Public Health Practice vs Research: Implications for Preparedness and Disaster Research Review by State Health Department IRBs David Perlman, Ph.D. Former Director, Human Research Ethics Program, NJDHSS President & Founder, E4 – Eclipse Ethics Education Enterprises, LLC Senior Lecturer, Penn School of Nursing Associate, Penn Center for Bioethics

Public Health is Different: Human Subjects Research in Public Health Institutions

The Problem The regulations for the protection of human subjects define research in terms of several key concepts: Intent Systematic investigation Generalizability At Departments of Health, this definition can prove vexing for determining when activities are research or public health practice.

Is it Public Health Practice or Public Health Research? Two guidance documents are seen as authoritative Council of State and Territorial Epidemiologists (CSTE) (on left) Centers for Disease Control (CDC) Guidelines (on right)

CSTE Report Source: CSTE, 2004, p. 14.

CDC Guidelines Progression of its argument: Research is defined as a “systematic investigation…designed to develop or contribute to generalizable knowledge” Key word: “designed” – “the major difference between research and non-research lies in the primary intent of the activity” Therefore, the intentionality of the investigator proposing an activity becomes paramount.

CSTE Considerations General legal authority Specific intent Responsibility Participant Benefits Experimentation Subject Selection

The Upshot CDC’s guidelines solely locate the distinction on the specific intent of the activity and therefore on the intentionality of the investigator Obvious problem: investigators can game the system to avoid IRB review and additional protections for subjects CSTE Report provides a more nuanced set of considerations to guide decision-making

Why is the Distinction Important? Depending on whether a public health activity is deemed practice or research, a variety of federal and state laws and regulations for the protection of human subjects and their identifiable private information will apply. Regardless of the determination, public health officials are legally and ethically required to protect the interests of individuals, but the primary focus is on the health of populations.

Why Should This Matter? Some things should not go to the IRB, whereas some should: “Public health practice activities that are misclassified as research require public health authorities to engage in time-consuming reviews through governmental or private sector IRBs. In some cases, the mere assessment by an IRB, even when expedited, may thwart an activity to the detriment of the public’s health. In other cases, the IRB may require additional protections for persons viewed as human research subjects that defeat public health objectives in principle or design, or for lack of funding” (CSTE, 2004, p. 21). “Conversely, public health research that is misclassified as practice may allow governmental health authorities to collect and analyze sensitive health data in possible violation of health information privacy interests, or interact with human subjects without complete adherence to research protections to the detriment of the individual participants” (CSTE, 2004, p. 21).

Finding the Crucial Balance Therefore, it is paramount to determine which activities constitute research versus practice And, the discussion thus far has only focused on what I would term non-preparedness, non-catastrophic public health activities Analyzing public health activities in this burgeoning area deserves additional consideration

Epidemics and Disasters Are Different

Preparedness Initiatives and Disaster Research: A Dilemma Some preparedness initiatives and research activities during, in response to, and after disasters are likely to blur the line between public health practice and research Current regulations and guidance documents don’t have a mechanism to address the following dilemma: If it is research, then it must be prospectively approved by an IRB. Time and a host of additional public health considerations may limit the ability to seek prospective approval of research after disasters How can the public be assured that public health officials will safeguard their individual rights of protection under the federal regulations governing human subjects research? That is, what mechanism(s) can be used to balance the need to protect individuals and the need for scientific data? Additional question at end: What training in ethics should be provided to public health officials who will be called on to conduct research in disaster situations?

Is This a New or Novel Question? My research seems to indicate “yes” There is literature on ethics of research after disasters My focus is on public health activities that blur the line between practice and research during disaster responses

Some Initial Thoughts about Potential Remedies Re-tool the IRB system such that prospective approval for certain projects is not required Dr. Emanuel has thought a great deal about how our current system of research protection can be revamped (Emanuel et al., 2004, Annals of Internal Medicine) Perhaps revamping the system to regionalize or federalize public health research versus practice determinations and IRB review of research projects

FDA Regulatory Provisions for Emergency Research FDA regulations have provisions for emergency research at 21 CFR 50.24: Prospective informed consent not required Community consultation before implementation of the project is required Provision is only for providing an unproven clinical investigative drug, device, or biologic, not for research into public health disasters or epidemics. According to FDA (2006, personal communication), only about 24 projects have utilized this mechanism since its inception in 1996 This mechanism is not without ethical challenges and detractors (see AJOB 2006 issue)

DHHS Regulatory Provisions for Emergency Research DHHS also enacted the FDA’s provisions in the following guidance document found on the OHRP website. So there is some justification for such a mechanism.

Consensus and Cooperation at the National Level CSTE CDC

What Should Happen Now? Only 35 State Departments of Health seem to have IRBs Every State Department of Health should: Have an IRB, and Be knowledgeable about the potential research implications of their preparedness initiatives and have an IRB member ready and available to review disaster projects.

Shameless Self-Promotion (Perlman, 2008, Disaster Medicine and Public Health Preparedness 2: 185-191)

Additional Research and Development on These Topics Phase I R43 “stimulus” grant to NCI: Research on how Departments make the distinction Providing an educational algorithm to assist in making determinations Establishing a public health and social-behavioral IRB CDC Contract for public health responder ethics training: Key informant interviews with veteran responders Building a learning management system for interactive web-based ethics education Disclosure: These projects are submitted as small business opportunities through my small ethics education company, E4 – Eclipse Ethics Education Enterprises, LLC.

David Perlman, Ph.D. 215-266-9196 dperlman002@yahoo.com Thoughts or Questions? David Perlman, Ph.D. 215-266-9196 dperlman002@yahoo.com