Educating for the Responsible Conduct of Research in Behavioral Health

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Educating for the Responsible Conduct of Research
in Behavioral Health

• Terry DiLorenzo
• Jill Becker-Feigeles
• Margaret Gibelman
• Yeshiva University, New York, NY

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Dr. Margie GibelmanWurzweiler School of Social
Work Yeshiva University
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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, Psychiatry,
  Psychiatric Nursing, Social Work

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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.

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The Problem (contd)

• 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.

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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.

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Methods

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

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Phase 1 Results
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Response Rate

• Sent Completed
• Nursing 96 49 51.0
• Psychology 548 141 25.7
• Psychiatry 127 31 24.4
• Counseling 178 40 22.5
• Social Work 177 66 37.3
• Total 1126 327 29.0
• excludes undeliverable surveys

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Is formal education in RCR required of those
conducting research?

• Yes No Not
• Sure
• Nursing 85.7 2.0 2.0
• Psychology 87.2 9.2 0.7
• Psychiatry 64.5 3.2 3.2
• Counseling 75.0 17.5 2.5
• Social Work 77.3 13.6 1.5

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What components of RCR are covered in curricula?

• Confidentiality Informed
  Human Conflict of Consent Subjects
  Interest
• Nursing 81.6 81.6 77.6 65.3
• Psychology 80.9 80.9 83.0 63.1
• Psychiatry 45.2 54.8 51.6 51.6
• Counseling 75.0 72.5 75.0 60.0
• Social Work 81.8 75.8 81.8 57.6

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Faculty familiarity with standards of responsible
research conduct

• Not at Somewhat Familiar
  Very
• All Familiar Familiar
  Familiar
• Nursing 0.0 6.1 24.5
  57.1
• Psychology 0.0 6.4 27.0
  63.8
• Psychiatry 0.0 6.5
  19.4 45.2
• Counseling 0.0 10.0 30.0
  55.0
• Social Work 1.5 9.1 24.2
  57.6

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Student familiarity with standards of responsible
research conduct

• Not at Somewhat Familiar Very
  
• All Familiar Familiar
  Familiar
• Nursing 0.0 16.3 40.8 30.6
• Psychology 0.0 17.7 36.9
  41.8
• Psychiatry 14.3 28.6 23.8
  23.8
• Counseling 5.0 17.5 50.0
  9.0
• Social Work 1.5 27.3 47.0
  13.6
• Fellows

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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

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Phase 2
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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.

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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?

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Interview (Contd)

• 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?

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Methods (Contd)

• 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

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Content Analysis (Preliminary)

• First level 150 codes in 10 major categories
  (e.g., formal review, informal review, advising)
• Pattern Coding grouping into meta-codes (e.g.,
  advising as informal review)
• Hypothesis testing

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Results (Preliminary)
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Formal Review Processes

• All had IRB or HSC
• IRB review process is front-loaded
• Rigorous examination of proposalhuman 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

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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 Masters projects/research for courses
  formally reviewed

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Informal Review Processes

• Faculty
• 4 require signatures of head of unit or dean
• Student
• Doctoral research reviewed by advisors/committees
• Masters/other research reviewed by advisors or
  schools representative to IRB

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Education/Training

• Faculty
• 7 required formal (University-based) training for
  faculty, primarily on-line
• 2 had formal mentoringtenure 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
  coursesResearch, Ethics, Practice

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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

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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 ideabecause
  there would be an expectation that every single
  faculty member knows a lot about the field and
  that simply isnt true. And if you look in the
  backgrounds of people who have masters degrees
  in social work in this country, 90 of them never
  had an ethics course and wouldnt know.so I
  think its serious. I think its 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 Im not yet aware of
  really good models for addressing at a doctoral
  level.

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Respondents Recommendations

• IRB follow-up on protocols
• You knowthe 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
  theyre doing what they said they were
  going to be doing
• As someone who has reviewed probably 100 IRB
  applications, you dont ever know what happens.
  And there are some people who, when they get
  feedback, take awhile ..to respond so you dont
  know did something happen? Did they just go ahead
  anyway? Did they misunderstand? You just dont
  know and even for students, they dont have to
  report in with the IRB when they complete their
  process.

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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.

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Conclusions (Contd)

• Many require training of all engaging in
  research.
• Informal review rarely conducted for faculty
  informal review for doctoral research more
  extensive than for masters projects of classroom
  research.
• RCR content included in most curricula, but
  methods/courses vary.