Human subjects and teaching scholarship


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Human subjects and teaching scholarship

  2. 2. Federal Regulations and Policy stemming from Belmont Principles 45 CFR 46 – DHHS Policy for Protection of Human Research Subjects 21CFR50, 56, etc. – drugs, devices, biologics Common Rule, DOD, DOE ……
  3. 3. ActivitiesrequiringIRBapproval 45 CFR 46.102(f) RESEARCH A systematic investigation designed to develop or contribute to generalizable knowledge. 45 CFR 46.102(d) AND HUMAN SUBJECT A living individual about whom an investigator conducting research obtains 1) data through intervention or interaction with the individual, or 2) identifiable private information
  4. 4. Quality Improvement • OHRP FAQ’s • To determine whether these regulations apply to a particular quality improvement activity, the following questions should be addressed in order: • (1) does the activity involve research(45 CFR 46.102(d)); • (2) does the research activity involve human subjects (45 CFR 46.102(f)); • (3) does the human subjects research qualify for an exemption (45 CFR 46.101(b)); and • (4) is the non-exempt human subjects research conducted or supported by HHS or otherwise covered by an applicable FWA approved by OHRP.
  5. 5. QI as HSR Goals Purpose Methods Publication is not the main determinant Is it Research?? A systematic investigation designed to develop or contribute to generalizable knowledge.
  6. 6. Is this HSR? • A weekly survey to determine work hours by all housestaff. • A survey of housestaff regarding concentration, motor skill and sleep patterns to be tied to work hours. • Using “clickers” for a pre and post test as part of a TBL and obtaining ward scores to correlate with knowledge as determined by pre and post scores. • Implementation of a discharge summary template to improve adequacy of summary. Training half of the housestaff on the template and providing it to the other half. Did the template and/or the training improve the adequacy. • Receiving a dataset with MCAT scores and board pass rates and comparing by age, gender, and year of enrollment for past 5 years. Data set contains age, gender, year of MCAT, MCAT score, year of board exam and board score. • Beginning a pilot project to train third year residents to teach fourth year medical students how to convey bad news to a patient. The program will involve role play, video, and writing. A survey will be conducted with the residents, students and with the students again at the end of their internship.
  7. 7. Document your decision! • If you determine that it is not HSR then make a note to your study file with an explanation of how you determined that. • If you determine it is HSR then you will need to submit to the IRB.
  8. 8. IRB ReviewContinuum Exempt Expedited Full Low Risk High Level of potential risk determines route of review
  9. 9. Minimal risk The probability and magnitude of harm or discomfort anticipated in the research are not greater in and of themselves than those ordinarily encountered in daily life or during the performance of routine physical or psychological examination or tests. 45 CFR 46.102(i) and 21 CFR 56.102(i)
  10. 10. “Risk Assessment” Not just physical risks! Consider: - Emotional distress - Embarrassment/ stigma - Risk to financial status - Risk to social status - Risk to employment - Risk to criminal/ civil liability - Invasion of privacy - Etc.
  11. 11. Vulnerable Populations • Children (less than 18 in VA) • Pregnant women and neonates • Prisoners • Students • Employees • Trainees • Adults with decisional challenges
  12. 12. Mechanisms for Initial IRB Review •Exemption* •Expedited Review •Full Review (Convened) *FDA requirements differ from the 45 CFR 46 and Common Rule
  13. 13. Exemption Categories: 45 CFR 46 101 (b) 1. *Typical educational practices 2. *Anonymous surveys, interviews, or observation of public behavior (generally not applicable to children) 3. Research with elected public officials, appointed public officials, candidate for public office) 4. *Existing data, documents, pathological specimens, if publicly available or unidentifiable (no identifiers retained) 5. Evaluation of public benefit service programs 6. Taste and food quality evaluation and consumer acceptance studies
  14. 14. Exempt [46.101(b)] 1. Research conducted in established or commonly accepted educational settings, involving normal educational practices
  15. 15. Exempt [46.101(b)] 2. Survey, interviews or observations of public behavior, unless - information obtained is recorded in such a manner that human subjects can be identified, directly or through identifiers linked to the subjects; and - any disclosure of the human subjects’ responses outside the research could reasonably place the subjects at risk of criminal or civil liability or be damaging to the subjects’ financial standing, employability, or reputation
  16. 16. Exempt [46.101(b)] 4. Research involving the collection or study of existing data, if the data are publicly available or if the information is recorded by the investigator in such a manner that subjects cannot be identified, directly or through identifiers linked to the subjects
  17. 17. Categories for Expedited Review: No greater than minimal risk! Clinical studies: IND/IDE NOT required Blood sample collection (routine methods –small amounts) Prospective collection of biological samples— noninvasive means Data collected though noninvasive means (routinely practiced in clinical settings) Materials (data, documents, specimens etc.) have been collected or will be collected for non-research purposes Collection of voice, video or digital data for research purposes Individual or group behavior, surveys, interviews, oral histories
  18. 18. Exempt<<< Review >>>Expedited (1) Minimal risk One IRB or Qualified Exempt reviewer Fits one of 6 categories of research Usually no recorded identifiers, with some exception Topic generally not sensitive Minimal risk research One IRB reviewer outside of convened meeting Fits one of 7 expedited categories (for initial review) May include identifiers (direct or indirect) Topics not sensitive OR may include some sensitive topics, but confidentiality securely protected
  19. 19. Exempt <<< Review >>>Expedited (2) • Non-vulnerable populations, with some exception • Exempt from formal informed consent requirement (but subjects deserve to know about the research if possible) • Exempt from continuing IRB review • Populations may include regulated vulnerable & others with adequate protections • Required formal informed consent process OR justify a waiver of consent • Requires IRB continuing review at least annually
  20. 20. Full IRB Review Does not qualify for exempt or expedited review based on risk assessment by PI and/or IRB……. Greater than minimal risk! (some non-HSR requires IRB approval per regs) 2 reviewers present the study at a convened meeting IRB majority finds all Criteria for Approval are satisfied
  21. 21. Additional Review Requirements • Type of Review Categories for Exempt and Expedited • Documents: Surveys, Questionnaires, Ads • Engagement of outside investigators or institutions • GWAS criteria • HIPAA • COI as relates to human subjects • Congruence of grants • IRB office: CITI training, COI resolution, other review groups (ex. investigational drug plan, biohazards)
  22. 22. 8CriteriaforIRBApproval 45CFR46.111(a) Select One or More IRB_Approval_Conditions Filter by Number Total Selected: 8 1-8 of 8 Number Long Name 1 Risks to subjects are minimized (i) by using procedures consistent with sound research design and do not unnecessarily expose subjects to risk and (ii) if appropriate, by using procedures already being performed for diagnostic or treatment purposes 2 Risks to subjects are reasonable in relation to anticipated benefits, if any, to subjects, and the importance of the knowledge that may reasonably result 3 Selection of subjects is equitable 4 Informed consent will be sought from each prospective subject or the subject's LAR to the extent required by 45 CFR 46.116 / 21 CFR 50.20 5 Informed consent will be appropriately documented in accordance with 45 CFR 46.117 / 21 CFR 50.27 6 When appropriate, the research plan makes adequate provision for monitoring the data collected to ensure the safety of subjects 7 The research plan includes adequate provisions to protect the privacy of subjects and to maintain the confidentiality of data 8 When some or all of the subjects are likely to be vulnerable to coercion or undue influence, additional safeguards have been included in the study to protect the rights and welfare of these subjects.(46.111 (b)) Total Selected: 8 1-8 of 8
  23. 23. Duty to Report • VCU Policy goes beyond traditional mandatory reporters • Should be in your consent if appropriate
  24. 24. Consent • Not formally required for Exempt • Required for Full board or Expedited unless waived with required and if applicable information • Waiver of Consent: Waiver of some or all elements of informed consent/permission may be appropriate: - research is no greater than minimal risk - no impact on rights or dignity of participants - not practicable to obtain informed consent - provide debrief after the research, as appropriate • Waiver of Documentation of Consent • Research presents no more than minimal risk* • AND • Research involves procedures that do not require written consent when performed outside of a research setting • Consent Templates on VCU IRB website • RAMSIRB Consent Groups: This is the types of folks you will be consenting. For instance if you are consenting medical residents for one survey, nursing staff for another then that would be two groups.
  25. 25. Once Approved the Fun Starts • Regulatory Binder • Data Security • Continuing Review • Amendments • Study Closure • Prompt reports: Unanticipated Problems and SAEs • Non prompt reports
  26. 26. RAMSIRB • Main VCU IRB website • RAMSIRB • Must have VPN on computer if not at VCU/VCUHS • Sign in with eid • What you need to get started: CITI, FIR, PI CV, Consents, Surveys, your plan. • Student Trainee research • Determine what type of research it is
  27. 27. Helpful hints to RAMSIRB • Add editors • Conversion Amendments • Have to answer questions with * • Help text • You have to upload one document when you get to the personnel screen. PI CV is usually it. This will then appear anytime a document is requested. This is a running list of documents. Do not delete a document unless you really want it gone from the system. • Create a dummy study if want to see what happens with different choices or know what you will be asked. • Once submitted reviewer makes comments to you in the review section on each page. If changes required before approval or need clarifications they will send it back to you (electronically). You need to respond to every reviewer comment even if to say OK or done or changes made. Then submit again. Only those on the side with current access can work on it. You can however look to see progress on the first screen • If you have a question about a submitted study you can send a public comment in the system.
  28. 28. HELP! • Email or talk to me • Send public comment in an already submitted protocol • Other reviewers, IRB panel coordinators • Michelle Stickler, Christine Davison, Susan Kimbrough • for questions about the content of the study forms • for technical issues