by Amal Matar, 2010 Pillars of PRIM&R Award Recipient
As a relatively young, Middle Eastern woman, who has only taken baby steps in the field of research ethics, I was surprised to be named the 2010 Pillars of PRIM&R Award recipient. The award involved presenting my research to almost 2,500 attendees at PRIM&R’s 2011 Advancing Ethical Research (AER) Conference. Participants came from all over the United States, but there were more than 100 individuals from the developing world.
The experience was very valuable. Besides networking with research ethicists, researchers, contract research organizations, and institutional review board members, I lead a section of a pre-conference program titled “Obtaining Consent in the Face of Culture, Religion and Language in Resource-Limited Countries.” In a room with more than 50 attendees, we discussed a case study (developed with the help of Dr. Henry Silverman and Dr. Hany Sleem) that addressed the most common issues regarding informed consent in Egypt.
One of the major concerns discussed was the language of the informed consent. In the Egyptian context, care must be taken when translating the informed consent form (ICF) into Arabic, because the content is then read in an Egyptian dialect for research participants who may be illiterate. Important questions to consider include how simple should an ICF be so low-literacy populations can comprehend it, and whether a high school or lower grade language level is more appropriate. We also discussed methods for shortening the length without obscuring any of the ICF components as defined in international guidelines (as long as 40 pages sometimes!).
Another issue we considered was the local culture’s impact on consent. For example, considering gender issues in research—this would entail having a female researcher approach a female participant, particularly in research of gynecology/obstetric nature. Also considered was the need to obtain permission from a chief (Omda) or village leader, which might make the consent process more complex. It was emphasized that permission from the village leader should not undermine the autonomy of the research participants, but rather provide support to their decision-making process.
In a country where the illiteracy rate is as high as 40% and 20% of the population is under the national poverty line, many research participants could be categorized as vulnerable and therefore extra measures should be taken to avoid their undue inducement and protect against their exploitation.
After the lengthy discussion of the case, a role play was acted out where I became a poor Egyptian woman who could not read or write and was being recruited for breast cancer research involving genetic analysis. The interchange between one of the attendees and I was quite demonstrative, because she tried to use the simplest language possible to explain medical terminologies such as genes, genetic analysis, and research. In her recruitment strategy, she considered the husband and village chief. I think the audience was able to comprehend some of the challenges that are faced when obtaining consent from research participants in Egypt.
I have to admit that the session gave me insight into how pharmaceutical companies, researchers, and IRB members in one country may find it difficult to understand the nuances and differences across cultures. Though we all agreed on general principles of research ethics—autonomy, beneficence, non-maleficence, and justice—implementing such principles varies widely across cultures and only through sessions such as these can we communicate the differences and the best way of addressing them.