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New NIH Application Requirements Great Plains IDeA-CTR Network

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Presentation on theme: "New NIH Application Requirements Great Plains IDeA-CTR Network"— Presentation transcript:

1 New NIH Application Requirements Great Plains IDeA-CTR Network
February 12, 2018 Bethany DeCarolis, CRA, Assistant Director Sponsored Programs Administration

2 Agenda “FORMS-E” application requirement Selecting the correct funding opportunity Defining a clinical trial NIH interpretation of a clinical trial PHS Human Subjects and Clinical Trial Information form

3 “FORMS-E” application requirement

4 Reminder: FORMS-E Grant Application Forms & Instructions Must be Used for Due Dates On or After January 25, 2018 (NOT-OD ) – 10/24/ Reminder: FORMS-E Grant Application Forms & Instructions Must be Used for AHRQ Due Dates On or After January 25, 2018 (NOT-HS ) – 11/02/ You are using a FORMS-D application package. If you are submitting to a due date on or before January 24, 2018 you are using the correct forms and no action is needed (NOT-OD ). If you are submitting to a later due date, you are using incorrect forms and MUST move to FORMS-E for submission by the due date. You are using a FORMS-E application package. If you are submitting to a due date on or after January 25, 2018 you are using the correct forms and no action is needed (NOT-OD ). If you are submitting to a due date on or before Jan 24, 2018, you are using incorrect forms and MUST move to FORMS-D for that due date.

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8 Selecting the correct funding opportunity

9 Clinical Trial Not Allowed Parent Clinical Trial Required Parent
Reminder: Policy on Funding Opportunity Announcements (FOA) for Clinical Trials Takes Effect January 25, 2018 (NOT-OD ) – 11/30/2017 Activity Code Clinical Trial Not Allowed Parent Clinical Trial Required Parent R01 PA PA R03 PA N/A R21 PA PA R13 February 2018 R15 PA K01 PA PA K02 PA PA K08 PA PA K99/R00 PA PA F T32 PA

10 Clinical Trials: Special Considerations for Career Development, Fellowship, Training, and Research Education Programs (NOT-OD ) – 11/06/2017 Kirschstein NRSA Individual fellows Cannot propose to lead an independent clinical trial Can propose research experience in clinical trial led by sponsor or co-sponsor Kirschstein NRSA Institutional trainees Cannot lead independent clinical trials Can gain research experience in clinical trial led by mentor or co-mentor Institutional Research Education Grants (R25) participants

11 Revision: NIAMS Only Accepts Clinical Trial Applications Proposing Mechanistic Studies for Clinical Trial Parent R01 and R21 Announcements (NOT-AR ) – 11/03/ NHLBI Only Accepts Clinical Trial Applications Proposing Mechanistic Studies for the NIH Parent R01 Clinical Trial Required Announcement (NOT-HL ) – 11/03/ NIMH Only Accepts Clinical Trial Applications Proposing Mechanistic Studies for Clinical Trial Parent R01 and R21 Announcements (NOT-MH ) – 11/03/ NCCIH Policy for Submission of Parent R01 Applications Proposing Clinical Trials (NOT-AT ) – 11/03/2017

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13 Defining a clinical trial

14 NIH's 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

15 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 Prospectively assigned 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 Intervention 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: 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 Pre-specified goal(s) or condition(s) that reflect the effect of one or more interventions on human subjects’ biomedical or behavioral status or quality of life Examples: 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 and /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.

16 NIH interpretation of a clinical trial

17 Clinical trial versus clinical research
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?

18 Might be a clinical trial even if:
You’re studying healthy participants Your study doesn’t have a comparison group (e.g., placebo or control) Your study is only designed to assess the pharmacokinetics, safety, and/or maximum tolerated dose of an investigational drug Your study is utilizing a behavioral intervention Might not be a clinical trial if study: Is intended solely to refine measures Involves secondary research with biological specimens or health information

19 Case studies https://grants. nih
Case studies The study involves the recruitment of healthy adolescent volunteers followed over time to assess brain development and factors that influence brain development. Participants are administered a battery of standard measures at each visit including blood draws, surveys, various cognitive performance measures (e.g., working memory tasks), and brain scans (e.g., fMRI) to assess the association of these measures over time.

20 Case studies The study involves the recruitment of healthy adolescent volunteers followed over time to assess brain development and factors that influence brain development. Participants are administered a battery of standard measures at each visit including blood draws, surveys, various cognitive performance measures (e.g., working memory tasks), and brain scans (e.g., fMRI) to assess the association of these measures over time. Does the study involve human participants? Yes, the healthy adolescent volunteers are human participants. Are the participants prospectively assigned to an intervention? No, not in this context. The battery of standard measures and the brain scans are being used to describe patterns and associations over time, but not to modify them. Not a clinical trial

21 Case studies https://grants. nih
Case studies The study involves patients with acute occipital stroke who are suspected of suffering visual field loss. They are randomized to a drug or to matching placebo. The investigators seek to determine whether the drug affects post-stroke changes in cortical visual representation as measured by fMRI.

22 Case studies The study involves patients with acute occipital stroke who are suspected of suffering visual field loss. They are randomized to a drug or to matching placebo. The investigators seek to determine whether the drug affects post-stroke changes in cortical visual representation as measured by fMRI. Does the study involve human participants? Yes, the participants are acute stroke patients. Are the participants prospectively assigned to an intervention? Yes, the participants are prospectively assigned, by formal randomization, to receive a drug or placebo. Is the study designed to evaluate the effect of the intervention on the participants? Yes, the study is designed to determine whether the drug affects post-stroke changes in cortical visual representation. Is the effect being evaluated a health-related biomedical or behavioral outcome? Yes, cortical visual representation is a health-related biomedical outcome. Yes, a clinical trial

23 Case studies https://grants. nih
Case studies The study involves the recruitment of patients prior to brain surgery. While an fMRI is performed, half of the volunteers will be randomly assigned to perform a language listening task, and half will be assigned to perform a language generation task. Brain function maps will be used by surgeons to identify language areas for surgical planning. The investigators will compare post-operative language function in the two groups.

24 Case studies The study involves the recruitment of patients prior to brain surgery. While an fMRI is performed, half of the volunteers will be randomly assigned to perform a language listening task, and half will be assigned to perform a language generation task. Brain function maps will be used by surgeons to identify language areas for surgical planning. The investigators will compare post-operative language function in the two groups. Does the study involve human participants? Yes, the participants are patients enrolled prior to brain surgery. Are the participants prospectively assigned to an intervention? Yes, the participants are prospectively assigned to an intervention, a language listening task or a language generation task during pre-operative fMRI brain function mapping. Is the study designed to evaluate the effect of the intervention on the participants? Yes, the study is designed to compare the impact of different methods of brain function mapping on post-operative language function. Is the effect being evaluated a health-related biomedical or behavioral outcome? Yes, post-surgery language function is a health-related outcome. Yes, a clinical trial

25 Case studies https://grants. nih
Case studies Prior to a study of the effects of interference on working memory and brain function, an investigator wishes to test the study procedures and adjust the difficulty of the memory tasks for a range of individuals. To do so, the investigator runs a few healthy volunteers through the procedures and adjusts and finalizes the procedures prior to initiating the formal study

26 Case studies Prior to a study of the effects of interference on working memory and brain function, an investigator wishes to test the study procedures and adjust the difficulty of the memory tasks for a range of individuals. To do so, the investigator runs a few healthy volunteers through the procedures and adjusts and finalizes the procedures prior to initiating the formal study Does the study involve human participants? Yes. Are the participants prospectively assigned to an intervention? Yes, the participants are prospectively assigned to different interference conditions. Is the study designed to evaluate the effect of the intervention on the participants? No, the purpose of these preliminary or practice runs is to evaluate and refine the study procedures, not the effect of the intervention on the participants. Not a clinical trial

27 PHS Human Subjects and Clinical Trial Information form

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29 PHS Human Subjects and Clinical Trials Information form
Exemption numbers 7 and 8 aren’t currently in use If human specimens/data are used BUT not human subjects research Information on who is providing the data/biological specimens and their role in the proposed research Description of the identifiers that will be associated with the human specimens and data List of who has access to subjects' identities Information about the manner in which the privacy of research participants and confidentiality of data will be protected

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31 PHS Human Subjects and Clinical Trials Information form
Basic information Study population characteristics Protection and monitoring plans Protocol synopsis Other clinical trial related attachments

32 PHS Human Subjects and Clinical Trials Information form
Basic information

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34 PHS Human Subjects and Clinical Trials Information form
Section “Yes” to all CT questions “No” to any CT questions 2. Study population characteristics Required 3. Protection and monitoring plans 4. Protocol synopsis Do not complete 5. Other clinical trial related attachments If specified in the FOA

35 PHS Human Subjects and Clinical Trials Information form
2. Study population characteristics

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39 PHS Human Subjects and Clinical Trials Information form
3. Protection and monitoring plans

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41 Guidance on Implementation of the NIH Policy on the Use of a Single Institutional Review Board for Multi-Site Research (NOT-OD ) – 10/11/2017 Multi-site study in which each site will conduct the same protocol involving non-exempt human subjects research must utilize a sIRB Must Be registered with the HHS Office for Human Research Protections Have membership to adequately review the proposed study Might be An institutional IRB that is associated with either Awardee Participating site An independent, commercial, or unaffiliated IRB A central IRB organized to review the proposed study

42 Guidance on Exceptions to the NIH Single IRB Policy (NOT-OD ) – 10/11/2017 Does not apply to Foreign sites Career development (K), institutional training (T), or fellowship (F) awards Exceptions Policy-based Prohibited by a federal, state, or tribal law, regulation, or policy Time-limited Ancillary studies to ongoing research without a sIRB Other Must request prior approval Post-award Addition of a new domestic site unable to use sIRB

43 NIH requires a data and safety monitoring plan (DSMP) commensurate with the trial’s risks, size, and complexity The overall framework for safety monitoring and what information will be monitored The frequency of monitoring, including plans for interim analysis and stopping rules The process by which Adverse Events (AEs), including Serious Adverse Events (SAEs) such as deaths, hospitalizations, and life threatening events and Unanticipated Problems (UPs), will be managed and reported, as required, to the IRB, the person or group responsible for monitoring, the awarding IC, the NIH Office of Biotechnology Activities, and the Food and Drug Administration Individual(s)/group responsible for trial monitoring and advising the appointing entity Potential monitoring options include: PI: Might be acceptable in some cases (e.g., low risk trials, not blinded) Independent safety monitor/designated medical monitor: A physician or other expert who is independent of the study Independent Monitoring Committee or Safety Monitoring Committee: A small group of independent experts Data and Safety Monitoring Board (DSMB): A formal independent board of experts including investigators and biostatisticians NIH requires the establishment of DSMBs for multi-site clinical trials involving interventions that entail potential risk to the participants and for Phase III clinical trials Phase I and Phase II clinical trials may also need DSMBs Describe the general composition without naming specific individuals

44 PHS Human Subjects and Clinical Trials Information form
4. Protocol synopsis

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47 Dissemination plan Ensure that clinical trials are registered in and results information is submitted to ClinicalTrials.gov Include specific statement relating to posting of clinical trial information at ClinicalTrials.gov in informed consent documents Has an internal policy in place to ensure that clinical trials registration and results reporting occur in compliance with policy requirements

48 PHS Human Subjects and Clinical Trials Information form
5. Other clinical trial related attachments

49 Reminder: New Appendix policy for NIH/AHRQ/NIOSH Applications submitted for Due Dates On or After January 25, 2017 (NOT-OD ) – 01/13/2017 Blank data collection forms, blank survey forms, and blank questionnaire forms Simple lists of interview questions Blank informed consent/assent forms Items specified in the FOA Do not include: Data, data compilations, lists of variables or acronyms, data analyses, publications, manuals, instructions, or descriptions or drawings/figures/diagrams of data collection methods or machines/devices

50 February 5 R01 deadline UNMC submitted 34 applications 20 were submitted on the deadline Clinical trials Not allowed: 26 Required: 1 Optional: 7

51 Q&A

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