Responsible Research with Human Participants

1. Responsible Research with Human Participants Dr. Elizabeth Hill, ProfessorIRB Chair Voice: 313-578-0405 Fax: 313-578-0507E-mail: hillelm@udmercy.edu Cate Caldwell, PhDDirector, OSPRA Voice: 313-992-1544Fax: 313-993-1534E-mail: caldwecr@udmercy.edu

2. Ethics • Professional ethics • Privacy and consent issues are concerns in many contexts outside of research: • E.g., American Medical Association, American Psychological Association codes • Federal privacy rules • Health Insurance Portability and Accountability Act (HIPPA) • Family Educational Rights and Privacy Act (FERPA) • And others • Research ethics

3. Research Ethics • What is research? RESEARCH is defined as “a systematic investigation, including research development, testing and evaluation, designed to develop or contribute to generalizable knowledge”

4. Research Ethics • What is research? • Publication of results outside the university is a critical issue • Distinct from practice • Individual cases • Distinct from teaching assessment • Teaching evaluations • Distinct from student projects in classes • Ethical conduct is still required

5. Research Ethics • What is research with human subjects? • HUMAN SUBJECT is defined as “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 • Research with animals also requires ethics review, conducted by Institutional Animal Care and Use Committees

7. Research Ethics Trigger EventsEthical Milestones The Nazi Experiments Nuremberg Code, 1947 Tuskegee Syphilis Study National Commission for the Protection of Human Subjects of Biomedical & Behavioral Research, 1974 * Belmont Report, 1978 * Common Rule, 1991

8. The Belmont Report The principles of the Belmont Report govern all research supported by the U.S. Government. The ethical principles outlined in the report are the basis for subsequent regulations designed to ensure protection of human subjects in research. • Respect for Persons • Beneficence • Justice

9. The Belmont Report • Respect for persons • Informed consent • Protection of privacy and maintaining confidentiality • Additional safeguards for protection of vulnerable populations to prevent coercion or undue influence • Protection of individuals with reduced autonomy

10. The Belmont Report 2. Beneficence • maximize benefits and minimize harm • an independent person/board must review all research and assess the risk/benefit ratio • this assessment includes evaluation of the study design and the ability of the researcher

11. The Belmont Report 3. Justice • selection of subjects must be equitable • inclusion of appropriate populations without unnecessary exclusion of populations-- fairness of inclusion and distribution of results • equitable distribution of research burdens and benefits

12. Federal Regulations Current regulations were developed to comply with the principles in the Belmont Report Title 45 Public Welfare Department Of Health And Human Services National Institutes Of Health Office For Protection From Research Risks Part 46 Protection Of Human Subjects Known as 45 CFR Part 46 or the Common Rule www.hhs.gov/ohrp/humansubjects/guidance/45cfr46.htm • Federal protection of human subjects is overseen by the Office of Human Research Protections (OHRP) at Health and Human Services (HHS) www.hhs.gov/ohrp/

13. Federal Regulations • 45 CFR 46 • A set of guidelines-- not meant to be rules • Each institution interprets the guidelines for their types of research • Research facilities may require more than one review board, depending on the variety of research conducted at the facility

14. UDM Policies • ALL researchers/experimenters working with human subjects in research investigations are required to obtain clearance from UDM’s IRB PRIOR to running the experiments/studies • See our website: http://www.udmercy.edu/academicaffairs/ospra/irb/index.htm • ALL researchers/experimenters are required to complete the online training course entitled “Program for the Protection of Human Research Subjects” conducted by the Collaborative Institutional Training Initiative • See the website: http://www.citiprogram.org

15. UDM Policies • For all projects, regardless of the level of review, an application must be submitted to the IRB prior to the initiation of any research involving human subjects. • Most federal agencies have a “Just-in-time” policy. That is, you don’t need to have IRB approval at the time of proposal submission, but you must have IRB approval prior to the acceptance of award funds. • The IRB chairperson is responsible for determining the review status of each project. • Three levels of IRB review / continuing review

16. UDM Policies • Exempt- minimal risk to participants (risk equivalent to everyday life) • educational research • anonymous surveys • secondary/archival data • naturalistic observation • quality control • Please note that exempt research projects still need to be submitted to the IRB. Exemptions are granted by the IRB chair.

18. UDM Policies • Expedited Only research in categories 1-7 in 45 CFR 46.110(b)(1) may be reviewed through an expedited procedure. This list of categories can be found on our website at http://www.udmercy.edu/academicaffairs/ospra/irb/guidelines/index.htm#ExemptionExpedited • Also, the study must • Be no more than minimal risk • Collect no sensitive information • Not recruit protected populations as participants • Not be classified research

20. UDM Policies • Full Committee • greater than minimal risk • intervention/experimental studies which require investigational new drug applications • vulnerable subjects (prisoners, children, pregnant women) • These decision tables and others can be found on the Health and Human Services (HHS) Office for Human Research Protections (OHRP) website at http://www.hhs.gov/ohrp/policy/checklists/decisioncharts.html

21. UDM Policies The Make-Up of UDM’s IRB • At least 5 members with varying backgrounds • Sufficient diversity (gender, race, expertise) to represent research facility • At least one member must be knowledgeable of all institutional commitments, regulations, and applicable laws • At least one member must be from outside the research facility • At least one member must represent non-scientific interests • For review of any project, the IRB can invite person(s) with particular expertise as a temporary non-voting IRB member

22. UDM Policies Goals of the IRB • Review study design and determine risk/benefit of each project • Determine if all requirements of Informed Consent are fulfilled • Determine if additional safeguards are provided for vulnerable populations

23. UDM Policies • All forms, procedures, and meeting dates are available at http://www.udmercy.edu/academicaffairs/ospra/irb/index.htm • Proposals must be submitted on the provided form-- a Word file available on the web page • Proposals submitted for exempt or expedited review may be submitted at any time—plan on a 1-2 weeks for review • For consideration at a full committee review, the application must be submitted three weeks prior to the next scheduled IRB meeting • The full committee meets every two months • Exempt and Expedited categories of research are listed on the website

24. UDM Policies Confidentiality • Data with personal identification should be stored in a confidential manner. • To assure confidentiality, unless necessary all identification should be removed from the actual data. • When identification of data is necessary, information that would enable the investigator to readily ascertain the identity of the individual to whom the private information or specimens pertain should be replaced with a code number. • The key to decipher the code, enabling linkage of the identifying information to the private information or specimens, should be kept secure, separate from the data.

25. UDM Policies Informed Consent: Each subject must be informed of • expectations of their participation- including time requirements and procedural details • contact information for the investigator and the IRB Chairperson • expectations of risks and benefits (details of confidentiality, voluntary nature of participation, with no penalty or loss of benefits for nonparticipation or withdrawal, explicit statement that subject may withdraw at any time, compensation, if any) • details regarding the storage of information, including identification of stored materials and access by others Required elements of informed consent are listed on the IRB webpage, along with an example consent form

26. UDM Policies The responsibility for the protection of human subjects does not rest solely with the IRB. It is shared between the PI, and the IRB, and rests with the Institutional Official (at UDM this is the Academic Vice President for Academic Affairs). • Institutional Official: AVP Pam Zarkowski • Special Assistant to the AVP: Lisa Zessin • IRB Chairperson: Elizabeth Hill This shared responsibility includes appropriate training of all researchers. • Cate Caldwell, Director of OSPRA, may also be able to answer your questions.

27. UDM Policies CITI ethics training course - online Go to www.citiprogram.org. Register as a new user (username and password) Select University of Detroit Mercy Select a learner group e.g., Social/Behavioral, Biomedical, Students conducting no more than minimal risk research, Archives/Records/Specimens, Educational/Pedagogical Research Complete the Basic Course (text and quizzes)

28. FAQs Q: My study participants will be minors. What additional steps must I take? A: Research with children or adolescents requires a parental consent form and a child assent form. The assent form must be written to be understandable by the age group of your participants. (Assent forms for children 7-13 are written at the 3rd grade level, forms for adolescents 13-17 are written at the 5th grade level.) If the research is minimal risk, only one parent must consent. If the research is more than minimal risk, both parents must consent.

29. FAQs Q: If I assign a student research project in one of my classes, do my students need to go through the IRB? A: It depends. If the student plans to seek publication, then yes. If it is only to complete the requirements of the course, then no. However, it is important that the student take ethical considerations into account, especially in studies with more than minimal risk to participants. It is advisable that they go through the IRB process in these cases, even though they are not required to submit. (Some universities require student research with more than minimal risk to go through the IRB.)

30. FAQs Q: My study was approved by another IRB. Do I still need to go through the UDM IRB? A: Yes, but it is an abbreviated process. We ask that you complete the Project Summary Form and attach the prior approval.

31. FAQs Q: I want to recruit UDM students, faculty, or staff as study participants on the UDM listserv. Do I need IRB approval to do that? A: Yes. The text of the recruitment script, the context in which the recruitment takes place (e.g. posting a message on a newsgroup, mass emailing, and websites created for recruitment of participants) must be reviewed and approved by the IRB. Please send all such messages to OSPRA and/or the IRB chair for prior review before distribution.

32. Investigator Responsibilities • to obtain IRB approval for all projects prior to recruitment of subjects and compliance with all IRB determinations • protecting the rights of subjects according to 45 CFR 46 • obtaining and documenting the informed consent for all subjects, as appropriate • ensuring that each potential participant understands the nature of the research and their participation • fully debrief all subjects, when necessary • to inform the IRB of any unanticipated events during the conduct of the protocol • to inform the IRB of any changes in protocol following committee approval prior to implementation of changes-- must obtain IRB approval for all protocol changes • report to the IRB the status of the protocol one year after approval and, if necessary, submitting an extension