Policy Title

Protection of Human Subjects

Statement

This policy assures that:

a. The rights and welfare of the human subjects are adequately protected;

b. The procedures used to obtain informed consent are adequate and appropriate;

c. The risks to the human subject are reasonable in relation to the anticipated benefits to the subject.


Scope

Faculty, staff, and students

Policy Number:2.4.06
Effective Date:06/01/2020
Date Reviewed: 04/27/2020
Last Review Date: Apr 1 2023 12:00AM; 04/20/2021
Responsible Official: Director of Grants and Sponsored Research Development
Responsible Office: Grants and Sponsored Research Development
Contact Information:

Macfeat House, (803) 323-2460, https://www.winthrop.edu/grants/

Definitions

1.0 Specific meanings of bold terms seen throughout this policy can be found within the University's policy definition glossary by following the link below.

1.1 http://www.winthrop.edu/policy-definitions-glossary

Winthrop University acknowledges and accepts its responsibilities for protecting the rights and welfare of human subjects participating in research. 


This policy assures that:

a. The rights and welfare of the human subjects are adequately protected;

b. The procedures used to obtain informed consent are adequate and appropriate;

c. The risks to the human subject are reasonable in relation to the anticipated benefits to the subject.


The Chief Academic Officer serves as the Authorized University Representative (AUR) who represents the University in any legal matters concerning Institutional Review Board (IRB) decisions. The AUR oversees the enforcement of IRB decisions in instances where members of the Winthrop community fail to follow proper protocols designed to protect human subjects or act in ways that could potentially harm human subjects. The IRB will review suspected and alleged protocol violations, subject complaints, or violations of Winthrop IRB policies and/or applicable state and federal regulations. Failure by the researcher to respond to IRB decisions on these matters in an appropriate manner will be referred to the AUR. The Winthrop IRB has the authority to suspend or terminate approval of research that is not conducted in accordance with its requirements or that pose serious threat to human subjects and will report suspensions to the AUR.


To request review of your proposed research project by the IRB, complete the Request for Review of Research Involving Human Subjects form, Informed Consent form, and other documents as related to your research.

Guides are listed on the IRB website

(https://www.winthrop.edu/grants/institutional-review-board-irb.aspx)


Forms are available on the GSRD Forms website

(https://www.winthrop.edu/grants/forms.aspx)


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