IRB Operations and Recordkeeping

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IRB operations

Review process

The IRB’s review process conforms to the Federal Policy for Protection of Human Subjects and the terms of the Federal-Wide Assurance established between the Northwestern Health Sciences University and the National Institutes of Health’s Office for Human Research Protections. The review process is the same for all research involving human subjects supported or otherwise subject to regulation by any federal department or agency, sponsored by any other extramural entity, or initiated and funded within the University. The authority conveyed to the IRB includes decisions to approve, disapprove, require modifications, monitor, suspend, and terminate research projects involving human subjects. Under no circumstance may a decision of the IRB to disapprove a project be reversed by another agency of Northwestern Health Sciences University. The IRB does not evaluate the scientific merit of the research; yet, the scientific merit is a factor in weighing the risks against benefits of the research.

Meeting schedule and agenda

The IRB meets monthly; however, the IRB may be called for an interim review session by the Chairperson at the request of any IRB member or institutional official to consider any concerns with the rights and welfare of subjects involved in research. A meeting may be canceled if no IRB applications are received within 10 days of the scheduled meeting. Meetings are not open to the public; however key personnel involved in the research under review will be invited to present their studies at IRB meetings. Additionally, the IRB may invite individuals with competence in special areas to assist in the review of issues that require expertise. These individuals will not participate in IRB voting.

Meeting agendas are set as follows:

  1. Approval of the previous month's meeting minutes
  2. Discussion of any IRB matters pending from previous meetings
  3. Review of IRB applications
  4. Discussion of IRB functions, procedures, guidelines, and other general issues pertinent to the committee as necessary

Full review of IRB applications

IRB applications for initial and continuing full review must be received at least ten days before a scheduled IRB meeting (see Meeting and Submission Dates). For an initial review, a primary reviewer will be assigned to the application no less than seven days prior to a scheduled meeting. The full review of IRB applications will occur during convened meetings at which a majority of the members of the IRB are present, including at least one member whose primary concerns are in nonscientific areas. In order for the research to be approved, it must receive the approval of a majority of those members present at the meeting.

At the convened IRB meeting:
  1. The Principal Investigator (PI) or designated key person for the research project will be invited to make a short presentation. The presenter will be excused from the meeting after the presentation.
  2. The primary reviewer will present the application to the IRB following the items on the "IRB Reviewer's Comments" form.
  3. The IRB will discuss the application.
  4. The PI or designee will be invited back to the discussion for clarification of items as necessary.
  5. The PI or designee, advisors, and any IRB member with a conflict of interest will be excused from the meeting for the final discussion and vote.
  6. The vote and any recommendations will be recorded by an IRB coordinator.
  7. All copies of the IRB application will be returned to an IRB coordinator.

Notification of IRB review status

The PI will receive written notification of the IRB application status no later than 10 business days after the meeting.

Additional review requirements

Continuing review occurs at least annually, but high-risk projects sometimes require more frequent review. The terms of the review, as well as the documentation required for any special review, will be specified with the approval notification.

Exempt review and minor changes in approved research

Exempt applications will be reviewed by the IRB Chairperson or designated IRB member. The investigator will receive notification of IRB review status within 14 business days. If the project does not qualify as exempt, it will be referred back to the investigator with the appropriate application form. Minor changes in approved research will be reviewed by the IRB Chairperson or designated IRB member. The investigator will receive notification of IRB review status within 14 business days.

Prompt reporting of changes in research activity

Investigator responsibilities

Investigators acknowledge and accept their responsibility for protecting the rights and welfare of human research subjects and for complying with all applicable provisions of 45CFR46. Research investigators shall promptly report to the IRB any proposed changes in research activity; changes shall not be initiated without IRB approval except where necessary to eliminate apparent immediate hazards to the research subjects. Research investigators shall promptly report to the IRB any unanticipated problems involving risks to subjects and others.

IRB responsibilities

The IRB Chairperson shall be responsible for submitting written notification to the appropriate institutional officials and the Office for Human Research Protections (OHRP):

  1. Any unanticipated problems involving risks to human subjects or others
  2. Any instance of serious or continuing noncompliance with regulations or the requirements or determinations of the IRB; or
  3. Any suspension or termination of IRB approval.

IRB recordkeeping

IRB records related to research studies shall be retained for at least 3 years after completion of the research, and the records shall be accessible for inspection and copying by authorized representatives of the Office for Human Research Protections (OHRP) at reasonable times and in a reasonable manner.

The IRB shall prepare and maintain adequate documentation of IRB activities including the following:

  1. Copies of all IRB applications reviewed:
    a. Scientific evaluations, if any, that accompany the applications
    b. Approved sample informed consent documents
    c. Progress reports submitted by investigators
    d. Serious adverse event reports
  2. Minutes of IRB meetings which shall be in sufficient detail to show:
    a. Attendance at the meetings
    b. Actions taken by the IRB
    c. The vote on these actions including the number of members voting for, against and abstaining
    d. The basis for requiring changes in or disapproving research
    e. A written summary of the discussion of controversial 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 identified by:
    a. Name and earned degrees
    b. Representative capacity
    c. Indications of experience such as board certifications, licenses, etc., sufficient to describe each member's chief anticipated contributions to IRB deliberations
    d. Any employment or other relationship between each member and the institution; for example: full-time employee, part-time employee, a member of governing panel or board, stockholder, paid or unpaid consultant.
  6. Written documentation of IRB functions and operations
  7. Copies of statements of significant new findings provided to human subjects in research (i.e., informed consent must include a statement that significant new findings developed during the course of the research which may relate to the subject's willingness to continue participation will be provided to the subject).
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