Department of Research - Institutional Review Board

Committee for the Protection of Human Subjects

Leslie Francke
Academic Research Specialist
(989) 583-6984
lfrancke@synergymedical.org


Forms

All investigators planning on doing research at Synergy Medical, Covenant HealthCare and St. Mary's must complete the following tutorial and submit a copy of the certificate of completion to the Synergy Research Department with their IRB application.

Tutorial Link:
http://phrp.nihtraining.com/users/login.php


IRB Application for all Projects:

Word version

PDF version

Other Related Forms:
Application Review Procedure: Word Application Review Procedure: PDF Consent Form: Word HIPAA IRB: Word HIPAA IRB: PDF Renewal Form: Word Renewal Form: PDF Closure Form: Word Closure Form: PDF

View the IRB Resource Guide

Synergy Medical (Synergy Medical) encourages the conduct of research in and among its departments and in collaboration with other educational institutions and entities. Synergy Medical, while respecting the right of academic freedom in research, is also committed to adhering to basic ethical principles underlying the acceptable conduct of research involving human subjects. These basic principles: respect for persons, beneficence, and justice, are particularly relevant to the protection of human subjects in research, and are the accepted requirements for the ethical conduct of research.

Synergy Medical has standards for the conduct of research that mandate well-conceived and well-conducted research. The Institutional Review Board (IRB) has been established to assist in maintaining those standards. Although regulations and policies exist to guide ethical standards, they are no guarantee of ethical conduct in research. Individual researchers and IRB members have the responsibility to make ethical considerations in the conduct of research and to have a clear understanding of policies regarding human subjects.

Any research that involves human subjects conducted by Synergy Medical faculty, staff, residents or students, is under the jurisdiction of the IRB. Principal investigators who propose human subject research that is not specifically exempted must follow the guidelines for preparing and submitting proposals for review by the IRB. The IRB has the authority to suspend or terminate research that is not being conducted in accordance with the IRB's requirements, other institutional or federal requirements, or has been associated with any serious harm to subjects. Concerns regarding the conduct of research must be reported to the Chair of the IRB by any individual having such knowledge.

The IRB is responsible for determining that:

	The welfare and rights of human subjects are adequately protected and informed consent procedures are in place, if necessary.
	Human subjects are not placed at unreasonable physical, mental, or emotional risk as a result of research.
	The benefits of the research outweigh the risks to subjects.
	The researcher(s) is/are qualified to conduct research involving human subjects.

Meetings and Deadline
Meetings of the IRB are convened by the Chair, or the Chair's designee, at a minimum of once per month provided there are applications to review. Applications are due no later than 2 weeks prior to the IRB meeting, which is held the 1st Tuesday of the month. If this deadline is not met, the application will not be reviewed until the next month - there are no exceptions to this requirement. Emergency meetings may be convened, as appropriate and require at least 24 hours notice.

All applications submitted MUST have:

IRB Training Manual

If you have questions about the application or the IRB in general, please contact John Clements at (989) 583-6861, jclements@synergymedical.org or Leslie Francke at (989) 583-6984, lfrancke@synergymedical.org.