IRB Policy and Procedures

Pace University Institutional Review Board Policy
and Procedure for Proposal Review

Policy

It is the policy of the Pace University Institutional Review Board (IRB) to assure unbiased review of all submitted proposals for research and to inform the principal investigator submitting the proposal results of that review

Procedure

1. All research proposals submitted by someone affiliated with Pace  University will be reviewed in a standard manner.

2. All research proposals are to be submitted to:

Beatrice Moy, 163 William St, Room 316, Pace New York Downtown Campus. Proposals can be submitted electronically at PaceIRB@pace.edu.

3. Principal investigators are required to submit materials 8-10 weeks in advance of the date a decision is requested. In the case of Full Review Studies (see IRB application guidelines), submission is required 8-10 weeks prior to the next scheduled IRB meeting (contact Brian Evans at bevans@pace.edu or Lin Drury at ldrury@pace.edu for dates). The IRB will attempt to convene a special meeting if necessary to accommodate the principal investigator’s compliance with an external funding deadline; however, submission is required 8-10 weeks prior to the special meeting date.

4. On receipt of a proposal for review, the IRB Coordinator will preliminarily assess the completeness of the submission. If the submission is incomplete the IRB Coordinator will so inform the principal investigator and request the additional material. Once the submission is deemed complete, the IRB Coordinator will so advise the principal investigator and will distribute the materials to the assigned members of the IRB. Exempt studies will be reviewed by one member of the committee; expedited studies will be reviewed by two committee members; full review studies are sent to the entire IRB membership for review.

5. The IRB Coordinator logs in all submitted proposals and maintains this log for all proposals. The log entry for each proposal includes: the IRB code number (assigned by the Coordinator); the name of the principal investigator; the title of the proposal; a brief description of the proposal that specifies the intervention or hypothesis to be tested or, in the case of qualitative proposals, the method for data collection and analysis; the assignment of the proposal for exempt, expedited or full review: the dates of IRB review; a summary of action taken by the IRB; the date of enrollment of the first subject; and the date for annual IRB review.

6. The designated IRB member(s) will perform the initial review of each proposal, including the assessment of the completeness, clarity, scientific merit, risk/benefit, and ethical propriety of the proposal.  If the proposal is deemed exempt or expedited, the IRB Chairperson will so notify the principal investigator.

7. If the proposal is deemed to require a full review, the principal investigator will be required to submit additional copies of the proposal to be forwarded to the entire IRB membership by the IRB Coordinator. The complete proposal is reviewed by the entire IRB membership. The IRB Chairperson will communicate in writing the results of the IRB review to the principal investigator.

8. The IRB Coordinator will maintain complete files of all proposals submitted and all correspondence and other documentation pertaining to each proposal.

9.  On a quarterly basis, the IRB Coordinator will report to the full IRB documentation of all logged proposals for that quarter, using the “Log of Proposals Received.”

Compliance

Consistent with Federal Regulations (45 CFR n 46.113), the IRB

                   ". . . . . shall have authority to suspend or terminate approval of research that is not being conducted in accordance with the IRB's requirements or that has been associated with unexpected serious harm to subjects. A suspension or termination of approval shall include a statement of the reasons for the IRB's actions and shall be reported promptly to the investigator, appropriate institutional officials, and the department or agency head."

Human subjects research that deviates from the policies, procedures, stipulations, decisions, state or federal law is non-compliant and subject to further inquiry by the IRB.