Educating for the Responsible Conduct of Research in

Educating for the Responsible Conduct of Research in Behavioral Health Terry Di. Lorenzo Jill Becker-Feigeles Margaret Gibelman Yeshiva University, New York, NY

Dr. Margie Gibelman Wurzweiler School of Social Work Yeshiva University

Behavioral Health § The application of medical, psychiatric, psychological, social work, and educational principles and practices to the diagnosis and treatment of mental health and substance abuse disorders § Includes: Counseling, Psychology, Psychiatric Nursing, Social Work

The Problem § Emphasis on educating for RCR has focused primarily on biomedical sciences; § Behavioral health professionals are increasingly contenders for public grants and contracts and producers of research; § Behavioral health research typical involves interactions with vulnerable populations.

The Problem (cont’d) § Little is known about RCR education in behavioral health; § Little is known about the use of mentoring, collaboration, and internal (school-specific) oversight to review and monitor research; § Even less is known about relationship between behavioral health professional schools and University IRBs.

Goals of the Research § Describe research review and monitoring § § § mechanisms in behavioral health education programs; Examine perceptions about adequacy of procedures regarding research review and monitoring; Examine mentoring and other forms of collaboration to promote socialization to research norms; Determine extent to which RCR content is included in curricula or provided through other mechanisms.

Methods § Mixed method approach: § Phase 1: Survey § Mail/on-line survey of deans/directors § Phase 2: Interview § Qualitative interviews with subsample of survey respondents

Phase 1: Results

Response Rate Nursing Psychology Psychiatry Counseling Social Work Total Sent* Completed 96 49 548 141 127 31 178 40 177 66 1126 327 *excludes undeliverable surveys % 51. 0 25. 7 24. 4 22. 5 37. 3 29. 0

Is formal education in RCR required of those conducting research? Nursing Psychology Psychiatry Counseling Social Work Yes No 85. 7 87. 2 64. 5 75. 0 77. 3 2. 0 9. 2 3. 2 17. 5 13. 6 Not Sure 2. 0 0. 7 3. 2 2. 5 1. 5

What components of RCR are covered in curricula? Confidentiality Informed Consent Nursing Psychology Psychiatry Counseling Social Work 81. 6 80. 9 45. 2 75. 0 81. 8 81. 6 80. 9 54. 8 72. 5 75. 8 Human Conflict of Subjects Interest 77. 6 83. 0 51. 6 75. 0 81. 8 65. 3 63. 1 51. 6 60. 0 57. 6

Faculty familiarity with standards of responsible research conduct Not at Somewhat All Familiar Nursing Psychology Psychiatry Counseling Social Work 0. 0 1. 5 6. 1 6. 4 6. 5 10. 0 9. 1 Familiar 24. 5 27. 0 19. 4 30. 0 24. 2 Very Familiar 57. 1 63. 8 45. 2 55. 0 57. 6

Student familiarity with standards of responsible research conduct Not at All Familiar Nursing 0. 0 Psychology 0. 0 Psychiatry* 14. 3 Counseling 5. 0 Social Work 1. 5 *Fellows Somewhat Familiar 16. 3 17. 7 28. 6 17. 5 27. 3 40. 8 36. 9 23. 8 50. 0 47. 0 Very Familiar 30. 6 41. 8 23. 8 9. 0 13. 6

Phase 1: Conclusions § Formal procedures to educate students/faculty in RCR vary considerably § Most respondents reported that procedures to socialize students/faculty to RCR could be improved

Phase 2

Methods § Interview development § Based on Phase 1 results, pool of questions generated by research team; § Additional questions generated by experts in selected disciplines; § Pilot testing and refinement of instrument.

Interview § What procedures are used to review and monitor faculty and student research? § Do you have your own internal review procedures? § Are there procedures in place for ensuring the accuracy of research findings prior to publication? § What is the level of participation of your faculty on university IRBs?

Interview (Cont’d) § How adequate are research review and monitoring procedures perceived to be? Have any issues/problems arisen? § To what extent does the curriculum include RCR content? § What efforts are made to provide students/junior faculty with mentors to guide research development?

Methods (Cont’d) § Sample § Random Selection of those agreeing to be interviewed agreed interviewed* Nursing 4 1 Psychology 11 5 Psychiatry 3 0 Counseling 4 1 Social Work 13 9 * Two interviews not included in content analysis

Content Analysis (Preliminary) q. First level: 150 codes in 10 major categories (e. g. , formal review, informal review, advising) q Pattern Coding: grouping into metacodes (e. g. , advising as informal review) § Hypothesis testing

Results (Preliminary)

Formal Review Processes § All had IRB or HSC § IRB review process is “front-loaded” § Rigorous examination of proposal—human subjects, consent, procedures, and less frequently, methodology § No monitoring of on-going research, except annual progress report where required by IRB/HSC § Limited review of accuracy of Findings

Formal Review Processes § Consideration of science § 3 had a formal assessment of science § (4 had informal assessment of science) § IRB Constitution § 1 had separate panels for behavioral vs. biomedical § 7 always had rep from discipline on IRB § Student Research § Doctoral research reviewed by IRB/HSC § Not all Master’s projects/research for courses formally reviewed

Informal Review Processes § Faculty § 4 require signatures of head of unit or dean § Student § Doctoral research reviewed by advisors/committees § Master’s/other research reviewed by advisors or school’s representative to IRB

Education/Training § Faculty § 7 required formal (University-based) training for faculty, primarily on-line § 2 had formal mentoring—tenure committee, associate dean § Student § 7 required formal training (University-based) for all students conducting research, primarily on-line § 2 had dedicated RCR courses for doctoral students § RCR primarily infused into other courses—Research, Ethics, Practice

Misconduct § RCR training relates to allegations § No allegations of misconduct reported where formal education in RCR is required prior to conducting research § 2 reports of misconduct and 2 authorship disputes in 2 of 9 where formal RCR training is not required prior to conducting research

Respondents’ Recommendations § Recommendation for separate ethics course that has focus on ethical conduct in research § “Well I believe in a separate ethics course. I think that this whole business of infusing ethics throughout the curriculum is a bad idea…because there would be an expectation that every single faculty member knows a lot about the field and that simply isn’t true. And if you look in the backgrounds of people who have master’s degrees in social work in this country, 90% of them never had an ethics course and wouldn’t know…. so I think it’s serious. I think it’s a hugely serious issue. ” § Connecting RCR in classroom to practice § “Bridging classroom to practice conduct together, in the topic of research, or in the topic of clinical work, is a gap that I’m not yet aware of really good models for addressing at a doctoral level. ”

Respondents’ Recommendations § IRB follow-up on protocols § “You know…the IRB receives the proposal, approves certain procedures, and we just assume that those are being carried out. So [it might not be a bad idea to select people to] demonstrate that [they’re] doing what [they] said [they] were going to be doing” § “… As someone who has reviewed probably 100 IRB applications, you don’t ever know what happens. And there are some people who, when they get feedback, …take awhile. . to respond… so you don’t know did something happen? Did they just go ahead anyway? Did they misunderstand? You just don’t know and even for students, they don’t have to report in with the IRB when they complete their process. ”

Conclusions § Research review primarily at proposal stage; focuses on human subjects, informed consent, methods. § Limited attention to scientific merit, oversight of on-going research, and accuracy of findings beyond the review by advisor/committee. § IRB constitution varies, some disciplines lack appropriate representation.

Conclusions (Cont’d) § Many require training of all engaging in research. § Informal review rarely conducted for faculty; informal review for doctoral research more extensive than for master’s projects of classroom research. § RCR content included in most curricula, but methods/courses vary.