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Human Subjects Protections in NIH SBIR/STTR Applications Ann Hardy, DrPH NIH Extramural Human Research Protection Officer Office of Extramural Programs.

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Presentation on theme: "Human Subjects Protections in NIH SBIR/STTR Applications Ann Hardy, DrPH NIH Extramural Human Research Protection Officer Office of Extramural Programs."— Presentation transcript:

1 Human Subjects Protections in NIH SBIR/STTR Applications Ann Hardy, DrPH NIH Extramural Human Research Protection Officer Office of Extramural Programs (OEP), OER SBIR Conference October 21-23, 2014

2 2 Learning Objectives After this presentation, you will: Understand the regulatory basis for human subjects protection in research Define human subjects research and apply the regulations to common research designs Distinguish exempt and non-exempt human subjects research Understand the human subjects requirements for NIH applications and awards

3 3 HHS Regulations 45 CFR part 46: Protection of Human Research Subjects –Subpart A - Basic Requirements for Protection –Subpart B, C, D – Additional protections for Pregnant Women/Fetuses/Neonates; Prisoners; Children –Subpart E – IRB Registration Office for Human Research Protections (OHRP) is responsible for ensuring compliance

4 4 45 CFR 46 - Subpart A Applicability Key Definitions Institutional Responsibilities –Assurance (FWA) –Institutional Review Board (IRB) Sponsoring Agency Responsibilities

5 5 Do The Regulations Apply to My Project? Does activity involve Research? Does research involve Human Subjects? If yes, is human subjects research Exempt? ASK QUESTIONS IN THIS ORDER! Human Subject Regulations Decision Chart:

6 6 Research – a systematic investigation designed to develop or contribute to generalizable knowledge –includes research development, testing, evaluation, pilot studies Definition of Research

7 7 Definition of Human Subject … a living individual about whom an investigator (professional or student) conducting research obtains –Data through intervention or interaction with the individual –Identifiable private information 7 OR

8 8 Definition Deconstructed a living individual – Regulations do NOT apply to research involving materials from deceased individuals 8

9 9 Definition Deconstructed about whom an investigator conducting research obtains –Data through intervention or interaction Examples: Collect biological samples (blood) Administer a questionnaire Conduct MRI Manipulating environment and noting response OR 9 Collected for THIS Research

10 10 Definition Deconstructed –Identifiable Private Information Identity of subjects can be readily ascertained by ANY of the investigators Name or Unique # linked to name -Who is an investigator? -Anyone involved in conduct of the research (study, analysis, interpretation of research data, co- authorship). Does NOT include providing info or samples. OHRP guidance on coded info and specimens Collected for OTHER purpose

11 11 Definition Examples PI will use materials from a brain bank; donors consented prior to death for materials to be used for research Not human subjects research because the federal regulations only apply to living persons PI will purchase tissue from commercial vendor Not human subjects research because not collected for research and no identifiers

12 12 Definition Examples At time of clinical blood draw, an extra tube of blood is collected for research –Yes, because this tube is being collected specifically for research. This is different from using left-over blood that was collected for clinical reasons.

13 13 Is the Human Subjects Research Exempt? 6 categories of human subjects research activities that are so low risk, they are EXEMPT from the regulations All other human subjects research is classified as NON- EXEMPT HUMAN SUBJECTS RESEARCH Exempt Non-Exempt About 13% of SBIR/STTR awards that involve human subjects are exempt

14 14 Categories of Exempt Human Subjects Research (1) Research in educational settings on educational practices (2) Educational Tests, Surveys, Interviews… (not if ID and info disclosure put subject at risk; parts not applicable to research w/ children) (3) Tests, Surveys, Interviews with public officials, or if federal law requires confidentiality (4) Collection/Study of existing data, specimens if recorded by investigator in way subjects cannot be identified (5) Research approved/conducted by Federal Agencies on public benefit programs (6) Evaluation of taste or food quality

15 15 Exemption 1 Research conducted in educational settings on educational practices such as instructional strategies, techniques, curricula …. Examples: –Study to determine effectiveness of on-line training as supplement to regular instructional approach for teaching anatomy to medical students. –Study to determine effectiveness of planned activities to increase the public’s awareness of oral health to be delivered at a community science museum.

16 16 Exemption 2 Research involving use of educational tests, surveys, interviews or observation of public behavior unless ID AND disclosure could harm Examples: –Focus group to discuss general barriers to use of community health centers Some parts not applicable to research with children

17 17 Exemption 4 Research involving the study of existing data, documents, records, specimens if publicly available OR info recorded by the investigator in manner that subjects cannot be identified directly or indirectly

18 18 Research Involving Coded Data/Specimens OHRP Policy Guidance 2008: Research involving only use of coded data/spec from living individuals is NOT human subjects research IF –Info/spec not collected for proposed research AND –Investigator(s) cannot readily ascertain identity of subjects Provider will not to share ID w/ investigator Written policies prohibiting release of ID (repositories) Clarified that most research with existing data/specimens –Not HS research (no one has ID’s) OR –Non-exempt (investigator has ID’s) 18

19 19 Tricky Issues in Applying Guidance Who is an “investigator” –Anyone involved in any aspect of the research Only providing data/spec is not “involvement” Assisting w/ data analysis or interpretation, authorship is involvement PI involved in primary collection or associated w/ repository NO circumstances where investigators could identify “Excess” clinical samples When is E4 applicable?

20 20 Exemption 4 Research involving the study of existing data, documents, records, specimens if publicly available OR info recorded by the investigator in manner that subjects cannot be identified directly or indirectly

21 21 When is E4 Applicable? For E4 –Investigator initially obtains identifiable info/specimens AND –“Records the data in such a manner that subjects cannot be identified” – break link Examples –PI accesses identifiable data but extracts research data w/o identifiers that can no longer be linked back. –PI goes through set of existing excess clinical samples to identify those of interest. She removes label with identifiers and marks tubes with random number and basic non-identifiable clinical info.

22 22 Expert Advice and Product Testing Using expert consultants to improve research design or advise on research process – NOT research Persons to test a new product to identify flaws – NOT human subjects research Pilot test of new product –May be human subjects research if collecting data about individuals and/or identifiable private info

23 23 Examples Computer design experts will review your software product to identify flaws and overall usability (colors, font, readability, navigation) –Probably not research Conduct a small pilot study of your survey system with end users. –It Depends You ask patients to wear your new prosthetic device and provide feedback –Is HS research

24 24 Is it Human Subjects Research? Ask Questions in THIS ORDER 1/Does it meet the definition of human subjects research? Data through intervention or interaction OR Identifiable private information For secondary use of specimens/data –Who are investigators; is provider an investigator? –Who has access to identifiers or can link? If No, NOT Human subjects research (STOP) 2/If Yes, do any of the Exemptions apply? Yes: Exemption # No: Non-exempt human subjects research Living Subjects

25 25 Sponsoring Agency Responsibilities 25 Regulations require Agencies to evaluate applications and proposals involving human subjects: 1.Risks subjects 2.Adequacy of protections 3.Benefits 4.Importance of knowledge to be gained NIH evaluates through peer review No funds expended unless regulatory requirements are met; can withdraw funding for non-compliance

26 26 Human Subjects Section of Grant Application Risks to Human Subjects –Human subjects involvement and characteristics Demographic and health characteristics Inclusion and exclusion criteria Rational for involvement of vulnerable populations –Sources of materials What materials (specimens, records, data) How will materials be collected Who has access to information –Potential Risks Physical, psychological, financial, legal or other risks Alternative treatments/procedures

27 27 Human Subjects Section (con’t) Adequacy of Protection Against Risks –Recruitment –Informed consent Children – assent; parental permission How consent will be obtained; info provided –Protections against risk Procedures to minimize risk; protect privacy and confidentiality Additional protections for vulnerable populations Ensure necessary medical/professional intervention Data and safety monitoring 27

28 28 Human Subjects Section (con’t) Potential Benefits of Research to Human Subjects and Others –May not be direct benefit to subjects –Compensation is not a benefit –Discuss risks in relation to anticipated benefits Importance of Knowledge to be Gained –Discuss in relation to risks 28

29 29 Preparing the Human Subjects Section All proposed research will fall into one of six scenarios: A. No Human Subjects B. Non-Exempt Human Subjects Research C. Exempt Human Subjects Research D. Delayed-Onset of Human Subjects Research E. Clinical Trial F. NIH-defined Phase III Clinical Trial

30 30 Scenario A: No Human Subjects Are Human Subjects Involved? ___ Yes ____ No 30 Provide clear justification if using human specimens or data Only post-mortem samples will be used Samples will be purchased from a commercial vendor and will be provided without identifiers

31 31 Scenario B: Non-Exempt Research Are Human Subjects Involved? ___ Yes ___ No Research Exempt?___ Yes___ No Clinical Trial?___ Yes___ No NIH-Defined Phase III CT?___ Yes___ No Human Subjects Section- no page limitations –Address 4 required points (risk, protections, benefits, knowledge) Inclusion of Women and Minorities Planned Enrollment Tables Inclusion of Children 31

32 32 Scenario C: Exempt Research Are Human Subjects Involved? ___ Yes___ No Research Exempt___ Yes____No Exemption Number (mark all) __1 __2 __3 __4 __5 __6 Clinical Trial? ___ Yes___ No NIH-Defined Phase III CT?___ Yes___ No Human Subjects Section –Justify selection of exemption(s) –Sources of research materials Inclusion of Women and Minorities* Targeted/Planned Enrollment Tables* Inclusion of Children* * Not required for Exemption 4 32

33 33 Scenario D: Delayed Onset HS Research Are Human Subjects Involved?____ Yes___No Research Exempt?____ Yes___No Clinical Trial?____ Yes___No NIH-Defined Phase III CT ?____ Yes___No Delayed Onset: Human subjects research anticipated but Specific plans cannot be described (45 CFR ) Human Subjects Section – explain why delayed onset If funded, you will have submit human subjects section, FWA and IRB approval before involving human subjects 33 Mark as applicable

34 34 Scenarios E & F: Clinical Trial Clinical Trial: Prospective research study designed to answer questions about biomedical or behavioral interventions NIH Defined Phase III Trial: broad-based, prospective trial, often to provide scientific basis for change in health policy or standard of care (Scenario F) All other Phases (Scenario E) 34

35 35 Scenario E: Clinical Trial (not Phase III) Are Human Subjects Involved? ___ Yes ___ No Research Exempt?___ Yes___ No Clinical Trial?___ Yes___ No NIH-Defined Phase III CT?___ Yes___ No Provide information required for Scenario B (Non- Exempt Human Subjects Research) Must have a Data and Safety Monitoring Plan May need Data and Safety Monitoring Board (DSMB) 35

36 36 Scenario F: NIH-defined Phase III Clinical Trial Are Human Subjects Involved? ___ Yes ___ No Research Exempt?___ Yes___ No Clinical Trial?___ Yes___ No NIH-Defined Phase III CT?___ Yes___ No Provide information required for Scenario E Generally requires Data and Safety Monitoring Board (DSMB) 36

37 37 Inclusion of Women, Minorities, and Children By law, Women and Minorities must be included in clinical research studies; in Ph III CT in numbers adequate for valid analysis By NIH policy, children should also be included in human subjects research unless scientific/ethical reasons (NOTE: Children are < 21 years) NOTE: difference between children according to HS regulations and children according to inclusion policy

38 38 NIH Uses Two Definitions for Children For purposes of human subjects protection: Children are persons who have not attained the legal age of consent for research treatment/procedures where research will be conducted. For the purposes of inclusion: Children are individuals under the age of

39 39 Cost or convenience is NOT an acceptable reason for exclusion Inclusion should be tied to scientific goals of project Enrollment tables (recently revised) Inclusion of Women, Minorities, and Children

40 40 Planned Enrollment Report 40 For Internal NIH Use Only

41 41 Peer Review of HS and Inclusion Each reviewer assesses human subjects protections and inclusion Peer review group will determine overall rating of “acceptable” or “unacceptable”. May affect overall score – 24% SBIR/STTR applications involving HS are deemed Unacceptable vs 18% overall Summary Statement: will note Unacceptable on front page; nacceptable for HS or inclusion is bar to funding 41

42 42 What Happens to Grants with Unacceptable Code for Human Subjects? For grants in the fundable range: –PI submits written response –After Program Officer approves response, submit request to OEP for review and code change –OEP reviews entire Human Subjects plan OEP concurs OEP may request additional information

43 43 Common HS Concerns Source of existing specimens/data; missing or inadequate justification for no human subjects research Risks -physical, psychological, reputation, employability, financial, etc. Missing/inadequate Data & Safety Monitoring Plans for Clinical Trials Confidentiality of data Inadequate protections for vulnerable populations Coercive recruitment Incidental findings not addressed

44 44 Institutional Responsibilities: Documents institution’s commitment to regulations Designate a registered Institutional Review Board (IRB) FWA Reviews/approves proposed research and on-going research at least annually IRB & FWA and IRB approval required for funded institutions and sites engaged in human subjects research (just-in time) ( ) For cooperative projects, may rely on single IRB ( )

45 45 Additional NIH Award Requirements Certification that Key Personnel have completed appropriate human subjects research education –Protecting Human Research Participants Tutorial: Annual IRB approval Update Inclusion enrollment in annual progress report 45

46 46 Cumulative Inclusion Enrollment Report 46 For Internal NIH Use Only

47 47 Human Subjects Resources Office of Extramural Research Human Subjects Web site: OHRP Web site : Coded Information/Specimens Resources (VIDEO) –OER Flow Chart Code Specimen Guidance cisionChart.pdf cisionChart.pdf

48 48 Contact Information


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