Handbook of Operating Procedures
Chapter 10 - Research
Previous Publication Date: June 15, 1998
Publication Date: May 5, 2022
Policy Reviewed Date: May 5, 2022
Policy Owner: VP for Research

10.10 Human Research

I. POLICY STATEMENT

The University of Texas at San Antonio (UTSA) is committed to protecting the rights and welfare of Human Subjects in Research by adopting ethical principles and ensuring compliance with applicable federal and state laws and university regulations.

II. RATIONALE

Ethical principles for the use of Human Subjects in Research are embodied in federal regulations and administered by the United States Department of Health and Human Service’s Office of Human Research Protections. Research conducted on behalf of UTSA must comply with the applicable federal and state laws and regulations and any additional protections imposed by oversight and/or sponsoring agencies. This policy also requires compliance with UTSA’s Federalwide Assurance (FWA 00003861) for any Human Subjects Research.

III. SCOPE

This policy applies to all UTSA employees and students, visiting researchers, Investigators and individuals who conduct Human Subjects Research. It is applicable to Research activities regardless of where the research occurs.

IV. WEBSITE ADDRESS FOR THIS POLICY

http://www.utsa.edu/hop/chapter10/10.10.html

V. RELATED STATUTES, POLICIES, REQUIREMENTS OR STANDARDS

Department of Health and Human Services, Protection of Human Subjects 45 CFR Part 46
Department of Health and Human Services, Promoting Objectivity in Research 42 CFR Part 50 Subpart F
Food and Drug Administration, Protection of Human Subjects 21 CFR Part 50
Food and Drug Administration, Institutional Review Boards 21 CFR 56
Ethical Principles and Guidelines for the Protection of Human Subjects of Research, The Belmont Report.
UTSA Human Research Protections Program Policies and Guidance
UTSA Handbook of Operating Procedures (HOP) Policy 10.04, Conflicts of Interest in Research & Intellectual Property

VI. CONTACTS

If you have any questions about research with human subjects, contact the following office(s):

The Office of Research Integrity
IRB@utsa.edu

VII. DEFINITIONS

Human Subjects:
1. The Department of Health and Human Services (DHHS) defines a Human Subject as a living individual about whom an Investigator (whether an employee, student, or affiliated individual) conducting Research:
  1.1 obtains information or biospecimens through intervention or interaction with the individual, and uses, studies, or analyzes the information or biospecimens; or
  1.2 obtains, uses, studies, analyzes, or generates identifiable private information or identifiable biospecimens.
2. The Food and Drug Administration (FDA) defines a Human Subject as:
  2.1 an individual who is or becomes a participant in Research, either as a recipient of a test article (investigational drug, biologic, or device) or as a control and may be either a healthy human or a patient;
  2.2 an individual on whose specimen a device is used; or
  2.3 unidentified tissue specimens when medical device Research involves in vitro diagnostics.
Investigator:
1. An individual performing various tasks related to the conduct of Human Subject Research activities such as:
  1.1 Obtaining information about living individuals by intervening or interacting with them for Research purposes.
  1.2 Obtaining identifiable private information about living individuals or biospecimens for Research purposes.
  1.3 Obtaining voluntary informed consent of individuals to be Subjects in Research.
  1.4 Studying, interpreting, or analyzing identifiable private information, data, or biospecimens for Research purposes.
Research:
1. DHHS defines Research as a systematic investigation, including research development, testing, and evaluation, designed to develop or contribute to generalizable knowledge. This is the default definition for UTSA activities unless the FDA definition applies as described in item 2.
2. FDA defines Research as an activity that involves a drug or device, other than use of a marketed drug in the course of medical practice, or the use of a device to evaluate safety and effectiveness of that device, and data from the activity will be submitted to, or held for inspection by, the FDA in support of a marketing or research application for an FDA-regulated product.
See additional definitions listed in the Institutional Review Board (IRB) office policy, HRP-001: Definitions.

VIII. RESPONSIBILITIES

Institutional Official
1. Appoints and removes IRB members, chairs, and vice-chairs.
2. Determines what IRBs UTSA will rely upon.
3. Disapproves, suspends, or terminates Human Research.
4. Limits or restricts privileges to conduct Human Research.
5. Oversees the Human Research program.
Institutional Review Board (IRB)
1. Formulates and implements procedures to assure UTSA compliance with federal, state, and institutional regulations for safeguarding the welfare and well-being of Human Subjects involved in Research.
2. Reviews and approves all Human Subjects Research proposals on an annual basis.
3. Reviews and approves proposed changes to approved protocols.
4. Educates Investigators, employees, students, and affiliated researchers on Research with Human Subjects and promotes best practices for the ethical conduct of such activities.
5. Determines whether financial interests related to the Research and the management, if any, allow approval of the Human Research.
6. Suspends or terminates approval of Human Research found to be non-compliant or associated with unexpected serious harm to Human Subjects.
Investigator
1. Obtains all required approvals prior to conducting Human Subjects Research.
2. Cooperates in review of protocols on an annual basis.
3. Submits any proposed changes to approved protocols to the IRB.
4. Notifies the IRB if any Human Subjects are harmed (physically or psychologically).
5. Notifies the IRB and the Office of Research Integrity of any improper disclosure of private information, economic loss, property loss or damage or other harmful or potentially harmful occurrence.
See further responsibilities described in the IRB office policies posted to the IRB office website, including:

IX. PROCEDURES

The involvement of Human Subjects in Research will be permitted to begin only after the IRB has approved the Research protocol, the informed consent document, the testing instruments, and other requirements of the IRB.

Standard Operating Procedures for the Human Research Protection Program are posted to the IRB office website. These procedures describe requirements for researchers, IRB members, and designated staff responsible for supporting the Human Research Protection Program. Changes to Standard Operating Procedures that affect Human Subjects Investigators will be developed in consultation with the UTSA faculty senate research subcommittee and IRB members.

X. SPECIAL INSTRUCTIONS FOR IMPLEMENTATION

None

XI. FORMS AND TOOLS/ONLINE PROCESSES

Forms, checklists, and guidance for new and continuing research are found on the IRB office website. To submit a new IRB application or a modification to a previously approved study, visit the online submission system, Cayuse IRB.

XII. APPENDIX