A. IRB responsibilities:
1 . Continuation (renewal) of research: HHS policy (45 CFR 46.109(c)) and FDA regulations (21 CFR 56.108(a) (1) and 56.109(c)) require the IRB to conduct continuing review (to approve or disapprove the continuation of a research project) at intervals appropriate to the degree of risk, but at least annually. The IRB will determine which research projects need verification from sources other than the investigator that no material changes in the research have occurred since the previous IRB approval (21 CFR 56.108(a) (2)).
2. Revisions of research:
The IRB is responsible for ensuring that changes in or revisions of approved research, including protocol changes or consent form changes, during the period for which IRB approval has already been given, may not be initiated without IRB review and approval except where necessary to eliminate apparent immediate hazards to human subjects (21 CRF 56.108 (a) (3-4)).
3. Adverse events:
IRB continuing review responsibilities also include reviewing reports, from the investigator or others, of adverse reactions and unexpected events involving risks to research subjects or others. Therefore, the IRB has established a procedure for receiving and reviewing these reports.
4. Termination of research:
The IRB has authority (45 CFR 46.113) to 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 harm to subjects. 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 and appropriate institutional officials.
B. Investigator Responsibilities
1 . Requests for Revisions (Changes) of Ongoing Research Projects (Form 2): Proposed changes in or revisions of ongoing previously-approved research during the period for which approval is authorized must be reviewed and approved before the change or revision can be implemented. This applies to changes/revisions in the research design and/or the consent form. Investigators must submit Form 2 to request revisions or changes. Investigators will be notified of Board action within seven days following the IRB meeting to which the application was submitted. Possible actions are: approval; approval with proviso(s); deferral for additional information; or disapproval.
Submission of Form 2 requires the original and 20 copies.
In accordance with 21 CFR 56.1 10(b), the IRB may use expedited review procedures to review minor changes. However, if the proposed change in the research study is not minor, then the IRB will review and act on the proposed change during a full board meeting. The IRB administrative section will assign proposed changes in research, as submitted by the investigator on Form 2, to either the expedited or full board review category.
2. Approval to Continue (Renew) an Ongoing Research Project (Form 3): Initial IRB approvals, and any subsequent approvals to continue the research, will be for specified periods of time; often one year, but not infrequently for time periods of less than one year. If it is necessary or desirable for the research project to continue beyond the time frame established by the most recent approval date, then it is the responsibility of the investigator to submit an "Application to Continue a Previously Approved IRB Project" (Form 3). This application (Form 3) should be submitted at least two weeks in advance of the desired IRB meeting date. Investigators will be notified as to Board action within seven days following the IRB meeting to which the application was presented. These applications for continuation will be either: approved; approved with proviso(s); deferred for additional information; or disapproved.
Submission of Form 3 requires the original and 20 copies.
The continuation of research after expiration of IRB approval is a violation of Federal Regulations (21 CFR 56.103(a)). If the IRB has not reviewed and approved continuation of a research study by the study's current expiration date, research activities should cease. No new subjects may be enrolled in the study. If the investigator is actively pursuing renewal (continuation) with the IRB and the IRB believes that an over-riding safety concern or ethical issue is involved, the IRB is permitted some flexibility for allowing currently enrolled subjects to remain in the research project for the brief time required to complete the continuation review process. When study approval is terminated by the IRB (for one example, due to lack of compliance with continuing review requirements), in addition to stopping all research activities, any subjects currently participating are to be notified that the study has been terminated. Procedures for withdrawal of enrolled subjects should consider the rights and welfare of subjects. If follow-up of subjects for safety reasons is permitted and/or required by the IRB, the subjects should be so informed and any adverse events and outcomes should be reported to the IRB and the sponsor.
It should be noted that the criteria for approving continuation of the research project are the same as the criteria for initial approval of the project. Therefore, the investigator must submit sufficient information for the IRB to ensure that: risks to subjects are minimized; risks to subjects are reasonable in relation to anticipated benefits; selection of subjects is equitable; informed consent is adequate and appropriately documented; where appropriate, the research plan makes adequate provision for monitoring the data collected to ensure the safety of subjects; there are adequate provisions to protect the privacy of subjects and to maintain the confidentiality of data; and that appropriate safe guards have been included to protect vulnerable subjects.
3. Reporting of Adverse Events (Form 4): The investigator has the obligation to report all serious adverse reactions and unexpected events. Such events will be reported on Form 4. The investigator will assess the event as to the potential impact on the benefit/risk ratio and consider the necessity of modifying the protocol, or at least the informed consent as a consequence of the event.
Submission of Form 4 requires the original and 20 copies.
All reports of unanticipated problems will be reviewed by the Administrative Section of the IRB. Reports considered to be of minor significance will be reviewed by an expedited process. More serious reports and those requiring significant revisions to the protocol and/or the consent form will receive full Board review at the next convened meeting of the IRB. In either case, within seven working days following a convened meeting of the IRB, the investigator will receive in writing confirmation of receipt of Form 4 and a report of the Boards action on investigator proposed revisions in the protocol and/or the consent form.
4. Request for Solicitation/Advertisement Materials (Form 6): Investigators are required to complete Form 6 on all proposed advertisement or solicitation materials to be used for subject recruitment. Submission of the sample advertisements, i.e., fliers, newsletters, letters to subjects or physicians, TV scripts, etc., must be included with Form 6.
Submission of Form 6 requires the original and 2 copies.
5. Final Reports (Form 7): Investigators are required to submit a final report (Form 7) to the IRB indicating that the research project has been completed as planned or terminated for other reasons including a brief summary of the study results, with emphasis on a comparison of the actual results to the investigator's original assessment of anticipated results, risk and procedures. Completion of Form 7 in its entirety will be sufficient to terminate or close an IRB project.
Submission of Form 7 requires the original and 20 copies.
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