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By Matt Harrington, BCBA · Behaviorist Book Club · Research-backed answers for behavior analysts

Frequently Asked Questions About Consumer Protections for Research in Human Service Agencies

Questions Covered
  1. When does clinical practice become research that requires ethical oversight?
  2. What options do agencies have if they cannot afford a full internal review board?
  3. How should research consent differ from clinical consent in practice-based settings?
  4. What safeguards protect participants from feeling coerced to join research?
  5. What are the particular challenges of single-case research designs in practice settings?
  6. How does the BACB Ethics Code address the dual role of researcher and clinician?
  7. What should a basic research review process include for a small practice?
  8. How should agencies handle data from practice-based research to protect confidentiality?
  9. Can parents who consent to clinical services be assumed to also consent to research?
  10. What role should external consultants play in agency research review?

1. When does clinical practice become research that requires ethical oversight?

The distinction between clinical practice and research is sometimes ambiguous, but general guidelines help clarify the boundary. Clinical practice involves applying established, evidence-based procedures to address individual client needs with the primary goal of benefiting that specific client. Research involves systematically manipulating variables to test hypotheses, generate generalizable knowledge, or evaluate the effectiveness of novel procedures with the intent to disseminate findings. Key indicators that an activity has moved into research include using experimental designs that require withholding or modifying treatment, implementing procedures specifically to generate data rather than to serve the client's clinical needs, and planning to publish or present the results beyond the agency.

2. What options do agencies have if they cannot afford a full internal review board?

LeBlanc, Nosik, and Petursdottir (2018) described several alternatives appropriate for agencies of different sizes and resources. Options include partnering with a university IRB that agrees to review external protocols for a fee, engaging an independent ethics consultant for protocol review, establishing a small review committee of two or three qualified individuals including at least one external member, or joining a community-based research review network. Even the simplest arrangement, having a qualified colleague independently review research protocols and consent documents, provides a meaningful layer of protection compared to no oversight at all.

3. How should research consent differ from clinical consent in practice-based settings?

Research consent must be more detailed and specific than clinical consent. It should explicitly describe the research purpose and questions being investigated, the specific procedures that constitute research versus routine clinical care, any potential risks beyond those associated with standard treatment, the participant's right to withdraw from research without losing access to clinical services, how research data will be stored and de-identified, plans for data sharing or publication, any potential conflicts of interest the researcher may have, and the process for reporting concerns about the research. Code 5.04 requires that this consent be voluntary and informed, which means the participant must genuinely understand what they are agreeing to.

4. What safeguards protect participants from feeling coerced to join research?

Key safeguards include having someone other than the treating clinician obtain research consent, providing a cooling-off period between the invitation to participate and the consent decision, clearly and repeatedly communicating that declining will not affect clinical services, ensuring the consent document explicitly states the right to withdraw at any time, creating a mechanism for participants to report concerns about pressure to participate, and separating research participation records from clinical records so that clinical staff are not aware of participation decisions. These safeguards acknowledge the inherent power differential in clinical relationships and the potential for subtle coercion.

5. What are the particular challenges of single-case research designs in practice settings?

Single-case designs present unique ethical challenges because they often require baseline phases where effective treatment is not yet implemented, reversal phases where treatment is temporarily withdrawn, and alternating treatments where the client receives different interventions in rapid succession. These design requirements can conflict with the clinical obligation to provide the most effective treatment available. LeBlanc, Nosik, and Petursdottir (2018) addressed these tensions by recommending that researchers carefully justify any departure from optimal clinical care, establish clear stopping rules for when to terminate research phases, and prioritize the participant's clinical welfare over the integrity of the experimental design when the two conflict.

6. How does the BACB Ethics Code address the dual role of researcher and clinician?

Code 5.03 (Research in Service Delivery) specifically addresses the challenges of conducting research within the context of ongoing clinical services. The standard requires that research activities not compromise the quality of clinical care and that participants have access to effective treatment regardless of their research participation decisions. The dual role creates potential conflicts of interest: a clinician may be tempted to delay introducing an effective treatment to extend a baseline phase, or to continue a less effective treatment to complete a research comparison. Code 1.11 (Conflicts of Interest) provides additional guidance on identifying and managing these conflicts transparently.

7. What should a basic research review process include for a small practice?

A basic research review process should include a written protocol describing the research question, design, procedures, and participant protections submitted before research begins. An independent reviewer with research ethics knowledge should evaluate the protocol for ethical compliance, assess the risk-benefit ratio, and review the informed consent documents. The review should result in one of three decisions: approved, approved with modifications, or not approved. Documentation of the review process and decision should be maintained. Even this minimal structure provides accountability and external perspective that significantly enhances participant protection compared to unreviewd research.

8. How should agencies handle data from practice-based research to protect confidentiality?

Code 5.05 (Confidentiality in Research) requires protection of participant privacy. Practical steps include storing research data separately from clinical records, de-identifying data as early in the research process as possible by removing or coding names and identifying information, limiting access to identified data to essential personnel, using secure storage systems with appropriate access controls, establishing data retention and destruction policies, and ensuring that published reports do not contain information that could identify individual participants. For small agencies where staff may recognize participants even from de-identified descriptions, particular care must be taken in how case details are presented in publications.

9. Can parents who consent to clinical services be assumed to also consent to research?

No. Consent for clinical services and consent for research are separate and distinct processes. A parent who agrees to ABA services for their child has not thereby agreed to participate in research. Research consent must be obtained specifically and separately, with a clear explanation of how research activities differ from or extend beyond routine clinical care. Code 5.04 requires that research consent be voluntary and informed, which means participants must understand specifically what they are agreeing to. Bundling research consent with clinical consent creates the potential for participants to agree to research without fully understanding or considering their decision.

10. What role should external consultants play in agency research review?

External consultants bring independence and objectivity that internal reviewers may lack, particularly in small agencies where internal reviewers may have collegial relationships with the researchers. An external consultant with research ethics expertise can evaluate protocols without the conflicts of interest that may affect internal reviewers. They can also bring knowledge of ethical standards and regulatory requirements that may exceed the internal expertise of a practice-focused agency. The role might range from reviewing individual protocols to helping the agency develop its overall research oversight infrastructure. Code 2.03 (Consultation) supports seeking external expertise when internal resources are insufficient for the task at hand.

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Clinical Disclaimer

All behavior-analytic intervention is individualized. The information on this page is for educational purposes and does not constitute clinical advice. Treatment decisions should be informed by the best available published research, individualized assessment, and obtained with the informed consent of the client or their legal guardian. Behavior analysts are responsible for practicing within the boundaries of their competence and adhering to the BACB Ethics Code for Behavior Analysts.

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