Policies

Protection of Human Subjects

Section: Sponsored Program Administration
Index: J-06

Policy

The University of Houston – Victoria (UHV) will comply with applicable laws and regulations relating to human subjects research including 45 Code of Federal Regulations (CFR) 46 (“The Common Rule”) which specifically addresses the protection of human study subjects as promulgated by the Department of Health and Human Services (DHHS). UHV assures that all of its research involving human subjects will comply with the terms of its Federalwide Assurance for the Protection of Human Subjects for research conducted under the auspice of the university. This policy complies with SAM 01.G.01 - Sponsored Research Activities and provides guidance in complying with federal law related to research with human subjects, including upholding the ethical principles and guidelines set forth in The Belmont Report, April 18, 1979, for the protection of human subjects.

Procedures

1. Administrative

   1. The President will serve as the Signatory Official acting officially in an authorized capacity on behalf of UHV for the Office of Human Research Protection IRB and FWA renewals ensuring the requirements of the assurances are satisfied.

   2. The Provost and Vice President for Academic Affairs has oversight responsibility and authority for the university’s Institutional Review Board (IRB) or the Committee for the Protection of Human Subjects and appoints the chair and members of the IRB with the President’s approval.

   3. The CPHS shall have at least five members, with varying backgrounds to promote complete and adequate review of research activities commonly conducted by the institution. Committee members shall be appointed for three year terms, starting at the beginning of the academic year. The committee’s faculty membership shall be tenured or tenure-track faculty. Faculty membership will include one representative from each degree granting school. Members will serve three year staggered terms. Thus each school will select a member every three years. In addition, one faculty whose primary concerns are in scientific areas shall be identified to serve a three year term. An external member will be selected and will serve a three year term. The external member shall be an individual who is not otherwise affiliated with the UHV and who is not part of the immediate family of a person who is affiliated with the institution. Every nondiscriminatory effort will be made to ensure that no CPHS consists entirely of men or women or of one profession.

   4. UHV shall maintain a Federalwide Assurance from the Office of Human Research Protections (OHRP).

   5. All research activities performed under the auspices of UHV, including cooperative research conducted with one or more public entities, in which human subjects are involved must be reviewed and approved by the Committee for the Protection of Human Subjects in accordance with UHV’s FWA and 45 Code of Federal Regulations (CFR) 46.

   6. The Office of Research and Sponsored Programs in conjunction with the CPHS will maintain procedures upholding current practices of the committee in conducting reviews and approvals. The procedures will be consistent with federal requirements, including those specified in 45 C.F.R., Part 46 and shall be available on the Office of Research and Sponsored Program webpages. The procedures will include processes for:

      1. Initial research review, continuing review, the reporting of findings and actions to the Investigator and the university;

      2. Identifying which projects require review more often than annually;

      3. Ensuring prompt reporting to the CPHS of proposed changes in approved research activity and such activities are not initiated without CPHS review and approval except when to eliminate apparent hazards to the subject; and

      4. Ensuring prompt reporting to the CPHS, necessary university officials, and external entities of any potential problems involving risks to the subjects or others or any serious or continuing noncompliance with federal regulations and any suspension or termination of CPHS approval.

2. Committee for the Protection of Human Subjects (CPHS) Review of Research

   1. The committee shall uphold the requirements in the federal regulations. All research involving human subjects must be reviewed by the CPHS. This includes survey research; research conducted by students, faculty, or staff; and both internally and externally conducted research on behalf of the university.

   2. The CPHS has the authority to approve or disapprove proposed research in accordance with applicable federal regulations, including 45 C.F.R. §46.109.

   3. Investigators shall be notified by university email of the CPHS decision. Notification will be included resubmittal instruction if applicable. If an application is disapproved, the CPHS will include in its written notification a statement of the reason for the decision and allow the investigator the opportunity to respond to the outcome.

   4. Research protocols involving the use of human subjects must provide evidence of the following:

      1. Risks to the subjects are minimized by using procedures consistent with sound research design which do not expose the subjects to unnecessary risk;

      2. Risks to subjects are reasonable in relation to the anticipated benefits, if any, to the subjects, and the importance of the knowledge that may reasonably be expected to result;

      3. Selection of subjects is equitable in terms of the purposed of the research and the setting in which it will be conducted;

      4. Informed consent will be sought from each prospective subject or the subjects legally authorized representative in accordance with §46.116;

      5. Informed consent will be documented in accordance to state and federal regulations and waivers of documentation shall only be approved in accordance with 45 CFR 26.117;

      6. When appropriate, the research plan makes adequate provision for monitoring the data collected to ensure the safety of the subjects;

      7. When appropriate, there are adequate provisions to protect the privacy and confidentiality of data;

      8. When some or all of the subjects are likely to be vulnerable to coercion or undue influence, such as children, prisoners, pregnant women, mentally disabled persons, or economically or educationally disadvantaged persons, additional safeguards have been included in the study to protect the rights and welfare of these subjects.

   5. Participation of human subjects in any study must be voluntary, refusal to participate will involve no penalty or loss of benefits to which the subject is otherwise entitled, and the subject may discontinue participation at any time without penalty or loss of benefits to which the subject is entitled and the information provided to gain subject consent must be adequate and appropriate.

   6. The CPHS shall have the authority to suspend or terminate approval of research that is not being conducted in accordance with the CPHS requirements or that has been associated with unexpected serious harm to subjects.

   7. All documentation associated with CPHS review is maintained by the Office of Research and Sponsored Programs. The ORSP provides staff support to the CPHS in its work, including tracking and monitoring submissions, maintaining records involving human participants.

References

Title 45 Public Welfare Department of Health and Human Services Part 46 Protection of Human Subjects

UHV Committee for the Protection of Human Subjects

Approved by:

[signature obtained]
Robert K. Glenn, Ph.D.
President

Date:

12/20/2022

Next review date: December, 2025 (3years)
Origination: Provost/Research and Grants