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)
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
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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.
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. 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
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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.
Reference
(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)“Research Ethics Training Curriculum: Responsible Conduct of Research: Essential
Elements of Informed Consent.” Family Health International. https://www.fhi360.org/.
(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.
(17) Sieber, J. E. (2001). Privacy and confidentiality: As related to human research in social
and behavioral science.
