Okay folx, I just wrapped up a day of grant submissions despite today, so here's the (it's long!) on #NIH #HumanSubjects requirements as promised.
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NIH changed their requirements on how the grants involving human participants were structured when they converted the app to Forms E in January 2018: https://grants.nih.gov/grants/guide/notice-files/NOT-OD-17-119.html

How do you determine if you're doing human subjects research? If you will be recruiting humans or using samples that can be linked to living humans by anyone on your team, then you're work doing non-exempt research. Here's a cool tool: https://grants.nih.gov/policy/humansubjects/hs-decision.htm

In these forms, the previously required information that was provided in the research strategy was taken out and put in its own section on the #SF424 forms. Answer this questionnaire with all yes and you have to fill in all 4/5 sections. If any answer is no, then you do Sec 1-3.

The changes in #NIH Forms F last year involves rightly swapping out the term subject with participant, and changing Recruitment of women, minorities and children to recruitment of women and minorities and Inclusion across the lifespan. https://grants.nih.gov/grants/electronicreceipt/files/high-level-form-change-summary-FORMS-F.pdf

On to content: Section 1 of the form has generic information about your title, exempt status and the questionnaire. Section 2 is Study Population characteristics, Section 3; Protection and Monitoring Plan and Section 4: Protocol synopsis. Section 5 is FOA specific other info.

Section 2: You talk abut your inclusion/exclusion criteria, your plans for recruitment of women and minorites, recruitment and retention plan, study timeline and your planned enrollment.

Make sure to review your clinic or #patient population and create your #enrollment plan accordingly. Add specific steps you will take to ensure underrepresented pop. recruitment, outline steps to make sure your study will be gender balanced, talk about what you'll do to retain.

Plans to cooperate with community organizations can be helpful to recruitment and retention plans; get letters of support. Don't forget to talk about #SoMe and how you can leverage it to target your #participant population.

Timeline: Be generic, you don't need to provide specific dates. But include when first participant in, when last participant out. This is where you can get fancy and include charts and tables. Interesting discussion on GANTT charts #onhere https://twitter.com/azfaust/status/1311715278359875584?s=20

Section 3: This is where you talk about steps you will take to protect your participants. The Protections of Human Subjects document goes here. Make sure to include information on all the four topics; Risks, protection from risks, benefits to participants and importance of work.

Add structure of study team, talk about how awesome your team is and what they will do; why they are best suited. Add data safety monitoring plan. What happens if you have a severe adverse event? Will you have a DSMB or a safety officer?

Note: #NIH policy requires that there be a single #IRB for the study if it is happening in more than one site. One central IRB (prime site) and each subsite will agree to use the central IRB using reliance agreements. Or you could use an outside IRB. https://grants.nih.gov/policy/humansubjects/single-irb-policy-multi-site-research.htm

Section 4: This is details of your clinical trial, if your study qualifies. There's protocol synopsis section where you talk about your study description, design, masking, intervention description, if your intervention is FDA regulated or not.

This is where you talk about outcome measures, whether they are primary or secondary, what would be the timing of measuring the outcomes and what they are. You talk about your dissemination plan, registering your trial on clinicaltrialsdotgov.

Statistical plan is now its own document. Detailed information on design, analysis and calculations are included here, but brief information can be included in the approach section.
*Be sure to talk to your #biostatistician early and often.*

Section 5 is FOA specific. If your FOA asks for docs, add them and name them as asked. Otherwise, leave this section alone.

All instructions on completing human subjects section can be found here: https://grants.nih.gov/grants/how-to-apply-application-guide/forms-f/general/g.500-phs-human-subjects-and-clinical-trials-information.htm

As always, READ THE RFA, start early, and most importantly, talk to your friendly neighborhood #ResearchDevelopment professional. Chances are, we have templates of all of these docs that we can draft, if we're part of the team from the start and all you have to do is tweak them!