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OSP Informational Session for NIH Researchers on FORMS E
Wednesday, January 10, 2018
4:00 PM - 4:45PM
Auditorium B, DHMC
The presentation will cover the new NIH Human Subjects and Clinical Trials Information Form by showing the additional required questions and how to select the correct FOA.
To attend remotely click on the link below after 3:50PM on January 10th for a live-stream of the presentation:
https://video.dartmouth-hitchcock.org/media/Global+2/1_dkfar49z<https://na01.safelinks.protection.outlook.com/?url=https%3A%2F%2Fvideo.dartmouth-hitchcock.org%2Fmedia%2FGlobal%2B2%2F1_dkfar49z&data=02%7C01%7CStephanie.Morgan%40dartmouth.edu%7Ce6311537cdfb489da21808d546ecfc2c%7C995b093648d640e5a31ebf689ec9446f%7C0%7C0%7C636492906023295488&sdata=Yh%2FEYZlF70WL7ST%2FMBVQeBzfRebKrJEPeHn8%2F4Vdcjo%3D&reserved=0>
During the presentation, remote participants can email questions to [log in to unmask]<mailto:[log in to unmask]> which will be monitored during the presentation and questions will be read and answered as they are received.
FORMS E
Important Changes to NIH Forms
NIH will require the use of application packages with a Competition ID of 'FORMS-E' for due dates on or after January 25, 2018.
Applications prepared using the prior 'FORMS-D' packages for due dates after January 24, 2018 will be rejected without review by NIH.
Changes are focused on human subjects questions and clinical trials but other changes apply to all applications:
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1. If your research involves human subjects in any way, including human specimens and data, please be aware of the new questions below:
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2. If "yes" to Human Subjects you will need to create a Study Record:
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*Study Record Screen Shots Appear After the Resource Links Below*
Links to resources:
Is my project a clinical trial?
Decision-making tool: https://grants.nih.gov/policy/clinical-trials/definition.htm<https://na01.safelinks.protection.outlook.com/?url=https%3A%2F%2Fgrants.nih.gov%2Fpolicy%2Fclinical-trials%2Fdefinition.htm&data=02%7C01%7CStephanie.Morgan%40dartmouth.edu%7Cefd1fe6d9f72497cc58f08d5463425dc%7C995b093648d640e5a31ebf689ec9446f%7C0%7C0%7C636492112162774243&sdata=XbxaO%2FUFdRzvvg%2B8uu5wg0S9TpBXwB0cSzIEEwHHad4%3D&reserved=0>
See example case studies here: https://grants.nih.gov/policy/clinical-trials/case-studies.htm<https://na01.safelinks.protection.outlook.com/?url=https%3A%2F%2Fgrants.nih.gov%2Fpolicy%2Fclinical-trials%2Fcase-studies.htm&data=02%7C01%7CStephanie.Morgan%40dartmouth.edu%7Cefd1fe6d9f72497cc58f08d5463425dc%7C995b093648d640e5a31ebf689ec9446f%7C0%7C0%7C636492112162774243&sdata=Ftv%2BiqrY9RS4tMHe9uATd8XuzEvQup0UDF8sgfsn8UY%3D&reserved=0>
FAQ: https://grants.nih.gov/grants/policy/faq_clinical_trial_definition.htm<https://na01.safelinks.protection.outlook.com/?url=https%3A%2F%2Fgrants.nih.gov%2Fgrants%2Fpolicy%2Ffaq_clinical_trial_definition.htm&data=02%7C01%7CStephanie.Morgan%40dartmouth.edu%7Cefd1fe6d9f72497cc58f08d5463425dc%7C995b093648d640e5a31ebf689ec9446f%7C0%7C0%7C636492112162774243&sdata=aIm6P%2F4qBx7uxWe2ThwSjlxNtSqRC7tU5pIbL%2FkkF6Y%3D&reserved=0>
Training Video for the Study Record: https://grants.nih.gov/policy/clinical-trials/new-human-subject-clinical-trial-info-form.htm<https://na01.safelinks.protection.outlook.com/?url=https%3A%2F%2Fgrants.nih.gov%2Fpolicy%2Fclinical-trials%2Fnew-human-subject-clinical-trial-info-form.htm&data=02%7C01%7CStephanie.Morgan%40dartmouth.edu%7Cefd1fe6d9f72497cc58f08d5463425dc%7C995b093648d640e5a31ebf689ec9446f%7C0%7C0%7C636492112162774243&sdata=Vyg8DnTspFFlvjirkJkqdqlh4aeaQ5Zi59HAiSzMJTk%3D&reserved=0>
Instructions the Study Record: https://grants.nih.gov/grants/how-to-apply-application-guide/forms-e/general/g.500-phs-human-subjects-and-clinical-trials-information.htm<https://na01.safelinks.protection.outlook.com/?url=https%3A%2F%2Fgrants.nih.gov%2Fgrants%2Fhow-to-apply-application-guide%2Fforms-e%2Fgeneral%2Fg.500-phs-human-subjects-and-clinical-trials-information.htm&data=02%7C01%7CStephanie.Morgan%40dartmouth.edu%7Cefd1fe6d9f72497cc58f08d5463425dc%7C995b093648d640e5a31ebf689ec9446f%7C0%7C0%7C636492112162774243&sdata=rJLSx7kppsL3OZxmc76HWDJ%2BTlC2y1uacTfar3kmTtM%3D&reserved=0>
Screen Shots of New Form and Study Record:
[The PHS Human Subjects and Clinical Trials Information form landing page has several sections. The first section is the display of information entered on the R&R Other Project Information form , including whether Human Subjects are involved and exemption information. The second section is used when Human Subjects = No. You must indicate whether your research involved human specimens and provide an explanation. The third section is used when Human Subjects = Yes with buttons to add full or delayed onset studies. An "Other Requested information" attachment is also available on the landing page.]
Data Collection for Delayed Onset Study
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Study Record: PHS Human Subjects and Clinical Trials Information
Full study records are comprised of 5 sections.
[Section 1 - Basic Information 1.1 Study Title 1.2 Is this Study Exempt from Federal Regulations? Yes or No 1.3 Exemption Number (check boxes 1 through 6) 1.4 Clinical Trial Questionnaire - If all questions in the Clinical Trials Questionnaire are Yes, then study will be flagged as a clinical trial. 1.4.a Does the study involve human participants? 1.4.b Are the participants prospectively assigned to an intervention? 1.4.c Is the study designed to evaluated the effect of the intervention on the participants? 1.4.c Is the effect that will be evaluated a health-related, biomedical, or behavioral outcome? 1.5 Provide the ClinicalTrials.gov Identifier (e.g., NCT87654321) for this trial, if applicable.]
[Section 2 - Study Population Characteristics 2.1 Conditions or Focus of Can enter up to 20 conditions at 255 chars. each. 2.2 Eligibility Criteria - Text entry of inclusion / exclusion criteria up to 15,000 characters. 2.3 Age field plus Dropdown: Years, Months, Weeks, Days, Hours, minutes 2.4 Inclusion of Women, Minorities, and Children - Attachment 2.5 Recruitment and Retention Plan - Attachment 2.6 Recruitment Status - Dropdown: Not yet recruiting; Recruiting; Enrolling by invitation; Active, not recruiting; Completed; Suspended; Terminated (Halted Prematurely); and Withdrawn (No Participants Enrolled) 2.7 Study Timeline - Attachment 2.8 Enrollment of First Subject - date field with associated Dropdown: Anticipated, Actual Ability to add Inclusion Enrollment Report(s)]
Inclusion Enrollment Report Data Collection will be in Study Record
[Inclusion Enrollment Report Using an Existing Dataset or Resource. Yes or no. Answer required. System Enforced. Enrollment Location Type. Domestic or Foreign. Answer required. System Enforced. Enrollment Country(ies) - UNITED STATES OF AMERICA Enrollment Location(s) Comments - Enter up to 500 characters - Some non-zero counts in either Planned or Cumulative tabled are required, unless a Comment is provided. System enforced.]
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[Section 3 - Protection and Monitoring Plans 3.1 Protection of Human Subjects - Attachment 3.2 Is this a multi-site study that will use the same protocol to conduct non-exempt human subjects research at more than one domestic site? Yes, No, or N/A. If yes, describe the single IRB Plan in an attachment. 3.3 Data and Safety Monitoring Plan - Attachment 3.4 Will a Data and Safety Monitoring Board be appointed for this study? Yes or No. 3.5 Overall structure of the study team attachment]
[Section 4 - Protocol Synopsis 4.1 Brief Summary 4.2 All Study Design fields (4.2.a-4.2.g) 4.2.a Narrative Study Description 4.2.b Primary Purpose - Dropdown: Treatment, Prevention, Diagnostics, Supportive Care, Screening, Health Services Research, Basic Science, Device Feasibility, Other. If "other", text explanation up to 255 characters required. 4.2.c Interventions Intervention type - Dropdown: drug (including placebo), device (including sham), Biological/Vaccine, Procedure/Surgery, Radiation, Behavioral (e.g. Psychotherapy, Lifestyle Counseling), Genetic (including gene transfer, stem cell and recombinant DNA), Dietary Supplement (e.g. vitamins, minerals), Combination Product, Diagnostic Test, Other. Name Description 4.2.d Study Phase - Dropdown: Early phase 1 (or phase 0), Phase 1, Phase1/2, Phase 2, Phase 2/3, Phase 3, Phase 4, Other. If "other", text explanation up to 255 characters required Is this an NIH-defined Phase III clinical trial? Yes or No 4.2.e Intervention Model - Dropdown: Single Group, Parallel, Cross-Over, Factorial, Sequential, Other. If "other", text explanation up to 255 characters required 4.2.f Masking - Yes or No. If yes, additional selection required. Choose Participant, Care Provider, Investigator, Outcomes Assessor. 4.2.g Allocation - Dropdown: N/A, Randomized, Non-randomized.]
[Section 4 - Protocol Synopsis (cont.) 4.3 Outcomes or Measurements - Name; Type - Dropdown: Primary, Secondary, Other; Time Frame; Brief Description 4.4 Statistical Design and Power - Attachment 4.5 Subject Participation 4.6 Will the study use an FDA-regulated intervention? Yes or No. 4.6.a If yes, describe the availability of Investigational Product (IP) and Investigational New Drug (IND)/Investigational Device Exemption (IDE) - Attachment with description required if answer to FDA-regulated intervention is Yes. 4.7 Dissemination Plan - Attachment]
[Section 5 - Other Clinical Trial-related Attachments 5.1 Other Clinical Trial-related Attachments - Add Attachment. Only use this section for attachments specifically requested in an FOA.]
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