General Medicine Institutional Review Board (IRB) Panel #1 is responsible for protecting the rights and welfare of the human subjects of research protocols that are conducted by intramural investigators in NHGRI, NHLBI and a number of other institutes.
The General Medicine IRB Panel #1 formed when the National Human Genome Research Institute (NHGRI) IRB merged with the NHLBI IRB. The other IC-based IRBs will also be reorganizing over the course of the next several months.
The new IRB will meet weekly on most Tuesdays from 10:00 am - 12:00 noon. The first meeting of the new IRB is scheduled to be held on Tuesday, June 19, 2018. A full schedule of meetings is forthcoming. The old NHGRI IRB may hold a small number of additional meetings to complete actions that are in process in parallel with the new IRB.
The General Medicine IRB Panel #1 has begun using NIH iRIS as its protocol management system. PTMS is being phased out, and NHGRI will no longer use PTMS for IRB submissions. An archived version of PTMS will remain available to search for legacy protocol data.
A new website for the reorganized IRB system is under development. This page is intended to provide NHGRI Principal Investigators and research teams with quick access to the most relevant information and points of contact for the reorganized IRB and new IT system.
For more information:
For technical issues related to establishing iRIS user accounts or accessing/using the site.
The following forms, templates and guides are available for research teams who are submitting a research protocol to the IRB.
- NHGRI Protocol Template
- Temporary Change of Principal Investigator (PI)
- Consent Form Template
- Consent Form Guide
- Watermarked Assent Form Template
- NHGRI Dual Signature Page Consent Template
- Decision Tree for Prompt Reporting of Events Occurring During HHS- and FDA-Regulated Research
- Designation of Reimbursement for Travel and Subsistence (DRTS) Form
The Designation of Reimbursement for Travel and Subsistence (DTRS) Form should be filled out in the PTMS. It only needs to be filled out ounce unless something changes in reimbursement.
Education and Training
Computer Based Training
NHGRI follows the policy set by NIH OHSRP (see NIH HRPP SOP 25 v.1 5-31-13 ) . Training records, requirements and access to required courses may be found at the OHSRP website: https://federation.nih.gov/ohsr/nih/investigator-training.php.
Other "just-in-time" courses through CITI are optional unless specifically requested by the IRB. PIs may elect to require their research staff to take specific "just-in-time" CITI courses when relevant to the content of their research.
Additional Helpful Documents
For IRB Members
IRB Chairs, Vice-Chairs, and Members are required to attend:
- A scheduled IRB meeting
- IRB Member Orientation held by OHSRP
Contact OHSRP at email@example.com or 301-402-3444 to schedule this training.
- The NIH Clinical Research Training
- The CITI Social and Behavioral Education Modules
- One of the following:
- The New IRB Member Online Training
Personal Financial Holdings
All covered research protocols, as defined by OHSRP SOP 21.3D, are subject to conflict-of-interest review by the NHGRI Deputy Ethics Counselor (DEC), both at the time of initial review and for amendments that involve adding new investigators. To obtain review and clearance, PIs should complete and send the "Clearance of NIH Investigator Personal Financial Holdings by IC Ethics Office" form (SOP 21 Appendix D) to the NHGRI DEC at least two months ahead of the anticipated IRB review date. SOP 21 Appendix E and F may also need to be filed, if applicable. Clearance of these forms from the DEC office will be needed to upload with your NIH IRB submission action.
You will need to download Conflict of Interest form, fill it out and submit it to "Ethics" at NHGRIEthics@mail.nih.gov and type in the Subject Line:
Protocol Review - PI Last Name, First Name, (Protocol Number), Type of Protocol -Review (i.e. IR, CR, or Amendment).
If you have any questions you can also contact OHSRP at OHSR_nih_ddir@od.nih.gov.
Note: If the Protocol is not considered "covered" then investigators do not need to fill out the Conflict of Interest Form. However, there is a requirement for all FTEs on protocols to have at least an HHS Form 717-1 on file. PIs are encouraged to contact the NHGRI Ethics Branch directly when adding AIs to their protocols to confirm that AIs who are FTEs have completed required disclosure forms.
Policies and Forms
- HRPP Standard Operating Procedure/Policy Approval & Implementation (SOP Number: 21)
Conflict of Interest Requirements for Researchers and Research Staff
- SOP 21 Appendix A: A Guide to Avoiding Financial and Non-Financial Conflicts or Perceived Conflicts of Interest in clinical Research at NIH
- SOP 21 Appendix C: Algorithm for Decisions Regarding Financial Disclosure
- SOP 21 Appendix D: Clearance of NIH Investigator Personal Financial Holdings by IC Ethics Office
- SOP 21 Attachment E: Conflict of Interest (COI) Certification for NIH Employees Who Do Not File Financial Disclosure Forms 717 or 450
- SOP 21 Attachment F: Conflict of Interest (COI) Certification for Non-Federal Employees
- HHS 717-1 Guidance, Form and Instructions
Appendix C: Algorithm for Decisions Regarding Financial Disclosure
COI Assessment ONLY for "Covered Protocols"
"Covered" protocols involve interests that may lead to the financial benefit or loss to any individual or entity. This includes studies:
- of investigational drugs and devices
- whose research question involves a commercially available drug or device
- involving a CRADA or Clinical Trials Agreement
- involving collaboration with a substantially affected organization (defined below), or
- involving intellectual property
Substantially Affected Organization (SAO): A biotechnology or pharmaceutical company, a medical device manufacturer; or a corporation, partnership, or other enterprise or entity significantly involved, directly or through subsidiaries, in the research, development, or manufacture of biotechnological, biostatistical, pharmaceutical, or medical devices, equipment, preparations, treatments, or products (5 CFR § 5501.109(b)(10)).
COI Assessment is for "Covered Individuals" ONLY.
"Covered" individuals are persons that may realize financial benefit or loss as a result of participation in the protocol. The PI is responsible for deciding who on their covered protocol is identified as a covered individual and, therefore, needs to have COI clearance. Covered individuals include:
- Personnel who have independent decisional roles in conducting a covered research protocol. These individuals are influential in the design, direction, or conduct of a covered research protocol, or engaged in the analysis or interpretation of data.
- The principal investigator, personnel whose resume or CV is provided to a sponsor, personnel listed on an FDA 1572 Form, and personnel who obtain informed consent or who make decisions about research eligibility.
- Others who have decisional responsibilities as above, e.g. as co-investigator, research nurse, associate investigators, or an individual who interprets or analyzes research data.
Who is not a "Covered Individual"?
- Individuals who participate only through isolated tasks that are incidental to the research (for example, scheduling patient tests), and those individuals who support research of many protocols through the performance of routine patient care tasks are not covered individuals.
- Examples include technicians, phlebotomists, Office of Patient Recruitment and Public Liaison (PRPL), or those screening for multiple protocols.
NHGRI Ethics Branch Contact:
Leonard Ross, J.D., M.S.A.
Chief, Ethics Branch
National Human Genome Research Institute, NIH
Building 31, Room B1B55
31 Center Drive
Bethesda, MD 20814
Phone: (301) 594-5957
Fax: (301) 594-5501
Please contact Leonard Ross or Office of Human Subjects Research Protection (OHSRP) with any questions about the Conflict-of-Interest Review policy.
National Institutes of Health (NIH)
- Office of Human Research Protections
- NIH Ethics Consult Service
- NIH Radiation Safety Committee (RSC)
- NIH Clinical Research Studies Active Consent / Assent Documents
- Certificates of Confidentiality Kiosk
- Recombinant DNA Advisory Committee (RAC)
- Genomic Data Sharing
U.S. Federal Government
- 45 CFR 46 Federal Policy for the Protection of Human Subjects
- Office for Human Research Protections (OHRP)
- OHRP Approved Federal-Wide Assurances (FWAs)
- FDA Guidance for IRBs, Clinical Investigators and Sponsors
- FDA Investigator-Initiated Investigational New Drug (IND) Applications
Last updated: June 20, 2018