World Health Organization 23 April, 2018 WHO Training Manual Ethics in epidemics, emergencies and disasters: Research, surveillance and patient care Learning Objective 3.4 Describe specific measures required to protect and collect data and biological materials during public health surveillance L.O. XX Title

Outline General Overview Case Study The Role of Biological Specimens in Emergency Public Health Surveillance Why Are Biological Specimens Ethically Sensitive? Ethical Issues Summary/Conclusion Suggested time 0-15 (15 min) 16-20 (5 min) 21-35 36-56 (20 min) 56-60 Activity Introduction Reading Team preparation Team presentations and discussion Summary and conclusion L.O. XX Title

General Overview Biological specimens (e.g., blood samples) may be taken for a variety of emergency public health surveillance purposes, including Determining who has been exposed to a novel virus or chemical agent Identifying the prevalence of a drug-resistant bacteria in a particular population Developing new vaccines The collection and analysis of biological specimens raises several ethical issues, concerning the possibility of an uncomfortable collecting process, risk of stigmatization and the possibility of exploitation.

Why Are Biological Specimens Ethically Sensitive? Individual and cultural attitudes about the status of blood and other biological materials Danger of stigmatization and discrimination if negative health information is discovered For individuals (if the identity of the sample source is known or discoverable) For communities from which samples have been obtained (even without individually identifiable information) Concerns about exploitation If specimens are used to develop interventions that will not be accessible to the community If specimens are used to make profitable products and the community does not share in the benefits The importance of maintaining trust in the system

Ethical Issues Informed consent to the collection of biological specimens Key questions in determining the necessity of informed consent: will individually identifiable information be collected with the specimens; could the disclosure of information related to the specimens lead to stigmatization or discrimination, on either the individual or community level; will public health goals be compromised if individuals are given the opportunity to refuse to have their specimens collected and analysed (National Bioethics Advisory Commission 1999). L.O. XX Title

Ethical Issues Defining the concept of “individually identifiable” information Use of stored specimens for additional purposes Equitable distribution of benefits

Potential Safeguards Prior oversight by ethics committee Informed consent of sample sources Consultation with local community Limiting collection, use, and disclosure of individually identifiable information to the minimum necessary Confidentiality protections for individually identifiable information (storage, access, disclosure) Material transfer agreements

When Is Consent Necessary? Does the activity constitute “research”? Will individually identifiable information be collected? Could the information generated lead to stigma or discrimination (for individuals and/or groups)? What would be the public health consequences of recognizing refusals to participate?

What Should Be Discussed in the Consent Process? What will be done with the sample? What individually identifiable information (if any) will be kept with the sample? Who will have access to this information? If the sample reveals negative health information, will the person from whom the sample was obtained be told? Who else will be told? What confidentiality protections are in place? How long will the sample be stored? Might the sample be reused for other purposes?

Defining “Individually Identifiable” Information Even if sources’ names are not recorded, it may be possible to figure out who they are Information about where they live Facility admission and discharge dates Information about family members When samples are taken from discrete communities, guaranteeing anonymity may not be possible

Use of Stored Specimens for New Purposes Example: public health officials seek to use blood collected as part of patients’ clinical care to determine how many people in a community have been exposed to a virus or chemical agent. Considerations: Is the use consistent with the sources’ original consent? If not, is it possible to re-contact the sources to obtain consent, or at least to provide notice? Can the samples be anonymized to minimize risks of discrimination and stigma? What methods of community consultation might be considered? L.O. XX Title

Case Study Over the past few weeks, isolated cases of a new, highly deadly, strain of the flu virus have been reported in remote villages of the Republic of Coconut Paradise. In response, the government of the country has contacted your organization, an international medical relief agency, for assistance in collecting biological specimens from village inhabitants. The specimens will be used to characterize the strain, assess its prevalence and modes of transmission, and begin the work necessary to develop a vaccine. The government proposes to go door to door in the villages in which cases have been reported and request household residents to (1) contribute a blood sample; and (2) answer some short questions related to their current health status and behaviours (for example, where they get their food and water, where they work or go to school, whether they have recently attended large public gatherings). The answers to the questions will be kept with the specimens and identified by the date, time, and general location of the collection, but no names will be recorded. Samples will be tested at a central government laboratory, and the results will be correlated with the information obtained through the questionnaire. No information will be reported back to the individuals who provided the samples. Samples that test positive for the flu virus will be shipped to a commercial vaccine producer in Europe. L.O. XX Title

Case study questions In groups please discuss the following questions (15 min.): What should the household residents be told before they are asked to give blood or participate in the survey? Might it be possible to discover the identities of individuals who test positive for the flu virus? If so, what risks does this create? Described what safeguards should be established to protect the confidentiality of the biological materials. Should information about the test results be reported back to the persons who provided the samples? What conditions should be placed on the use of the samples by the European vaccine producer? Should this project undergo an ethical review and/or community consultation? If so, who should be involved in these processes? L.O. XX Title

Summary Various ethical issues may arise from collecting and analysing biological specimens Intrusive and uncomfortable collection process Risk of stigmatization/discrimination if undesirable health information is discovered Risk of exploitation if specimens used to develop interventions not accessible to that individual/community, or where profits are not given to source community Need prospective review of activity to determine how to address such factors

Sources National Bioethics Advisory Commission (1999). Research Involving Human Biological Material: Ethical Issues and Policy Guidance. Rockville: National Bioethics Advisory Commission.

Chapter author Acknowledgements Coleman, Carl H., Seton Hall University School of Law, Newark, New Jersey, United States of America L.O. XX Title