Research with human participants at Carnegie Mellon University

1. Research with human participants at Carnegie Mellon University Ethical considerations and the Institutional Review Board - IRB

2. What is the IRB? • The IRB is a diverse group of scientific and non-scientific individuals who conduct the initial and ongoing review of research studies in order to ensure the protection of the rights, safety, and well-being of human subjects participating in those studies. The federal code of regulations governs the composition and conduct of the IRB. • US Dept of Health & Human Services (HHS) Office for Human Research Protections (OHRP) http://www.hhs.gov/ohrp • Typically all federally funded institutions have an IRB

3. The IRB at CMU • Office of Research Integrity and Compliance • http://www.cmu.edu/research-compliance/human-subject-research

4. Purpose of the IRB • The IRB is not a gatekeeper designed merely to allow or prevent your research. They are a body of professionals here to guide you through mentoring, education, and feedback on your application to ensure the ethical conduct of your research.

5. Ethical considerations • Informed consent • Clear communication of project • Voluntary participation • Confidential information • Information gathering or test of product, not a test of the user

6. Protection of research participants • Degree of risk • Psychological • Physical • Vulnerable participants • Pregnant women • Fetuses • Prisoners • Minors / children (< 18 years) • Participants with cognitive disabilities

7. IRB Project review • Does my project need to be reviewed?The IRB is only charged with reviewing research that involves people as research participants. Your project needs to be reviewed if it meets the following criteria: • Research means a systematic investigation (including development, testing, and evaluation) designed to discover or contribute to a body of generalizable knowledge (the extent to which research findings and conclusions from a study conducted on a sample population can be applied to the population at large). • Human Participants include those who are actively involved in the research process (being interviewed, filling out surveys, etc.). They also include those who may not be in front of us: those who provided medical samples, left records of their activities through applying for marriage licenses, etc. • See flowchart, Columbia University

8. Levels of Review • What are the levels of review? The levels of IRB review include Exempt, Expedited and Full. The level of review depends on the risk to the human participants. The IRB makes the determination of level. • Exempt - Studies that involve no or low risk • Expedited - Studies that involve minimal risk • Full - Studies that involve a greater than minimal risk, deal with questions of a sensitive nature, or involve minors or other vulnerable participants will require a Full Board Review • CMU IRB Decision flowchart: • http://www.cmu.edu/research-compliance/human-subject-research/documents/2015-expedited-decision-tree.pdf

9. Exempt review • What is Exempt review? Research projects that involve human participants and meet the criteria for exempt review. Examples of studies in this category are anonymous questionnaires or surveys that do not involve a sensitive topics, research being conducted in educational settings involving normal curriculum, and research on archival data. The following criteria for exemption set forth in Federal regulations (45 CFR 46). • http://www.cmu.edu/research-compliance/human-subject-research/faqs.html#qu9

10. Expedited review • What is Expedited review? Expedited review protocols are studies that pose no more than minimal risks to the participants and meet the criteria for Expedited Review under 45 CFR 46.110. Examples include studies using questionnaires, surveys, and interviews that are not anonymous. Applications may be submitted at any time.

11. Full review • What is Full review? Full review protocols involve more than just minimal risks, vulnerable participants or questionnaires/surveys on a sensitive topic. These protocols are reviewed by the Full IRB at the monthly board meetings (the first Tuesday of each month). Applications must be submitted at least two (2) weeks prior to the meeting.

12. Classroom Projects • I teach a course and several of my students want to conduct a research project involving human subjects. Do they need to file with the IRB?

If students are conducting human subjects research as part of a class assignment, or to satisfy a degree requirement, the IRB must review the proposed research. However, class assignments to teach or practice research methodology generally do not require IRB approval unless the effort is intended to produce generalizable knowledge. When students conduct research as part of a course of study, a faculty member ultimately is responsible for the protection of subjects, even if the student is the primary researcher and actually directs the project. Consultation with IRB staff is recommended for situations in which it is not clear whether a submission is required • From Columbia University: http://www.columbia.edu/cu/irb/faq.html#c12

13. Why is this class project not subject to IRB? • Federal definition of research is not met: Typically classroom/studio work does not meet the official definition of “research”, but rather is characterized as the collection of information to inform project development or design. • Project to teach or practice research methodology • Not specifically intended to be generalizable nor published [see CITI page]

14. Subjects vs participants • Why do you talk about "human research participants"? Is this the same as "human subjects"? The phrases "human subjects" and "human research participants" can be used interchangeably. The disadvantage of using the term "human subjects" is that it objectifies the people who have volunteered to take part in the research.

15. Application and consent forms • See sample consent forms • Online IRB completion, SPARCS: • http://www.cmu.edu/research-compliance/human-subject-research/guidance-forms.html

16. Training and certification • NIH National Institutes of Health (pre 2010) • CITI Collaborative Institutional Training Initiative New requirement February 2010 https://www.citiprogram.org

17. Summary • Research ethics video

18. Next steps… ALL students: • Familiarize yourself with the IRB site and forms • CITI course certificates due in class Tuesday April 4 MDES Thesis students: • Thesis proposal reviews with Teri Reiche & Doug McFarland (date / time TBA) • IRB applications due with thesis proposals Wed April 26 • Note “Faculty Advisor Assurance” form required! IRB Contact: • Teresa Merolli Reiche treiche@andrew.cmu.edu • Doug McFarland dougmc@andrew.cmu.edu