Protection of Research Subjects: The IRB Process

Transcription

1 Protection of Research Subjects: The IRB Process Ethics in Patient-Oriented Research October 13, 2010 Sharon Friend Director, OHRPP

2 Overview Charge and Function of the IRB Conducting Risk and Benefit Assessments Research Involving Collaborations with Other Institutions 2

3 What is an Institutional Review Board (IRB)? An independent internal review committee Composed of institutional members (UCLA faculty) with relevant expertise and at least one nonaffiliated member and at least one nonscientific member Reviews proposed human subjects in research conducted by UCLA faculty and students regardless of funding source and usually regardless of site Based on federal criteria, IRB has the authority to approve, require changes or disapprove human research. 3

4 What is the mission and charge of UCLA IRBs? Ensure ethical principles are applied to the conduct of research Assure federal criteria for approval of human subjects research and institutional policies are met Promote and facilitate the protection of the rights and welfare of human subjects in research Support and facilitate the conduct of human research at UCLA 4

5 What do both the IRB and the PI consider in applying the ethical principles? Beneficence (Be nice!) Design studies to minimize risk to the extent possible maximize benefit (both individual and societal) Respect for Persons (Be respectful!) Obtain informed consent before involving participants (or using private identifiable information) in research Assure confidentiality provisions are in place. Justice (Be fair!) Select participants who are likely to benefit from research participation Do not systematically include or exclude participants for convenience. 5

6 Human Research Is any research or clinical investigation that involves people or identifiable data from people. 6

7 What is research? Research is a systematic investigation, including research development, testing and evaluation, designed to develop or contribute to generalizable knowledge. Systematic Investigation: a proposed research plan that incorporates data collection & analysis Generalizable Knowledge: designed with intent to draw general conclusions (beyond population(s) studied), inform policy, and/or disseminate findings. 7

8 What is a Human Subject? A living individual about whom an investigator (faculty or student) conducting research obtains data Through an intervention or interaction with the individual, or Access to identifiable, private information. 45 CFR (f) 8

9 What is not Human Research? The following are types of studies that may not be considered human research at UCLA: Analysis of data or specimens that do not include private or personally identifying information Studies using public data sets 3 or fewer individual case studies Quality improvement activities Guidelines and decision tree on OHRPP website and short questionnaire in webirb to assist investigators IRB review may not be required 9

10 When Is IRB Review Required? All human subjects research requires prior IRB review and approval before initiation (New Studies) All modifications or changes made to an IRBapproved study require IRB approval prior to initiation (Amendments) All continuation of an IRB-approved study beyond its approval period (usually one year) requires IRB approval (Continuing Review) 10

11 What are the levels of IRB Review? There are three levels of IRB Review, depending on level of risk: Full Committee for more than minimal risk Expedited review for minimal risk studies Exempt certification for studies that fall into one of six federal categories 11

12 What is the Best News Ever about the UCLA IRB Review Process? There is now a web-based on-line submission system: webirb. It s much easier to submit an application. The program uses a smart form that walks you through the process and provides help text on the side or within links. Approval times are much faster! WebIRB submissions are even faster! 12

13 What is webirb? Web-Based IRB Submission, Review and Tracking System 13

14 How does it support PIs and Research Staff? Homepage with access to information on all studies 14

15 How does it support PIs and Research Staff? Track status of submissions Receive feedback and approvals online 15

16 What Were the IRB Turnaround Times in July 2010? From time of complete submission to time of full IRB approval: Full Committee: 34 days Expedited: 6 no subject contact 12 subject contact Continuations: 9 expedited 21 full committee 16

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18 What is the focus of the IRB Review? Assessing Risks and Benefits: Risks associated with the research, as distinguished from the risks of procedures the subjects would receive even if not participating in research Determining that the risks are minimized to the extent possible Identifying the probable benefits to be derived from the research Determining that the risks are reasonable in relation to the benefits to subjects, if any, and the importance of the knowledge to be gained Assuring that potential subjects are provided with an accurate and fair description of the risks or discomforts and the anticipated benefits 18

19 How do you conduct a risks assessment? Identify risks associated with the research: How are risks different than those risks the subject would encounter if not participating in the research? Consider the subject population: Are the research participants particularly sensitive or vulnerable to the risks posed by the research? Do the risk(s) meet the definition of minimal risk? Does research fit into an exempt or expedited category of review or does it require full committee review? 19

20 Definition of Minimal Risk Minimal risk means that 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 of the general population or during the performance of routine physical or psychological examinations or tests. 20

21 Expedited Research No more than minimal risk to subjects Expedited protocols are reviewed by an IRB subcommittee Seven federally-defined categories Informed consent or waiver of consent or waiver of signed consent with appropriate justification required 21

22 Full Committee Research Greater than minimal risk to subjects Full committee protocols are reviewed at a convened IRB meeting Informed consent required in almost all cases Includes most clinical trials: studies involving non FDA-approved drugs and devices or medical interventions 22

23 Loss of Confidentiality Which potential risks need to be considered for all levels of IRB review? Has to do with issues surrounding data Data security needs to established and described seek IT help if needed Primary source of complaints to IRBs (beyond why didn t I get paid on time) Loss of Privacy Has to do with personal privacy Important in recruitment and screening as well as practice 23

24 What are the Special Issues for Industry-Sponsored Clinical Trials? Need to coordinate IRB approval and contract Sponsor pays IRB Review Fees Consent form needs to be revised to Use UCLA standard requirements for indemnification and ownership of tissue Be in lay language and not overly legal Data Safety Monitoring Boards usually required IRB cannot require a major change in the science and expect the company to revise the protocol it s either thumbs up or thumbs down 24

25 Examples of Expedited or Full Committee Research or Research Not Requiring IRB Review Randomized double-blind study for the safety and efficacy of investigational drug XYZ Review of medical records of patients in hospital from 1990 to present to study correlation of Alzheimer s and heart disease Randomized double-blind study to compare two approved surgical procedures (lumpectomy vs mastectomy) 25

26 More Examples Analysis and comparison of UCLA medical student socio-economic and educational background and admission records to evaluate predictors of ability to graduate Questionnaires for parents of parents whose children have recently died from cancer to assess grief coping mechanisms Phase IV (post marketing) Drug Study 26

27 Examples continued Comparison of psychotherapy vs medication for the treatment of depression Collection of saliva samples from people who developed a cold and cough within the last 48 hours to study the genes related to asthma Survey of physicians at UCLA to ask their opinions about physician-assisted suicide whether they have participated in physician-assisted suicides 27

28 Examples continued Analysis of facial expressions of people who are lying Analysis of facial expressions of children who are afraid of spiders Study of elder abuse among caregivers Skin samples collected via punch biopsy for SCNT (somatic cell nuclear transfer) study Skin samples sent from UCSF with or without PHI (private health information) 28

29 Waves of the Future Continued push to rely on other IRBs OHRP FDA AAHRPP CTSAs Study Sponsors Local Institutions 29

30 What s Currently in Place at UCLA? UC-Wide Memorandum of Understanding (MOU) to rely on each others IRBs 2011) Being used for Expedited and Exempt Studies Used over 700 times since 2006 Plans for expanded use for Full Committee Studies in spring 2011 CTSA MOU for Cedars, LABioMed, Charles Drew and UCLA limited implementation but plan for expanded use in spring of 2011 Use of Federal-wide IRBs NCI, NIDA, NICHD, others Western IRB commercial, pay for review 30

31 More Waves Revised medical consent form templates (to be used also for multi-site UC and CTSA studies) UCLA-wide guidance on the use of remnant tissue and specimens for research Expanded education including video-training on advanced topics in human research Expanded use of ability to rely on other IRBs (beyond UCs and CTSAs--longer term but in planning) 31

32 Last Minute Tips #1 Refer to the OHRPP website for webirb online application Links to application Information about training (monthly Noontime Series and Learn at Lunch) UCLA consent form templates UCLA OHRP guidelines on various topics 32

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34 #2 Writing Musts Consider the audience Not all IRB members are scientists Avoid acronyms Use lay language for recruitment and consent documents Be consistent Within the application Make sure that study aims, methods, risks, benefits and alternatives are consistent Between application and consent documents Between application and sponsor protocols or grants Use the same name for the study drugs throughout the submission 34

35 Final Tips #3 Contact the OHRPP with any questions before or during the application process #4 Bonus Tips: Do not group related full committee studies into a complicated application. Submit a separate application for each study or phase of study. Do group data analysis or retrospective chart reviews into one study when useful for your purposes. 35

36 We re Here to Help OHRPP Website: Medical IRBs Telephone: (310) webirb Help Desk