Research Involving Human Subjects (I.C.1)

Volume ­­I: Academic and Research Affairs
Chapter C: Safety
Responsible Executive: Executive Vice President for Research and Partnerships
Responsible Office: Human Research Protection Program
Date Issued: May 1, 2021
Date Last Revised: N/A

TABLE OF CONTENTS

Contacts
Statement of Policy
Reason for This Policy
Individuals and Entities Affected by This Policy
Exclusions
Responsibilities
Definitions (defined terms are capitalized throughout the document)
Related Documents, Forms and Tools
Website Address for This Policy
History and Updates
Appendix

CONTACTS

STATEMENT OF POLICY

All Research involving Human Subjects conducted at or by Purdue University must be guided by the highest ethical standards and adhere to applicable federal, state, and local laws and regulations. The overarching ethical principles of respect for persons, beneficence and justice, as articulated in the Belmont Report and codified in the Common Rule (45 CFR part 46), must be upheld at all times during the design and conduct of Research involving Human Subjects.

Purdue University’s Human Research Protection Program (HRPP) implements measures to cultivate Purdue’s commitment to protect human participants in Research. The HRPP establishes the review processes and educational training requirements for individuals conducting Human Subjects Research under the auspices of the University. The HRPP maintains standard operating procedures (SOPs) that detail the processes researchers must follow regarding various aspects of Human Subjects Research, including, but not limited to, documentation and records management, informed consent, project monitoring, reporting of unanticipated or adverse events, and additional considerations when dealing with certain potentially vulnerable populations.

A core component of the HRPP is the Institutional Review Board (IRB), charged with the review of proposed Human Subjects Research that is not otherwise excluded or exempted under regulation. The IRB functions independently of, but in coordination with, other institutional committees and offices appropriate for expert consultation and guidance on issues related to the protection of Human Subjects involved in Research. Individuals directly involved in the business development functions of the University may not serve as members of the IRB and do not carry out the operations of the review processes.

For Research activities overseen and conducted by Purdue University, the IRB has the authority to:

• Approve, require modifications to secure approval, or disapprove Human Subjects Research activities.
• Conduct review, observe, or require monitoring of any activity believed or confirmed to involve Human Subjects Research.
• Suspend or terminate the approval of Research not being conducted in accordance with the IRB requirements or that has been associated with unexpected harm to participants.
• Defer review of a protocol to another qualified IRB when needed by the regulations or due to expertise or conflicts of interest.
• Make recommendations directly or indirectly affecting Human Subjects Research to the University via the Institutional Official.

Research approved by the IRB may be subject to further review and approval (or disapproval) by officials of the institution (e.g., President, Provost, Institutional Official). However, no one may approve Human Subjects Research (i.e., authorize it to proceed) that has not been approved by the IRB.

Violations of this policy or of the standards, procedures, and requirements set forth by the HRPP and/or IRB may result in disciplinary action, up to and including termination of employment or expulsion.

REASON FOR THIS POLICY

The purpose of this policy is to promote the highest ethical standards for the treatment of human participants in Research and to assume responsibility for safeguarding their rights and welfare.

INDIVIDUALS AND ENTITIES AFFECTED BY THIS POLICY

1. All faculty, staff, students and other individuals who propose or are engaged in Research under the auspices of Purdue University.
2. University officials who may be involved in review of Research proposals initiated within their units and/or proposals subject to review separate from or in addition to IRB review.
3. All staff of the HRPP and members of the University IRB.

EXCLUSIONS

The HRPP does not review Research activities that are not conducted under the auspices of Purdue University (e.g., those referenced in the policy on Conflicts of Commitment and Reportable Outside Activities (III.B.1) or other consulting, professional, or business activities).

RESPONSIBILITIES

Associate Vice President for Research, Regulatory Affairs

• Serve as the Institutional Official.

Human Research Protection Program (HRPP)

• Prepare and disseminate standard operating procedures (SOPs) and best practices related to the use of Human Subjects Research. Periodically review and update these documents to ensure the highest ethical standards.
• Provide advice and consultation to faculty and staff on matters of employing Human Subjects in Research.
• Keep abreast of all granting agency rules and regulations involving Human Subjects Research and initiate practices in the requirements of grants funded by the various agencies.
• Report, from time to time, to the EVPRP via the Institutional Official, and make recommendations concerning University practices that will meet the requirements on grants awarded by agencies.
• Coordinate reviews by external IRBs as necessary.

Institutional Review Boards (IRBs)

• Review proposed Research programs and projects to obtain group decision on guarding the safety, rights, welfare, dignity and privacy of Human Subjects, and approve, approve with stipulations, or disapprove the Research in accordance with established policies, standards, and HRPP SOPs.

Faculty, Staff, Students and Others Conducting Purdue Research

• Comply with laws, regulations, university policies, and HRPP standard operating procedures, and professional and ethical standards that regulate Research with Human Subjects.
• Follow HRPP SOPs for initial submission and approval of proposals, continuing review, modification to the program or project, reporting of unanticipated problems and adverse events, and document retention.
• Inform the IRB of any risks involved for human participants that are known at the time of initial review and apprise the IRB of any new risks identified during the course of the program or project.
• Respect the privacy of Human Subjects participating in Research and protect the confidentiality of data gathered for the program or project.

DEFINITIONS

All defined terms are capitalized throughout the document. Refer to the central Policy Glossary for additional defined terms.

Human Subject(s)
A living individual about whom an investigator (whether professional or student) conducting Research:

• Obtains information or biospecimens through intervention or interaction with the individual, and uses, studies, or analyzes the information or biospecimens; or
• Obtains, uses, studies, analyzes, or generates identifiable private information or identifiable biospecimens.

Institutional Official
Specific duties of the Institutional Official are outlined in the HRPP’s SOPs.

Research
A systematic investigation, including research development, testing, and evaluation, designed to develop or contribute to generalizable knowledge.

RELATED DOCUMENTS, FORMS AND TOOLS

Purdue University’s Human Research Protection Program

Policies and Standards

• HRPP Standard Operating Procedures
• Compliance with HIPAA Privacy and Security Regulations (S-10)
• Conflicts of Commitment and Reportable Outside Activities (III.B.1)
• Individual Financial Conflicts of Interest (III.B.2)
• Institutional Conflicts of Interest (III.B.6)
• Responsible Conduct of Research (S-20)

Regulations

• The Belmont Report: Ethical Principles and Guidelines for the Protection of Human Subjects of Research
• 45 CFR part 46

WEBSITE ADDRESS FOR THIS POLICY

www.purdue.edu/policies/academic-research-affairs/ic1.html

HISTORY AND UPDATES

May 1, 2021: This policy supersedes Executive Memorandum No. B-45 dated February 17, 1977.

APPENDIX

There are no appendices to this policy.