UPDATED: March-2001

RESEARCH INVOLVING HUMAN SUBJECTS P 202R

Issued by: Office of the Vice President for Research
Replaces: Policy 51, February, 1979
Approved: November, 1989
Revised: March 2001

The use of human subjects in research is governed by laws and regulations set forth at the campus, State and Federal levels. The University operates under a Federalwide Assurance, FWA# 00000125. The faculty, staff and students of the University are mandated to comply with these laws and regulations.

This policy applies to all University faculty, staff and students using University facilities, the facilities of another institution, or any other off-campus site. The policy also applies to visitors and users of the campus or off-campus University facilities.

The Committees on Research Involving Human Subjects (CORIHS) are the Institutional Review Boards for the University, as required by: The purpose of CORIHS review is to assure protection of the rights and welfare of human subjects in research. These rights include ensuring that the subject has the opportunity to voluntarily give informed consent.

All investigators who conduct research directly with human subjects, or indirectly via data or biological specimens derived therefrom, must undergo training on the protection of human subjects in research activities. This requirement is independent of funding status. The campus has implemented a program to meet this requirement. The program is coordinated by the Associate Director for Research Compliance. Determination of applicable personnel, and responsibility for arranging such training, lies with the principal investigators.

Violations:

Reports of violations of this policy will be brought before CORIHS at a convened meeting. CORIHS will make a determination regarding the need for additional information or further investigation. The affected Chair and Dean will be copied on all correspondence between the committee and the involved parties. Upon determination that a violation of this policy has
occurred, CORIHS may, for example, require that the activity in question be halted until such time that corrective action is taken.

In situations where subject safety is involved, and/or the violations are apparent, the Chair of CORIHS, in consultation with other IRB members and/or administrators as appropriate, may take immediate action (e.g., suspend the activity/activities in question) prior to review by the full committee.

If CORIHS determines that the violation involves possible scholarly or scientific misconduct, the Vice President for Research will be notified, and appropriate action will be taken in accordance with established University assurances, policies, and procedures.
PROCEDURE: APPLYING FOR APPROVAL FOR RESEARCH INVOLVING HUMAN SUBJECTS
  1. All research involving human subjects conducted, on the Stony Brook campus, or under the auspices of the University, the Research Foundation of SUNY, or any campus-related organization, must be reviewed and approved by CORIHS prior to commencement of the research activity.
    Materials submitted for review should include the current "Application For Approval for Research involving Human Subjects, " a detailed protocol outlining all experimental procedures including anticipated risks and benefits to the subject, and consent forms (in accordance with 45 CFR 46 [DHHS] and, when applicable, 21 CFR 50 [FDA]). The requisite number of copies of the application and supporting documents (as fully detailed in the current version of the CORIHS Guidelines) must be endorsed by the department chair or unit head and should be submitted to the Office of Research Compliance. Investigators will be notified in writing of the outcome of CORIHS' review.
  2. Applications for research involving human subjects which use University Hospital patients or facilities may require additional forms
  3. Approved research must be renewed at least once annually. Renewal forms are sent to the principal investigator approximately 3 months prior to the end of the approval period. If the investigator does not secure continued approval by the time the prior approval period lapses, all human subject activities associated with the project must stop immediately until approval is obtained.
  4. Unanticipated problems involving risks to subjects, adverse events or other problems must be reported promptly to CORIHS for evaluation.
  5. Any revisions or amendments to the approved research activity must be submitted to CORIHS prior to implementing the new activity in order to determine the need for additional committee review. The only exception to this requirement is a protocol revision that must be implemented immediately to protect subject safety.
  6. Participation by students in any teaching activity which involves risk to the student, or is unusual or not necessary to the course of study or training in which it occurs must be accompanied by the student's voluntary, informed consent and must be reviewed and approved by CORIHS.
  7. 7. There are additional policies for:
    1. special subject populations (e.g., pregnant women, minors, subjects with diminished capacity to consent)
    2. research involving investigational drugs or devices
    3. emergency use of investigational drugs or devices
    4. use of biological specimens in research
INQUIRIES/REQUESTS:
Associate Director for Research Compliance RELATED FORMS:
Application for Approval for Human Subjects Research
Application for Continued Approval for Human Subjects Research
Application for 5 Year Continued Approval for Human Subjects Research
Application for Exempt Category Review

RELATED DOCUMENTS:
DHHS: Code of Federal Regulations, Title 45 Part 46: Protection of Human Subjects
FDA: Code of Federal Regulations, Title 21 Parts 50 (Informed Consent), 56 (IRB's), 312 (Investigational New Drugs), 812
(Investigational Device Exemptions)
The Belmont Report: "Ethical Principles and Guidelines for the Protection of Human Subjects of Research"
SUNY-Stony Brook: Guidelines for Research Involving Human Subjects - CORIHS
Compliance Web site at: http://www.research.sunysb.edu/research/policies/complnce.html
Appropriate Articles of the NYS Public Health Law

SUNY Memo to Presidents, vol.81, No. 10 "Assurances of Compliance with Human Subjects Research Regulations"