E90: Human Beings as Subjects in Research

Approved by: Faculty Senate
Effective: April 25, 2017
Responsible FS Committee: Research Policy Committee
Office Responsible for Administration: Vice President for Research and HSC Vice Chancellor for Research

Policy Rationale

In the oversight of all Human Subjects Research, the University of New Mexico (UNM) as a whole, is committed to protecting the rights and welfare of participants in Human Subjects Research consistent with the ethical principles outlined in the April 18, 1979, report of The National Commission for the Protection of Human Subjects of Biomedical and Behavioral Research titled “Ethical Principles and Guidelines for the Protection of Human Subjects of Research,” also known as “The Belmont Report”:

• Respect for Persons
• Beneficence
• Justice

Policy Statement

UNM aims to promote a culture of compliance with the highest legal and ethical standards for the conduct of human research. UNM recognizes research as one of its chartered enterprises and shares responsibility for promoting and managing this activity with its individual researchers when conducted under its auspices.

To ensure comprehensive protection of the rights and welfare of subjects in human research across a diverse social-behavioral and biomedical research enterprise, UNM holds two distinct Federal Wide Assurances (FWAs) approved by the U.S. Department of Health and Human Services, one for the University Main Campus and a separate FWA for the Health Sciences Center (HSC). Under these agreements, UNM assures that all of its activities related to human subjects in research (“Human Subjects Research”) are conducted in accordance with all applicable federal regulations (e.g., 45 C.F.R. § 46, 21 C.F.R. § 50, 21 C.F.R. § 56, 21 C.F.R. § 312, 21 C.F.R. § 812).

Applicability

All academic and research UNM units, including the Health Sciences Center and Branch Campuses.

Definitions

HRRC refers to UNM HSC’s Human Research Review Committees (HRRC)

IRB. Refers to the UNM Main Campus Office of the Institutional Review Board (IRB)

Human Research Subject. The United States Department of Health and Human Services (HHS) defines a human research subject as a living individual about whom a research investigator (whether a professional or a student) obtains data through 1) intervention or interaction with the individual, or 2) identifiable private information (32 C.F.R. 219.102(f)

Who should read this policy

• Faculty, staff, and students conducting research
• Members of the Faculty Senate and the Research Policy Committee
• Academic deans or other executives, department chairs, directors, and managers
• Administrative staff responsible for sponsored research management.

Related Documents

UNM Regents’ Policy Manual

• Policy 5.1 “The Faculty’s Role in UNM’s Academic Mission”
• Policy 5.14 “Human Beings as Subjects in Research”
• Policy 5.13 “Research Fraud”

Faculty Handbook

• E40: Research Misconduct

Contacts

Direct any questions about this policy to Office of the Vice President for Research or the HSC Office of Research.

Procedures

All Principal Investigators and involved researchers engaged in Human Subjects Research are required to:

1. Obtain approval from the IRB or HRRC following the procedures established by the Main Campus Office of the IRB (OIRB) and the Main Campus IRB; or the HSC Human Research Protections Office and the HSC’s Human Research Review Committees (HRRC), depending on the Principal Investigator’s primary appointment. Procedures are posted on the respective websites and are regularly and continually updated to comply with federal regulations and accreditation standards.

2. Monitor ongoing research and teaching activities under their supervision to ensure that they continue to be conducted in accordance with approved protocols.

3. Ensure that all personnel involved in Human Subjects Research under their supervision are appropriately trained on the applicable laws, rules, and regulations regarding Human Subjects Research as well as the Main Campus IRB’s or HRRC’s policies and procedures, as the case may be, with respect to Human Subjects Research.

4. Comply with and ensure compliance with all determinations and additional requirements of the IRB and/or HRRC, as the case may be, with jurisdiction over the research.

History

• Research Misconduct Policy (amended) Approved by Faculty Senate April 25, 2017
• Revised November 15, 1966