Curricular approaches to research ethics training for psychiatric investigators

Abstract

Rationale

Training in research ethics is crucial for psychiatric investigators. Addressing ethical dimensions of human subjects research requires knowledge about the rules and norms governing research; sensitivity to ethical implications of actions; and skills in ethics problem solving. Investigators in training who are physicians have the additional challenge of developing identities as investigators that sometimes conflict with their identities as physicians.

Objectives

To propose a curriculum for psychiatric research ethics training.

Methods

Review of literature on ethics education and presentation of a curricular approach to research ethics training for psychiatric investigators.

Results

Research ethics can be learned and should be taught. Involvement of active investigators in teaching research ethics is important. While core topics of psychiatric research ethics training have not yet been identified, there are available models from which to draw. Research ethics should be introduced early and integrated throughout the research training period. Lack of resources and institutional support can be obstacles to development of comprehensive research ethics curricula. Small-group, case-based discussion is best for teaching ethics problem-solving skills. Examples of teaching module ideas and a fully developed sample teaching module are presented.

Conclusions

There is opportunity for creative models for teaching psychiatric research ethics. Work is needed to identify core topics, target pedagogical strategies to trainees at different levels, and develop evaluation methods.

Appendix

Sample teaching module: clinical practice versus clinical research

Main objective

To introduce psychiatrists to differences between clinical practice and clinical research and differences between professional identities of physician-investigators and physicians

Background reading

• Chen DT, Miller FG, Rosenstein DL (2003b) Clinical research and the physician-patient relationship. Ann Intern Med 138:669–672

• Kass NE, Sugarman J, Faden R, Schoch-Spana M (1996) Trust, the fragile foundation of contemporary biomedical research. Hastings Cent Rep 26:25–29

• Klein JE, Fleischman AR (2002) The private practicing physician-investigator: ethical implications of clinical research in the office setting. Hastings Cent Rep 32:22–26

• Lidz CW, Appelbaum PS (2002) The therapeutic misconception: problems and solutions. Med Care 40:V55–V63

• Miller FG, Rosenstein DL, DeRenzo EG (1998) Professional integrity in clinical research. JAMA 280:1449–1454

Background material (for instructors)

While individuals may receive treatment in the context of both clinical practice and clinical research, the orientation of physicians is different in these two contexts. Ethically, clinical practice is oriented toward providing patients with individualized care by physicians who are dedicated to the patient's best interests. The risks of diagnostic procedures and treatment interventions are justified solely by anticipated medical benefits to the patient. The guiding ethos is referred to as "personal care." Some aspects of the personal care ethos may operate in clinical research. However, as scientists, physician-investigators are interested in patients primarily as members of groups from which data can be obtained for answering scientific questions. Clinical research can include research procedures that impose discomforts or risks of harm on patient-subjects that are not compensated by personal diagnostic or therapeutic benefits; these are justified, in the language of the Federal regulations governing research, by "the importance of the knowledge that may reasonably be expected to result." In clinical trials, patient-subjects may be randomized to treatment alternatives (or placebo); patient-subjects and physician-investigators may be blind to which alternative is received; and protocol-driven limitations may be placed on the types and dosages of treatments. These features depart significantly from personal care. While patient-subjects may receive benefit from research participation, that is not the primary purpose of research.

Lack of appreciation for these differences on the part of patient-subjects has been described and can contribute to thinking that the research has been designed to provide them with personalized medical benefit, a misunderstanding that has been called "therapeutic misconception" (Lidz and Appelbaum 2002; Kass et al. 1996). It is important that physician-investigators and personal physicians are alert to the potential for therapeutic misconception (Chen et al. 2003b)

While the distinctions between clinical practice and research also profoundly affect what is considered ethical with regard to research design, the layers of independent review that human subjects research undergoes serves in part to assure that these ethical implications are adequately considered. However, no matter how extensive the regulations and oversight bodies are, appropriate handling of the ethical issues that arise within the investigator-subject relationship relies heavily on the physician-investigator (Miller et al. 1998; Klein and Fleischman 2002) (Table 2).

Table 2. Table to use as part of teaching session (sample responses in italics)

Case for discussion

Ms. Freed is a 37-year-old actress who has been married for 16 years and has a 13-year-old son. Ms. Freed has bipolar affective disorder type I, a history of two psychiatric hospitalizations, and has been relatively stable on valproic acid, mirtazepine, and olanzapine for 2 years without a full-blown manic episode. She still has episodes of depression that, while not incapacitating, do not allow her to perform optimally. She dislikes the side effects of weight gain and hair loss associated with these medications. In addition, her glucose has been difficult to control. She had been stable on lithium for 9 years until she developed lithium-related renal dysfunction. For the following year, she had adequate trials of multiple other medication regimens with poor symptom control. Her first hospitalization occurred early in her course and resulted in an affective disorder diagnosis and contact with her psychiatrist, Dr. Jones, with whom she has remained in treatment for 11 years, in weekly psychotherapy and medication management. It was during the medication changes that she had her second hospitalization, which lasted almost 3 months for out-of-control behavior and poor judgment.

On the internet, she found a randomized placebo-controlled clinical trial for a new mood stabilizer. She looked into the trial and discovered that, in order to qualify, she cannot be stable on medication. The investigator instituted that requirement because the trial includes a medication wash-out period and a placebo control. Ms. Freed is desperate to try a new medication. She contacts the investigator, Dr. Smith, and gets a screening appointment. She requests a copy of the consent form to look over prior to her screening appointment. At her regular appointment with Dr. Jones, she mentions that she wishes to enroll in this clinical trial and asks for advice.

Sample issues for case discussion (encourage discussion of reasons why answers are given)

• Ms. Freed:

  • What questions should she ask the physician-investigator? Her own psychiatrist?

  • What impact might this study have on her husband and family?

  • What should count as a legitimate reason for wanting to participate? Hope for personal benefit? Altruism? Belief that new medications are always better?

• Dr. Jones (personal psychiatrist):

  • How should she respond to Ms. Freed's request? Is she allowed to give advice?

  • Should it matter if Ms. Freed is currently hypomanic or manic? Depressed? In what ways?

  • How can she assess if Ms. Freed has a "therapeutic misconception?"

  • How can she help Ms. Freed decide on assigning a surrogate decision-maker and creating research advance directives?

  • How important is it if this trial is in-patient versus out-patient? What if the trial did not allow continuation of psycho-therapy?

  • Should Dr. Jones continue to monitor Ms. Freed's clinical course? Would this be a violation of boundaries?

• Dr. Smith (physician-investigator):

  • What should Dr. Smith do if Ms. Freed is hypomanic or manic? Should Dr. Smith ask for Dr. Jones' opinion regarding enrollment?

  • Should Dr. Smith allow Ms. Freed to continue seeing Dr. Jones during the trial?

  • What should Dr. Smith do if Dr. Jones contacts her and asks for information about Ms. Freed during the course of her enrollment? Does it matter if Dr. Jones is calling because Mr. Freed is concerned about his wife?

  • Should Dr. Smith evaluate whether Ms. Freed has a "therapeutic misconception?"