Module 4: Consent, Privacy, and Confidentiality

Code of Ethics

Ethical code has evolved over time, and changes are often spurred by media attention following an unethical experiment. Ethical codes for research now include specifications that may seem elementary, but were not always incorporated into studies. The Nuremberg Code, for instance, states that participation in research and experiments must be voluntary. This specification came after Nazi physicians routinely performed involuntary experiments in which the subjects were forced into participation. The inhumane nature of these experiments necessitated the inclusion of autonomy and voluntary participation into contemporary ethics codes.(1)

Today, the Belmont Report is arguably the paramount code of ethics, used by the regulating agencies of many U.S. organizations.(2) The report highlights three main guidelines for human research: respect for persons, beneficence, and justice. The first emphasizes the need for human research subjects to be considered autonomous; those without sufficient autonomy (such as children) must be given certain protections and considerations. The second component, beneficence, refers to the need for the benefits of the study to outweigh any harm sustained by the participants. Although benefits and risks are not explicitly defined by the Belmont Report, the task of ensuring that the risks and benefits are appropriately balanced is left to the presiding ethics review board or the IRB (Institutional Review Board) to determine whether the research is justifiable. It is the researcher’s responsibility to describe, in detail, all associated risks and benefits of the research to avoid miscommunication between the review board and the investigator.(3) Last, the justice component of the report refers to considerations of vulnerable populations, and the benefits and findings of the research must be distributed equally. For instance, researchers may not use low-income populations for human research and then only utilize these findings to benefit a different population.(4)

The Researcher in the Community

Researchers occupy a position of respect and trust in the community.  The Nuffield Council on Bioethics emphasizes this position in their report on research ethics in developing countries:

“Researchers from developed countries may not be fully aware of prospective participants’ considerable trust in and respect for medical doctors and other healthcare practitioners, even those with modest qualifications. This may be especially true if the healthcare practitioners have been trained in Western countries. It is questionable whether researchers from developed countries are well prepared for the enormous responsibility that this attitude of respect and trust places upon them.”(5)

It is important for researchers to understand how to conduct their research in a manner that honors this trust, both for the sake of their research participants and for the sake of their study’s validity.  Even the most well-intentioned and well-trained researchers can make mistakes in this area, so it is essential to think carefully about how to ensure that participants have given informed consent to participate in a research study.

Informed Consent

As described in the Belmont Report, informed consent allows for the confirmation of autonomy among all research participants. Informed consent, usually in the form of a document signed by the subject, relays all pertinent and relevant research information, such as risks and benefits, to the potential subject, allowing him or her to make an informed decision regarding participation.(6) Subsequently, the participant is given the opportunity to withdraw from the research or experiment at any time and for any (or no) reason.(7) This process is a basic legal and ethical standard by which all research must abide.  According to Family Health International, “Informed consent is not merely a legal requirement or a document to be signed; it is a communication process between the researcher and the participant that starts before the research is initiated and continues throughout the study. It is essential that the information provided is understood by the potential participant and empowers that person to make a voluntary decision about whether or not to participate in the study”.(8) Researchers must take on the responsibility of making sure that the participants in their study are provided with, and fully understand, all of the following before consenting to take part:

• What can the participant expect during the study, and what does their participation entail?

• What are the reasonably foreseeable risks?

• What are the expected benefits that the participant may receive through taking part in the study?

• What are advantageous alternatives to participating?

• What are the rights of confidentiality and privacy?

• What will be compensation for injuries should any occur during the study?

• Who should the participant contact if they have any concerns or questions?

The individual must know that participating is entirely voluntary.(9)

Potential Difficulties with Informed Consent

Although these guidelines seem like common sense, there are several potential issues to informed consent that researchers must be especially concerned about when doing work in developing countries.

• Potential Problem: Participants in developing countries are often non-literate and cannot give informed consent through signing forms

  • Possible Solution A: Instead of using written waivers and consent forms, researchers can sign a form indicating that the appropriate information was given to the participant and that verbal consent was received.

  • Possible Solution B: Both the information communicated to the participant and the participant’s verbal consent may be recorded on audio tape and/or may be performed in front of an independent witness.(10)

• Potential Problem: Participants believe that they must participate in the research study in order to receive medical care or treatment.(11)

  • Possible Solution: The researcher must make sure that it is clear to participants that they may receive medical treatment without automatically having to consent to participating in the study. If this is not made sufficiently clear, participants may feel coerced into participating without the researcher being aware of it.

• Potential Problem: “The mechanisms of obtaining informed consent in developed countries evolved in communities that are literate and generally aware of modern health practices. Researchers can therefore engage the potential subjects on the basis of pre-existing scientific knowledge and concepts.”(12) These mechanisms are non-functional in non-literate communities and/or communities with different conceptions of health and disease.

  • Possible Solution: Researchers must carefully redesign their informed consent procedures in a manner that takes into account the characteristics of the community. A one-size-fits-all approach will not satisfy the principle of genuine informed consent.

For a more exhaustive list of challenges and solutions to informed consent in developing countries, please click here to open the Nuffield Council on Bioethics report and refer to chapter 2, “Consent,” which begins on page 9. 

Oral Cultures and Informed Consent

“Oral cultures such as those in various parts of Africa attach importance to personal social relation in contrast to literate and technologically developed ones where relations are impersonal, highly segmented, and formal. The requirement of informed consent in writing does not go down very well in African societies that are still steeped in oral tradition unlike in European contexts where this is embraced and/or demanded.”(13)

Whether or not a community is largely literate, a cultural emphasis on oral contracts and the importance of the spoken word may be the norm.  In these cases, researchers must be cognizant of the cultural differences between what they are used to and what the community deems appropriate.  It is always the responsibility of the researcher to adapt his or her methodologies to fit the cultural context in which the study is taking place.  Oftentimes, this means a fundamental reconsideration of what qualifies as “genuine consent” given the cultural context.

Community Consent and Individual Consent

“There has been a growing appreciation of the importance of community leaders and families in the context of decision-making. While the process of going through such community gatekeepers does not take away from the importance of the individual's understanding of and willingness to participate in the research, it adds an element of security in traditional societies where communal consciousness and living is the norm.”(14)

Cultural differences make up a large part of the potential difficulties to genuine informed consent, and researchers must be cognizant of the community structure in which they are conducting their research.  Although it may be time and labor intensive to secure multiple levels of consent from both the community and the individual participants, it is important for researchers to address these levels appropriately.

“Researchers should develop culturally appropriate methods for obtaining informed consent. In some settings, sensitivity to local cultural context requires that investigators provide opportunities for individuals to seek advice or permission from a third person, such as a spouse or head of household. Researchers also may need to consult with local community leaders before implementing a study. In every situation, researchers should pay attention to ethical issues arising from the imbalance of power between researchers and participants. Researchers should be creative in designing strategies to ensure adequate comprehension of study goals, procedures, risks and benefits. This may require implementing educational interventions before consent or developing methods for determining an individual’s comprehension of the study objectives.”(15)

Informed Consent: Final Thoughts

Informed consent is required protection for the participant.  Simply having a participant sign a form does not mean that they have given genuine consent.  The burden of responsibility is always on the researcher to make sure that his or her participants are fully informed and therefore may freely choose to participate in the study.  Potential participants must also be given adequate time to ask questions of the researcher, receive clear answers, and reflect on this information before choosing to participate. 

Case Study: Low birth weights in Madhya Pradesh, India(16)

While traditional methods of obtaining consent use a standard written form (tailored to the specific experiment) to record a participant’s signature, in many low-resource settings, investigators are faced with poor literacy levels and various cultural factors that prevent the use of this method. A research study in Madhya Pradesh, India illustrates this particular challenge. In this study, investigators performed qualitative and quantitative research regarding the incidence of low birth weight, and reasons for not weighing a child at birth. The study involved extensive contact with human subjects, and informed consent was obtained. Because of the low literacy rates in the community, informed consent was obtained verbally. However, investigators did not account for educational and cultural contexts that reduced the efficacy of the informed consent. It is possible that the women did not fully understand the research procedures. In this culture, it is appropriate to be polite to those in positions of (perceived) authority, and this may have prompted the women to consent, despite reluctance.

Fortunately, as researchers slowly gained a greater understanding of the cultural, they updated their methods of obtaining consent, and focus groups and surveys were conducted according to verbal and non-verbal cues from the participants. Although this is not necessarily a standardized methodology for obtaining consent, it helped to ensure that participation was voluntary. Overall, this case highlights a number of ethical issues that arise in the global health research arena. It is important for participants to understand the research goals and methods, and investigators must be sensitive to the local culture.

Privacy and Confidentiality

One of the conditions on which informed consent rests is that participants’ privacy will be respected.  Privacy refers to “persons and to their interest in controlling the access of others to themselves,” and no participant should ever be forced to reveal information to the researcher that the participant does not wish to reveal.(17) Confidentiality is equally important and refers to information about the person that has been revealed to the researcher.  Especially in medical research, researchers are in a position of responsibility and dealing with a great deal of very personal information that their participants have agreed to disclose.  Safeguarding this information is a key part of the relationship of trust and respect that exists between the researcher and the participant.  Depending on the type of study, personal identifiers such as names, birthdates, places of residence etc. may or may not have to be collected.  In situations where these data are collected, researchers may take several steps to ensure the confidentiality of their participants’ information, including:

• Use participant codes to label data instead of using names, and keeping a separate list of code-to-name match-ups.

• In interview studies, use the participant’s first name only (or even using an alias) when recording or publishing data. Most of the time, an alias will suffice, and is especially important to protect the participant if the published data includes other identifiers such as age, gender, community affiliations, or place of residence.

• Be careful not to publish enough information that the participant can be identified.

Footnotes

(1) Perlman, D. (2004). Ethics in clinical research: A history of human subject protections and practical implementation of ethical standards. SoCRA Source, 37.

(2) Ibid.

(3) National Institutes of Health. (1979). The Belmont report: Ethical principles and guidelines for the protection of human subjects of research.

(4) Zucker, D. (2007). The Belmont report. Wiley Encyclopedia of Clinics Trials.

(5) Nuffield Council on Bioethics. “The Ethics of Research Related to Healthcare in Developing Countries.”  London, 2002. https://www.nuffieldbioethics.org/assets/pdfs/Ethics-of-research-related-to-healthcare-in-developing-countries.pdf.

(6) U.S. Department of Health and Human Services. (n.d.). Informed consent- FAQs.

(7) World Health Organization (n.d.). Informed Consent Form Templates. Geneva, Switzerland: Research Ethics Review Committee.

(8) “Research Ethics Training Curriculum: Responsible Conduct of Research: Informed Consent as a Process.”  Family Health International. https://www.fhi360.org/.

(9) Ibid.

(10) Bhutta, Z. A. “Beyond Informed Consent” Bulletin of the World Health Organization. Vol. 82, No. 10. (October 2004). 

(11) Nuffield Council on Bioethics. “The Ethics of Research Related to Healthcare in Developing Countries.”  London, 2002.

(12) Ibid.

(13) Erinosho, O., ed. “Ethics for Public Health Research in Africa” Proceedings of an International Workshop in collaboration with the Special Programme for Research and Training in Tropical Diseases (TDR) of the World Health Organisation, with the support of the Federal Ministry of Health, Abuja, Nigeria, April 21-23, 2008. 

(14) Bhutta, Z. A. “Beyond Informed Consent” Bulletin of the World Health Organization. Vol. 82, No. 10. Page 774 (October 2004). 

(15) Marshall, P. A. “Ethical Challenges in Study Design and Informed Consent for Health Research in Resource-Poor Settings” Special Topics in Social, Economic and Behavioral Research No. 5, 2. 

(16) Marshall, P.A. (2007). Ethical challenges in study design and informed consent for health research in resource-poor settings. Geneva, Switzerland: TDR/World Health Organization.

(17) Sieber, J. E. (2001). Privacy and confidentiality: As related to human research in social and behavioral science.