1. NIH Forms E
Town Hall

2. SF424 Forms E Major Changes
Removal of Human Subjects Sections from the Research Plan and other form pages
Protections
Data Safety Monitoring Plan
Inclusion/Enrollment
Introduction of Human Subjects & Clinical Trials form

3. Why Changes to Clinical Trial Policies?
Government Accountability Office recommended:
NIH better track number of funded clinical trials
Improve data collection overall
Ensure results are published and/or reported in a public database

4. New Policies & Regulations
Primary Aims:
Enhance application and award processes to increase NIH’s ability to assess the merits and feasibility of clinical trial applications
Improve oversight and transparency
Increase the sharing of clinical trial results

5. Am I doing Human Subjects Research?

6. Is my submission a Clinical Trial?

7. NIH Definition of a Clinical Trial
A research study in which one or more human subjects are prospectively assigned to one or more interventions (which may include a placebo or other control) to evaluate the effects of those interventions on health-related biomedical or behavioral outcomes.

8. SF424 Forms E Program Announcements
All FOAS will specify the allowability of clinical trials in Section II. Award Information
All clinical trials FOAs will specify allowability of clinical trials in FOA title
FOAs that accept clinical trials will incorporate specific review criteria to ensure that reviewers appropriately consider clinical-trial related information

9. SF424 Forms E Weill Research Gateway

10. SF424 Forms E Human Subjects & Clinical Trial Form

11. SF424 Forms E Human Subjects & Clinical Trials Form

12. SF424 Forms E Human Subjects & Clinical Trials
Study Record Form
Section
Information
Example
HS Required?
CT Required? 1
Basic Information
Study Exemptions; Human Participants
Yes 2
Study Population
Study Focus; Inclusion Enrollment 3
Protection and Monitoring Plans
Protection of Subjects; DSMB
Partial 4
Protocol Synopsis
Narrative, Intervention Type No 5
Other CT Attachments
Upload Link

13. Human Subjects & Clinical Trial Form Section 1 – Basic Information

14. EXEMPT RESEARCH CATEGORIES
8 new categories defined in 45 CFR (d) (effective January 19, 2018)
Commonly used exempt categories:
“Research, conducted in established or commonly accepted educational settings, that specifically involves normal educational practices that are not likely to adversely impact students’ opportunity to learn required educational content or the assessment of educators who provide instruction.” [Category 1]
“Research that only includes interactions involving educational tests (cognitive, diagnostic, aptitude, achievement), survey procedures, interview procedures, or observation of public behavior (including visual or auditory recording)” that meet one of three criteria. [Category 2]
“Research involving benign behavioral interventions in conjunction with the collection of information from an adult subject through verbal or written responses (including data entry) or audiovisual recording if the subject prospectively agrees to the intervention and information collection…” that meet one of three criteria. [Category 3]
“Secondary research for which consent is not required: Secondary research uses of identifiable private information or identifiable biospecimens” that meet one of four criteria. [Category 4]

15. Am I doing Human Subjects Research?

16. Human Subjects & Clinical Trial Form Section 1 – Basic Information

17. Human Subjects & Clinical Trial Form Section 1 – Basic Information
Prospectively Assigned
A pre-defined process (e.g., randomization) specified in an approved protocol that stipulates the assignment of research subjects (individually or in clusters) to one or more arms (e.g., intervention, placebo, or other control) of a clinical trial.
Interventions
A manipulation of the subject or subject’s environment for the purpose of modifying one or more health-related biomedical or behavioral processes and/or endpoints. E.g., drugs/small molecules/compounds; surgical techniques, delivery systems such as face-to-face strategies, strategies to change health-related behavior (e.g., diet, cognitive therapy), treatment strategies, prevention strategies, diagnostic strategies.
Health-related Biomedical or Behavioral Outcomes
The pre-specified goal(s) or condition(s) that reflect the effect of one or more interventions on human subjects’ biomedical or behavioral status on quality of life. E.g., positive or negative changes to physiological or biological or psychological parameters, or disease process, or changes to quality of life.

18. Human Subjects & Clinical Trial Form Section 2 – Study Population Characteristics

19. Recruitment & Retention Plan
Tailored based on target population, research design, research procedures, etc. and include thorough “SWOT”-like analysis.
Recruitment considerations: feasibility plan (e.g. recruiting subjects from ED without prior discussions with ED leadership), targeted strategies, tailored recruitment tools,
Retention plans should be proactive (electronic reminders for visits, frequent communications, reimbursement for subject transportation costs, video conference, etc.)
Retention considerations: subject population, sufficient staff

20. Human Subjects & Clinical Trial Form Section 3 – Protection & Monitoring Plans

21. Single IRB Review and Data Safety Monitoring
Multi-Site/Center Applications:
Single IRB (“IRB of Record”) discussion with IRB office PRIOR to submitting grant application
Requires submission to WCM IRB office (in eIRB) regardless of where IRB review is taking place
Suggested language for inclusion in applications

22. WCM Data and Safety Monitoring Board (DSMB)
Independent committee
safeguarding clinical trial participants
monitoring interim safety and efficacy outcomes data in ongoing trials
Provides expertise, including recommendations regarding the continuation, modification, or termination of any or all arms of a study
Monitors 65 studies, including 29 IND holders and 21 multi-site studies
Meets on a monthly basis

23. Data and Safety Monitoring Plan (DSMP)
All protocols require a DSMP commensurate with the degree of risk and complexity of the protocol
Greater than minimal risk studies require a Data and Safety Monitoring Board
A DSMP should include:
Monitoring of risk (adverse events (SAEs, UAEs, UPs) including frequency and attribution)
Monitoring of data (aggregate data, accrual information, protocol deviations, interim analysis (if applicable))
Rules for study termination, including stopping rules for participants
How the monitoring will be conducted, how often, by whom (PI, DSMB, medical monitor)
Description of the composition of the DSMB, if applicable, including expertise of members

24. Human Subjects & Clinical Trial Form Section 4 – Protocol Synopsis

25. Human Subjects & Clinical Trial Form Section 4 – Protocol Synopsis

26. Human Subjects & Clinical Trial Form Section 5 – Other Clinical Trial-related Attachments
Provide additional trial-related information only if your FOA specifically requests it

27. Other NIH Mechanisms Training Awards Fellowship Awards
Do not support clinical trials (with the exception of some D43 and K12 awards)
All Training FOAs will be designated as “Clinical Trial Not Allowed” but will indicate that appointed trainees are permitted to obtain research experience in a clinical trial led by mentor/co-mentor
Some D43 and K12 FOAs will be designated as “Clinical Trial Optional’
Fellowship Awards
All will be designated as ‘No Independent Clinical Trials,’ but will indicate that applicants are permitted to propose research experience in a clinical trial led by sponsor/co-sponsor
Career Development Awards
FOAs that indicate ‘Clinical Trial Required’ will support independent clinical trials conducted by the applicant
FOAs that indicate “No Independent Clinical Trials” permit the applicant to propose research experience in a clinical trial led by a sponsor/co-sponsor

28. SF424 Forms E Human Subjects & Clinical Trials Resources
Walkthrough Video
SF424 Application Guide
NIH e-Protocol Template
NIH Definition of Clinical Trial Case Studies

29. Weill Cornell Resources
IRB
DSMB
Joint Clinical Trials Office Standardized Protocol Template
Joint Clinical Trials Office Subject Recruitment and Activation
Clinical & Translational Science Center
Weill Research Gateway Guides

30. Contact Information
Office of Sponsored Research Administration
IRB/Office of Human Research Protections & DSMB
Joint Clinical Trials Office
Study Recruitment