Human Participants Research – IRB

1. Human Participants Research – IRB Presentation Sept. 23, 2010 Office of Research Assurances (ORA) University of Idaho

2. Overview • Historical Context for Ethics in Research • University of Idaho IRB • IRB Processes for Exempt, Expedited, Full Board Reviews • Some Commonly Asked Questions • Contact Information

3. Historical Context for Ethics in Research

4. Ethical Consideration Working with people in research is a privilege, not a right. Institutions and investigators who enroll human participants in research take on the moral obligation to protect the rights and welfare of those who agree to participate in such research.

5. Examples of Historical Ethical Violations • Nazi Experiments • Nuremberg Trials • Tuskegee Syphilis Study • Milgram Experiment • Brooklyn Jewish Chronic Disease Cancer Study • Willowbrook Hepatitis Study • Stanford Prison Experiment

6. Nazi Experiments • High-Altitude Experiments • Freezing Experiments • Malaria Experiments • Mustard Gas Experiments • Bone, Muscle, and Nerve Regeneration • Epidemic Jaundice Experiments • Sterilization Experiments • Spotted Fever Experiments • Experiments with Poison

7. Nuremberg Trials During the Nuremberg War Crimes Trials, 23 German doctors were charged with war crimes against humanity for “performing medical experiments upon concentration camp inmates and other living human subjects, without their consent, in the course of which experiments the defendants committed the murders, brutalities, cruelties, tortures, atrocities, and other inhumane acts.” “Trials of War Criminals before the Nuremberg Military Tribunals under Control Council Law No. 10. Nuremberg”, October 1946 - April 1949. Washington D.C.U.S.G.P.O,1949-1953.

8. Nuremberg Code (1949) • First international document to advocate voluntary participation and informed consent Consists of Ten Rules: • Voluntary consent • Anticipate scientific benefits • Benefits outweighing risks • Animal experiments need to come first • Protection of subjects against remote possibility of injury • Experiments should only be conducted by scientifically qualified personnel • Subjects have ability to withdraw • Avoid suffering • No intentional death or disability • Stop the study if harm occurs

9. Tuskegee Syphilis Study • PHS Study in Macon County, Alabama • 1932: Recruited 300 black males • 1933: 300 Controls were added • 1943: Penicillin available for the military • Subjects taken off of WWII Draft List • 1949: The Nuremberg Code came about • 1951: Penicillin was made available to the public • 1966: Local ethics committee reviewed study • RESULTS: • 28 Deaths • 100 Cases of disability • 19 Cases of congenital syphilis

10. Milgram Experiment (1961)

12. The Brooklyn Jewish Chronic Disease Cancer Study • (1963) • Indigent, elderly subjects were injected with live cancer cells without their consent

13. Willowbrook Hepatitis Study The Willowbrook Hepatitis Study • (1963-1966) • New York • Conducted on mentally retarded, institutionalized children • Involved systematically infecting the children with hepatitis • Parents were coerced into consenting

14. Zimbardo’s Stanford Prison StudyAugust 1971

15. 1971-A psychology study of how ordinary people, college students, can behave in aggressive and dehumanizing ways based on the situation Originally this experiment was to be two weeks long, but it had to be cut short after 6 days because “guards” were beginning to abuse the “prisoners” and prisoners were showing signs of depression and trauma. 9 College Men Assigned to be “Guards” 9 College Men Assigned to be “Prisoners”

16. The Declaration of Helsinki (1964) • Principles established by the World Medical Association to guide physicians conducting medical research involving humans subjects Differentiated between therapeutic and non-therapeutic research: • Therapeutic research gives patients the opportunity to receive an experimental treatment that might have beneficial results. • Non-therapeutic research is conducted to generate knowledge for a discipline, and might have positive results in future patients.

17. Henry Knowles Beecher 1904-1976 • Prominent researcher and anesthesiologist • Chronicled 22 unethical studies • “Ethics in Clinical Research”, published in the New England Journal of Medicine, June 1966. • Beecher’s revelations led to IRBs and informed consent

18. Belmont Report (1979) Basic Ethical Principles Respect for Persons • Individuals should be treated as autonomous agents • Persons with diminished autonomy are entitled to protection Beneficence • The potential risks inherent in a project must be justified by the potential benefits • Do good, not just avoid harm Justice • Those who assume the risks of research should be representative of those who stand to benefit from the research. Summary of Ethical Principles for Research with Humans Nat. Commission for Protection of Human Subjects of Research Dept. Health, Ed., Welfare

19. Timeline of Critical Events • Broad ethical guidelines that assist scientists, subjects and society in understanding the ethical issues related to human subject research. • These historical guidelines have evolved since the 1940s and serve as a framework for current regulations. -Nuremberg code 1949 -U.S. Scandals 1960 -Declaration of Helsinki 1964 -Early NIH Policy 1966 -Tuskegee in open 1972 -National Research Act 1974 -Belmont Report 1979 -Common Rule 1991

20. Federal Regulations • 45 CFR 46 – Department of Health and Human Services (HHS) regulations concerning protection of human research participants • 21 CFR 51, 56 – FDA policies for human subjects research • Federal Wide Assurance (FWA) – Each institution receiving federal funding has an assurance, which is a contract with the government regarding the protection of human subjects. Allows UI to do research w/out direct approval from Office for Human Research Protection (OHRP) • HIPAA – Health Insurance Portability & Accountability Act - Protecting Personal Health Information

21. Federal Regulations The Common Rule (Federal Policy for the Protection of Human Subjects, 56 FR 28003, June 18, 1991) : 45 CFR 46 (HHS implementation of the Common Rule)

22. IRB at University of Idaho

23. The mission of the ORA is to facilitate and assist UI researchers in identifying and complying with all pertinent regulations and guidelines. We work collaboratively with researchers to develop and implement policies and procedures which assure compliance with minimal impact on research programs. This Office is part of the overall effort of UI to ensure the responsible conduct of research. The ORA was established in 2008. Office of Research Assurances (ORA)

24. IRB at University of Idaho IRB is charged with providing independent, objective review of research involving human participants in order to: • protect the rights and welfare of human research participants, and • ensure compliance of human participant research with established ethical standards and federal, state, and local regulations and policies.

25. Surveys Observation Interviews Accessing Private Records Taste Testing Clinical Trials Therapeutic Evaluations Experimental Treatments Human Subjects Research Methods

26. Human Participants/Research Definitions Research – a systematic investigation including research development, testing and evaluation, designed to contribute to generalizable knowledge Human Subject – a living person about whom an investigator conducting research obtains • data through an intervention or interaction with the individual, or • identifiable private information

27. More Definitions • Living Individual-The Specimen (s)/data/information must be collected from live subjects. • About whom- A human subject research project requires that the data received from the living individual is about the person. • Intervention-Includes physical procedures, manipulations of the subject, or manipulations of the subject’s environment for research purposes. • Interaction- Includes communication between the investigator and the subject. This includes face-to face, mail, and phone interaction as well as other modes of communication • Identifiable private information- Identifiable means the information contains one or more data elements that can be combined with other reasonably available information to identify an individual ( e.g. Social security #)

28. What Activities Require IRB Review?

29. Specific Populations • Crime victims • Students or employees under the supervisory or evaluative authority of the researcher • Substance abusers • Non-English speakers • Terminally ill • Institutionalized individuals • Children under 14 years outside established educational settings • Neonates/ Fetuses • Prisoners • Pregnant women • Decisionally impaired • HIV/AIDS patients • Native American Tribes

30. Doesn’t Need IRB Approval • Quality Assurance/Quality Improvement/Research Practica : http://www.uidaho.edu/ora/committees/irb/irbpolicies • Samples from deceased individuals • Not Sure?  Call 885-6162 or Email IRB@uidaho.edu

31. IRB Processes for Exempt/Expedited/Full Board Reviews

32. Three Types of IRB Review Exempt (45 CFR 46.101) • Limited categories of research exempt from Federal regulation and IRB review and oversight. Expedited Review (45 CFR 46.110) • Review by one or more IRB members of research that within certain prescribed categories and presents no more than minimal risk. Full review standards are applied. Full Board Review • Convened meeting of board, usually reserved for protocols presenting more than minimal risk, research that cannot be expedited, or projects presenting issues not previously considered by IRB.

33. Student Faculty (Faculty Advisor) IRB Student Review Process Overview

34. Exempt Research • Exempt research must meet at least one of six specific criteria (slides follow with more information) • PI needs to inform ORA of post exempt certification protocol changes to ensure that project still qualifies as exempt

35. Exempt Research in the Regulations 1. Research conducted in established or commonly accepted educational settings, involving normal educational practices, such as i. research on regular and special educational instructional strategies, or ii. research on the effectiveness of or the comparison among instructional techniques, curricula, or classroom management methods. Exemption also applies to children.

36. Exempt Research in the Regulations 2. Research involving the use of educational tests (cognitive, diagnostic, aptitude, achievement), survey procedures, interview procedures or observation of public behavior, unless: i. information obtained is recorded in such a manner that human participants can be identified, directly or through identifiers linked to the participants; and ii. any disclosure of the human participants ' responses outside the research could reasonably place the participants at risk of criminal or civil liability; or iii. be damaging to the participants ' financial standing, employability, or reputation. Exemption also applies to children (if anonymous) for educational tests. Exemption does not apply to children for survey procedures, interview procedures or observation of public behavior (observation of public behavior may apply to children if the researcher does not participate in the activities being observed).

37. Exempt Research in the Regulations 3. Research involving the use of educational tests (cognitive, diagnostic, aptitude, achievement), survey procedures, interview procedures, or observation of public behavior that is not exempt under category (2) of this section, if: i. the human participants are elected or appointed public officials or candidates for public office; or e.g. public official: mayor but a city planner would not be a public official. Chief of police is an elected public official but a police officer would not. ii. federal statute(s) require(s) without exception that the confidentiality of the personally identifiable information will be maintained throughout the research and thereafter.

38. Exempt Research in the Regulations 4. Research involving the collection or study of existing data, documents, records, pathological specimens, or diagnostic specimens, if these sources 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 participants.

39. Exempt Research in the Regulations 5. Research and demonstration projects which are conducted by or subject to the approval of department or agency heads, and which are designed to study, evaluate, or otherwise examine: i. public benefit or service programs; ii. procedures for obtaining benefits or services under those programs; iii. possible changes in or alternatives to those programs or procedures; iv. possible changes in methods or levels of payment for benefits or services under those programs. (Narrowly construed under Federal Regulations e.g. WIC, Disability Benefits)

40. Exempt Research in the Regulations 6. Taste and food quality evaluation and consumer acceptance studies: i. if wholesome foods without additives are consumed or ii. if a food is consumed that contains a food ingredient at or below the level and for a use found to be safe, or agricultural chemical or environmental contaminant at or below the level found to be safe, by the Food and Drug Administration or approved by the Environmental Protection Agency or the Food Safety and Inspection Service of the U.S. Department of Agriculture.

41. Submission of Project Proposal Form (Principal Investigator/Faculty Advisor) Changes noted by ORA Changes (if needed) Preliminary Review of Project Proposal (Staff at Office of Research Assurances) Contact PI for necessary Changes to protocol Review of Protocol (Staff at ORA) Exempt Certification Not Certified as Meeting an Exemption PI Changes Communicated (E-mail Notification) Re-submission Expedited/Full Board Review Protocol (IRB) Approval Process for Exempt Projects:

42. Expedited Review Two general categories of research available for expedited review (46.110(b)): • Research activities presenting no more than minimal risk and listed in NIH adjunct list of categories qualifying for expedited review • “minor changes in previously approved research during the period (1 year or less) for which the approval is granted”

43. Common Expedited Review Categories for Journalism/ Mass Communications Research Common Expedited Journalism Review Categories Category 6 Collection of data from voice, video, digital, or image recordings made for research purposes. Category 7 Research on group characteristics or behavior…or research employing survey, interviews, oral history, focus groups, program evaluation, human factors evaluation, or quality assurance methodologies.

44. Surrogate Surveys Surveys that elicit information from one person about another (husbands about wives, adult children about parents) may be considered to have two subject groups involved: • Direct Subjects – subjects that researchers interact with directly (husbands and adult children) • Indirect Subjects – subjects about which researchers obtain personally identifiable, private, and potentially detrimental information

45. Documents to Submit With Application • Survey instrument • Interview Questions • Consent Script (Oral Consent) • Written consent statement/description of research

46. Submission of Project Proposal Form (Principal Investigator/Faculty Advisor) Changes noted by ORA Changes (if needed) Preliminary Review of Project Proposal (Staff at ORA) Feedback: Approved or Deferred • Email, phone call • to PI if more info • is needed Review by 1- 2 IRB Members Approval granted Approval deferred pending specific changes PI Changes Approval Communicated E-mail Notification Re-submission Approval Protocol (IRB) Approval Process for Expedited Projects:

47. Full Board Review • Evaluation of application for protocol presenting more than minimal risk to subjects by IRB members. • Research involving Human Participants that does not qualify for expedited review. • Investigator has opportunity to provide answers to questions at the full IRB committee meeting

48. Submission of Project Proposal Form (Principal Investigator/Faculty Advisor) Changes noted by ORA Changes (if needed) Preliminary Review of Project Proposal (Staff at ORA) Pre-review by IRB Members Approval granted Approval denied Approval deferred pending specific changes PI Changes Approval Communicated E-mail Notification Re-submission Approval Protocol (IRB) Approval Process for Full Board Projects: • Email, phone call • to PI if more info • is needed

49. Avoiding Common Pitfalls • Key Concerns of Reviewers: • Are subjects protected from harm/embarrassment? • Confidentiality/anonymity of data • Risk/benefit ratio and scientific validity • Special populations • Abstract - too much theory, not enough on methods • Stating data as anonymous, but it’s confidential • Stating there are no risks in your study (see next slide) • Overstating benefits of study • Not attaching consent, & well-labeled survey materials • Poorly constructed consent form

50. Common Research Risks (Non-medical) • Disclosure of private/confidential information • Psychological risks (insult, trauma) • Social risks (embarrassment, rejection by peers) • Economic risks (loss of job, credit, insurance) • Legal risks (subpoena, fine) • Inconvenience/intrusiveness (boredom, frustration)