C. Review CategoriesAlthough exemptions from review are allowed per §45 CFR 46 (Common Rule).
NGHS IRB has agreed that exemptions will not be allowed. All studies otherwise qualifying as exempt will be handled as expedited applications.
Applications for review will be processed using the full board process unless they qualify for expedited or facilitated review.
As a means of keeping all members advised of activities affecting research proposals and allowing for comments regarding reviews conducted utilizing the expedited or facilitated review process, a ‘study by study’ listing with results of the expedited or facilitated review will be provided as a part of the "Standing Report" submitted to the Board at regularly scheduled meetings.
45 CFR 46.110(c)
A pre-review evaluation may be available through the IRB Coordinator dependent on time, need, complexity, etc.
1. Full Board: Initial Review
Every member of the IRB or the alternate, will be provided an agenda/application packet, containing identical information.
- NGHS IRB Initial Review Application
- Full Protocol
- Consent Document(s)
Stand-Alone’ HIPAA Authorization (for research)
NOTE: IRBs are not required to review and approve ‘stand alone’ HIPAA authorizations under the Privacy Rule, under 45 CFR 46, or under 21 CFR 56. Therefore, this IRB will not review, for approval, ‘stand alone’ HIPAA authorizations. Inclusion of this document (used by investigators and/or their support staff to obtain permission to use and/or disclose identifiable health information for research purposes) with other items submitted at the time of ‘Initial Review’ is to confirm that the document has been developed.
* Grant Applications
* Investigator’s brochure
* Interview guides
* Advertisements/Recruitment materials
* Any other available appendices (e.g. schemas)
All members will have equal responsibility to review and comment on each study action.
45 CFR 46.115(a)(1)
To facilitate the review process, it is required that the PI and/or a representative (e.g.. PI, Co/Sub-Investigator or Study Coordinator) with knowledge of the study attend the IRB meeting at which the new proposal will be reviewed. It is the PI’s responsibility to contact the IRB Office to make arrangements for meeting attendance. The PI must leavethe meeting prior to "calling the vote".
Researchers and/or research staff must provide the IRB Office the name(s) of the individual(s) who will be attending the IRB meeting as a representative for newly submitted research proposals, if that individual is not identified in the application as associated with the study (e.g. PI, Co/Sub-Investigator or Study Coordinator).
2. Expedited Review
Expedited review was designed to allow certain lower risk studies or common studies faster approval in order to reduce the impact on both members and investigators without substantive loss of protection of subjects. An expedited review application is to be submitted to the IRB Office.Federal regulations allow the IRB to review certain categories of research on an expedited review basis, if specified criteria as provided viahttp://www.hhs.gov/ohrp/humansubjects/guidance/expedited98.htm are met.
63 FR 60364-60367, November 9, 1998
The IRB Chair or one or more experienced reviewers, designated by the chairperson from among members of the IRB, may conduct the expedited review. In reviewing the research, the reviewer may exercise all of the authorities of the full Board (e.g. minor word substitutions or additions for clarification in ICD) except that the reviewer may not disapprove the research. The reviewer may refer the application to the full Board for a standard review as warranted.
45 CFR 46.110(b)
3. Facilitated ReviewFacilitated review is only used when the IRB of record is NCI’s Central Institutional Review Board (CIRB).
The IRB Chair and/or his/her designee(s) conducts the "facilitated review" and determines if the newly submitted protocol and informed consent document(s) are acceptable and appropriate in local context.
In reviewing the research, the reviewer may exercise all of the authorities of the full Board (e.g. minor word substitutions or additions for clarification in ICD) except that the reviewer may not disapprove the research. Additionally, the reviewer may refer the application to the full Board for a standard review as warranted.
A decision to accept the CIRB approval means that NCI’s CIRB is the "IRB of Record". Thus, the date of approval, the expiration date, the continuing review date and dates of amendment approvals will be the dates established by the CIRB.
Although it is understood that the local IRB is no longer required to perform amendment reviews, non-local SAE reviews, or continuing reviews for CIRB protocols, the NGHS IRB Chair will perform facilitated review for "Major Modifications", as defined by NGHS IRB.
All other types of amendments to CIRB protocols and/or ICDs, CIRB Continuing Reviews, and CIRB non-local SAE Reports will not be reviewed by this IRB. However, information related to these CIRB review activities will be summarized by the IRB Coordinator and provided to this Board via routine ‘Standing Reports’.
4. Post Approval Modifications
All changes to protocols must be reviewed and approved prior to implementation. Proposed changes must be submitted in writing.
Information, provided by the cooperative research group or sponsor, related to the expected type of IRB review (e.g.. no review necessary; expedited review; full board review) must accompany all materials submitted to the NGHS IRB for review. If information related to the expected type of IRB review is not provided by the cooperative research group or sponsor, the submitting party will be required to provide a statement, with the materials submitted for review, that no level/type of review was stipulated. Review of submitted materials will not occur without this information.
Modifications made to the study, including major modifications, will not change the expiration date unless the IRB specifically designates a new date at the time the modification is reviewed.
The IRB will attempt to refrain from requiring modifications mid-way through a protocol. However, if new information or insights necessitating changes becomes available then the IRB may deem it prudent to require protocol/study modifications.
Upon final approval, the IRB Office will forward to the PI and/or his/her research staff a copy of the first page of the consent form stamped with the approval date.
a. Administrative ModificationA protocol change that does not alter any substance at all may be an administrative alteration. Such a change should involve no change affecting subjects and/or requiring a change of the consent document.
Administrative modifications should be sent to the IRB office along with appropriate paper work (i.e.. Institutional Review Board: Protocol Modification Form). The Board will be informed of the administrative/editorial changes at an IRB meeting. A copy of the form reflecting IRB acknowledgement will be returned for the investigator’s file.
Examples of administrative modifications include:
- Memorandum explaining a study concept or other information that does not change study or consent.
- Temporary or permanent closure built into the study design or due to accrual goal being met.
b. Sudden ModificationA change to the protocol itself that is taken to reduce a risk of harm may be made without IRB approval. The investigator should submit the appropriate paper work to the IRB Office, within 5 working days, in order that the Board can be informed of the modification.
c. Minor ModificationsThe chair or one or more experienced reviewers, designated by the chairperson from among members of the IRB, may review "Minor" modifications using the expedited review process. Decisions available to the reviewer are: approval; approval contingent on a response; or, referral to full board. The action will be reported at the next meeting.
Examples of minor modifications include:
- Addition of another site known to the reviewer
- Changes in wording of protocol or consent forms to clarify a concept
- Minimal changes in level of risk
- Advertisements and other recruitment materials
- Small changes in compensation
- Grammatical or organizational changes in consent forms
Adding an investigator who has already been approved for another study if the study is in the same disciplinary area.
45 CFR 46.110(b)(2)
21 CFR 56.110(b)
d. Major Modifications of Approved Protocol
Major modifications will be circulated to all members and reviewed using the full board review procedures.
Examples of major modifications include:
- Changes in study design that involve increase risk or discomfort to participants
- A substantive change in enrollment numbers
- Any application for which no clear rationale is given.
5. Continuing ReviewUpon final approval, the IRB will determine a date for continuing review. This date will be one year or less from the approval date depending on: the degree of risk involved; the study design; or, the level of trust in the investigator or sponsor. This requirement is called "continuing" rather than "annual" review to lower the expectation of a one-year approval.
45 CFR 46.109(e)
21 CFR 56.109(f)
Continuing review of research, for which this IRB is the ‘IRB of Record’, will be accomplished using the full-review process, provided the research does not qualify for expedited review or facilitated review. The same elements will be considered during continuing review as were considered during initial review. However, the purpose of continuing review is to review the progress of the entire study, not just changes in it. Emphasis will be placed on new knowledge in the field, the progress report, reports submitted concerning adverse effects, if any, and the reported activity in the study.
When the full-review process is used, every member of the IRB or the alternate will be provided an agenda/application packet, containing identical information:
- Protocol summary
- NGHS IRB Continuing Review Application
- Copy of last consent document signed (participant’s identity obliterated)
Supporting documents (as appropriate)
- Grant Applications
- Investigator’s brochure
- Interview guides
- Advertisements/Recruitment materials
Any other available appendices (e.g. schemas)
OPRR Reports 95-01
Continuing review of research previously approved by the convened IRB may be accomplished using expedited review procedures if:
- The research is permanently closed to enrollment of new participants; all participants have completed all research-related interventions; and, the research remains active only for long-term follow-up of participants, or
- No participants have been enrolled and no additional risks have been identified, or
The remaining research activities are limited to data analysis.
63 FR 60364-60367