Procedures for IRB Members

Procedures IRB members will follow in reviewing proposed research

1. Document Processes. The Salish Kootenai College IRB will be responsible for maintaining records of all applications, minutes of meetings, decisions, and replies to applicants for IRB review. The IRB Secretary shall assure these responsibilities are met. All IRB applications for a reviewed research project will be stored for a minimum of three years after the review application for rejected proposals, and for at least three years after the completion of approved research, in a locked cabinet in the Office of Institutional Research. Specifically, and in accord with 45CFR46, it is the responsibility of the IRB to maintain:

  1. Copies of all research proposals reviewed, scientific evaluations, if any, that accompany the proposals, approved sample informed consent documents, progress reports submitted by investigators, and reports of harm to subjects.
  2. Minutes of IRB meetings shall be in sufficient detail. At a minimum the minutes will record attendance at the meetings, actions taken by the IRB, the vote on these actions including the number of members voting for, against, and abstaining, the basis for requiring changes in or disapproving research, and a written summary of the discussion of issues and their resolution.
  3. Records of continuing review activities.
  4. Copies of all correspondence between the IRB and the investigators.
  5. A list of IRB members in the same detail as described in §46.103 (b)(3).
  6. Written procedures for the IRB in the same detail as described in §46.103 (b)(4) and §46.103 (b)(5).
  7. Statements of significant new findings provided to subjects, as required by §46.116 (b)(5).

All records shall be accessible for inspection and copying by authorized representatives of the Department or Agency funding the research at reasonable times and in a reasonable manner. All IRB records are available for review by others besides authorized representatives of the funding agency upon request, except for those records that could potentially harm any human subjects or compromise the cultural and other intellectual property rights of the Confederated Salish and Kootenai Tribes. The full IRB shall vote on the release of IRB records.

2. Meeting Logistics. The SKC IRB will respond to requests for reviews of proposed research in a timely manner.

  1. Either the IRB Chairman or Secretary are authorized to respond to questions by research investigators about the SKC IRB process. Other IRB members shall refer questions they receive to the Chairman or Secretary.
  2. New IRB members must complete the same training in ethical research practices required of researchers applying for IRB review. In addition new IRB members must certify they have read and understand SKC policies and procedures govern the IRB.
  3. The Secretary shall collect all IRB review application materials from the research investigator. The Chairman and Secretary together will decide to confirm or reclassify what the research investigator indicated on the IRB review application form is the appropriate level of review for the proposed research. If the Chairman and Secretary do not agree the full IRB will make that determination.
  4. Proposed research that is classified as exempt does not require further review. Proposed research classified as requiring expedited review shall be reviewed by two members of the IRB. The Chairman shall select the two IRB members who will perform the expedited review. Proposed research classified as requiring full review shall be reviewed by all IRB members.
  5. The Chairman is responsible for convening IRB meetings. Full IRB meetings will be scheduled monthly. IRB members will have at least one week before the meeting to review applications.
  6. Either or both of the Confederated Salish and Kootenai Tribes Culture Committees will be asked for guidance as appropriate when the proposed research is classified as requiring cultural review.
  7. All IRB decisions are by majority vote, and meetings will be governed by standard parliamentary procedures.
  8. The SKC President may overall the SKC IRB on decisions regarding proposed research subject to cultural review.
  9. The SKC IRB is the sole authority governing decisions on exempt, expedited, and full review human subject research. The IRB has the authority to approve, require modifications in, or disapprove the proposed research.
  10. Any IRB member who is a principal investigator or co-investigator on a proposal being reviewed by the IRB can be present during IRB deliberations but must abstain from voting and be absent from the room during voting.
  11. Proposals classified as exempt since the last full IRB meeting will be recorded as such in the minutes of the next full IRB meeting.
  12. For each approved application a written approval sheet will be signed by all voting IRB members present at the meeting.
  13. Copies of proposals distributed to IRB members will be shredded after review except for one copy retained for the locked IRB file cabinet.
  14. IRB review at a minimum shall include

i. a review of the the Application Form: does the abstract description agree with the description in the consent form? Do the rationale and experimental design suggest that useful information is likely to result? Are there risks to the subjects? Is there a realistic chance of benefit?

 

ii. a review of the Informed Consent Form. Respect for persons requires that subjects, to the degree that they are capable, be given the opportunity to choose what shall or shall not happen to them. This opportunity is provided when adequate standards for informed consent are satisfied. Proposals requiring full or expedited review must use informed consent forms and seek consent from each prospective human subject or the subject’s legally authorized representative.

3. Notification. The SKC IRB will notify research investigators of the result of the review in a timely manner.

  1. Notification will include approval to proceed without conditions, approval to proceed with conditions, or disapproval. Notification may also include recommendations the investigator is not required to follow.
  2. Notification will be made to applicants and will be reflected in the minutes of the IRB Committee. IRB minutes will be posted electronically and will be made available in hard copy by the Chair of the IRB.
  3. Dissemination of Information on the SKC IRB Review Process. The SKC IRB will publish protocols for application for IRB review for each category of risk, and will post those protocols, application forms, and other relevant information as a link from the Salish Kootenai College Office of Institutional Research website.