Dear MERETI friends
Last week PRIM&R broadcasted a live online webinar entitled “Genetic Research: Benefits, Risks and Ethical Issues”. The session began with a short introduction on genetic research followed by an explanation regarding single gene mutations to more complex and rare genetic diseases. The webinar then discussed why we study genetics. Identifying a defective gene that causes a certain disease and diagnosing potential patients or carriers are important outcomes of genetic studies. Another reason for genetic research mentioned was that these studies would allow for “personalized medicine”; meaning it would allow physicians to know upfront who will and who will not respond to a specific medicine. New medicines and treatments would also be possible by understanding mechanisms of action of drugs and of disease development.
Genetic research involving human subjects raise many ethical questions about the risk involved; privacy is a major risk concern for example. Where, how, for how long, and for which purposes would the samples be stored are questions that need to be addressed. Other risks might include, but are not restricted to, the use of samples in non-specific research beyond the original disease of the participant, or even the unconsented use of the samples. Also, psychological stress and stigma to a community or an ethnic group warrants some thoughts.
An additional concern discussed was sharing of the results. In many instances, the clinical utility of the results is not yet clear to the scientific community or can be misunderstood by the patients or even the physicians. Unwanted information (e.g. paternity results) may be available during genetic research; how to deal with this information is the question. What about incidental findings? Should these be shared as well? Who should the results be shared with, the participant alone or the family members who would be affected as well with the disease or on whom the results would have an effect? The webinar posted a poll that asked the audience their opinion regarding the obligation of researchers to provide research participants access to results that were of known clinical utility. The results revealed a range of diverse opinions.
Many, if not most, of the above mentioned points are concerns that our RECs, in Egypt and the Middle East, think about and deal with. Consanguineous marriages occur frequently and resultant genetic diseases are not uncommon in our area. Genetic research although not as frequent as in the West yet, but will increase with time. We also have our concerns about sample transfer and genetic research that might be performed on our samples.
The informed consent was the topic of the second session. A number of information items like the purpose of the study, and identification of the research team, especially any commercial partners, the ability to withdraw the samples from the study and the clarification of benefits are similar to the known requirements of the research informed consent we are familiar with. Other particular items for genetic research that should be included in the document include the plans for distribution of DNA, data sharing and access to results, and specific genetic future use of samples. Details of the archiving of samples (for protection of privacy) and the consequences of the results, and whether incidental findings will be shared or not and with whom also need to be very clear in the genetics research consent form.
The webinar was very educational. I encourage you all to attend PRIMR webinars in the future, especially that CREEs will allow you to have free access for some of them.