NIH Clinical Trial Requirements https://grants.nih.gov/policy/clinical-trials.htm

NIH Initiatives to Enhance Clinical Trial Stewardship Clinical Trial FOAs Good Clinical Practice Enhancing Clinical Trial Stewardship at NIH Registration & Reporting Single IRB New Application Forms Accountability Transparency Efficiency Dissemination Clinical Trial Review Criteria Learn more at https://grants.nih.gov/policy/clinical-trials.htm

NIH Might Consider Your Human Subjects Research to be a Clinical Trial Does your study… Involve one or more human subjects? Prospectively assign human subject(s) to intervention(s)? Evaluate the effect of intervention(s) on the human subject(s)? Have a health-related biomedical or behavioral outcome? If “yes” to ALL of these questions, your study is considered a clinical trial Unsure how to answer the questions? We have a tool that can help! https://grants.nih.gov/ct-decision/

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 placebo or other control) to evaluate the effects of those interventions on health-related biomedical or behavioral outcomes.

Intervention “An “intervention” is defined as 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. Examples include: drugs/small molecules/compounds; biologics; devices; procedures (e.g. surgical techniques); delivery systems (e.g. telemedicine, face-to-face interviews); strategies to change health-related behavior (e.g. diet, cognitive therapy, exercise, development of new habits); treatment strategies; prevention strategies; and, diagnostic strategies.”

Health-related Biomedical or Behavioral Outcome “A “health-related biomedical or behavioral outcome” is defined as the pre- specified goal(s) or conditions(s) that reflect the effect of one or more interventions on human subjects’ biomedical or behavioral status or quality of life. Examples include: positive or negative changes to physiological or biological parameters (e.g. improvement of lung capacity, gene expression); positive or negative changes to psychological or neurodevelopmental parameters (e.g. mood management intervention for smokers; reading comprehension or information retention); positive or negative changes to disease processes; positive or negative changes to health-related behaviors; and positive or negative changes to quality of life.”

Broad Interpretation “Depending on how broadly one interprets … “to evaluate the effects of those interventions on health-related biomedical or behavioral outcomes”, this part of the clinical trials definition may include a wide range of basic behavioral and social science studies that manipulate an independent variable to observe a hypothesized modification of a behavioral process.” Director, NIH Office of Behavioral and Social Sciences Research, October 18, 2016

Resources To help you determine if your research is an NIH Clinical Trial, refer to these helpful resources: FAQs https://grants.nih.gov/policy/clinical-trials/case-studies.htm Case Studies

Why is this important? Picking the appropriate NIH funding opportunity New human subjects and clinical trials form (Forms E) Complying with NIH Clinical Trials requirements Registering the study and reporting results on ClinicalTrials.gov (for applications submitted on or January 18, 2017) Training in Good Clinical Practice required for all study team members engaged in the research (required as of January 1, 2017) Identifying a single IRB of Record for multisite studies (required for applications submitted as of January 25, 2018)

ClinicalTrials.gov Registration NIH Policy on Dissemination of NIH-Funded Clinical Trial Information “The purpose of the policy is to promote broad and responsible dissemination of information from NIH-funded clinical trials through ClinicalTrials.gov.  Disseminating this information supports the NIH mission to advance the translation of research results into knowledge, products, and procedures that improve human health.” ClinicalTrials.gov is a public website designed by NIH and FDA and hosted by the National Library of Medicine. Must be registered within 21 days after first subject is enrolled Registration Information - descriptive information, recruitment information, location and contact information, and administrative data.    Results must be reported with 1 year of final collection of data  Results Information - includes participant flow, demographic and baseline characteristics, outcomes and statistical analyses, adverse events, the protocol and statistical analysis plan, and administrative information.   

UM Resources Administrative liaison identified for each unit (typically a grants admin) Training available from Medical School Research Regulatory Affairs team. Register at: http://ttc.iss.lsa.umich.edu/ttc/?s=clinicaltrials.gov&submit=Search Office of Research Compliance Review (ORCR) monitoring non- IRBMED unites

Good Clinical Practice (GCP) Training GCP principles constitute international ethical and scientific quality standards for designing, conducting, recording, and reporting clinical trials Required for all members of the study team except administrative staff Training resources for Social/Behavioral Researchers MyLinc/MICHR/Social and Behavioral Best Practices CITI – Social and Behavioral Research Best Practices for Clinical Research Good Clinical Practice for Social and Behavioral Research eLearning Course hosted by the Society of Behavioral Medicine for NIH

sIRB Plan for Applicants/Offerors Application/proposal must include a plan that: Describes the use of an sIRB that will be selected to serve as the IRB of record for all study sites Confirms that participating sites will adhere to the sIRB Policy and describes how communications between sites and sIRB will be handled  Tip: sIRB Plan attachment will be included in the new Human Subjects & Clinical Trials Information form

U-M Strategy for NIH Single IRB Default position is to cede oversight to an external IRB, either a commercial IRB or another academic partner IRBMED has established relationships with a number of commercial IRBs Fees for external IRBs must be included in proposal budget Minimal impact for current IRB-HSBS research portfolio

Current IRB Responsibilities for NIH Clinical Trials Include required language in the consent form: “This trial will be registered and may report results on www.ClinicalTrials.gov, a publicly available registry of clinical trials.” Remind investigators about GCP training requirement (but IRB does not track) Remind investigators about ClinicalTrials.gov registration and to log the NCT number in eResearch Assist investigators with Single IRB processes

Key Resource NIH Clinical Trials for Grants and Contracts https://grants.nih.gov/policy/clinical-trials.htm Provides detailed information all NIH requirements Includes a good explanatory video regarding the new Forms E: https://www.youtube.com/watch?v=nz9NWFhYOG8