Ethical Challenges in Short-Term Global Health Training

Rory tries to devise a simpler consent form as he realizes that the participants in this study are not accustomed to completing lengthy forms. He considers a picture book. Click image to start video.

CASE 10: Understanding Informed Consent for Research

Vignette 3: Rory is relieved to realize that Dr. Hodari meant “formal consent” in a purely symbolic way – the consent of the women in the study would remain fully voluntary and informed. Rory was satisfied with this, but also wanted to remain vigilant of protecting the women’s autonomy.

After completing the consent process and conducting a few interviews, Rory becomes concerned that the consent forms approved by his home institution’s research ethics committee are unhelpful. Participants are not accustomed to seeing lengthy forms, even in their own language. He wonders if an alternative format might be helpful.

Rory is concerned that his own culture’s approach to obtaining informed consent is not appropriate in the culture in which he is working. He is considering changing the consent process to make it more culturally acceptable. Which of the following is an appropriate way of going about this? 

Before making changes, he should contact the local and home research ethics committees.
Although Rory should contact the ethics committees for such a change, this is not the only correct answer. Choose a different answer.
So long as key elements of informed consent are met, alternative formats – oral consent or picture books to aid the process – might be considered.
This is correct. Informed consent can take many formats. Indeed, ensuring accurate, concise information and its comprehension might require use of other formats. This is not the only correct answer, however. Choose a different answer.
Rory should consider pilot testing his alternative format before using it in his research.
Piloting the new format might be useful, but this is not the only correct answer. Choose a different answer.
All of the above.
This is correct. All of the above are appropriate ways of tailoring the informed consent process to the local setting.
© Stanford University Center for Global Health and the Johns Hopkins University Berman Institute of Bioethics.

Project funding provided by Doris Duke Charitable Foundation (DDCF)