Unit 6: Ethical considerations

1. Unit 6: Ethical considerations

2. After completing this unit, you should be able to: • Understand the basic ethical principles of working with humans • Define ‘informed consent’ and the procedures that help ensure it • Understand the importance of confidentiality and how to ensure it • Discuss the ethical considerations unique to behavioural surveillance

3. Ethical principles of working with humans • People must be respected and seen not as passive sources of data but as people whose rights and welfare must be protected. • Physical risk, psychological harm and stigmatisation must be minimised. • Risks and benefits from studies should be distributed fairly and evenly in populations.

4. What is informed consent? • Informed consent means that participants are told enough about the nature of surveillance to enable them to make an informed decision about whether or not to take part. • The decision to participate should be voluntary. • No project staff should pressure, coerce or deceive respondents in an effort to ensure their participation. • Staff should try to ensure that respondents are not pressured by gatekeepers or community members.

5. What information should be provided during informed consent? • The nature of the survey (e.g., length of interview and type of question) • The potential risks and benefits • How the information will be used • How privacy will be protected • That participation is voluntary • That participants have the right to refuse to answer any questions or stop the interview at any time • Participants should also be given a chance to ask questions

6. How should the consent procedure be documented? Oral consent is usually best in surveillance, as it ensures confidentiality. • Interviewers sign a statement verifying that the required information was provided and the respondent has given consent • Consent form used for each respondent • No signature required from respondent • No names recorded

7. Maximising participation • Although consent must be voluntary, we want to try to maximise participation in order to reduce bias. • We can maximise participation by, for example: • keeping interviews as short as possible • conducting fieldwork at times that are convenient to the participants • stressing the altruistic benefits of participating. • Recording the level and reasons for non-participation and basic socio-demographic information can be useful for assessing bias. • Response rates should always be reported in the analysis.

8. Using incentives • Appropriate for compensating or thanking participants for time away from work and out-of-pocket expenses • Should not be of so much value that they jeopardise the voluntary nature of informed consent • Can bias the sample towards those who have a greater need for the incentive • Respondent-driven sampling uses incentives. In this case it is ‘payment’ to the participant, who in their role of recruiters act as fieldworkers. This may not be appropriate in all settings.

9. Confidentiality • Protects subjects from adverse consequences that may arise from other people knowing their responses • Threats to confidentiality and measures to minimise them should be discussed during informed consent

10. Confidentiality, cont. • The best way to ensure confidentiality is to: • Ensure that names or other means of identifying respondents are not recorded on surveys. • Store data safely and appropriately. • Train fieldworkers on the importance of confidentiality. • Have clear disciplinary procedures for staff who breach confidentially. • Identify potential confidentiality problems and solutions in the pre-surveillance assessment. Fieldworkers may need to talk about stories that upset them, they should do so only with team members and in a way that does not easily identify the respondent.

11. Ethical considerations unique to behavioural surveillance

12. Potential ethical issues Potential solution · Ensure fully informed consent and absolute Increases stigmatisation and confidentiality discrimination of the group · Reporting should be neutral, e.g., “people at high risk of infection” · Reporting needs to be accompanied by public health communication about negative impact of stigma and discrimination on the epidemic · Loss of earnings Keep interview as short as possible · Remunerate lost earnings · Conduct interviews outside work times · Gatekeepers get angry at those Involve and work with the gatekeepers, stress the who participate benefits of surveillance · Gatekeepers who force participation Involve and work with the gatekeepers, stress the benefits of surveillance · Illegal activities are highlighted, Involve and work with law enforcement agencies resulting in a police crackdown so they understand the purpose of surveillance and the damage that could result from conducting repressive measures, like scattering the high- risk groups or driving groups underground · Participants get no direct benefit Report findings back to survey population from surveillance · Explain the indirect benefits during the informed consent procedure · Do not foster false expectations Examples: ethical issues in the surveillance of high-risk groups

13. Working with adolescents • Different countries will have different laws and standards about when an adolescent can participate in research involving sexual behaviours and when parental consent is required. • Generally, surveillance tries to minimise the number of participants ranging in age from 15-18, and to avoid including those under 15. • If it is necessary to include children under the age of 15, you should seek special guidance on research with children.

14. Benefits to participants • Surveillance offers no direct benefit to respondents. Some people believe surveillance is unethical in the absence of an intervention. • Indirect benefits can include: • Improving HIV prevention and care programmes • Raising public awareness and sympathy of the burden of disease in the population • Reducing stigma and effecting social change, especially around HIV infection • Feedback of results to the community

15. Benefits to participants Each country needs to decide the limitations of what fieldworkers can do in terms of personal assistance (for example, transporting a sick person to a healthcare facility, etc.)

16. Surveillance as research • Public health surveillance is not usually considered research and does not have the same formal requirements for documenting and reviewing ethical procedures. • Ethical safeguards are still an essential part of surveillance and procedures should go through local ethics committees and institutional review boards.

17. Small group discussion 1. What are some of the potential social harms caused by behavioural surveillance in high-risk groups in your setting? 2. What ethical issues/difficulties have you/could you experience conducting surveillance in your country?

18. Case study Design a consent form to be used with female sex workers.