16th Edition - October 5, 2018

Fall NIH funding deadlines are here! Proposals for human subjects research which will conduct the same protocol at multiple institutions must include a plan for compliance with the Final NIH Policy on the Use of a Single Institutional Review Board for Multi-Site Research.

The policy requires a single IRB (sIRB) to provide review for all sites. If you are working on a grant application which is subject to the policy, please contact Ryan Ballard at the Human Subjects Office (HSO) at 317-278-7812 or rcballar@iu.edu immediately to discuss the application requirements.

Identifying the single IRB

Identifying the sIRB (the IRB that will provide review for all sites) is an important part of the sIRB process. The NIH policy does not define which IRB should serve as the sIRB, and the decision should be made on a study-by-study basis after discussion with HSO and the participating sites, depending on the specific needs of the study. HSO staff will work with you to identify the most appropriate sIRB and assure that the identified sIRB is qualified to review the research.

Budgeting for single IRB

The sIRB process raises additional budgeting concerns:

• IRB fees - Serving as the single IRB requires additional resources for IRB offices. As such, the policy allows the single IRB to charge direct costs for their review. Once you’ve identified the single IRB for your proposal, be sure to ask about IRB review fees.
  • When IU is serving as the reviewing IRB, the budget should include $2,500 for review of each non-IU participating site.
  • View the IU IRB Fee Schedule.
• Regulatory - The single IRB process can be extremely complicated for study teams and requires additional resources for regulatory support which should be included in the budget. HSO will talk with you about appropriate levels of regulatory support given the nature and complexity of the proposal. Resources may be available through the Indiana CTSI.

View the IU HRPP Quick Guide on Submitting an Applicable NIH Grant Requiring sIRB for more information.

Final revisions to the Federal Policy for the Protection of Human Subjects (Common Rule) are effective January 21, 2019. Over the past months, the human research protection program has implemented early adoption of many of the changes found in the revised Common Rule, offering increased efficiency and reduced burden on investigators and staff prior to the January date.

HRPP will implement additional changes on January 21, 2019, to ensure the burden-reducing provisions of the revised Common Rule are available to as many researchers as possible. Changes will include: revised requirements for VA research, new exempt categories for all research, and a new format for IRB approval letters.

Education regarding the revised Common Rule will continue towards the end of 2018 and in early 2019. Webinars about the revised Common Rule will be offered in early January.  Stay tuned for more information! 

The Human Research Protection Program (HRPP) has released new guidance documents providing information and best practices for the conduct of human subjects research in the four following areas:

• Children - Including guidance for when children can consent for themselves, obtaining consent from parents/guardians, obtaining assent, returning positive pregnancy test results to children, and enrolling foster children and wards of the state.
• HIPAA - Including guidance on requesting to obtain verbal HIPAA authorization and appropriate safeguards for protected health information.
• Informed Consent - Including a list of required elements of informed consent, and guidance for writing a concise presentation of key information for federally-funded research, using flexible consent procedures, understanding “reasonably available” for legally authorized representatives and parents, conducting research procedures prior to written consent, documenting the consent process, and using the short form to document consent.
• Recruitment - Including which recruitment materials must be reviewed by the IRB and important reminders about recruitment.

View this and all HRPP guidance on the conduct of human subjects research.

The IRB review process begins with pre-review. Pre-review is conducted by a Human Subjects Office staff member, called a "screener," who reviews the information submitted, including all documents and attachments, to ensure consistency and confirm that all regulatory requirements are met. Important things to remember about pre-review:

• Pre-review comments are suggestions, offered to give researchers the best chance at approval by ensuring any potential issues are addressed prior to IRB review. Most pre-review should not be considered a directive.
• While most pre-review suggestions are rooted in regulation, there are often many ways to fulfill a single regulatory requirement and HSO staff can work with you to identify the best way to meet those requirements.
• Pre-review is a conversation. If you disagree with a pre-review suggestion, or if implementing the suggestion isn’t feasible or practical for you, talk to the screener directly about their reasoning and the options available to you. If you still disagree, the screener can request an Associate Director join the conversation, or you can request the submission be sent to the IRB for review without the change.
• Pre-review suggestions should not be confused with IRB provisions. IRB provisions are revisions requested by the IRB which must be made prior to approval, unless the IRB allows otherwise. If you are unsure whether the communication you have received from the HSO is a pre-review suggestion or an IRB provision, check with your screener.

See how to respond to comments on your IRB protocol for detailed instructions on viewing screener comments and responding to pre-review.

The HRPP recently published new guidance on obtaining valid informed consent. All researchers should review the guidance, especially if you are working on a new study submission. In addition, please keep the following in mind as you write consent forms:

• Don’t reinvent the wheel. The HRPP strongly encourages you to utilize sponsor-created consent templates. If an informed consent template is available for your study, please use it. Add any site-specific language, checking the HRPP guidance on informed consent for required language, then submit the final document to the IRB for review. The IU informed consent template is offered only as a tool and is NOT required.
• If your research is being conducted pursuant to a contract, the Informed consent language on compensation for injury must match the contract.
• Be creative! Don’t be afraid to integrate visual elements into your consent documents to help subjects understand the research.

New IU Research Organizational Charts, including the Office of Research Compliance - Human Research Protection Program (HRPP), are now available.