Human Participant Research at JHU

1. Human Participant Research at JHU "What You Need To Know To Get Started“

2. History, Ethics, and Regulations

3. History • Nuremberg Code (1948) • Tuskeegee Syphilis Study (1932-1972) • Wichita Jury Case (1953) • Miligram “Obedience to Authority” Study (1963) • Stanford “Zimbardo Simulated Prison” Study (1973)

4. Belmont Report(1979) • Respect for Persons • Treat individuals as autonomous agents • Protect persons with reduced autonomy • Beneficence • Maximize potential benefits and minimize potential risks • More than “do no harm” • Justice • Potential risks of research should be born equally by the members of our society that are likely to benefit from it • Distribute the risks and potential benefits of research equally among those who may benefit from the research

5. DEFINITIONS • “Research” • Research means a systematic investigation, including research development, testing and evaluation, designed to develop or contribute to generalizable knowledge. • 45CFR 46.102(d) • Tests a hypothesis and draws conclusions. • Research is described in a formal protocol and a set of procedures designed to reach an objective.

6. What is a Human Participant? • A “human participant” (volunteer) is a living individual about whom an investigator conducting research obtains: • data through intervention or interaction with the individual or • identifiable private information From: 45 Code of Federal Regulations (CFR) 46.102

7. What is an Institutional Review Board (IRB)? • The group or committee that is given the responsibility by an institution to review research projects involving human subjects. • Its primary purposes are • to assure the protection of the safety, rights and welfare of the human subjects. • determine if benefitof the research (to the individual or society) exceeds the riskto the participant (healthy volunteer or patient) • By Federal law, the group contains both scientific and non-scientific (community) members

8. All Human Subjects Research (HSR) must be submitted to the IRB for review! If you are unsure if your research is considered HSR, please contact the IRB Office for assistance BEFORE beginning your project!

9. Functions of the HIRB Office • Review Protocol Transactions • New, Amendments, Renewals, Deviations, Exceptions, Unanticipated Problems, Serious Adverse Events (SAEs) • Organize IRB meetings • Education for the the research community • Investigator and student support • Monitor and audit protocols to ensure compliance with regulations

10. Risk Levels • The Federal regulations only acknowledge two risk levels: • 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 examinations or tests.* • Greater Than Minimal Risk *45 CFR 46.102(i); 21 CFR 50.3(k)

11. Levels of IRB Review • Exempt: for minimal risk research • Expedited: for minimal risk research that does not meet exempt category • Full Board: for greater than minimal risk research

12. Exempt Research • The IRB, not the investigator, determines if the research is “exempt” • The research is exempt from further IRB review and from the Federal regulations • Six exempt categories • Category 1 and 2 most common at Homewood

13. Categories 1 and 2 • (1) Research conducted in established or commonly accepted educational settings, involving normal educational practices, such as (i) research on regular and special education instructional strategies, or (ii) research on the effectiveness of or the comparison among instructional techniques, curricula, or classroom management methods. • (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 subjects can be identified, directly or through identifiers linked to the subjects; and • (ii) 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.

14. Other Exempt Categories • (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 paragraph (b)(2) of this section, if:(i) the human subjects are elected or appointed public officials or candidates for public office; or (ii) federal statute(s) require(s) without exception that the confidentiality of the personally identifiable information will be maintained throughout the research and thereafter. • (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 subjects. • (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; or (iv) possible changes in methods or levels of payment for benefits or services under those programs. • (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.

15. Expedited Review • Minimal risk studies that do not meet exempt criteria • Does not have to be reviewed at fully convened meeting • 9 categories of expedited research • Category 5, 6, and 7 are most common at Homewood

16. Expedited Categories • (5) Research involving materials (data, documents, records, or specimens) that have been collected, or will be collected solely for nonresearch purposes • (6) Collection of data from voice, video, digital, or image recordings made for research purposes. • (7) Research on individual or group characteristics or behavior (including, but not limited to, research on perception, cognition, motivation, identity, language, communication, cultural beliefs or practices, and social behavior) or research employing survey, interview, oral history, focus group, program evaluation, human factors evaluation, or quality assurance methodologies.

17. Full Board Review • Greater Than Minimal Risk Transactions • Protocols are pre-reviewed by a HIRB Office • Full Review conducted by IRB members at a convened meeting • Determination is made for each protocol: • Approved • Contingently Approved • Deferred • Disapproved • A full quorum of at least 5 members is assembled • Non-scientists/unaffiliated members • Decision is rendered by a majority of the assembled quorum

18. Examples of Research That May be Minimal Risk • Survey • Interview • Focus groups

19. IRB must determine that the following requirements have been satisfied:Criteria for IRB Approval of Research45 CFR 46.111 • 1. Risk(s) to participants are minimized • 2. Risk(s) to participants are reasonable in relation to anticipated benefits and to the importance of the expected knowledge. • 3. Selection of participants is equitable • 4. Informed consent will be sought and the consent form includes all elements and in language understandable to participants

20. IRB Review Requirements (cont.) • 5. Provisions for obtaining and documenting informed consent are appropriate • 6. Privacy and confidentiality are adequately protected • If Applicable: • 7. Research plan makes provisions for data safety monitoring • 8. Additional safeguards are included to protect the rights and welfare of vulnerable participants.

21. Vulnerable Populations • Pregnant Women, Human Fetuses and Neonates (45 CFR 46, Subpart B) • Prisoners (45 CFR 46, Subpart C) • (requires prison advocate review) • Children (45 CFR 46, Subpart D) • Cognitively impaired individuals • Students/employees • Elderly

22. Principal Investigator (PI) • Must a faculty member or senior staff member • The IRB recognizes only one PI for each project • Students can not be PIs

23. How to Get Started with Your Research Study

24. PI Responsibilities: • Investigators must have expertise in the area • Assures that the conduct of the study complies with all ethical, scientific, and financial principles of JHU and the Federal government • Knows and follows applicable regulations (Federal, state, institutional policies) • Upholds ethical principles (Belmont Report) • Assures that there are adequate resources (space, staff, funding) to accomplish the research • Assures that all team members are adequately trained • Responds to participant concerns/complaints

25. Basic Educational Requirements for Investigators and Research Staff • CITI Training(online) • All individuals engaged in human participant research at JHU Homewood are required to completed CITI training every three years • https://www.citiprogram.org

26. To make your application process smoother… Plan ahead!! Usually a few revisions of the protocol are necessary Submit early!!! Exempt and expedited studies take up to a month Full board studies take longer; usually at least 2 months because the fully convened IRB only meets once a month

27. You study will likely take longer to be reviewed if it involves: Children Cognitively Impaired Prisoners International Research You should call the IRB Office discuss your research plans if your study will involve any of these!

28. For more information: Visit the HIRB website at http://web.jhu.edu/Homewood-IRB/policies.html Contact the HIRB Office 101 Whitehead Hall 410-516-6580 hirb@jhu.edu

29. Questions?