...

• Investigators should use the protocol and consent templates that are available on the OHSRP website IRB Templates page.
• Ancillary Some ancillary reviews must be completed prior to IRB review and/or approval of the protocol.

Where can I locate a protocol template when writing my protocol for IRB submission?

...

• ICs will conduct scientific review of complete protocols by a Scientific Review Committee within the office of the Clinical Director or Scientific Director unless waived by the IC leadership. All waivers of Scientific Review must be approved by the Chief Scientific Officer, Clinical Center (CC).
• Materials required for Scientific Review are outlined in the Policy for Scientific Review.
• Requests for Scientific Review are initiated in the electronic IRB (eIRB) system and information about this process can be found in the NIH SRC Researcher's Guide.
• Scientific review must be completed in the eIRB system prior IRB review of your submission.
• There is a prioritization process for protocols that require use of scarce resources at the Clinical Center.

...

• The 2018 Common Rule has specific requirements for cooperative multisite research as follows:
  • Per §46.114 (Cooperative Research), any institution located in the United States (US) that is engaged in cooperative research must rely upon approval by a single IRB for parts of the research conducted in the US. The reviewing IRB will be identified by the Federal department or agency supporting or conducting the research or proposed by the lead institution and which is accepted by the Federal department or agency supporting the research.
  • These requirements for review by a single IRB do not apply if the law requires that more than one IRB review the study (e.g., if tribal law requires local IRB review) or if the federal entity supporting/conducting the research determines that single IRB is not appropriate
• For multi-site protocols conducted by NIH IRP investigators that were submitted for initial review after January 25th, 2018, the NIH Single IRB (sIRB) policy requires that there be only one Reviewing IRB. It does not apply to foreign sites or when it is prohibited by a federal, tribal, or state law, regulation, or policy. Any other requests for exception from the sIRB policy must be made through the NIH IRB Office.
• In the case of a PI who will be involved in a multisite study that is subject to the NIH sIRB policy, once it has been determined who will serve as the Reviewing IRB, it is likely that a reliance agreement between NIH and other participating site(s) will need to be executed. Please refer to Reliance and Single IRB (sIRB) Resources page on the OHSRP website. If it is determined that a reliance agreement is needed the link for the request form is here. (NIH login is required.)
• NIH investigators do not have the authority to sign or otherwise commit to any reliance agreement. The authority to execute reliance agreements on behalf of the NIH, is delegated to the OHSRP Director.
• If the NIH investigator is involved in a multi-site protocol that is being overseen by a non-NIH IRB, research related event reporting should be conducted according to the Reviewing IRB's policies. Additionally, if the event occurs at an NIH site and meets the NIH reporting criteria per Policy 801, Reporting Research Events, a reportable event new information (RNI) form should also be submitted in the NIH electronic IRB system

...

• IC Deputy Ethics Counselor (DEC) clearance for "covered research protocols", as applicable.
  • "Covered research protocols" include the following and need clearance by the IC Ethics Office (also referred to as "DEC Clearance"):
    • studies of investigational drugs and devices
    • studies with a research question about a commercially available drug or device
    • studies involving collaborations with a substantially affected organization (SAO) or another for-profit entity when the entity is receiving specimens and/or data from the NIH for the purpose of developing a product
  • Most interventional protocols will be covered research protocols unless the intervention does not involve the criteria listed above (e.g., a behavioral intervention might not meet the criteria for a covered research protocol or use of a device for physiological exploration where there is no intent to develop a commercial application).
  • Non-covered research protocols include NIH research protocols that are categorized as Natural History studies, unless these studies meet the criteria for covered research protocols listed above.
  • When the PI determines that the protocol meets the definition of a covered research protocol, the following steps occur. (See Policy 102, Investigator Conflict of Interest and Government Royalties for more detailed information on this process.)
    1. NIH investigators and statisticians on For covered research protocols must review the Guide to Avoiding Financial and Non-Financial Conflicts or Perceived Conflicts of Interest in Clinical Research at the NIH, the PI must provide all investigators and individuals (including NIH employees, non-NIH federal employees, and individuals who are not federal employees) who will be engaged in activities as well as those involve in statistical analysis of primary endpoint data whose role has the potential to bias the research results, even if they are not otherwise engaged in human subjects research, with a copy of the Guide to Avoiding Financial and Non-Financial Conflicts or Perceived Conflicts of Interest in Clinical Research at the NIH found in the Reference section at the end of Policy 102, Investigator Conflict of Interest and Government Royalties.
    2. Relevant NIH federal employees and other federal employees within the Executive Branch must complete any public, confidential, or supplemental financial disclosure reports required by NIH Ethics requirementstheir employing agency.
    3. NIH employees Investigators who do not file a public or confidential financial disclosure reports must sign a a Conflict of Interest (COI) Certification for Federal Employees (Non-NIH and NIH) Who Do Not File a Financial Disclosure ReportForm. Most commonly, in the context of a NIH study team, it is the study statistician who is a federal employee and who is not otherwise required to file a financial disclosure report who needs to complete the COI Certification. In addition, non-NIH federal employees who are working on an NIH study team are not financial disclosure filers at the NIH, so they must also complete this COI Certification.NIH investigators or statisticians who are not federal employees, must also sign the Conflict of Interest (COI) Certification for Non-Federal Employees
    4. The PI must collect and submit the relevant COI Certification Forms in the eIRB system.
    5. The PI initiates DEC review in the eIRB system by going to the tab labeled Manage Ancillary Reviews.  Additional information can be found in the NIH DEC Researcher's Guide.  
    6. The PI's Ethics Office conducts an assessment of actual and apparent conflicts of interest for all investigators listed on the protocol and, if any federal employees have actual or apparent conflict of interest, the Ethics Office works with the employee, the NIH PI, NIH Ethics Official(s) and, as needed or appropriate, the NEO Director and/or the Office of the General Counsel, Ethics Division, to identify an appropriate remedy under applicable law.
    7. Upon completion of the COI review, approval of the IC DEC is noted in the eIRB system (also known as the DEC Clearance).

...