Ethical Issues in the Conduct of Research at a Multidisciplinary Clinic

ABSTRACT

We describe the process our interdisciplinary clinic used to create an institutional policy regarding research participant recruitment from among our client base. We demonstrate how certain elements of the client-clinician relationship can lead to inadvertent ethical quandaries in research recruitment, including implicit coercion and fostering of “therapeutic misconception.” Our internal policy deliberations focused on five central dilemmas, each requiring a careful evaluation of ethical principles. Interpersonal and cross-disciplinary differences of opinion required a delicate balance among competing priorities. The final policy represents our attempt to resolve these ethical paradoxes in a way that allows us to support and pursue valuable clinician-researcher partnerships while prioritizing both our clients' clinical care and their rights to autonomy and fully informed consent.

Clinician-researcher partnership - research recruitment - therapeutic misconception - ethics

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APPENDIX

ARTZ CENTER

Policy for Recruitment of Research Participants

The Artz Center for Developmental Health and Audiology supports research activities that may yield information that advances knowledge in our disciplines and across our disciplines within our Developmental Home framework. To that end, we are pleased to assist in recruiting research participants for research activities and to support the research collaborations and activities of our staff.

Because we work with vulnerable populations, the following procedures are in place to protect our clients and our organization. The Artz Center takes the position that protection of human subjects is paramount, and that the participation in research activities is entirely a voluntary and free choice for our families/clients. From the ASHA statement on protection of human subjects: “Precautions should be taken to guard against the perception of possible manipulation or coercion that may be part of teacher-student, clinician-client, or doctor-patient relationship”.

The following are our policies regarding research activities within the Artz Center:

• Outside research activities:

  • ^ Researchers seeking help in subject recruitment must present evidence of approval from their Institutional Review Board (IRB) and any written material that is to be available to families must have IRB approval.

  • ^ Written material available to families must clearly state the organization or person(s) sponsoring the research as well as the specific purpose(s) of the research.

  • ^ Written material regarding research projects will be posted in our lobbies and family waiting areas.

  • ^ Clinical and office staff may not directly suggest that a client or family participate in such studies. If a family or client asks about a research project, they should be directed to contact the researchers.

  • ^ Clients and families go through an Informed Consent procedure as part of their participation in the project that is stipulated by the IRB. Their choice to participate in a research project is voluntary, and interactions regarding participation are between the family/client and the researcher. Artz Center staff are not part of this process.

  • ^ Clinical or office staff may not allow their personal opinion of the usefulness or appropriateness of a research project to influence whether participation is available to families. All IRB approved research activities may be posted within our public spaces.

• Collaborative Research Activities of Artz Center Staff

  • ^ Artz Center staff my elect to participate as research co-investigators and collaborators with research teams locally and nationally and seek to offer voluntary research opportunities to Artz Center families.

  • ^ Any collaborative research activity within the Artz Center requires an IRB approval with special attention to assuring that subject recruitment procedures emphasize the voluntary nature of participation.

  • ^ No clinician shall be soliciting patients directly for Artz Center collaborative research activities, but support staff of the Artz Center may ask if families are interested in receiving information about voluntary participation in collaborative research activities of Artz Center clinical staff, as stipulated and approved by an IRB.

  • ^ Inquiries from families about the Artz Center research activities should be directed to the Artz Center project lead.

  • ^ Informed consent procedures are always required within IRB approval and may occur either on-site or off-site with research assistants or clinicians not directly involved with clients who may be participants, not clinic support staff.

  • ^ Artz Center Staff wishing to engage in collaborative research activities within the Artz Center must seek approval from an Artz Center Research Oversight Team which includes the Executive Director, the Medical Director, Program Directors and other appropriate administrative staff. A brief written request for approval must stipulate and include the following:

    • ▪ Background scientific information about the proposed project

    • ▪ The scientific and clinical merit of the project to the Artz Center's mission of developmental health and audiology

    • ▪ The specifics of subject recruitment procedures along with IRB approval/submission

    • ▪ Proposed budget and financing implications including productivity impacts

  • ^ The Artz Center Medical Director oversees collaborative research activities and is responsible for strict adherence to these policies.