IRB 2010 Update

1. IRB2010 Update Elaine Major Director of Institutional Compliance 215 Wannalancit, ext. 3452 www.uml.edu/ora/institutionalcompliance

2. Institutional Review Boards: • Protect rights and welfare of research subjects • Review research to ensure participants are protected and aware of any risks • Serve as interface between researchers & participants • Allow universities to stay eligible for federal funding

3. Brief History of IRBs • Early to mid-1900s, research not regulated • 1948 Nuremberg Code (basic elements include voluntary and informed consent, risk/benefit analysis, right to withdraw w/out penalty) resulted from Nazi physicians forcing prisoners to undergo horrifying procedures for research • 1955 Wichita Jury Study (study by U of Chicago using deception- jurors were not notified they were being audio-taped) • 1962 Thalidomide Experience (pregnant women treated w drug to reduce morning sickness. No informed consent to indicate drug was still experimental) • 1973 Congressional Hearings (led by Sen. Edward Kennedy) re ethical problems w medical research; • Milgram Study (obedience to authority) • San Antonio Contraception Study (not informed might get placebo) • Tuskegee Syphilis Study (subjects not informed research was to study course of disease and treatment not provided when discovered penicillin treated it) • 1974 Current IRB System Established

4. IRB Authority • Institution signs agreement (FWA) to comply with regulations and protect human subjects • IO or Chancellor may not overturn an IRB disapproval – can override approval • ALL projects that involve human subjects need IRB review (funded or not!) • Federally funded projects require proposals also be submitted to the IRB for review

5. IRB Process Briefs • All submissions and approvals electronic • Need hard copy of signatures only • ALWAYS go to website • Training is required (every 3 years) • Requirement for your class! • Meeting schedule posted on website • PIs invited to attend IRB meetings • Renewal notices sent electronically • CR must be within 30 days of expiration date

6. Education/Training Options • Collaborative IRB Training Initiative (CITI) • www.citiprogram.org • NIH • Protecting Human Research Participants http://phrp.nihtraining.com/users/login.php

7. Key Definitions Key Definitions • Research – Systematic investigation designed to develop or contribute to generalizable knowledge • Human Subject Research –data obtained through intervention or interaction with a living individual for generalizable knowledge • Evaluation – Systematic gathering of information but used to revise, alter, or provide feedback about an object or process. Not intended to contribute to generalizable knowledge • Minimal risk - Harm or discomfort no greater than ordinarily encountered in daily life of a normal, healthy person or during performance of routine physical or psychological examinations or tests

8. Review Categories (45 CFR 46) • Exempt (NOT exempt from review) • Expedited • Full Review required when: • Greater than minimal risk • Vulnerable populations (prisoners) • Sensitive research topics • PIs encouraged to attend the meeting

9. Considerations • Does it involve living human subjects? • WHAT is being obtained? • Is it research or a course requirement? • Risk- magnitude and probability • Vulnerable populations • Collaborating institutions • Cannot do retroactive reviews!!! • Implications for graduate students and timing of data collection • Journals often require proof of IRB approval

10. Vulnerable Populations • Children • Pregnant women • Human fetuses and neonates • Prisoners- must be full review • Other: economically disadvantaged, elderly, terminally ill, employees, cognitively impaired

11. Review Categories (45 CFR 46) • Exempt (NOT exempt from review) • Expedited • Full Review required when: • Greater than minimal risk • Vulnerable populations (prisoners) • Sensitive research topics • PIs encouraged to attend the meeting

12. Typical Exempt Research Must be anonymous and <minimal risk • Conducted in established educational setting and involves normal educational practices • Use of educational tests, survey procedures, interview procedures or observations of public behavior AND anonymous and no risk • Study of existing data- if publicly available and recorded so that subjects are anonymous • Taste and food quality evaluation and consumer studies

13. Characteristics for Exempt • Must be minimal risk and no identifiers • After IRB determination, no more oversight unless amendment affects change in category • If so, resubmit as new application for expedited or full review • File automatically closed out after one year, records retained for three years • Typical examples: • Observational research in educational settings • Anonymous surveys, interviews, or observations • Collection or use of existing data, records, specimens

14. Expedited Categories Can use identifiers but must be < minimal risk • Collection of blood samples (for healthy adults) • Noninvasive collection of specimens (hair, nail clippings, deciduous teeth, sweat, saliva, placental tissue, dental plaque, mucosal cells) • Collection of data through noninvasive procedures (physical sensors applied to body, ultrasound, MRI, EKG, moderate exercise, muscular strength testing, flexibility testing, etc. (not x-rays or microwaves) • Existing data not collected for research (routine medical records or leftover specimens) • Voice, video, digital, or image recordings for research purposes (requires special consent document) • Research on group characteristics or behavior that involves no stress or employs survey, interview, oral history, focus group, etc.

15. Characteristics for Expedited • Can collect identifiable data but no more than minimal risk • Minor changes in approved research • Can include vulnerable populations- except prisoners • Examples- educational research, psychology studies, evaluating robotic computers, research on service learning practices, continuing review

16. Submitting an Application • Submit all documents as Word files • Student research must be submitted by PI (faculty advisor) • Application form and all supporting documents • Informed consent • Letter of support • Training certifications • PI Assurance and Signature Page-fax or mail • If subjects speak language other than English: submit Translation & Certification form after approval

17. Top Reasons for Delays • Considerations with informed consent • Waivers • Use easy to understand language • Outline time commitment required • Include any incentives and what must be completed to receive • Think about ALL potential risks • Write in 3rd person (you are being asked to ...) • Provide contact information for questions after the research • Missing support letters from collaborators • Training certification information • Application does not have enough detail to clearly describe the project, all activities, and processes • Funded project but proposal not submitted

18. Informed Consent Process • Central protection for participants under regulations • 3 key purposes • Discloses information to potential subjects to make informed decision • Facilitates understanding of what is disclosed • Promotes voluntary response as to whether or not to participate • Meant to be communicated to participants in ACTIVE sharing process: • Purpose of research and duration • How data are to be used • Procedures and any discomfort • Any risks/benefits (including if confidentiality is broken) • Disclosure of alternative treatments/procedures • Voluntary and can withdraw from study at any time • PI contact information • For minors, may include assent or passive consent of parents • Communicate in language/terms subjects understand • Where incentives are provided, include plan for early withdrawal

19. Waivers of Informed Consent Must be specifically requested and approved! Two types: • Waiver of Documentation of IC • For research that is no more than minimal risk to subjects • Only record linking subject to research is the document and it may pose a risk to subjects • Obtaining IC may diminish the scientific merit of the research • Subject will still be consented and can have documentation if desired • Waiver of Informed Consent • For research that is no more than minimal risk • Waiver does not adversely affect rights and welfare of subjects • Research could not be done w/o waiver • Subjects provided additional information after participation

20. Implied and Passive Consent • Implied: Ex. Survey sent by mail or electronic • Materials clearly state that by responding, the subjects have agreed to participate • IRB MUST approve the alteration to process • Participants are still allowed to not answer • Passive: Collecting data from children at school (Opt Out procedure) • Parents contacted and requested to return form if do NOT want children to participate • IRB MUST waive requirement for specific parental permission

21. Data Retention • IRB records- retained for 3-5 years after completion of research (depends on sponsor and purpose for data) • Research data- same but may be longer • To retain data with Identifiers- must submit form for annual renewal • If data de-identified, can keep indefinitely but close protocol with Final Report Form

22. Collaborative Agreements • Used to reduce duplication of effort • For institutions with an IRB and FWA only • Defers authority to one IRB and is reported to OHRP • FWA updated annually to indicate organizations UML relies upon • International research activities

23. Miscellaneous • ALWAYS go to the website to get the newest forms • Submit applications to IRB@uml.edu • If publishing images, separate release form required • Research with children can receive exempt or expedited review – depends on risk and identifiers • Apply for waiver for any alteration to consent process • Once assigned, always refer to IRB Protocol No. • Amendments used for changes to personnel, protocol, funding, survey tool, etc. • Alwaysreport incidents or problems encountered during the research to the IRB Compliance Office

24. For Information and Assistance • IRB Administrator Stephen_Moses@uml.edu, x4134 • IRB Assistant Amy_Finneral@uml.edu, x4698 • Websitewww.uml.edu/ora/institutionalcompliance • References • DHHS http://www.dhhs.gov/ohrp/ • DHHS 45 CFR Part 46 • IRB Management and Function 2006 by Bankert and Amdur (in Library)