Guidelines and Format for Submitting Proposals

The Institutional Review Board for Research Involving Human Subjects adopts the following guidelines for its consideration of applicable research proposals and the format for the submission of applicable research proposals. These guidelines and submission format are consistent with the "Policies for the Protection of Human Subjects in Research" at The University of North Carolina at Pembroke. These guidelines shall be subject to periodic review and chance as deemed to be appropriate by the Review Board.

GUIDELINES

1. The Review Board shall meet during the first week of each month.

2. Research proposals must be submitted no later than the third Friday of each month for consideration at the following month's meeting.

3. The principal investigator(s) shall submit ten (10) copies of each research proposal in the format specified by the Review Board.

4. A quorum of two-thirds of the Review Board, excluding ex officio members, must be present for the consideration of any proposals or other relevant matters.

5. A majority vote will be necessary for approval of any Review Board actions.

6. The principal investigator, or designated representative, shall be present at the meeting of the Review Board for which a submitted proposal is being considered. The principal investigator will present a brief synopsis of the research proposal and respond to questions as appropriate.

7. The Chairman of the Review Board shall provide written notification of the Review Board's actions to the principal investigator of a research proposal.

8. The format for the submission of research proposals shall be as follows and address the following relevant questions. Each proposal should be as brief as possible and still address each of the pertinent concerns indicated in the following section.
 

FORMAT  Title Name of the Principal Investigator(s) [Note: If the principal investigator is a student rather than a faculty member, then the faculty member supervising the research proposal, course number and title are to be indicated.]  Overview or Abstract  Brief Summary of Purpose(s) or Goal(s)  Method  a. Materials and/or Procedures to be Used  b. Procedures for Identification of Subjects  c. Method of Subject Selection  Ethical Considerations  a. Informed Consent by Subjects  b. How is this obtained?  What records are to be retained?  Description of procedures for subject withdrawal without prejudice.  Relationship, if any, to course credit for subject participation.  Risk of Physical and/or Psychological Harm  Privacy, Confidentiality, and Anonymity  Provisions for Subject Debriefing as appropriate  Reporting of Results  a. What procedures will be used?  b. How and where will results be reported/used?  Retention of Records and/or Results a. How will data be stored?  b. How long will individual data be retained?  c. How will data be destroyed?