1. New NIH Human Subjects & Clinical Trials Information
Ayisha Ali & Nadia Hajjar
The goal of the NIH in updating these forms was to consolidate human subjects, inclusion enrollment, and clinical trial information previously collected across multiple agency forms

2. What is the difference between clinical research and a clinical trial?
Clinical research includes all research involving human participants. It does not include secondary studies using existing biological specimens or data collected without identifiers or data that are publicly available.
Clinical trials are clinical research studies involving human participants assigned to an intervention in which the study is designed to evaluate the effect(s) of the intervention on the participant and the effect being evaluated is a health-related biomedical or behavioral outcome

3. How can researchers determine whether a proposed study is a clinical trial?
The following questions should be used to determine whether a study meets the NIH clinical trial definition:
▪ Does the study involve human participants?
▪ Are the participants prospectively assigned to an intervention?
▪ Is the study designed to evaluate the effect of the intervention on the participants?
▪ Is the effect being evaluated a health-related biomedical or behavioral outcome?
If the answers are all “yes,” the study is a clinical trial.
If any answers are “no,” the study is not a clinical trial
If the PI is unsure, encourage the PI to reach out to the program officer.
* If the PI is still unsure after answering these questions, encourage them to reach out to the program officer for confirmation

4. New Human Subject Form
New form is included in all applications (whether or not human subjects or clinical trials are involved)
Required form fields vary based on a number of factors, including:
Whether study is delayed onset
Announcement-specific instructions
Human subject exemptions
Whether study involves a clinical trial

5. R & R Other Project Information Form
NIH will continue to collect Human Subjects information on the R & R Other Project Information form

6. When Human Subjects = No
When human subjects is NO, Applicants answer a single question, provide associated Attachment (as applicable), and are done with form unless Instructed in announcement to include other requested Information attachment
Information populated in
this Field from R&R other
project information form
Human specimen/ data question:
Answer to this question required
and system enforced when
Human subjects is NO.
An attachment has to be
Uploaded If you answer YES.

7. When Human Subjects = Yes (not delayed onset)
Full Study records require quite a bit of data
New data collection leads applicants through clinical trial information collection requirements
Data collection expanded for new policies
Check FOA to determine if
attachment is needed
If yes to Human Subject, add Study
Title. Study title must be unique with in the application.

8. Delayed Onset Studies
Delayed onset - no well defined plan for human subject involvement at time of application
Does NOT mean delayed start of study
Minimal data collection
Must justify why full study information can not be provided
Required if Delayed onset study is included. In addition to justification,
must include information on how the study will comply with NIH single IRB if multi-site research Is involved.
Cannot add Delayed Onset study if you answer NO to human subjects question

9. Study Record: Section 1-Basic Information
Exemption 4- Research involving the collection or study of existing data or specimens if publicly available or information recorded that subjects cannot be identified

10. Study Record: Section 2- Study Population Characteristics
Recruitment and Retention Plan- Describe how you will recruit and retain participants. Address both planned and proposed recruitment
Study Timeline- Provide a description or diagram describing the study timeline
Conditions-At least 1 entry is required but the PI can provide up to 20 study population characteristics. If available, use appropriate descriptors from (MeSH)
Inclusion- Women, Minorities and Children all together

11. Inclusion Enrollment Report
Planned enrollment must be completed when answer
to “using existing dataset” question is NO
If YES then only complete cumulative enrollment.

12. Study Record: Section 3 Protection and Monitoring Plans
All of Section 3 is required for all studies involving human subjects unless noted otherwise
Data and Safety monitoring plan is only required if you answered “Yes” to all the questions in the clinical trial questionnaire
If not-clinical, but has human subjects, the overall structure of the study team is optional
If Yes to multi-site, single IRB plan must be included

13. Study Record: Section 4 Protocol Synopsis
Study Design: all questions under the study design are system enforced
Brief Summary: is required for CT studies unless noted in FOA
*Limited to 5000 characters
Interventions: up to 20 allowed

14. Study Record: Section 4- Continued
Outcome Measures: At least one outcome measure is required for CT studies. Up to 50 outcome measures are allowed
Dissemination plan: one dissemination plan is sufficient. You may attach the same plan for multiple studies

15. Study Record: Section 5- Other Clinical Trial-related Attachments
Attachments in this section are allowed for CT only. Up to 10 attachments can be uploaded, only if noted in FOA.

16. Tips on How to connect with your PI on New Forms
Confirm with PI if the proposal is Clinical Trial or Not Clinical Trial
For some research grants NIH has specific FOA for CT and for not CT
PI’s are not familiar with new Human subjects forms
Send them the screen shots of the forms
Convert forms into PDF fillable forms
Set a meeting to complete these forms
Note: Please do not try to answer any question on your own.
Note: You will experience errors for copy and pasting the text in some fields.

17. NIH Single IRB
The policy affects multi-site studies involving non-exempt human subjects research funded by NIH, and applies to grant applications with due dates on or after January 25, 2018
This policy applies to the domestic sites of NIH-funded multi-site studies where each site will conduct the same protocol involving non-exempt human subjects research. It does not apply to career development, research training or fellowship awards.

18. Single IRB at Proposal Stage
Single IRB plan: The justification must include the following elements:
Describe how you will comply with NIH policy on use of sIRB for Multi-site research
Provide the name of the IRB that will serve as the sIRB of record.
Indicate that all identified participating sites have agreed to rely on the proposed sIRB and that any sites added after award will rely on the sIRB.
Briefly describe how communication between sites and the sIRB will be handled
Indicate that all participating sites will, prior to initiating the study, sign an authorization/reliance agreement that will clarify the roles and responsibilities of the sIRB and participating sites.
Indicate which institution or entity will maintain records of the authorization/reliance agreements and of the communication plan.
Note: Do not include the authorization/reliance agreement(s) or the communication plan(s) documents in your application.

19. Single IRB at Proposal Stage
NU IRB of Record
Letter of Support:
A letter reflecting the acknowledgement that the NU IRB is willing to serve as IRB of record for the study.
This must be obtained from NU IRB office and should be included in the proposal with single IRB plan.
Sub-award
A letter of support from sub-awardee sites indicating they are willing to cede review to the NU IRB is required.
This letter should be uploaded into InfoEd internal documents

20. QUESTIONS?