Human Research Protections Program - Governing Principles, Policy, and Organizational Structure

SUBJECT:

Human Research Protections Program- Governing Principles, Policy, &
Organizational Structure

 Policy Number:
10.3.1		 Effective Date:
May 21, 2026
  Supersedes:
November 20, 2018
November 20, 2015
October 21, 2011
June 10, 2011
April 9, 2011
March 2007 Revision, Parts I and III, “The Protection of the Rights and Welfare of Human Subjects of Research at FAU”		 Page 1 of 4
  Responsible Authorities:
Vice President for Research
Associate Vice President, Research Integrity
Human Research Protection Program Staff
Institutional Review Board

  1. Background

    The Human Research Protections Program (HRPP) at Florida Atlantic University (FAU) is governed by several guiding principles and laws. Investigators (whether professional or student), research staff, Institutional Review Board members, and HRPP staff are expected to abide by these principles and laws.

    FAU follows the ethical principles described in the “Ethical Principles and Guidelines for the Protection of Human Subjects of Research” also known as “The Belmont Report.” FAU applies its ethical principles to all human subjects research regardless of support or geographic location. Clinical trials should be conducted in accordance with the ethical principles in that have their origin in the Declaration of Helsinki and are consistent with good clinical practice and the applicable regulatory requirements.

  2. Purpose

    This policy establishes FAU’s HRPP and its commitment to protect the rights and welfare of human subjects.

  3. General Statement

    FAU is committed to developing, implementing and maintaining a systematic and comprehensive HRPP with appropriate leadership and monitoring. The Vice President for Research (VPR) have overall responsibility for FAU’s HRPP. The VPR is the designated Institutional Official (IO) who delegates shared responsibility for the HRPP to the Associate Vice President for Research Integrity.

  4. Policy

    It is the policy of FAU that the rights and welfare of human subjects participating in research engaged in by FAU must be adequately protected. This applies to all research meeting the definition of human subjects research (HRP-401, “Definitions”), regardless of funding or mechanism of funding. All human subjects research must be submitted to FAU’s Institutional Review Board (IRB) for review and may not begin until approved or communication from the IRB has been issued determining no further review required, even if it has been approved by other FAU departments or officials.

    For human subjects research conducted, funded, or otherwise subject to regulations by a federal department or agency who is a signatory of the Common Rule, FAU applies the regulations of that agency relevant to the protection of human subjects. For human subjects research as defined by the U.S. Food and Drug Administration (FDA), FAU applies 21 CFR §50 and §56. For clinical trials, FAU commits to apply the “International Conference on Harmonisation – Good Clinical Practice E6” (ICH-GCP).

    For human subjects research conducted, funded, or otherwise subject to regulations by a federal department or agency who is a signatory of the Common Rule, FAU applies the regulations of that agency relevant to the protection of human subjects as detailed below.

    • 10 USC 980, DOD Instruction 3216.02, OPNAVINST 5300.8B, and SECNAVINST 3900.39D to human subjects research conducted or funded by Department of Defense (DOD).
    • DOE Order 443.1A to human subjects research conducted or funded by Department of Energy (DOE).
    • 28 CFR §22 and §512 to human subjects research conducted or funded by Department of Justice (DOJ).
    • 34 CFR §97 Subpart D (equivalent to 45 CFR §46 Subpart D), 34 CFR §98, 34 CFR §99, and 34 CFR §356 to human subjects research conducted or funded by Department of Education (ED).
    • 40 CFR §26 and EPA Order 1000.17 Change A1 to human subjects research conducted or funded by Environmental Protection Agency (EPA) or where the results of the human subjects research are to be submitted to EPA.

    When the laws of a local jurisdiction encompass activities not included in the definition of human subjects research, FAU complies with those laws.

  5. Components and Responsibilities of the HRPP

    1. Institutional Official. The IO is the leader of the HRPP. The IO is authorized to:

    • Allocate HRPP resources
    • Appoint and remove IRB members, IRB chairs, and IRB vice-chairs
    • Bind HRPP policies on FAU
    • Determine what IRBs FAU will rely upon and sign Institutional Authorization Agreements
    • Disapprove human subjects research
    • Assess and evaluate HRPP and personnel needs
    • Limit or condition privileges to conduct human subjects research
    • Prohibit publication of research
    • Require destruction of research samples or data
    • Determine that reported information represents a serious or continuing noncompliance, an unanticipated problem involving risks to subjects or others, may issue a suspension of IRB approval or termination of IRB approval.

    The IO may not reverse a decision of the convened IRB, including disapproval, suspension or termination, or whether reported information represents a serious or continuing noncompliance, an unanticipated problem involving risks to subjects or others.

    1.1 The IO is responsible to:

    • Oversee the HRPP.
    • Ensure the independence of the review process.
    • Ensure that complaints and allegations regarding the HRPP are appropriately handled.
    • Ensure that the HRPP has sufficient resources, including IRBs, appropriate for the volume and types of human subjects research reviewed, so that reviews are accomplished in a thorough and timely manner.
    • Establish a culture of compliance with HRPP requirements.
    • Investigate and correct allegations and findings of undue influence on the human subjects research review process.
    • Investigate and correct systemic problems related to the HRPP.
    • Periodically review HRPP policies and procedures.
    • Periodically review HRPP resources.
    • Review and sign federal assurances (FWA) and addenda.

    2. IRB and HRPP Staff Members. IRB members, IRB chairs, IRB vice-chairs, and HRPP staff members are responsible to:

    • Follow HRPP policies and procedures
    • Undergo initial training and continuing training activities per FAU requirements, including training on specific federal agency requirements when such research is reviewed.
    • IRB members and HRPP staff members ultimately report to the IO for HRPP issues.

    2.1 The IRB has the authority to:

    • Determine whether an activity is human subjects research.
    • Determine whether FAU is engaged in human subjects research.
    • Decide whether financial interests related to the research and the management, if any, allow approval of the human subjects research.
    • Approve, require modifications to secure approval, and disapprove all humans subjects research activities overseen and conducted by FAU.
    • Suspend or terminate approval of human subjects not being conducted in accordance with HRPP requirements or that had been associated with unexpected serious harm to participants.
    • Observe, or have a third party observe, the consent process and the conduct of the human subjects research.

    FAU may rely upon the IRB of another organization provided an Institutional Authorization Agreement approved by the IO is in place.

    3. Faculty, Students, and Staff. All FAU faculty, students, and staff engaged in human subjects research are responsible to:

    • Be aware of this policy and follow obligations as outlined in HRP-400, “Principal Investigator Obligations”.
    • Be aware of the definition of human subjects research (HRP-401, “Definitions”).
    • Consult the IRB when there is uncertainty about whether an activity is human subjects research per Policy 10.3.2. “Human Subjects Research (HSR) Determinations.”
    • Not conduct human subjects research without IRB approval.
    • Report allegations of undue influence related to the IO or HRPP.
    • Report allegations of noncompliance or findings of noncompliance with human subjects research to the IO or HRPP per Policy 10.3.5 “Reporting Problems with Research.”

    4. Office of General Counsel (OGC). OGC works with the IO on HRPP issues and is responsible to:

    • Provide legal advice related to the HRPP to the IO, IRB, and investigators.
    • Identify relevant state and international laws.
    • Resolve conflicts among applicable laws.

    5. Office of Sponsored Programs (OSP). OSP works with the IO and HRPP Staff on HRPP issues. OSP is responsible to review funded research awards and contracts for compliance with HRPP requirements.

  6. Procedures

    FAU makes written materials describing the HRPP available to all individuals conducting human subjects research through its website. When written materials or procedures are changed, the HRPP staff, through the Research Integrity Office communicates to affected individuals through one or more of the following actions:

    • Email communications
    • Website postings
    • Newsletters
    • Direct outreach at organizational meetings
    • Training
    • Mentoring

  7. Policy Renewal

    As needed

  8. References

    The Belmont Report
    10 USC 980, DOD Instruction 3216.02

    International Conference on Harmonisation- E6
    21 CFR Parts 50 and 56
    28 CFR Part 22 and 512
    32 CFR Part 219
    34 CFR Part 97
    40 CFR Part 26
    45 CFR Part 46

POLICY APPROVAL

Initiating Authority

Gregg B. Fields, Ph.D., Vice President for Research
5/26/2026

Executed signature pages are available in the Initiating Authority Office(s)