The 2010 publication of “The Immortal Life of Henrietta Lacks” by Rebecca Skloot has rekindled interest among the general public about various issues surrounding the conduct of clinical research.
In the 60 years since Mrs. Lacks’ cells were removed by a researcher, the United States has come a long way in addressing and enforcing protections for research study participants. Extensive regulations have been put into place, leading to continuous discussion and debate about the best way to conduct research as theories and technology constantly evolve. A constantly changing environment in clinical research demands that these issues are always being revised and updated.
I believe that there are three significant activities that help to illustrate and summarize the respect that the research community has for protection of study volunteers.
First, studies are required to undergo independent review by what are known as “Institutional Review Boards” or “IRBs.” These IRBs serve to weigh a study’s social value, scientific validity, fair subject selection, and most notably that risks are minimized and any benefits [be they gained by the participants and/or society] maximized. IRBs also critique the way in which the study will be monitored, primarily to ensure that participants are protected while a study is being conducted.
Second, an informed consent process, meaning a conversation and not merely a document to be signed, must take place between each study participant and the researcher(s). This process is meant to promote trust through an open dialogue that includes presentation of the risks, individual benefits (if any), procedures, payments, and compensation for a study. It is required to clearly state that participation is voluntary and cannot interfere with other opportunities to receive medical care.
Third, all enrolled study participants must be treated with respect. This refers to the actual conduct of safety monitoring activities that the IRB has reviewed, as well as enforcement of consent as a process. Researchers must make modifications to their research study based upon what they have read in scientific literature, respond to unanticipated events that have occurred by making any necessary procedure or consent process changes. Any changes or revisions to the research study must be reported to and approved by the IRB before they can be implemented. Study participants are also to be informed and then allowed to make their own decisions as to whether to continue to remain enrolled in the study.
While violations of these regulations sometimes still occur, study participants can rest assured that the majority of researchers take their responsibilities very seriously as scientists and as fellow citizens, following the regulations and ethical principles regarding research conduct and the protection of human study participants.
If you are interested in participating in research, as many people have before us to our collective benefit, then become an educated study participant. Become familiar with your rights, as well as your responsibilities and those of the researcher(s).
Read a related article on the New York Times Sunday Review called “The Immortal Life of Henrietta Lacks, the Sequel.”
|Carson Reider clinical research consultant / RSA|