2 Choose a Process
3 Institution Review/Council
Your institution has recently submitted an application that involves human subjects research. What happens next?
After submission, your application is assigned to an NIH Institute or Center and an Scientific Review Group (SRG)
- Your application will be assigned to the NIH Institute or Center (IC) best suited to fund your application should it have sufficient merit. (More than one IC may be assigned if appropriate.)
- Your application will also be assigned to a Scientific Review Group (SRG). An SRG typically includes 20 or more scientists from the community of productive researchers. The SRG will conduct the peer review of your application.
- You may question either your study section or IC assignment by contacting the Scientific Review Officer (SRO) named in your notification or the Center for Scientific Review (301-435-0715).
- During the peer review, the scientific and technical merit of the application is discussed. This discussion will include addressing whether the human subjects protection plan is adequate and whether any of the reviewers had concerns. If reviewers are unable to make a determination regarding human subjects involvement or have concerns regarding the human subjects plan the application will be coded as “Unacceptable” for human subjects. The application will receive a Human Subjects Code 48; which allows for the issuance of an award with restrictions against the involvement of human subjects activities.
- After Peer Review, there is a second level of review conducted by the Advisory Council/Board. Program staff evaluate the applications, considering impact scores and IC needs and interest. They provide a grant-funding plan to the Advisory Council. The Advisory Council, considering the funding available and the goals of the IC, advises the IC director. The IC director makes the final funding decisions.
Not Funded - Next StepsFunding on the first attempt is difficult, but not impossible. If an application does not result in funding, there may be an opportunity to respond to the reviewers’ comments and resubmit the application. Applicants just receiving their summary statements may wish to discuss the critiques with the Program Officer. Amended applications can be re-submitted for review one time after initial review. If the PI chooses to resubmit an application, the investigator should address any human subjects concerns identified during the first review.
Fundable ScoreAfter the Advisory Council meeting, if an application results in an award, the applicant will be working closely with the Program Officer of the funding IC on scientific and programmatic matters and a Grants Management Officer on budgetary or administrative issues. The Grants Management Specialist will contact the applicant to collect information needed to prepare the award. Most information and all official documents must be received from the institution’s administrative officer (AO) or with the AO’s countersignature.
3 Institution Restricted Award
- During the peer review process, if the SRG has concerns or finds the human subjects information incomplete the application will be rated as “Unacceptable” for human subjects and be given a HS Code 48.
- An award with restrictions against the involvement of human subjects activities may be made prior to IRB approval of the human subjects protocol or an IRB determination of exempt human subjects research or that human subjects are not involved
- Once the funding IC receives either the IRB approval date or an IRB determination that the study is exempt human subjects research or does not involve human subjects the HS Code will be changed and the restrictions can be lifted.
3 Institution Institutional Responsibilities
Awardee institutions with research studies that involve human subjects must continually monitor the studies for human subjects protections. As such the institution must have:
- A current Federalwide Assurance (FWA) filed with OHRP, and
- Annual IRB approval.
InclusionAll studies involving clinical research must be monitored for inclusion tracking of women, minorities and individuals of all ages. For information and questions regarding inclusion monitoring and tracking please refer to the NIH Inclusion Policies and Procedures pages:
Adverse EventsAn adverse event is defined as any unfavorable and unintended sign (e.g., an abnormal laboratory finding), symptom, or disease temporally associated with the involvement in a clinical research study. Adverse events can include serious and non-serious adverse events and unanticipated problems. An investigator is responsible for knowing the policies of the local IRB, adhering to these policies, and maintaining a copy of the policies in the study file. An investigator is also responsible for the accurate documentation, investigation and follow-up of all possible study-related adverse events. All adverse events must be reported to the IRB and, if appropriate, the DSMB and the NIH. All unanticipated problems must then be reported to the Office of Human Research Protections (OHRP) by the IRB. The timeline for reporting adverse events is commensurate with the severity of the event.
Clinical TrialsFor studies that involve a clinical trial, monitoring of the clinical trial should be conducted as described in the Data and Safety Monitoring Plan. Requirements for registration at ClinicalTrials.gov can be found here. If you have any questions regarding the monitoring of your study contact your Program Officer.
Changes to Human Subjects
If your study did not originally include human subjects. If you would like to add a human subjects component to your existing NIH-funded grant you will need to discuss this potential award modification with your Program Officer. You cannot initiate human subjects research without first getting prior approval from your Program Officer. Additionally, before you can start any non-exempt human subjects research you must submit to your IC: a complete Protection of Human Subjects section, your institution’s Federalwide Assurance (FWA) number, an unconditional IRB approval, and certification that all the key personnel involved in the human subjects component of your study have received human subjects education.
If you would like to change the approved human subjects component of your study. Please discuss any considered changes to your approved protocol with your Program Officer. Changes that increase the risks to subjects, will now include a vulnerable population, such as children, or change from an exempt study to non-exempt (for example, a study that involves surveying adults about internet use (Exemption 2) will now include children) must receive NIH approval before the changes can be made. These changes may also require IRB notification and approval.
If the human subjects component of your study has been completed. The human subjects determination reflects the view of the peer review group regarding the involvement of human subjects for the duration of an award period. In exceptional cases where all aspects of human subjects research are completed before the end of the project period, a restriction will be placed on your Notice of Award that allows non-human subjects research to be conducted. This would not require on-going IRB approval. However, if you are conducting analysis of study data and can still link specimens or data to identifiers, on-going IRB approval continues to be required.