Human Subjects Research

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Title: Human Subjects Research
Policy Owner: Office of the Vice President for Research
Applies to: Employees, Faculty, Students, Others
Campus Applicability: All Campuses
Effective Date: May 25, 2018
For More Information, Contact Office of the Vice President for Research
Contact Information: (860) 486-3001
Official Website: http://research.uconn.edu/

REASON FOR POLICY

The University of Connecticut is committed to ensuring the safety, rights and welfare of all participants involved in human subjects research conducted at or by the University of Connecticut on all its campuses, including UConn Health (the “University”). This policy establishes that whenever the University engages in human research it will be guided by the ethical principles of the Belmont Report and will comply with applicable legal requirements. It is the responsibility of all components of the human research protection program to work collaboratively to ensure research with human subjects is conducted in accordance with such ethical principles and legal requirements.

APPLIES TO

All University faculty, employees, students, postdoctoral fellows, residents and other trainees, and agents who supervise or conduct human subject research.  Such research includes, but is not limited to, obtaining data through intervention or interaction with individuals, using identifiable private information or identifiable biospecimens from living individuals and using human tissue to evaluate the safety or effectiveness of an investigational device.

DEFINITIONS

Human Research Protection Program (“HRPP”):  The University’s comprehensive system designed to ensure that the University meets ethical principles and legal requirements for the protection of the safety, rights and welfare of human participants in research.  The HRPP encompasses all University-associated individuals and units responsible for the conduct and oversight of research involving human participants.

Human Subject or Human Participant:

  • A living individual about whom an investigator (whether professional or student) conducting research obtains data through intervention or interaction with the individual, or identifiable private information. [45 CFR 102(f)]
  • An individual who is or becomes a participant in research, either as a recipient of the test article or as a control. Such subject may be either a healthy individual or a patient. For research that evaluates the safety or effectiveness of a device, the definition also includes a human on whose specimen an investigational device is used. Such subject may be in normal health or may have a medical condition or disease. [21 CFR 56.102(e); 21 CFR 812.3(p)]
  • Any other individual meeting the legal requirements of a human subject or human participant in research.

Institutional Official (“IO”): The individual appointed by the President of the University who is legally authorized to act for and on behalf of the University in matters related to human subject research and the protection of human research participants. The IO oversees the HRPP and is responsible for ensuring that it functions effectively and that the University provides appropriate resources and support to comply with applicable legal requirements governing human subject research.

Institutional Review Board (“IRB”): A multidisciplinary group whose membership meets applicable legal requirements, which reviews, approves, and oversees all University research involving human subjects. An integral component of the HRPP, the IRB review ensures the protection of the safety, rights and welfare of human subjects and that applicable legal requirements are met.

Research:

  • A systematic investigation, including research development, testing and evaluation, designed to develop or contribute to generalizable knowledge. [45 CFR 102(d)]
  • A clinical investigation, meaning any experiment that involves a test article and one or more human subjects, and that either must meet the requirements for prior submission to the Food and Drug Administration (“FDA”) under section 505(i) or 520(g) of the Federal Food, Drug, and Cosmetic Act, as amended (the “Act”), or need not meet the requirements for prior submission to the FDA under these sections of the Act, but the results of which are intended to be later submitted to, or held for inspection by, the FDA as part of an application for a research or marketing permit. [21 CFR 102(c)]
  • Any other activities meeting the legal requirements of research involving human subjects or human participants.

POLICY STATEMENT

The University will designate one or more IRBs for the review of research involving human participants.

The IO is delegated the authority to develop policies and procedures, and to implement a program to ensure the safety, rights and welfare of human participants in research that is legally compliant.

All human subjects research, regardless of sponsorship or funding, must be reviewed and approved by a University designated IRB before research begins unless specifically exempted from review by policy or procedure.

Designated IRBs are granted the authority to:

  • Approve, require modifications to secure approval, or disapprove research involving human subjects;
  • Suspend or terminate approval of research not being conducted in accordance with the IRB’s requirements or that has been associated with unexpected serious harm to human subjects;
  • Take actions determined necessary to ensure legal compliance and adherence to University policy, and to mitigate issues associated with unanticipated problems or risks to human participants and others;
  • Observe, or have a third party observe, the consent process or conduct of the research; and
  • Conduct continuing review of research annually or at intervals appropriate to the degree of risk.

University personnel may not approve research involving human participants if it has not been approved by a University designated IRB.  Research that has been approved by a designated IRB may be subject to further review and approval or disapproval.

Research Subject to the Common Rule. Human subject research that is conducted or supported by any federal department or agency that has adopted the Federal Policy for the Protection of Human Subjects, known as the Common Rule, will comply with the requirements set forth in the Health & Human Services Regulations at 45 CFR part 46 (including subparts A, B, C and D), unless the research is otherwise exempt from these requirements.  Relevant HRPP and IRB policies and other applicable legal requirements of the department or agency conducting or supporting the research may also apply.

Research Subject to FDA Regulation. Clinical investigations regulated by the FDA under section 505(i) or 520(g) of the Act (21 U. S.C. § 355(i)) will comply with the applicable FDA regulations. These regulations include, but are not limited to: Protection of Human Subjects (21 CFR part 50), Institutional Review Boards (21 CFR part 56), Investigational New Drug Application (21 CFR part 312), Applications for FDA Approval to Market a New Drug (21 CFR part 314) and Investigational Device Exemptions (21 CFR part 812).  Relevant HRPP and IRB policies may also apply.

Other Research. For all other research involving human participants, the University applies the policies of the HRPP, which are guided in their development and implementation by the Health & Human Services Regulations at 45 CFR part 46 (including four subparts) and the International Conference on Harmonization Good Clinical Practice Consolidated Guidelines.

ENFORCEMENT

Violations of this policy may result in appropriate disciplinary measures in accordance with University By-Laws, General Rules of Conduct for All University Employees, applicable collective bargaining agreements, the University of Connecticut Student Code, and other applicable University Policies.

ADDITIONAL RESOURCES

45 CFR part 46 (including subparts A, B, C and D)

21 CFR part 50

21 CFR part 56

21 CFR part 312

21 CFR part 314

21 CFR part 812

ICH GCP (E6)

Belmont Report: Ethical Principles and Guidelines for the Protection of Human Subjects of Research (1979)

POLICY HISTORY

Revisions: 2/16/2011; 5/25/2018 (Approved by President’s Cabinet)