PROCEDURE

Investigator Responsibilities

Investigator:

Completes, electronically signs, and submits FOR200 IRB application eForm with the continuing review section completed:
- FOR200 IRB application eForm updated with any changes
Submits one copy of the following:
- Revised consent document(s) with changes highlighted, if applicable,
- A “clean” copy of the consent document(s) to receive IRB approval stamp,
- Addendum informed consent document(s) for currently enrolled participants, if applicable, and
- Summaries of reportable problems (including adverse events) for determination as to unanticipated problems involving increased risks to subjects or others.
Submits an updated funding application, if applicable.
- Endeavors to submit continuing review application materials at least 30 days prior to expiration date to avoid a lapse in the protocol.
Ceases all research activities including stopping new enrollment, recruitment, advertisements, procedures on current participants, and collection of identifiable private information if the IRB has not reviewed and approved the research by the expiration date; makes a written request to the IRB for research activities to continue following expiration of IRB approval if there is an overriding safety concern or ethical issue present such that it is in the best interests of individual participants to continue participating in research interventions and interactions.

OIRB Responsibilities

Administrative Staff:

Receives the submission in the electronic system and assigns it to the appropriate reviewer.
Receives Investigator's Progress Report submissions and verifies the “Convened,” “Continuing,” or “Final” status.
Checks to see if protocol is open or closed to accrual, open for data analysis only, or long-term follow-up.
Reviews protocol submissions for completeness and notifies Investigator and contact of any deficiencies.
Schedules protocol for appropriate IRB committee review.
Forwards materials for distribution to IRB in accordance with PRO145 Procedure for Timing of Document Distribution for IRB Meetings.
Sends communication of IRB actions, approval form, and stamped informed consent document to Investigator.
Drafts communication of IRB action to Investigator for review by management staff.
Enters final actions into the electronic system (i.e., approved or additional information required).
Sends communication of IRB actions to Investigator.
Once final approval is issued, enters date issued into electronic system and emails approval and stamped approved informed consent document(s).
Prepares draft minutes of the IRB meeting for review by the management staff.

Reviewing Staff:

Reviews protocols prior to meeting.
Answers queries from IRB members.
Takes notes on IRB actions for each protocol during convened meeting Drafts, reviews and issues communications on behalf of the IRB to the Investigator.

IRB Responsibilities

IRB member:

Receives the following information, as applicable:
- IRB application eForm with the continuing review section completed,
- Informed consent document(s),
- Summaries of reportable problems (including adverse events) for determination as to unanticipated problems involving increased risks to subjects or others,
- Preliminary research findings,
- Manuscripts,
- Abstracts,
- DSMB or other monitoring reports, and
- Progress reports to and from sponsors.
Reviews all information provided in enough depth to discuss each protocol during the meeting.
Contacts OIRB management staff assigned to meeting or Director to obtain protocol file or relevant minutes before or during meeting.
Contacts OIRB management staff assigned to meeting or Director to obtain information provided any other reviewer (e.g. primary reviewers).

Each Primary Reviewer assigned a protocol for primary review:

Reviews all materials found in the electronic protocol record in depth to lead discussion at the meeting.

The IRB to perform continuing review of each protocol in a substantive and meaningful way in accordance with the criteria at 45 CFR 46.111, 21 CFR 56.111, and any other funding sources, as applicable:

Discusses the following specific areas related to the research, as applicable:
- Status of the Study - open to enrollment, follow-up only, data analysis only, closed and final reports. (Note: Continuing IRB review applies to research open for long-term follow-up only when all research interventions are completed, as well as, research open for data analysis only.),
- Changes in risk-benefit ratio of study based on study findings,
- Reports of summaries of reportable problems, non-compliance, complaints about the research, monitoring reports and makes specific determinations of unanticipated problems involving risks to subjects or others and non-compliance as appropriate,
- Written informed consent document(s) to assure the consent document embodies the necessary elements and any significant new findings that may relate to the participant’s willingness to continue participation,
- Adequacy of the data safety monitoring plan,
- Recruitment activities including number of participants screened, enrolled, and withdrawn with respect to the research and characteristics of the study population,
- Conflicts of interests, if applicable,
- Other information provided by the Investigator, and
- Other information relevant to the IRB’s adequate review of the research.
Discusses and determines if review interval is appropriate (no longer than 1 year) based on the criteria in POL022 UAB Policy on IRB Review of Human Subjects Research by Convened Board.
Discusses and determines whether the project needs verification from sources other than the investigators that no material changes have occurred since previous IRB review in accordance with POL022.
Takes action by simple majority vote and documents findings that the protocol falls into one of the following classifications:
- Approved - No modifications required. Research activity meets 45 CFR 46.111 or 21 CFR 56.111.
- Additional Information Required - May be used when there are specific modifications required by the IRB to be reviewed by one voting IRB member by the expedited procedure before formal approval can be issued. Cannot be used for modifications or clarifications that are related to the regulatory criteria for approval.
- Deferred for Response - IRB requested clarification to the human subjects protocol. The response to the IRB and/or informed consent document will be reviewed at a convened meeting of the IRB before formal approval can be issued.

The entire protocol submission (protocol, grant/funding application, sponsors’ protocol, appropriate departmental approvals and informed consent document) will be available to the IRB for the review of the response.

Disapproved - The research did not meet 45 CFR 46.111 or 21 CFR 56.111.
Sponsor-Imposed Suspension - The IRB receives written notification from the Investigator that the sponsor has suspended the research study. This will be acknowledged by the IRB Committee, Chair or his/her Designee when the appropriate level of review determines the suspension is appropriate. The IRB may impose additional criteria for suspension, if needed, to protect the participants from potential harm. This determination may be made for interim data analysis; inadequate drug availability; in response to a DSMB report/recommendation; or a planned stopping point.
Suspension of IRB Approval - IRB made a determination to temporarily suspend or withdraw approval of all or some specific research activities indicating that the specified activities must cease immediately. The only exception will be for the continuation of IRB approved follow-up activities necessary to protect the participants’ safety.
Termination of IRB Approval - The IRB made a determination to permanently withdraw approval of all research activities, indicating that the specified activities must stop immediately. The only exception will be for the continuation of IRB approved follow-up activities necessary to protect the participants’ safety.
Completion (Final Report/Study Closure) - The IRB made a determination to accept the Final Report submitted by the investigator and change to study to completed in the electronic system.

Provides written communication to the Investigator of IRB action within 10 working days. If a protocol is deferred or disapproved for any reason, the committee includes reasons for the action and an invitation to respond to the IRB in writing or in person. Any suspension or termination of IRB approval or sponsor-imposed suspension will be processed according to POL038 UAB Policy on Suspension or Termination of IRB-Approved Research and Administrative Hold and PRO140 Procedure for Suspension or Termination of IRB-Approved Research and Administrative Hold.
Notifies the Investigator whose protocol has lapsed that IRB approval of the protocol has expired. Notice includes a statement that no new enrollment may occur and all research activities must cease including recruitment, advertisements, procedures on current participants, and collection of identifiable private information unless the Investigator initiates a memorandum to the IRB requesting that research activities for currently enrolled participants continue because the interventions are in the individual participants’ best interests. The IRB chair or designee will decide which individuals may continue in the research because of an overriding ethical concern. This decision will be communicated in writing to the investigator.