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Module 4: Consent, Privacy, and Confidentiality

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”(1)

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

Informed Consent 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”. (2)  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 conctact if they have any concerns or questions?
• The individual must know that participating is entirely voluntary.(3)

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.(4)
• Potential Problem: Participants believe that they must participate in the research study in order to receive medical care or treatment.(5)
  • 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.”(6)
•   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 be open the Nuffield Council on Bioethics’s report and refer to chapter 6, “Consent,” which begins on page 72. 

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.”(7)

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.”(8) 

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.”(9)

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. 

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.(10)  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.

Go To Module 5: Culture, Language Barriers, and Interpreters >>

Footnotes

International Research Online Course

• Table of Contents
• Module 1
• Module 2
• Module 3
• Module 4
• Module 5
• Module 6
• Module 7
• Module 8
• Module 9