Continuing Education & Resources for Mental Health Professionals

Ethical Practice Model Adapted for Research

Protecting Confidentiality Rights: An Ethical Practice Model

(Adapted for Use in Research Settings)

Mary Alice Fisher, Ph.D.


            A. Understand Subjects’ Rights and Your Ethical Responsibilities in Behalf of Those Rights

            B. Learn the Laws that Can Affect Confidentiality of Research Subjects

            C. Clarify Your Personal Position About Confidentiality and its Legal Limits in Research

            D. Decide When/How You Will Limit Confidentiality Voluntarily

            E. Develop Plan for Ethical Response to Laws That Require You to Disclose “Involuntarily”

            F. Choose Reliable Ethics Consultants and Legal Consultants and Use as Needed

            G. Devise Informed Consent Forms that Reflect Your Real Intentions

            H. Prepare to Discuss Confidentiality and Its Limits in Understandable Language


            A. Inform Prospective Subjects About Limits of Confidentiality

            B. Inform Prospective Subjects & Obtain Permission Before Recording Voices or Images

            C. Inform About Foreseeable Uses of the Information to be Gathered

            D. Inform about Factors That Might Influence Willingness to Participate  (e.g., Risks/Benefits)

            E. Inform About Right to Decline to Participate or to Withdraw Once Participation Begins

            F. Inform About Consequences of Declining/Withdrawing

            G. Explain Any Roles or Potential Conflicts of Interest That Might Affect Confidentiality

            H. Obtain Informed Subject’s Consent to Participate, Understand These Conditions         


            A. Respect the Rule: Disclose Identifiable Info Without Subject’s Consent Only if Legally Unavoidable

            B. Inform Subject Adequately About Content and Implications of the Potential Disclosure

            C. Obtain and Document the Subject’s Consent Before Disclosing


            A. Notify Subject of Pending Legal Demand for a Disclosure Without Subject’s Consent

            B. Respond According to Plan (from Step 1,E above)

            C. Limit Disclosure of Confidential Information to the Extent Legally Possible


            A. Avoid Making Unethical Exceptions to the Confidentiality Rule

            B. Establish and Maintain Protective Policies and Procedures;

            C. Monitor Record Keeping Practices; Separate Research Data from Names of Subjects

            D. Train Staff in Policies for Protecting Privacy and Confidentiality

            E. Anticipate Legal Demands; Prepare to Respond Ethically 

            F. Protect Subject Identity in Presentations, Research Reports, Consultations


            A. Model Ethical Research Practices; Confront Others’ Unethical Practices

            B. Provide Peer Consultation About Confidentiality Ethics in Research

            C. Teach Ethical Practices to Students, Supervisees, Employees, Agency, Institution


Adapted From:
Fisher, M.A. (2008). Protecting Confidentiality Rights: The Need for An Ethical Practice Model. American Psychologist, 63 (1), 1-13.

(Article available in html at

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Articles Related to Federal Certificate of Confidentiality in Research Settings

Fisher, C.B. & Vacanti-Shova, K. (2012).  The responsible conduct of psychological research: An overview of ethical principles, APA Ethics Code standards, and federal regulations. In: APA handbook of ethics in psychology, Vol 2, In:  S. J. Knapp, M.C. Gottlieb, M.M. Handelsman, & L.D. VandeCreek, Editors, APA handbook of ethics in psychology, Vol 2. Washington, DC, American Psychological Association, (pp. 335-369). doi: 10.1037/13272-016

Haggerty, L.A. & Hawkins, J. (2000).  Informed consent and the limits of confidentiality.  Western Journal of Nursing Research, 22, 508-514. doi: 10.1177/01939450022044557

Melton, G. B. (1990). Certificates of confidentiality under the Public Health Service Act: Strong protection but not enough. Violence and Victims, 5, 67-71.

Traynor, M. (1997).  Countering the excessive subpoena for scholarly research.  Retrieved from

            “C. Obtain Federal Confidentiality Protection, If Available:  In the area of public health, federal law offers two sources of confidentiality protection. First, there are federal statutory provisions that limit the disclosure and use of information obtained in the course of research supported or conducted by the Public Health Service. For example, one provision protects information obtained through activities carried out or supported by the Agency for Health Care Policy and Research . . .

            “Second, some public officials have the authority to grant confidentiality protection under certain circumstances. For instance, one such provision gives the Secretary of Health discretion to grant federal confidentiality certificates for a range of both publicly and privately funded research projects. . .

            “These two statutory provisions do overlap to some extent. While logically one might assume that confidentiality protection is enhanced when these provisions are used in combination, this is not the case. According to federal authorities, a confidentiality certificate will weaken the protection that qualifying projects receive under the self-executing statutory grant of confidentiality.20 There are two explanations for this result: First, federal confidentiality certificates give the researcher discretion to disclose the protected data. In contrast, under a statutory grant of confidentiality, the researcher may disclose the protected data only if the research subject contents after notice. Second, a federal confidentiality certificate only protects the names or other identifying characteristics of the research subjects. In contrast, a statutory grant of confidentiality protects all data obtained in the course of activities falling under the scope of the statute.21 It is important for researchers to have knowledge of these differences so they may determine what information is protected, and when they may legally disclose protected information.

            “These public health statutes illustrate the variety of federal confidentiality protections which may be available to resourceful researchers. Thus, they are well-advised to investigate possible sources of statutory protection before resorting to home-spun confidentiality assurances.”

From: Traynor, M. (1997). 

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