INST 150 - Protection of Human Subjects
Number: INST 150
Effective: June 7, 2017
Last Reviewed: June 23, 2023
Department: Instruction and Student Services
Last Revision: July 3, 2023

Purpose

To establish policies and reference procedures to protect the rights, well‐being, and personal privacy of individuals serving as Human Subjects, to assure a favorable climate for the conduct of scientific inquiry, observations, collection of historical data, surveys, and questionnaires, and to protect the interests of CWI when conducting research involving Human Subjects. 

Scope

This policy applies to all research projects involving Human Subjects.

Definition

Federal Wide Assurance (FWA): Pursuant to the Department of Health and Human Services’ (DHHS) regulations providing for the protection of Human Subjects, 45 CFR 46.101, et seq., every institution engaged in human subjects research that is funded or conducted by DHHS must obtain an Assurance of Compliance approved by the Office for Human Research Protections (OHRP). NOTE: All research activity involving Human Subjects will be subject to such an assurance regardless of whether the activity is funded or unfunded.

Human Subject: A living individual about whom a professional or student investigator conducting research obtains data through intervention or interaction with the individual or collects identifiable private information, 45 CFR 46.102 (f). Human Subject under United States Food and Drug Administration (“FDA”) regulations includes an individual who is or becomes a participant in research, either as a recipient of a test article or as a control. A “subject” may be a healthy human or a patient. 21 CFR 56.102 (e).

Institutional Review Board (IRB): An administrative body established to protect the rights and welfare of human research subjects recruited to participate in research activities conducted under the auspices of the institution with which it is affiliated, established, and registered with OHRP.

Research: A systematic investigation, including research development, testing, and evaluation, designed to develop or contribute to generalized knowledge. 45 CFR 46.102(d). Research includes surveys and interviews, behavioral investigations, retrospective reviews of medical information, experiments with blood and tissue, and demonstration and service programs and clinical trials. In addition, the FDA includes under the definition of reviewable research any use of an FDA regulated product except for use of a marketed product in the practice of medicine. Under this definition of Research, CWI includes the collection of historical data and the review of records, observations, and questionnaires that will be used, shared, or published outside of the CWI campus.

Policy

CWI is committed to the ethical principles for the protection of Human Subjects in research set forth in the Belmont Report of the National Commission for the Protection of Human Subjects in Biomedical and Behavioral Research and the federal rules and regulations, 45 CFR 46.101, et seq. The College recognizes and accepts responsibility, which it shares with its investigators and other researchers, for determining that research involving Human Subjects fulfills these ethical principles. The following general guidelines apply equally to all research involving Human Subjects, whether carried out solely with College resources or with assistance of outside funds. The College assumes responsibility for communicating and explaining these policies and guidelines to all College personnel and for providing procedural guidelines to affect their observance. 

Guidelines

HUMAN SUBJECTS RESEARCH

Under federal regulations as prescribed by DHHS and the OHRP, the College requires the review of all human subjects research by an IRB prior to conducting any research.

For research involving Human Subjects, the College uses as its guide the federal rules and regulations including 45 CFR Part 46, entitled “Protection of Human Research Subjects” (HHS regulations), 21 CFR Part 50, entitled “Protection of Human Subjects” (FDA regulation), and 21 CFR Part 56, entitled “Institutional Review Boards” (FDA regulations). Other applicable FDA regulations, which the IRB and the investigator must follow, depending on the study, include 21 CFR Part 312, “Investigational Drugs” and 21 CFR Part 812, “Investigational Devices.” Importantly, the National Institute of Health (NIH) and FDA publicize additional guidelines for the conduct of certain types of research from time to time.

AUTHORITY AND JURISDICTION

The President of the College has designated the Provost as CWI’s official signatory and Institutional Office (IO), who is responsible and has oversight for all Human Subject research activity. The IO shall designate a Human Protections Administrator that shall provide for day-to-day oversight of all human subject research at CWI. In order to conduct nonexempt human subject research, CWI shall, as required, enter into an agreement with an IRB such a relationship will be documented by a written agreement between CWI and the other institution or organization operating the IRB that outlines the relationship and includes a commitment that the IRB will adhere to the requirements of CWI’s FWA. The IO shall confirm annually that such an agreement has appropriate composition and representation, according to federal guidelines.

The IRB has the following authority and responsibilities:

  1. Review all research projects that will involve Human Subjects submitted by HPA prior to contact involvement of Human Subjects and to determine whether the appropriate level of review should be exempt, expedited, or full board, depending on the risk, confidentially, and identifiable information required for the research project.
  2. Approve, disapprove, or require changes in all research (including protocols, consent documents, etc.) and notify the researcher in writing of this status. Should the IRB disapprove or terminate a research project, the principle investigator may request to present more information either in person or in writing to the IRB, explaining why he or she believes the project should be approved or continued. However, a final IRB decision to require modifications in, disapprove, suspend, or terminate a project is irreversible. No other committee or official, either College or federal, can override such an IRB decision. Further, no committee or person can approve an investigator to conduct any research that an IRB has not approved. 45 CFR 46.112.
  3. Notify federal government agencies and sponsors of approvals and disapprovals or forward such notification to investigators for submission as applicable.
  4. Ensure prompt reporting by investigators to the OHRP as well as any sponsoring agency of unanticipated problems involving risk to subjects or others;
  5. Ensure prompt reporting to the IRB by investigators of compliance with IRB or federal policies or regulations, and report serious or continuing noncompliance to appropriate federal agencies;
  6. Suspend or terminate a previously approved project and notify applicable agencies;
  7. Conduct continuing reviews of ongoing research as well as any other monitoring such research may require.

Referenced