There are several training modules for new investigators that cover the ethical and regulatory requirements for conducting research with human subjects. Investigators must complete the required training activities before they will be permitted to submit protocols for review.
Prior to IRB review, NIH requires that all intramural research protocols involving human subjects undergo review of scientific content. To fulfill this requirement, all NHGRI protocols undergo review by the Scientific Review Committee (SRC) at the time of initial submission and then again every three years (or more frequently per the IRB's discretion). The SRC provides investigators with a written review and a summary of outstanding comments and concerns. The PI must address these concerns in a memorandum to the Branch Chief, whose signature indicates that the response is satisfactory. This is required for both initial and triennial review.
Required elements for SRC Submission:
In fulfilling their mandate to protect the rights and safeguard the welfare of research subjects, PIs' submitted protocols and the IRBs initial review of protocols must take into account federal regulatory requirements and those of the NIH Human Subjects Research Protections Program.
Each submission will undergo administrative review by NHGRI IRB staff to determine that each of the required items has been submitted. Initial submissions to the IRB are requested two weeks earlier than the deadline for other kinds of submissions to allow enough time for this review and follow up with investigators, if needed. (See the SRC and IRB Submission Calendar.)
In addition, there are a number of more substantive ways for investigators to receive assistance with the development of a study. NHGRI protocol navigators are available to help with writing and revising protocol documents and consent forms. (See the NHGRI Protocol Service Center (PSC)). The NHGRI Bioethics Core can consult with investigators at any point during the protocol's development to discuss targeted ethical questions that might arise. The Bioethics Core is also able to offer an informal pre-review of completed protocols with the goal of helping investigators to spot and prepare for possible ethical concerns that the IRB might raise. This pre-review service is not required but is highly recommended, particularly for high risk and/or complex studies. If a pre-review is desired, early submission is requested in order to allow for sufficient review time.
PIs should plan to attend the IRB meeting at which their initial protocol application will be reviewed. PIs are asked to provide an informal (no slides) 5-minute overview of the protocol to summarize the research question and design, risks to participants and plans to minimize these risks, plans for selecting and recruiting participants, and the approach that will be used to obtain informed consent. The IRB coordinator will inform the PI of the approximate time at which the protocol will be reviewed.
As soon as possible upon completion of IRB review (usually within a week), the IRB staff notifies PIs of the IRB actions, stipulations and recommendations. Upon receipt of final IRB approval and documentation of all other required approvals, the IRB staff forwards the protocol packet to the NIH Office of Protocol Services (OPS). OPS obtains necessary approvals from the Clinical Center, assigns a protocol number, prepares date-stamped consent / assent forms, and posts the approved consent / assent forms on the Web. Please note that in order to ensure that the approved version is being used, research teams should always use this posted version of the consent form.
Required elements for initial protocol submissions to the IRB:
All open IRB protocols must be reviewed at least once a year by the IRB, at intervals appropriate to the degree of risk, to ensure the continued protection of the rights and welfare of research participants.
All ongoing protocols undergo a more extensive review, including review by the Scientific Review Committee (SRC), every three years. At this time, protocols should be rewritten and updated to account for any changes in the study design as well as changes in the corresponding scientific field that have an impact on the study.
Reminder memos with deadlines will be sent to the PIs by the IRB staff as well as automated reminders from PTMS.
Each IRB submission will be reviewed by IRB staff to determine that each of the required items has been submitted.
Required elements of continuing review submissions to the IRB:
Expedited review is a process by which the review of a submission (initial, continuing, triennial or amendments) is performed by the IRB Chair, Vice Chair or other IRB members designated by the Chair / Vice Chair, rather than by the full Board. As specified in 45 CFR 46.110 [hhs.gov], submissions may be considered for expedited review if the procedures present no more than minimal risk to human subjects and fall within specific categories [hhs.gov].
Most initial reviews are not performed on an expedited basis. To discuss exceptions, please contact the NHGRI IRB Chair.
Expedited review may be requested by the PI or may be initiated by the IRB chair.
For use with new submissions, continuing reviews, triennial reviews and amendments.
Please submit materials into PTMS and place under the header of IRB Notice and Response. Please then email NHGRIIRBOffice@nih.gov and let the office know that the stipulations have been submitted in PTMS.
Any changes to approved protocols, consent forms, and associated documentation must be reviewed by the IRB via an amendment. Amendments may be submitted at the time of continuing review or during the period between these reviews and must be approved by the IRB, Clinical Director and the Office of Protocol Services.
Required elements of amendment submissions:
New procedures for reporting unanticipated problems, adverse events, and protocol deviations, as described in SOPs 16 [federation.nih.gov], are effective immediately. Add guidance for reporting categories. A decision tree [federation.nih.gov] to help guide investigators through the unanticipated problem reporting requirements is also available.
PIs must submit the closure request after all subject accrual, data collection, and data analysis are completed. Required elements for closure submissions:
Exemptions and "Not Human Subjects Research" Determinations
The NIH Office of Human Subjects Research Protections (OHSRP) is authorized to determine that some research activities are exempt from IRB review or are not considered to be research involving human subjects. If a PI thinks his/her research activities fits into one of these categories, s/he should complete the appropriate "Request for Determination' form on the OHSRP website at: https://federation.nih.gov/ohsr/nih/formtmp.php [requires NIH Login]- under the Investigator Resources section, click on Forms and Templates.
Radiation Safety Committee (RSC)
All studies that expose subjects to ionizing radiation for research purposes must undergo review by the Radiation Safety Committee (RSC). Protocols may be submitted for radiation safety review at any time during the IRB review process, but IRB review is not final and the study cannot begin until all required approvals are in place and documented.
Food and Drug Administration (FDA)
An IND or IDE is required for some studies using pharmaceuticals or devices. It is the responsibility of the PI to determine if an IND / IDE is needed and, if so, to obtain approval. Protocols may bee submitted for FDA review at any time during the review process, but approval is not final and the study cannot begin until all required approvals are in place and documented. The IND / IDE number must be provided to the IRB.
Recombinant DNA Advisory Committee (RAC) and Gene Transfer Research
Human gene transfer ("therapy") trials conducted at, or sponsored by, institutions receiving NIH funding for recombinant DNA research must be reviewed by the RAC. Protocols that raise novel or particularly important scientific, safety or ethical considerations are discussed by the RAC at one of its quarterly public meetings.
For questions regarding any submission, please email: NHGRIIRBOffice@nih.gov.
Last Updated: February 19, 2016