related documentation such as HIPAA authorizations, waiver of authorization, accounting for disclosure logs, must be maintained for six years from the completion of the study.
2.
[Name of Institution] ensures that all investigators will be given ready access to: a.
[Name of Institution]
’s FederalWide Assurance (FWA) b.
The IRB Authorization Agreement (IAA) entered into with the cognizant IRB and its parent institution c.
Copies of pertinent federal regulations and state laws d.
The Belmont Report e.
Other pertinent federal policies and guidelines related to the involvement of humans in research f.
IRB forms and guidelines
J. Disclosure and Management of Personal Interests in Research
[All Research Affiliate applicants must include a Disclosure of Interest policy statement specific to the Institution. You may choose to adopt the following template policy, or you can create your own.]
Policy:
[Name of Institution] takes steps to identify actual or potential sources of conflict of interest in human research and either eliminate, reduce or manage such conflict.
Researchers and study persons who are engaged in human research are required to carry out their responsibilities in a manner that avoids or minimizes any real or potential interest that may adversely affect the protection of research participants, the credibility of the research or the community’s trust in the institution.
Who Must Disclose:
Principal investigators and individuals who are responsible for the design, conduct or reporting of research must make known any financial interest or non-financial relationship or interest regarding any specific research project to the Principal
Investigator and fully disclose the interest or relationship to the IRB and [Name of
Institution].
Reporting and Review of Disclosures:
[Two options for review are given below. Choose the one that applies to your institution.]
[Name of Institution] will review all disclosures of interest and determine whether management of the interest is required. Management may include disallowing participation in the research. Management decisions regarding constraints on the
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activities of
[Name of Institution]’s
employees will be conveyed to the IRB reviewing the research protocol. Where
[Name of Institution]’s management plan and the IRB management plan are not in agreement, the plan that provides the most stringent protection to human research participants will be the one implemented.
Or
[Name of Institution] will defer review of disclosures of interest to the IRB reviewing the research. [Name of Institution] will abide by the determinations of the IRB.
Research with Other Institutions:
[Name of Institution] acknowledges that language above notwithstanding, research team members of [Name of Institution] may need to abide by the disclosure of interest policies and procedures of the partner research institution.
II. Practices
A. Training
1.
The core curriculum of human subject protection training for all researchers and pertinent staff includes: a.
The terms and conditions of [Name of Institution] ’s FederalWide Assurance
(FWA) as appropriate for federally funded research b.
The terms and conditions of the IRB Authorization Agreement (IAA) [Name of
Institution] entered into with the cognizant IRB and its parent institution. c.
The Belmont Report d.
Federal regulations found at 45 CFR 46 and all its Subparts e.
Cognizant IRB’s policies and procedures f.
The HIPAA Privacy Rule, if appropriate g.
Other applicable state law and federal regulations
1.
All researchers and pertinent staff may complete the National Institutes of Health
(NIH) on-line tutorial on human research protections to meet training requirements
(found at http://phrp.nihtraining.com/users/login.php
). Copies of the training certifications for [Name of Institution] personnel will be submitted to the IRB with the research protocol application.
2.
The HPA and SO will complete the Office of Human Research Protections (OHRP)
Assurance Training Modules (found at http://ohrped.od.nih.gov/CBTs/Assurance/login.asp
).
3.
When possible, the SO and HPA will attend human research protections training initiatives offered by appropriate sponsors.
4.
Completion of all training requirements will be documented and recorded for each individual and will include a) individual’s name, b) date, c) topic, and d) instructor
(source). Copies of all such documents are kept on file [state where, e.g., personnel
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files, research files are submitted to the reviewing IRB as required, and available for review by cognizant IRB personnel when necessary.
B. Research Review/Conduct of Research
1.
All research protocols involving the direct or indirect interaction or interventions with humans must obtain IRB approval before the research project may be initiated.
2.
The Principal Investigator (PI) is responsible for ensuring continuing approval of research protocols at the time intervals deemed appropriate by the IRB. The PI must inform the HPA should the protocol approval expire. Such notification must be made no later than 5 days after the protocol’s approval expiration date or 5 days after the discovery that the protocol’s approval has expired.
3.
All changes to approved research protocols must be submitted to the designated IRB for review and approval before being initiated, except when such changes are necessary to eliminate immediate hazards to research participants. In such cases, when modification or deviation of the approved protocol is necessary, it will be reported to the IRB per IRB policy and to
[Name of Institution]’s
HPA within 48 hours of occurrence.
C. Data and Safety Monitoring and Adverse Events
1.
All research protocols must contain a Data and Safety Monitoring Plan (DSMP) commensurate with the degree of risk involved, the size and complexity of the study, and should be appropriate to the study population and research environment. The plan must include provisions for data review and performance of safety reviews, at a specified frequency appropriate for the level of risk undertaken by research participants. The plan must also include provisions for reporting unanticipated problems and adverse events as required by IRB policy and to the [Name of
Institution]’s HPA and external organizations as appropriate.
2.
Adverse event reporting must be conducted in accordance with the DSMP as specified in each individual protocol. Reporting is required irrespective of whether the study is ongoing or completed.
3.
In addition to adverse event reporting specified in the protocol’s DSMP, adverse events must be reported as follows: a. Both anticipated and unanticipated serious adverse events must be reported to
[Name of Institution] ’s HPA and SO within [identify the timeframe in which the
Institution requires internal reporting] of the occurrence becoming known to the
Principal Investigator. b.
Adverse events that are (a) serious AND unanticipated AND possibly, probably or definitely related to the research and adverse events that are (b) anticipated but occurring with a greater frequency than expected, must be
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reported to the designated IRB in the timeframe specified by IRB policy and to the
[Name of Institution]’s
HPA within [identify the timeframe in which the
Institution requires internal reporting] of the occurrence becoming known to the
Principal Investigator. All such reports must be made using the appropriate IRB form provided for that purpose. c. Whenever a serious adverse event form is submitted to an IRB, the reporting individual shall maintain in the protocol file at [Name of Institution] a copy of all correspondence between the principal investigator and the IRB relating to the serious or unanticipated adverse event. All documents received by the [Name of
Institution] must be date stamped indicating receipt. Correspondence and documentation associated with serious or unanticipated adverse events will also be maintained in a [Name of Institution] adverse event file. Documentation regarding reporting of serious adverse events must include evidence of review by the cognizant IRB. The [Name of Institution] file will be made available, upon request, to authorized IRB personnel or other persons as authorized in the protocol. d. All adverse events must be retained by the principal investigator and reported to the research sponsor as required. A summary of all events may be required when requesting continuing review of a protocol by an IRB.
D. Unanticipated Problems Involving Risks to Participants or Others
1. Unanticipated problems or events involving risks to participants or others are those problems, risks or events that occur during the conduct of the research, but were not expected and therefore were not cited in the written protocol or consent form(s) reviewed by the IRB.
2. The following unanticipated problems must be reported to the designated IRB in the timeframe specified by IRB policy and to the
[Institution’s]
SO/HPA within [identify the timeframe in which the Institution requires internal reporting] of the event becoming known to the principal investigator: a. Problems or events that are unexpected (in terms of nature, severity, or frequency) given the research procedures and protections described in the protocol and the characteristics of the participant population; b. Problems or events that suggest that research participation places the participant(s) or others at greater risk or harm (including physical, psychological, economic, or social harm) than was previously known or recognized; and c. Problems or events that are related or possibly related to the participant’s involvement in the research.
3. Reporting of unanticipated problems is required irrespective of whether or not the study is on-going or completed. An example is the theft of a laptop used to
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store identifiable data collected from research participants even after the participants had concluded all research interventions.
4. Whenever an unanticipated problem/event report is submitted to an IRB, the reporting individual shall maintain in the protocol file at [Institution] a copy of all correspondence between the principal investigator and the IRB relating to the unanticipated problem/event. All documents received by or retained at
[Institution] must be date stamped indicating receipt. Correspondence and documentation associated with unanticipated problems/events will also be maintained in a [Institution] unanticipated problem/event file. Documentation regarding the reporting of unanticipated problems/events must include evidence of review by the cognizant IRB. The [Institution] file will be made available, upon request, to authorized IRB personnel or other persons as authorized in the protocol.
5. All reported unanticipated events must be retained by the principal investigator and reported to the research sponsor as required. A summary of all reported events may be required by the IRB when requesting continuing review of a protocol.
E. Research Compliance and Oversight/Noncompliance
1.
Noncompliance means conducting research involving humans in a manner that is inconsistent with the protocol as approved by an IRB or otherwise disregards or violates regulations governing such research. This can include, but is not limited to, failure to obtain IRB approval for research involving humans, inadequate or nonexistent procedures for informed consent, inadequate supervision in research involving novel interventions or procedures, failure to follow recommendations made by the IRB or to ensure the safety of subjects and failure to report appropriate adverse events or proposed protocol changes to the IRB and to the HPA at [Name of
Institution] .
Definitions:
Any action or activity associated with the conduct or oversight of research involving human participants that fails to comply with either the research plan as approved by a designated IRB, or federal regulations or institutional policies governing human subject research. Noncompliance may range from minor to serious, be unintentional or willful, and may occur once or several times. Noncompliance includes failure to have protocols reviewed by the IRB as required, protocol deviations in protocols approved by the IRB, including deviations made in the interest of a single participant such as changing a participant’s scheduled study visits. Noncompliance may result from the action of the investigator, research personnel, or a participant, and may or may not impact the rights and welfare of research participants or others or the integrity of the study. Complaints or reports of noncompliance from someone other than the Principal Investigator or study
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team personnel are handled as allegations of noncompliance until such time that the report is validated or found to be invalidated or dismissed.
Minor Noncompliance: Any behavior, action or omission in the conduct or oversight of research involving human participants that deviates from the approved research plan, federal regulations or institutional policies but, because of its nature, the research project, or subject population, does or did not : a.
harm or pose an increased risk of substantive harm to a research participant; b.
result in a detrimental change to a participant’s clinical or emotional condition or status; c.
have a substantive effect on the value of the data collected; and d.
result from willful or knowing misconduct on the part of the investigator(s) or study staff.
Examples of minor noncompliance may include, but are not limited to, the following:
•
Changing study personnel without notifying the IRB;
•
Shortening the duration between planned study visits;
• Implementing minor wording changes in study questionnaires without first obtaining IRB approval;
• Routine lab missed at scheduled visit and re-drawn later.
Serious Noncompliance: Any behavior, action or omission in the conduct or oversight of human research that, in the judgment of a convened IRB, has been determined to:
1.
adversely affect the rights and welfare of participants;
2.
harm or pose an increased risk of substantive harm to a research participant;
3.
result in a detrimental change to a participant’s clinical or emotional condition or status;
4.
compromise the integrity or validity of the research; or
5.
result from willful or knowing misconduct on the part of the investigator(s) or study staff.
Examples of serious noncompliance may include, but are not limited to, the following:
•
Conducting non-exempt research that requires direct interaction or interventions with human participants without first obtaining IRB approval;
•
Enrolling participants who fail to meet the inclusion or exclusion criteria in a protocol that involves greater than minimal risk and that in the opinion of the IRB Chair, designee, or convened IRB, places the participant(s) at greater risk;
•
Failing to submit a continuing review application to the IRB before study expiration for an ongoing study;
• Failing to obtain and/or document a participant’s informed consent provided the IRB has not granted a waiver of consent;
•
Failing to retain copies of signed informed consent forms;
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•
Performing a study procedure not approved by the IRB; or failing to perform a required study visit or procedure that, in either case, may affect subject safety or data integrity;
•
Failing to follow the safety monitoring plan;
•
Enrolling study subjects after the IRB-approval of a study has expired; or
• Failing to report serious adverse events and/or unanticipated problems to the IRB in accordance with IRB Policy 710 Reporting Adverse Events and
Unanticipated Problems .
Continuing Noncompliance: A pattern of noncompliance that, in the judgment of a convened IRB:
1.
indicates a lack of understanding or disregard for the regulations or institutional requirements that protect the rights and welfare of participants;
2.
compromises the scientific integrity of a study such that important conclusions can no longer be reached;
3.
suggests a likelihood that noncompliance will continue without intervention; or
4.
involves frequent instances of minor noncompliance, for example, repetitive protocol deviations.
Examples of continuing noncompliance may include, but are not limited to, the following:
•
Repeated failure to respond to requests from the IRB to resolve an episode of noncompliance or a pattern of minor noncompliance, such as repetitive protocol deviations; or
•
Consistently late submissions of continuing review applications or other items that require prompt reporting to the IRB.
2.
[Name of Institution]’s SO or HPA will review all allegations of noncompliance with human research regulations. Any individual or organization may submit a written complaint or allegation of noncompliance to the HPA and/or the IRB. [Name of
Institution] may also initiate a complaint based on information available to [Name of
Institution] (e.g., deficiencies noted in IRB files, media or scholarly reports of research activity subject to committee jurisdiction).
3.
[Name of Institution]
’s HPA and other officials deemed appropriate will review the allegation of noncompliance, the response from the researcher and any other information necessary to conduct its investigation.
4.
Based on its investigation, [Name of Institution] will prepare a report summarizing the information it considered and outlining its conclusions and recommended actions.
The report will be reviewed by the IRB, HPA and SO.
5.
[Name of Institution] is required to report to [Name of Institution]
’s Signatory
Official and the appropriate federal Department or agency any “serious or continuing noncompliance” with the regulations governing the protection of humans in research
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or the requirements or determinations of the IRB Committee. Whenever possible,
[Name of Institution] will coordinate with the IRB before submitting such reports.
6.
When the IRB or [Name of Institution] makes a decision to suspend or terminate approval of research for any reason, the following individuals, in addition to the investigators listed on the protocol and the departments/institutions involved in the research, will be notified, where applicable: a.
The Institutional SO b.
IRB Chair(s) of institutions participating in the research under an Inter-
Institutional Agreement to the FWA c.
Appropriate federal departments or agencies d.
Food and Drug Administration e.
The funding agency
7.
Notice will be given as outlined above within five working days of such suspensions or terminations.
8.
All investigators are required to report to [Name of Institution]
’s
HPA and to the IRB as soon as possible but no later than five (5) calendar days after discovery: a.
Serious or continuing noncompliance with the federal regulations or IRB requirements (e.g., not adhering to the procedures in the approved protocol and/or conducting research activities not listed in the approved protocol), and/or b.
Suspension of termination of IRB approval.
F. Protocol Confidentiality Protections
1.
Adequate provisions must be made for protecting the confidentiality and privacy of the participant’s interactions with research staff and of the information gathered from participants in research. Provisions must be appropriate to the risks associated with study participation. (Note: the Institution should choose those that are most appropriate given their institutional obligations, e.g. HIPAA Privacy and Security
Rules.)
To protect participant confidentiality, appropriate provisions must be made for the storage of research data. The investigator must explain how privacy and confidentiality of information obtained during the recruitment, screening and conduct of the research will be maintained. Measures taken to protect the privacy and confidentiality of the data obtained during a study will be reviewed by the IRB.
2.
Participants should not be promised anonymity unless the research data is fully stripped of identifiers. Anonymity cannot be guaranteed unless there is no method by which the investigator can connect the research results with individual research participants providing the data. If there are codes, a master list or sufficient demographic information that would enable the investigator to identify participants, the research is not anonymous even though the participant names do not appear in the research data. In this case the data would be considered to be confidential.
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III. Special Topics: Policy Statements
[Insert individual policy statements here as appropriate to the nature of the Institution’s research. In addition, all applicants must include in this section a Conflict of Interest policy statement specific to the Institution. You may choose to adopt the template policy provided to you or you can create your own.]
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Signature Page
This Policy Document was adopted by ___________________effective ____________.
By: _____________________
Title:
Date: _____________________
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