Research at Salisbury University

Research Compliance

Constitution 

• Membership
• Purposes and Functions
• Procedures
• Criteria

Acknowledging and accepting its responsibility to protect the rights and welfare of human subjects participating in research at this institution, Salisbury University hereby constitutes a Committee on Human Research which will function as follows:

Membership

1. Members shall be appointed by the SU Provost in accordance with the regulations of the Department of Health and Human Services.
2. There shall be no less than ten and no more than fifteen members constituting the Committee.
3. Membership shall include:
   1. at least one representative from each School
   2. persons actively involved in research
   3. at least one member with expertise in ethical issues
   4. at least one community representative
   5. persons of each sex
   6. student(s)
4. The Chair and Vice-Chair will be elected by the Committee each year.
5. Members shall be appointed to a three-year renewable term.

Purposes and Functions

1. The protection of human subjects in any and all research done at Salisbury University. This includes but is not limited to:
   1. safeguarding of the research subject, particularly with respect to any undue
      harm or unnecessary risks
   2. insuring that the subject is fully informed about the nature, purposes, risks,
      etc. of the research
   3. the protection of the subject’s privacy under the recognized canons of
      confidentiality
2. The education of the university community, particularly its researchers, as to the responsibilities and duties of those involved engaging in sound, ethical research.
3. The review and approval of all research involving human subjects done under the auspices of the university or by individual members of the university community or by researchers not directly involved with the university who nonetheless propose to use university personnel including Faculty, Staff, Students or University facilities in their research.
4. The Committee shall have the authority to forestall, suspend or terminate any research that is not proposed or conducted in accordance with its guidelines.

Procedures

1. The Committee shall follow the procedures outlined in the regulations (CFR 45) of the Department of Health and Human Services.
2. The Committee shall have regularly scheduled meetings, properly proclaimed.
3. The Committee may, if it so wishes, respond to questions and give further information.
4. The Chair or Chair’s designee will review applications for exempt or expedited review and present them in summary fashion to the Committee. Where there is a question about whether the proposal qualifies as exempt or expedited, the full Committee shall decide the issue by majority vote.
5. On non-expedited reviews, the majority of the members present voting in favor is necessary to gain approval for the proposal. At least one member not from the scientific community must be present.
6. A majority of the membership must be present to vote on a research proposal that does not qualify for an expedited review.
7. The Committee’s decision shall be reported promptly to the researcher. If modifications are suggested or the proposal is rejected, the Chair will provide reasons for such action.
8. The Committee reserves the right to make further inquiries and conduct a follow-up investigation of any approved protocol.
9. The Committee shall issue an annual report of its business to the Academic Provost.

Criteria

The following criteria are central to the committee’s determination.

1. Research:
   -Are the researchers qualified and is the research methodology adequate and the
   purposes of the study appropriate to the field of investigation? (The more risk
   involved, the more stringent this requirement holds.)
2. Risk/Benefit:
   -Are the risks, if any, minimized and do the benefits of the study outweigh any
   risks?
3. Protection of Subjects:
   -Are the rights, dignity and welfare of subjects adequately protected?
4. Informed Consent:
   -Are the subjects informed of the nature of the research by appropriate methods?
   -Where deception is used, what methods are employed to insure subjects’ protection from risks of research?
   -Is consent voluntary without any undue manipulation and when subjects are
   legally unable to give consent, is consent procured from authorized guardian(s)?
   -Is the right to withdraw at any time clearly communicated to the subject?
5. Privacy and Confidentiality:
   -Are the subjects’ privacy protected and confidentiality assured?