Edward Foote

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Ed Foote (Pharmacy and Nursing), Chair
Justin Matus (Business)
Linda Gutierrez (Science and Engineering)
Anne Pelak (Grant Support)
Ed Schicatano (Arts, Humanities and Social Sciences)

The Wilkes University Human Subjects Review Committee is charged with ensuring that human subjects are adequately protected in research involving humans that is undertaken by Wilkes students, faculty or administrative members. The Committee not review biomedical research proposed by Wilkes faculty, but it will require that appropriate approvals from an external HSR be obtained in such cases. The HRS policy is an adaptation of federal regulations and directives regarding IRBs (Institutional Review Boards) that are typically responsible for reviewing all types of research involving human subjects, including biomedical.

Does all research involving humans need to be reviewed?
No. There are exemptions to the requirement for HSR approval. For example, oral histories are exempt, as are many (though not all) types of educational tests. If your research includes human subjects, you are urged to carefully read the University policy to determine if your research is exempt from review. If you are uncertain after reading the policy, please direct any questions to the chair of HSR.

How do I submit proposed research (protocol) for review?
An application form can be downloaded from this site. The form is designed to gather information necessary for the members of HSR to review your research plans. In some cases, a consent form will also be required. A sample form is also available for download.

Forms:

HSR Policy (important directions)
HSR Application Application should be downloaded and TYPED

Sample Consent: Behavioral Health

Useful Links:

FDA Guidance for IRB's and Researchers

Department of Health and Human Services Document on Research
AAUP report on IRB's and social science research
Univesity of Minnesota website: an excellent resource for consent forms.

Need help with randomization? Go to randomizer.org

Online computer-based training sites for researchers and HSR committee members:

Human Subject Assurance Training: Office for Human Research Protections

HSR News