Ethics Review in Public Health Research: Standard Procedures and Challenges

WHO Training Manual Ethics in epidemics, emergencies and disasters: Research, surveillance and patient care Learning Objective 2.1 Describe standard procedures that should govern an ethics review of research activities, including public health research

Outline 1. Introduction Standard procedures for ethics review Differences between biomedical research and public health research Areas covered by standard ethics reviews Ethics review of public health research Challenges raised by the review of public health emergencies research 2. Debate altering review standards 3. Case Study and discussion SARS and CDC 4. Summary 0-20 (20 min) 21-45 (25 min) 46-70 (25 min) 71-85 (15 min) 86-90 (5 min) Suggested time Introduction Debate Case discussion Discussion Summary and conclusion Activity L.O. 2.1

Background Broad international agreement on the need for independent unbiased ethics review of research involving humans Research ethics committee (REC) or institutional review boards (IRB) (in the USA) Research with human subjects must submit to the REC a detailed description of the research project Research protocol provides an account of how ethical issues will be addressed through the project L.O. 2.1

Biomedical research vs public health research Most normative instruments governing research were developed specifically with a clinical/biomedical model in mind Many of these standards also applicable to public health/epidemiological research, although some aspects might change, including: Concern for direct harm to individual participants may be replaced by a concern for harm to whole groups Requirement for individual consent may be levied Ability to withdraw from studies may be limited Use of aggregate data less individually identifiable but raises question of group privacy L.O. 2.1

11 Areas covered by ethics reviews 1. relevance of research to disaster situations 2. informed consent and voluntariness 3. role of community consultation and participation 4. exploitation 5. dignity, privacy and confidentiality 6. risk minimization L.O. 2.1

11 Areas covered by ethics reviews 7. Professional competence 8. Public interest and distributive justice 9. Dissemination of results 10. International collaborative research 11. Institutional responsibilities and arrangements (Sumathipala et al. 2010) L.O. 2.1

Other areas for review Balance of therapeutic and non-therapeutic risks and benefits Adequacy of proposed informed consent process Sufficiency of information Voluntariness Mechanism to ensure individual s capacity to understand Confidentiality Protection of vulnerable populations Equitable distribution of benefits and burdens of participation L.O. 2.1

Ethics review of public health research Most traditional normative instruments governing research have clinical/biomedical model May need to change aspects of traditional review Harm-benefit balance may be altered Requirement for informed consent could be waived Limited ability to withdraw from studies Confidentiality issues L.O. 2.1

Challenges reviewing public health emergency research 1. Altered research designs new ethical and logistical challenges 2. Limited expertise of REC members in public health emergencies 3. Community representation may not be feasible 4. Altered standards e.g. standard of care, waiving consent L.O. 2.1

Discussion Come up either with arguments in favor or against of the following question: Is it ever permissible to alter the review standards of research ethics committees? L.O. 2.1

Case Study (I) In March 2003, during the worldwide SARS outbreak, [the U.S. Centers for Disease Control and Prevention (CDC)] engaged in a series of efforts to systematically identify potential SARS cases and those within contact of these persons. As part of these activities, CDC focused efforts on potential cases of SARS spread through casual contact among airline travelers. CDC asked state and local public health agencies to assist in following up with potential contacts. In particular, during this critical time, if CDC became aware of a person known or suspected to be infected with SARS who had recently flown into or within the United States, it would identify the flight, contact the airline for the flight manifest, and then ask state or local public health agencies to help locate persons who had flown with the individual, and thus may have been exposed to SARS . L.O. 2.1

Case Study (II) Sometimes, obtaining flight manifests and locating named individuals would result in a 3-4 weeks administrative delay between the time CDC suspected a potential exposure and when an investigation could be conducted. Nevertheless, CDC requested that state or local agents supervise physicians to draw blood samples and obtain medical histories of healthy, unaffected air travelers who were on the plane with a known or apparent SARS case. When administrative delays mounted, the time period for performing these blood tests on asymptomatic individuals would have surpassed their likely incubation period for SARS, revealing only that they may have been exposed. Thus, the tests would not directly benefit asymptomatic individuals who were not cases because they were not ill. (Hodge and Gostin, 2004, pp. 34-35) L.O. 2.1

Case Study Discussion 1. The effort to identify applicable cases is often the first step in a research project. What might be the research question here? 2. If this is a research study, what questions would you have as an REC member? L.O. 2.1

Small group discussion Each group should take a position on one of the three following questions, and summarize: a) Why do we go to so much trouble to oversee the ethics of research? Does it not add unnecessary costs to research? b) Service on a research ethics committee is time- consuming. Is it worth it and why? c) Should REC approvals be unanimous, or is it acceptable for there to be dissenting votes on individual protocols? L.O. 2.1

Summary/Conclusion For research on public health emergencies, a research ethics committee would need to be sure that members understand the research design at least some of them have adequate expertise community representation is available alterations in both clinical and public health standards are weighed Preparing for research on public health emergencies might itself be one of the most important duties of a research ethics committee L.O. 2.1

Sources Hodge JG, Gostin LO. Public Health Practice vs. Research. Atlanta: Council of State and Territorial Epidemiologists (CSTE), 2004. (Available at http://www.vdh.virginia.gov/OFHS/policy/documents/2012/irb/pdf/Publi c%20Health%20Practice%20versus%20Research.pdf, accessed 22 September 2014) Sumathipala A, Jafarey A, De Castro LD, Ahmad A, Marcer D, Srinivasan S, et al. Ethical Issues in Post-Disaster Clinical Interventions and Research: A Developing World Perspective. Key Findings from a Drafting and Consensus Generation Meeting of the Working Group on Disaster Research and Ethics (WGDRE) 2007. Asian Bioethics Review 2010;2(2):124-142. DOI: 10.1353/asb.2010.0020 L.O. 2.1

Acknowledgements Chapter authors Goodman, Kenneth, University of Miami Bioethics Program, University of Miami, Miami, Florida, United States of America Litewka, Sergio, University of Miami Bioethics Program, University of Miami, Miami, Florida, United States of America L.O. 2.1