In 1966, a Massachusetts researcher Henry K. Beecher, M.D., published an essay discussing proposed federal rules concerning human experimentation. In this essay, he wrote that even though at times ethical breaches were evident, he doubted that “cons
(NNPA) – In 1966, a Massachusetts researcher Henry K. Beecher, M.D., published an essay discussing proposed federal rules concerning human experimentation. In this essay, he wrote that even though at times ethical breaches were evident, he doubted that “consent in any fully informed sense” was obtainable. He argued that “the presence of an intelligent, informed, conscientious, compassionate, and responsible investigator offered the best protection for human research subjects.” But this could hardly be accurate, given that a researcher wouldn’t entirely act on behalf of the trial participant. At the recent 2010 Bioethics, Health Disparities and Clinical Trials Fellowship held at the University of Maryland School of Medicine’s National Bioethics Research Center and hosted by renowned researcher Claudia Baquet, M.D., ( Meharry Medical College ) a wealth of information around research trials and informed consent was shared with journalists representing the National Newspaper Publishers Association. The journalists also discussed reasons that Blacks are reluctant to participate in research trials, as well as reviewed the origins of safeguards that protect all trial participants. Informed consent is the process of learning about a research study. It is necessary to protect the safety, rights and welfare of participants; to ensure that participation in research is always voluntary; and provide information about the research study so a person can decide whether or not to participate. It usually starts as a discussion between the potential participant and the study team, and it’s a continuous exchange of information – including strong questions – while a participant is involved in the study. It is essential for the protection of human subjects in research, and it is always voluntary. The Principal Investigator of the research project is ultimately responsible for obtaining informed consent from participants. The participant has to understand the language, and the terms of the research have to be simple, as opposed to scientific or medical. The eight essential elements of informed consent are: research purpose and procedures; risks and discomforts; potential benefits; provisions for confidentiality; voluntary participation and right to withdraw without penalty; alternative procedures or treatment; management of research-related injury; and contacts for additional information. Other additional elements could include the prospect of unforeseeable risks; circumstances under which participation may be ended by the investigator; additional costs to the subject, if any; consequences of a decision to withdraw; significant new findings to be provided; and number of subjects participating. It must be noted that the well-being of the participant should be at the heart of any research; as opposed to any gains or so-called “bragging rights” or notoriety for the Principal Investigator. However, research isn’t always a process of taking blood samples or poking around a participant’s body. It could be a simple written survey or the tracking of a participant doing a particular task over time, i.e., exercise. Chicagoan Audrey Clay, a 55-year-old financial analyst, has been involved in a research study that tracks women who are going through menopause. The study’s duration is between 10-15 years, and Clay says she was glad to sign up. “I have been in the program for 12 years now, and I have learned so much about menopause, weight gain, mood swings and other change-of-life issues.” While Clay is familiar with the Tuskegee Study, she says her project was different, in that no shots or meds were given. “The clinicians measure our fat ratio and BMI, as well as monitor blood pressure, but they are mostly tracking data.” As for the question of informed consent, Clay says she fully understood the perimeters of the study when she signed up and that she also understands that she can end her participation at any time. This is in part because well-documented bioethics violations – such as the Tuskegee Study, the injustices against Henrietta Lacks, and the atrocity of the Willowbrook State School in Staten Island, N.Y., where mentally ill children were given “milkshakes” with hepatitis – have prompted various protections for participants. In 1974, the U.S. National Research Act was passed by Congress. It created the National Commission for the Protection of Human Subjects of Biomedical and Behavioral Research, which identified basic ethical principles to govern research. This act also established the modern Institutional Review Board System (IRB), which is a group or committee that is given the responsibility to review research projects involving human subjects. The board is comprised of both scientific and non-scientific members. And no human subject may be involved in any project until the project has been reviewed and fully approved by the Institutional Review Board. Out of the Commission was borne the Belmont Report in 1979, which ruled that respect for persons, beneficence (maximum benefits and minimum harms) and justice (risk and benefits are distributed equally among those who may benefit from the research) were necessary components in clinical trials and research. Finally, under ethical standards, research participants should receive, at a minimum, the best standard treatment. If a new approach is discovered within the research, then participants should be among the first to benefit. Possible risks associated with clinical trials could be unknown side effects or other risks of the new drug or treatment; the fact that new treatment may not help all participants; and the inconveniences associated with participating in the research, such as travel, time off work. Dr. Baquet is Director of the University of Maryland-Baltimore-Academic Program in Minority Health and Health Disparities Education and Research and has earned a grant portfolio of more than $80 million from federal, state and foundation sources. She has conducted IRB-sanctioned research studies in the Baltimore area, as well as “think tanks” and “mini-medical” boot camps, whose participants come from barbershops, churches and grocers. Dr. Baquet also published the "Analysis of Maryland Cancer Patient Participation in NCI-Supported Cancer Treatment Clinical Trials," in the July 2008 issue of the Journal of Clinical Oncology. The manuscript, based on two and a half years of research by Dr. Baquet, is the only such state analysis of its kind and is a model for other states wishing to monitor clinical trial accrual and diversity. “Sharing grant money with the community is showing a level of respect and is necessary,” Dr. Baquet added. “We need more prevention trials and better representation of Blacks in all trials.” Copyright 2010 NNPA