Human Subjects Research

1. Human Subjects Research Dustin Yocum, MA Institutional Review Board University of Illinois

2. Objectives • Discuss what an Institutional Review Board (IRB) does • Find out why the IRB exists • Discuss the regulations and classifications • Discuss the application process • Discuss the elements of informed consent • Field questions

3. What does the iRB do? • Independent Review and Oversight Committee • Board of experts in conducting research • Uphold federal, state, and local regulations • Review research applications for ethical standards • Purpose of the IRB is to facilitate safe and ethical research with human subjects conducted by UIUC students, faculty, and staff

4. Why does the irb Exist? • Examples of research with serious ethical issues • Tuskeegee Syphilis Study • Human Radiation Exeperiments • Milgram Study • Willowbrook State School Hepatitis Study

5. Federal Regulations • 45 CFR 46 – Common Rule - Regulations for the Protection of Human Subjects of Biomedical and Behavioral Research • Basic regulations established in 1974 • Adopted by 16 federal agencies as the Common Rule in 1991 • Proposed changes in the regulations being reviewed

6. Belmont Principles • Respect for Persons • Individual autonomy, above the value of the research, to society or to any individual person • Protection of individuals with reduced autonomy • Beneficence • Do not harm, regardless of benefits • Maximize benefits and minimize the risk of doing harm • Risk–benefit analysis should justify all risks • Justice • Equitable subject selection and distribution of research benefits and burdens

7. What Possible Harm? • Physical harm • Emotional distress, Psychological Trauma • Invasion of Privacy, Loss of Confidentiality involving: • Embarrassment, Loss of Social Status • Risk to Reputation, Employment, Financial Standing, Insurability • Criminal or Civil Liability

8. Investigator Responsibilities • The investigator is ultimately responsible for protecting the subject. • The use of human volunteers in research is a privilege, not a right. • Society’s trust in the research process determines funding, support, regulation

9. What is Human Subjects Research? • Research – A systematic investigation, including research development, testing and evaluation, designed to develop or contribute to generalizable knowledge. • Human Subject - A living individual about whom an investigator (whether professional or student) conducting research obtains: • (1) data through intervention or interaction with the individual, or • (2) identifiable private information.

10. What is Human Subjects Research? • Intervention • Includes both physical procedures by which data are gathered (for example, venipuncture) and manipulations of the subject or the subject’s environment that are performed for research purposes (45 CFR 46.102(f)). • Interaction • Includes communication or interpersonal contact between investigator and subject (45 CFR 46.102(f)).

11. What is Human Subjects Research? • Private Information • Information about behavior that occurs in a context in which an individual can reasonably expect that no observation or recording is taking place • Information which has been provided for specific purposes by an individual and which the individual can reasonably expect will not be made public (for example, a medical record) • Private information must be individually identifiable (i.e., the identity of the subject is or may readily be ascertained by the investigator or associated with the information) in order for obtaining the information to constitute research involving human subjects.

12. Levels of Review • Not Human Subjects Research • Exempt • 45 CFR 46.101(b) • 45 CFR 46.401(b) Children • Expedited (New and Continuing Cases) • 45 CFR 46.110 • No more than minimal risk and/or minor changes • Full IRB (New and Continuing Cases)

13. Not Human Subjects Research • In order to be considered human subjects research the activity must: • be systematically designed to contribute to generalizable knowledge • obtain information about living individuals • involve intervention or interaction • be individually identifiable • involve private information

14. Exempt research • Activity must classify as human subjects research • Submitted on Exempt application • Reviewed by staff member only • Minimal risk • 3 year approval period • Federal regulation do not apply (University regulations apply)

15. Exempt Category 1 • Exempts research conducted in established or commonly accepted educational settings, involving normal educational practices, such as: • (a) research on regular and special education instructional strategies, or • (b) research on the effectiveness of or the comparison among instructional techniques, curricula, or classroom management

16. Exempt Category 2 • Exempts research involving the use of educational tests (cognitive, diagnostic, aptitude, achievement), survey procedures, interview procedures, or observation of public behavior, unless • (a) information obtained is recorded in such a manner that human subjects can be identified, directly or through identifiers linked to the subjects; and • (b) 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

17. Exceptions to the Rule • Category 1 • Research on physical education that involves exercise if the activity is altered in a significant way for the purposes of the research • Category 2 • Research involving surveys that may cause the subject to experience severe emotional distress or discomfort • Research involving psychologically invasive surveys • Regarding Children: Research involving surveys, interviews, or observations of public behavior when the investigator is a participant in the activities being observed • All Categories • If the study is greater than minimal risk • Prisoners • Research involving deception

18. Expedited Research • Activity does not fall into one of the 6 exempt categories • Submitted on IRB-1 application • Review by staff and expert IRB member • Minimal Risk • 1 year approval period (continuing reviews) • Federal regulations apply

19. Full Board Research • When a study is considered more than minimal risk • Determined during review of IRB-1 applications • Reviewed by staff and full IRB committee • 1 year approval period • Approval period could be less if Board wants to review again • Board decides if study must stay Full Board after initial approval • Federal regulations apply

20. What is the Application Process? Is it human subjects research? IRB-1 or Exempt?

21. What do I submit? • Complete application (including signatures) • Research Team Attachment • Recruiting materials • Data collection measures • Consent forms • Additional forms(device/equipment, waivers, etc.) • Funding proposal • Approvals from outside institutions

22. What is the Process After I submit? • Application is submitted to www.irb@illinois.edu • Application is logged into system and assigned to a reviewer • Pre-Review is conducted • Correspondence and revisions • Once revisions are complete with IRB staff: • If exempt, study can be approved in IRB office • If expedited/full board, study will be sent to an expert reviewer. • Stipulations • Approval

23. CITI Requirements • All researchers must have completed the following CITI online training requirements before approval will be given: • Belmont Report - SBR • History and Ethical Principles - SBR • Defining Research with Human Subjects - SBR • Assessing Risk in Social Behavioral Sciences - SBR • Informed Consent - SBR • Privacy and Confidentiality – SBR • Online CITI training is good for 3 years

24. What if I need to make a change after approval? • Amendment Process • Complete the Research Amendment Form • Make revisions to all applicable parts of application • Make sure new documents are signed by RPI • Send revised/additional documents to staff reviewer

25. Elements of Informed Consent • Purpose • Procedures • Risks and Benefits • Voluntariness • Confidentiality • Contact Information • Signature Statement

26. Informed Consent Overview • Signed (written) Informed Consent • Waiver of Informed Consent • Alteration of Informed Consent • Waiver of Documentation

27. Informed Consent Overview • Informed consent is an ongoing process rather than just given/obtained at a moment of time. • No exculpatory language, 8th grade reading level, correct grammar/typos • Give participants opportunities to ask questions • Ensure participants understand what they have consented to do • Ensure participants understand that they can discontinue at any time

28. QUESTIONS?

29. Additional Resources • Campus IRB Web site: www.irb.illinois.edu • UIUC IRB Training Module: http://www.irb.uiuc.edu/edu/module1.asp • Belmont Report: http://www.irb.uiuc.edu/ethics/belmont.asp • Office for Human Research Protections (OHRP): http://ohrp.osophs.dhhs.gov/ • U.S. Food and Drug Administration (FDA): http://www.fda.gov/cdrh/index.html

30. Contact Information Main IRB Office Suite 203, MC–419528 East Green StreetChampaign, IL 61820 Phone: 217-333-2670 Fax: 217-333-0405 Email: irb@illinois.edu Online: www.irb.illinois.edu