Informed Consent in Healthcare: What It Is and Why It's Needed

Contributor(s): Rachel Bloom

Background

Ethnographic research involves using direct qualitative methodologies to gather insight on various social phenomena outside the confounding setting of scientific labs. In ethnographic studies, research teams deploy staff into the field, where they serve as direct liaisons with community members. While covert, deceptive field research – pretending to be part of the community that is the focus of study – can yield unique information about that group’s attitudes and norms, it has been challenged on ethical grounds (Erikson, 1995) and will not be the primary focus of this module. In most field studies today, researchers maintain overt relationships with community members, building rapport while remaining transparent about the institutional role they are playing. Once a researcher makes a few initial connections, those participants then serve as gatekeepers for access to the larger community (McAreavey & Das, 2013).

Research vulnerability for subjects arises as the joint product of participant characteristics and the given research context. Nonintervention studies are often focused on eliciting sensitive information from participants – including involvement in illegal behavior and risks to participants’ health – in order to generate critical knowledge (Fisher & Goodman, 2009, p. 35). In nonintervention research involving life-threatening or high-risk populations, participants are exposed to unique vulnerabilities not common to other forms of research involving corrective interventions or lower-risk populations. These vulnerabilities include the unintentional disclosure of sensitive social information (of which subjects themselves may be unaware), as well as a lack of clear confidentiality risks and reporting obligations among nonintervention researchers compared to clinical workers. In this context, the “scientist-citizen dilemma” presents itself: that is, researchers need to balance ensuring the scientific validity of their study while not exacerbating the kind of behaviors that pose active harms to participants’ health. This is often a concern in research concerning suicide (Gould et al, 2005; NIMH, 2020), violence (Becker-Blease & Freyd, 2006; Clark & Walker, 2011), and drug use (Ryan, Smeltzer & Sharts-Hopko, 2019).

Enter the importance of Goodness-of-Fit: a reciprocal learning process to identify research challenges and ethical issues, as well as informing approaches to confidentiality and informed consent (Fisher, 2015; Fisher & Yuko, 2015). Goodness-of-Fit analyses ask the central question: “What special life circumstances may render participants more susceptible to risks that arise in this research design? What aspects of the methodology, implementation, or dissemination may create or exacerbate such research risks? And how can research procedures be fitted to participant characteristics to best minimize risk?” (Fisher & Goodman, 2009, p. 27) It is important to note that compliance with IRB directives and federal regulations, while necessarily, is insufficient for conducting “truly ethical research” (Clark & Walker, 2011). Harms produced by interactions between researchers and study participants often arise from the dual obligations of investigators to gather ecologically-valid data while protecting participants, a so-called “scientist-citizen” dilemma (Fisher & Rosendahl, 1990). These harms can be minimized or controlled by “fitting” ethical procedures to issues the participants may be susceptible to, building resilience among the population to the potential harms of nonintervention research. Confidentiality procedures and guidelines should be fitted to a) the probability and severity of potential harms if confidentiality is and is not protected; b) the validity of the assessment of potential harm; and c) the availability of various social, legal, and service-based systems to support researcher decisions around confidentiality or disclosure.

In the case of field research people who inject drugs (PWID) who have or are at-risk for HIV, participants are exposed to a particular set of vulnerabilities. Sexual and drug-related behaviors among this population can perpetuate the physical and social risks of continuing to engage in what is thought of as “life-threatening behavior.” At the same time, the illegality of drugs including heroin makes it essential for researchers to smoothly navigate drug policies without jeopardizing the social or legal rights of prospective participants (Oransky et al, 2009). HIV nonintervention research can contribute to participant misconceptions about transmission mechanisms of HIV: for example, gathering samples from participant cheek swabs could suggest that HIV is transmissible through saliva and kissing (Clair, Singer, Huertas & Weeks, 2003). In addition, many people in more marginalized populations carry a suspicion of biomedical treatment and research (Shaw, 2005) stemming from historical trauma (Fairchild & Bayer, 1999), including the perception that they could be infected with HIV by researchers (Fisher et al, 2008). It is critical to build trust with this population both in order to advance HIV prevention efforts and to minimize harms from participating in nonintervention research (Abadie et al, 2018).

In the following video, you will meet Maria, a field researcher who is navigating the process of building rapport with recruited participants in a nonintervention study. She has been getting to know the members of the community she wants to understand: people who use heroin intravenously, and have or are at-risk of having HIV. In meetings with participants, Maria discusses sexual practices and observes drug use behavior that leads heroin users to share equipment. Steve, a drug user and study participant, agreed to be a part of the study two months ago and has introduced Maria to a number of his connections within the heroin-using community. The video begins depicting a transactional interaction, with Maria bringing Steve food; Steve seems both more willing and better physically-equipped to talk with her after eating. As you watch the video, keep in mind what sort of problems are arising for both Steve and Maria given the “current situation,” how they are both feeling throughout the interaction, and what should be done to resolve their conflict.

Discussion
Belmont Report Principles: Beneficence, Respect, Justice

Investigators carry the ethical responsibility of minimizing research harms among vulnerable populations (OHRP, 1993; S. Office of Human Subjects Research, 1979; Fisher, 2011). As-outlined in the Belmont Report, beneficence, respect, and justice are particularly salient ethical considerations for all human subjects-based research but especially nonintervention research (S. Office of Human Subjects Research, 1979). Beneficence in research is the doctrine of striving to do good, prevent harm to participants and involved populations, and maximize the accuracy of scientific knowledge produced by the research team. Respect for persons emphasizes that participants are responsible for the choices that they make, have the right to knowledge that would affect their health and safety, and have a right to privacy. Justice concerns the equitable distribution of research opportunities and benefits, the elimination of bias, and reparation for historic and current health disparities, as well as consistency in treatment of research participants. Keep these concepts in mind as you continue through this module and consider Maria’s ethical obligations towards the research population and its constituents.

This research was supported by a National Institute on Drug Abuse (NIDA) grant (R01 DA015649-01A2) to Fordham University, Principal Investigators, Celia B. Fisher, Ph.D. and Merrill Singer, Ph.D.
Reference: Fisher, C. B., & Goodman, S. J. (2009). Goodness-of-fit ethics for non-intervention research involving dangerous and illegal behaviors. In D.Buchanan, C. B. Fisher, & L. Gable (Eds.), Research with high-risk populations: Balancing science, ethics, and law (pp. 25–46). Washington, DC: APA Books.

Blurring of Researcher-Participant Boundaries: Power as a Two-Way Street

There can be many benefits to the direct social support and access to health information that researchers can provide to users after forming a strong foundation of trust. However, the very strength of this relationship can lead to coercion or harm – towards both the field researcher and the participant – if it begins to stress and push the boundaries initially set in the research relationship. Scientific and personal boundary issues around confidentiality and disclosure highlight the tensions of the scientist-citizen dilemma, as well as pose dignitary risks for community informants. These issues underlie the importance of setting clear boundaries, specifying limits of confidentiality, and addressing potentially problematic researcher-participant dynamics during informed consent procedures.

In the middle of this interview, Steve begins to bargain with Maria, asking her to give him the after-interview money so he can get his fix and then can continue to provide information. He tries to engage Maria in discussion of their “friendship.”

Questions:

  1. What kind of expectations has Maria been building up in her rapport with Steve?
  2. Researchers have to walk a fine line between forming trusting relationships with study participants and community members while taking care not to cross the boundary into friendship. How do you think Maria could have made that boundary seem less permeable to Steve?
  3. Were there any clear red flags around boundaries depicted in this video, or do you think it’s a matter of making small adjustments in Maria’s exchanges?

Distinctions between mandatory reporting obligations and ethical obligations: Confidentiality and Informed Consent

In scenarios where there are no explicit or agreed-upon guidelines, investigators are forced to make ad-hoc determinations as to whether the protection of participant confidentiality outweighs detriments to participant welfare stemming from that confidentiality.

In this video, Steve asks Maria to break confidentiality about “Chris,” someone Steve goes out with, inquiring what Chris might have said about him. Maria confirms she can’t share any information, unless Chris were planning to hurt Steve. Steve then communicates to Maria both that he is HIV+ and that he does not use protection during sexual activities with Chris, further specifying that he does not want Chris to learn of his status and thus find his sex life “ruined.”

HIV nonintervention research is unique in terms of its specific protocols around mandatory reporting (CDC, 2019). In this scenario, Maria is a social scientist who is not a licensed healthcare professional. In addition, the data collected from field research is not included in any participant’s healthcare records, nor does the study Maria is conducting involve HIV testing. For those reasons, the decision to share information with Chris depends upon the confidentiality limitations specifically outlined in the informed consent, whether such a statement clearly referred to HIV reporting, and the extent to which Maria has sufficient information regarding Steve’s HIV status, Chris’s HIV status and Chris’s awareness of HIV risk protections. In this scenario, Maria’s sense that she has reporting obligations meets none of these criteria.

Questions:

  1. How could Maria have been better-prepared to handle the conflict between confidentiality (respect) and concern for Chris’s partner (beneficence / justice) that arose in this video? Why might a researcher be pulled to disclose Steve’s HIV status, under these principles? What is Maria’s responsibility to the other participant, given that she knows him from the study? Does choosing to disclose or not-disclose Steve’s revealed status constitute “harm” to Steve, or his partner? How could researchers make clear in informed consent proceedings that “harm” might include sero-discordance with unaware partners?
  2. What do you think it means to be competent as a field researcher, in terms of navigating and communicating reporting procedure with participants?

Works Cited:

  1. Abadie, R., Goldenberg, S., Welch-Lazoritz, M. & Fisher, C.B. (2018). Establishing trust in HIV/HCV research among people who inject drugs (PWID): Insights from empirical research. PLoS ONE 13(12): e0208410. https://doi.org/10.1371/journal.pone.0208410. Accessible from: https://journals.plos.org/plosone/article?id=10.1371/journal.pone.0208410
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  3. CDC, 2019. State Laws that address High-Impact HIV Prevention Efforts. Accessible from: https://www.cdc.gov/hiv/policies/law/states/index.html
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  6. Erikson, K. (1995). Commentary. The American Sociologist, 26(2), 4-11
  7. Fairchild, A.L. & Bayer, R. (1999). Uses and abuses of Tuskegee. Science; 284:919–921. Accessible from: https://science.sciencemag.org/content/284/5416/919.long
  8. Fisher, C. B. (2011).  Addiction research ethics and the Belmont principles: do drug users have a different moral voice?  Substance Use and Misuse. 46(6), 728-741. DOI: 10.3109/10826084.2010.528125. Accessible from: https://www.ncbi.nlm.nih.gov/pmc/articles/PMC3638744/
  9. Fisher, B. (2015). Enhancing the responsible conduct of sexual health prevention research across global and local contexts: Training for evidence-based research ethics. Ethics &Behavior, 25 (2). DOI: 10.1080/10508422.2014.948956 Accessible from: https://www.ncbi.nlm.nih.gov/pmc/articles/PMC5823532/
  10. Fisher, C. B., & Goodman, S. J. (2009). Goodness-of-fit ethics for non-intervention research involving dangerous and illegal behaviors. In D.Buchanan, C. B. Fisher, & L. Gable (Eds.), Research with high-risk populations: Balancing science, ethics, and law (pp. 25–46). Washington, DC: APA Books.
  11. Fisher, C.B., Oransky, M., Mahadevan, M., Singer, M., Mirhej, G. & Hodge, G.D. (2008). Marginalized populations and drug addiction research: realism, mistrust, and misconception. IRB: Ethics and Human Research. 2008;30:1–9. Accessible from: https://www.ncbi.nlm.nih.gov/pmc/articles/PMC2804968/
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