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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.

Overview

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 An archived version of PTMS will remain available to search for legacy protocol data.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.

Documents

The following forms, templates and guides are available for research teams who are submitting a research protocol to the IRB.

Education and Training

For Investigators

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

In-Person Training

IRB Chairs, Vice-Chairs, and Members are required to attend:

  • A scheduled IRB meeting
  • IRB Member Orientation held by OHSRP

Contact OHSRP at ohsr_nih_ddir@od.nih.gov or 301-402-3444 to schedule this training.

Computer-based Training

  1. The NIH Clinical Research Training
  2. The CITI Social and Behavioral Education Modules
  3. One of the following:
  4. 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

Additional Information

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:

  1. of investigational drugs and devices
  2. whose research question involves a commercially available drug or device
  3. involving a CRADA or Clinical Trials Agreement
  4. involving collaboration with a substantially affected organization (defined below), or
  5. 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:

  1. 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.
  2. 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.
  3. 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"?

  1. 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.
  2. 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
E-mail: leonard.ross@nih.gov

Please contact Leonard Ross or Office of Human Subjects Research Protection (OHSRP) with any questions about the Conflict-of-Interest Review policy.

Contact

Sara Chandros Hull, Ph.D
Sara Hull, Ph.D.
  • Associate Investigator
  • Office of the Clinical Director

Last updated: June 20, 2018