Responsible Office: The office of the Director for Quality Assurance will provide the mandate to the IRB. To ensure independence of the IRB, the IRB will create and oversee a process which ensures fair, and timely review of all submitted research proposals. The IRB will keep the office of the Director of Quality Assurance informed of all decisions taken by the IRB.
1. All research proposals should be submitted electronically using the research format to email@example.com. The submission should include the research format, the informed consent form, the research instrument and a letter seeking IRB approval.
2. The members of the IRB and the external experts will provide their comments using the reviewer form.
3. The IRB will inform the Office of the Director of Quality Assurance of each decision.
4. The IRB will provide non-confidential summaries of the IRB’s work to the President’s cabinet.
Chair: This person will be initially selected by the President’s cabinet and will serve for a period of one year. Later the Chair will be selected by the members of the IRB and ordinarily will serve for a maximum of three calendar years. The same person may become eligible to serve again provided that three years have elapsed since s/he last served as Chair of this Committee
Scope: This Committee will have oversight of all Researchers (groups or individuals) and Research participants who are involved in research that is conducted under the auspices of WMSI.
Overview: The IRB has full responsibility to protect all the rights and welfare of actual or potential human research participants.
1. Determine which Research Proposal will involve human participant research;
2. Review research proposals then alternatively:
a. Approve the proposal without modification,
b. Determine what modifications are required to secure approval; or
c. Disapprove the research proposal.
3. Apply faithfully all policies related to research at WMSI;
4. Make recommendations that will improve the protection of human participants;
5. 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 participants. When the approval of research has been suspended or terminated, the associated research project will be discontinued until the approval is reinstated. Any suspension or termination of approval shall include a statement of the reasons for the IRB’s action and shall be reported promptly to the investigator, appropriate institutional official, and the department.
6. Meeting Schedule: The Committee should meet on a needs-to-basis. All documents to be considered at such meetings must be circulated to members at least 5 clear working days before the meeting date. Notwithstanding the Committee must meet at least once during each semester (four-month period).
1. On receipt of a proposal the IRB will consider whether the research proposal falls into an exempt category using the following documents: https://irb.unca.edu/exempt-expedited-and-full-review and section 46.101(b) of 45 CFR 46 available at https://www.hhs.gov/ohrp/regulations-and-policy/regulations/45-cfr-46/index.html#46.101(b)
2. If a proposal falls into the exempt category then the proposal is circulated electronically to all members of the IRB.
3. The IRB members will provide their inputs regarding the submitted research proposal within 10 calendar days.
4. IRB members will review all information given to participants as part of informed consent to ensure that such information is in accordance with appropriate laws, regulations, and international standards.
5. Based on inputs from the members the Chair of the IRB may either approve the proposal as it is, seeks revisions from the authors or reject the proposal.
6. The Chair shall inform the members electronically before approving a research proposal.
7. If the members on their initial review of a research proposal determine that the proposal is not belonging to an exempt category then a more rigorous review process will be followed.
8. Members will be provided a time period of 14 calendar days to critically review the proposal and ensure the protection of human subjects.
9. Members may require that additional information is given to the participants when, in the IRB’s judgment, the information would meaningfully add to the protection of the rights and welfare of participants.
10. Members should determine as required by university policies and/or Government regulations:
a. Waiver or alteration of the consent process.
b. Research involving pregnant women, human fetuses, and neonates.
c. Research involving prisoners
d. Research involving children.
11. The Chair of the IRB will call a meeting of all IRB members which the external experts can attend electronically.
12. Each member during the meeting will provide his/her decision regarding the research proposal.
13. Based on the decisions of the members and the external experts, the Chair of the IRB will notify investigators and the institution (dean) in writing of its decision to approve or disapprove the proposed research activity, or of modifications required to secure IRB approval of the research activity. If the IRB decides to disapprove a research activity, it shall include in its written notification a statement of the reasons for its decision and give the investigator an opportunity to respond in person or in writing.
14. Conduct continuing review of all research approved by the IRB at intervals appropriate to the degree of risk, but not less than once per year
15. The member secretary will prepare Minutes of the Meetings of the IRB which shall include the following:
a. Names of Attendees;
b. Attendees Affiliation;
c. Attendees representative capacity;
d. Actions or review of actions that were taken;
e. The vote on each action, if required, including number of yes, nays, and abstentions;
f. The basis for requiring changes in or disapproving research;
g. A written summary of the discussion of controverted issues and their resolution.
h. Separate deliberations for each action.
i. Attendance at the meeting for each action.
j. For initial and continuing review, the approval period.
k. The names of IRB members who absented themselves from the meeting due to a conflicting interest along with the fact that a conflicting interest was the reason for the absence.
Output: Written permission to carry out the research as requested along with modification, if any, that the IRB deem necessary. Permission will not be granted when the IRB has determined that the proposed research will remain problematic regardless of changes that are made.
a. At least five members;
b. At least one member must represent a non-scientific area (a lay member);
c. At least one member must not be affiliated with the institution or the trial site (an independent member);
d. At least one member is recommended to be able to review and evaluate the science, medical aspect and ethics of the proposed research;
e. At least one clinical faculty member
Decisions: Decisions are usually arrived at by consensus. Proposals may be accepted as submitted without the need for modifications. If a member of the IRB requests modifications they should mention whether they would like to review the modified proposal or whether a decision on the modified proposal can be made by the Chair of the IRB. If a member has requested a review of a revised proposal they are required to submit their decision about the proposal within seven calendar days.
CAAM-HP standards IS-12, IS-14, ED-12, ED-20