Research Participation

1. Research Participation History, Informed Consent, Participation, Protection

2. Why I Believe in Research… Barbara’s Story Listen to Barbara’s personal story…. http://orrp.osu.edu/irb/participants/

3. What Is Research?

4. Research Definitions, Facts and Examples Definitions • Research: an investigation designed to develop or contribute to generalizable knowledge (e.g., fact, theory, application); collecting and breaking down data in the hopes of answering a question • Human subject: a living individual about whom researcher obtains (1) Data through intervention or interaction, or (2) Identifiable private information

5. Research Definitions, Facts and Examples Facts • Federal regulations define when an activity is research involving human subjects. • All research involving human subjects must be approved by an Institutional Review Board (IRB) or determined to be exempt (released from review requirements) before any activity is performed.

6. Research Definitions, Facts and Examples • Testing new treatments (drugs, devices) • Review and analysis of existing data • Testing new educational materials • Interviews • Focus groups • Surveys • Observations Examples of Activities That May Be Research

7. Research Definitions, Facts and Examples • Pregnant women, fetuses, and neonates • Persons with diminished decision-making capacity • Economically or educationally disadvantaged persons • Racial and ethnic minorities • The very sick • College students • Prisoners • Children • Institutionalized persons Examples of Vulnerable Research Subjects

8. Why Should I Participate in Research?

9. Why Should I Participate in Research? Participating in research: • Increases your knowledge and awareness • Impacts others by contributing to research discoveries • Helps researchers understand disease, behavior, and learning processes • Contributes to society’s medical, intellectual, and social progress

10. What Is Research Protection?

11. Research Protections The moral obligation to protect participants is a group effort involving researchers, funding organizations, and Institutional Review Boards (IRBs). This obligation involves acting with concern and respect for all participants. Important tools for providing protection include: education, certification, and accreditation.

12. Ethical Principles and Application

13. Ethical Principles and Application There are three basic principles outlined in the Belmont Report that are central to the ethics of research involving human subjects and to guiding Institutional Review Boards in ensuring that the rights and welfare of research participants are protected: • Respect for persons • Beneficence • Justice

14. Ethical Principles and Application Principle: Respect for persons • Individuals should be given free choice in their decisions to participate • Persons with limited independence (e.g., children, mentally disabled adults) are entitled to protection

15. Ethical Principles and Application Application: Informed Consent • Participants must be given the opportunity to choose what shall or shall not happen to them to the degree that they are capable • The consent process must be informative, understandable, and clearly state that participation is a choice

16. Ethical Principles and Application Principle: Beneficence • Participants should not be harmed • Research should maximize possible benefits and minimize possible harms Application: Assessment of Risks and Benefits • The nature and range of risks and benefits must be considered

17. Ethical Principles and Application Principle: Justice • The benefits and risks of research must be distributed fairly Application: Selection of Participants • There must be a fair and impartial selection process • Participants should be treated fairly • Benefits and burdens are shared fairly

18. History of Regulations Governing Research

19. History of Regulations Governing Research Historical Injustices • 1932 – 1972 Tuskegee Syphilis Study • 1941 – 1945 Nuremberg Trials • 1950s Willowbrook Hepatitis Studies • 1955 Wichita Jury Trial • 1960s Milgram Studies of Obedience to Authority • 1962 Thalidomide Experience

20. History of Regulations Governing Research Ethical Codes • Nuremburg Code http://www.ohrp.osoph.dhhs.gov/irb/irb_appendices.htm • The World Medical Association Declaration of Helsinki http://www.wma.net/e/policy/17_c_e.html • The Belmont Report http://ohrp.osophs.dhhs.gov/humansubjects/guidance/belmont.htm

21. History of Regulations Governing Research Other • Congressional hearings • National Research Act of 1974 • Common Rule http://www.hhs.gov/ohrp/humansubjects/guidance/45cfr46.htm

22. What is the Institutional Review Board (IRB)?

23. Institutional Review Board (IRB) IRBs were established to protect the rights and welfare of humans participating in research. IRBs must receive enough information from researchers to provide a proper review of proposed research and to make the necessary decisions required by regulations for IRB approval. Review and approval are required before any study can begin. Continuing reviews, at least yearly, are required while the study is ongoing.

24. Institutional Review Board (IRB) IRB Member Composition: • Scientists and non-scientists; affiliates and non-affiliates • Different backgrounds and experience • Knowledge of their community • Knowledge of research protections IRB Member Roles: • Chair • Vice Chair • Member • Consultant

25. How is Research Approved?

26. How Is Research Approved? The following requirements must be met before the IRB can approve research: • Risks to participants are minimized • Risks are reasonable in relation to the expected benefits • Selection of participants is fair and unbiased • Informed consent is sought and obtained from potential participants or their legal representatives

27. How Is Research Approved? The following requirements must be met before the IRB can approve research (cont.): • Plans are in place to protect the privacy of participants and to maintain the confidentiality of data • Resources are available to monitor the data collected and to ensure the safety of participants, as appropriate to the degree of risk • Additional safeguards are provided for vulnerable populations

28. Partners in Protecting Your Rights

29. Partners In Protection • Department of Health and Human Services (DHHS) • Institutional Review Boards (IRBs) • Office for Civil Rights (OCR) • Departments of Defense, Education, Justice, and Veterans Affairs • Office for Human Research Protections (OHRP) • Food and Drug Administration (FDA) • Researchers • Data Monitoring Committees

30. What is Informed Consent?

31. Informed Consent Federal laws require that individuals who are considering participating in a study are given information about the study and time to think about if they want to be in the study. This process is called “informed consent.” Consent forms are to be written so people understand them. People should always ask questions before agreeing to be in a study.

32. Informed Consent Informed consent must include information about: • The nature and purpose of the research • What will go on in the study • Which parts of the study are experimental • How long the study is expected to take • Possible risks or discomforts • Possible benefits

33. Informed Consent Informed consent must include information about: • Options that may exist besides being in the study • Where you can get help if you are harmed from being in the study • Contact information for questions • Your choice to take part in the study • Your ability to leave the study at any time and for any reason

34. What Questions Should I Ask?

35. Questions to Ask • How many other people are in the study? • Will there be any costs for me? • Will my records be kept private? • What will happen at the end of the study? • Will I get a copy of the study results? • Will I still get paid even if I leave the study early? • Will there be follow-up?

36. Important Reminders

37. Important Reminders • Participation must not involve someone taking advantage of another due to his/her position of power. • Participation must not involve force, persuasion, threat, or violence. • Study participants are someone’s: • Parent • Grandparent • Child • Brother or Sister • Friend

38. Research Participation

39. Research Participation OSU hosts a research participant page on the IRB website. This page provides links to university departments that maintain lists of active research projects and educational links related to research involving human subjects. Research participants are invited to contact ORRP to provide feedback and/or obtain information. http://orrp.osu.edu/irb/participants

40. Questions