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Lowering the Risk: Ethical Practices When Doing Research with People

Wongbusarakum, Supin; Leisher, Craig; Gregg, Christopher E. 6/27/2012

Measuring the social impacts of conservation projects provides information essential for effective conservation, and making those measurements often involves obtaining information from people. But how do we ensure that our research involving human subjects1 adheres to ethical principles? Below we offer some guidance on best practices to ensure (a) that our studies are ethical and (b) to prevent or minimize different types of risks for both the human subjects and conservation organizations.

Historically, abusive biomedical experiments like those revealed by the Nuremberg War Crime Trials in 1945-46 and the 1932-1972 Tuskegee Syphilis experiments resulted in serious efforts to develop ethical standards for research involving human subjects. In the United States, for example, researchers working with human subjects are guided by the Belmont Report: Ethical Principles and Guidelines for the Protection of Human Subjects of Research (NIH 1979). Australia has a national statement on ethical conduct in human research (Australian Government 2009).

The Nature Conservancy is not involved in biomedical research, but rather in social and behavioral research in which the risk to human subjects is relatively low. Nevertheless, these types of research also have sets of rules and regulations for reviewing and inspecting their processes and procedures. Additionally, in many places in the world where customary and traditional ways of leadership are maintained, researchers must often go through a local village council or leaders prior to conducting any study. In the United States, federally funded projects require approval by an Institutional Review Board (IRB) that screens proposed human-subject research to assess the risks it poses to subjects, ensuring that it either meets ethical standards and has sufficient safeguards or meets criteria for exemption from U.S. Department of Health and Human Services regulations.2 Many journals only publish research that has received IRB approval.

Even if a specific project is not regulated by an IRB, however, there are ethical issues that we should be concerned with whenever we work and do research with people. The following three ethical principles based on the Belmont report are therefore recommended for adoption within the Conservancy.

Principle #1: Respect for Persons. People should participate in the research on a voluntary basis and be given information in a manner and context that allows them to  make an informed decision about participating in a research project. This information may include the purposes of the study, how the study will be conducted, how long the interview/survey will last, and how the study results will be used. It also includes a statement offering the subject the opportunity to ask questions and noting that the subject can withdraw at any time from the research. For a researcher, respect for persons means obtaining the free, prior and informed consent (FPIC) of subjects. (See this 2010 Oxfam report for more on FPIC and how to do it.)

For several recent Central Science household surveys, the FPIC approach involved meeting with appropriate local leaders to explain the research and ask for their formal written permission to conduct the study. Another approach would be to secure written or verbal consent from each individual being asked to participate in the study. Also, anytime a person under 18 years of age is involved in research, consent to participate must be obtained from their parent or guardian and the youth.

Principle #2: Beneficence. This principle has two elements: 1) do no harm to the people we study; and 2) maximize possible benefits and minimize potential harm. A researcher needs to protect subjects from any harm that may result from participating in the research. Doing so requires learning what is harmful; therefore, it is important to have basic knowledge of the community and its social dynamics.

Consider possible harm at every step of the research, including the study objectives; collecting, handling and storing data; and how research results are communicated. In particular, protecting data confidentiality is critical. To remain covered by the U.S. federal exemption, TNC must ensure that subjects cannot be identified through the information obtained and that the information collected will not lead to disclosures that could reasonably place subjects at risk of criminal or civil liability or damage their financial standing, employability or reputations. Risks and benefits of research may affect the individual subjects, the families of the individual subjects, and society at large (or special groups of subjects in society).

Principle #3: Justice. The selection of research subjects needs to be scrutinized in order to determine whether some classes are being systematically selected simply because of their easy availability, their compromised position, or their manipulability, rather than for reasons directly related to the problem being studied. Finally, research should not unduly involve persons from groups unlikely to be among the beneficiaries of subsequent applications of the research.

By following these principles, we can take important steps toward maintaining our high ethical standards, averting potential harm to those involved in our studies, and protecting TNC against reputational, organizational, legal and possibly financial risks.

Supin Wongbusarakum is a senior social scientist at The Nature Conservancy; Craig Leisher is a senior social science advisor at The Nature Conservancy; and Christopher E. Gregg is associate professor of geology at East Tennessee State University.

References and Resources

Australia Government, National Health and Medical Research Council. 2009. Human Research Ethics. http://www.nhmrc.gov.au/health-ethics/human-research-ethics

National Institute of Health (NIH), Office of Human Subject Research. 1979. The Belmont Report: Ethical Principles and Guidelines for the Protection of Human Subjects of Research. http://ohsr.od.nih.gov/guidelines/belmont.html

U.S. DEPARTMENT OF HEALTH AND HUMAN SERVICES (HHS), Public Health Services, National Institutes of Health 2004. Guidelines for the Conduct of Research Involving Human Subjects at the National Institutes of Health. http://ohsr.od.nih.gov/ guidelines/GrayBooklet82404.pdf

Oxfam Australia. 2010. Guide to Prior and Free Informed Consent. http://www.culturalsurvival.org/files/guidetofreepriorinformedconsent_0.pdf


1 A"human subject" is a living individual about whom an investigator obtains either (1) data through interaction or intervention with the individual, or (2) identifiable private information (HHS 2004).

2 The regulations pertaining to the protection of human subjects published by HHS are located at 45 C.F.R. Part 46. The regulations basically require that institutions that receive federal funding for research on humans set up and operate institutional review boards. Subpart A of that regulation, “The Basic HHS Policy for Protection of Human Research Subjects,” applies to “all research involving human subjects conducted, supported or otherwise subject to regulation by any federal department or agency” (Subpart A, Section 46.101). However, Paragraph (b) of the regulations allow for exceptions to the policy. Paragraph (b) states:

(b) Unless otherwise required by department or agency heads, research activities in which the only involvement of human subjects will be in one or more of the following categories are exempt from this policy:

The exception that applies to TNC is located at Section 46.101 (b)(2) which states:

(2) Research involving the use of educational tests (cognitive, diagnostic, aptitude, achievement), survey procedures, interview procedures or observation of public behavior, unless:

(i) information obtained is recorded in such a manner that human subjects can be identified, directly or through identifiers linked to the subjects; and (ii) any disclosure of the human subjects' responses outside the research could reasonably place the subjects at risk of criminal or civil liability or be damaging to the subjects' financial standing, employability, or reputation.