Is the medical information I send to the Chromosome 18 Clinical Research Center confidential? Who do they share my information with? How can I be sure my child is not experimented on?

These are reasonable questions that require a thorough explanation. That explanation requires some context and some history. There is, in fact, an extensive regulatory process dedicated to answering such questions and ensuring that research participant safety and education are a top priority. But most of this process happens behind the scenes, behind the green curtain so to speak, that make the whole clinical research system function at the highest standards. People on the outside of the research establishment participating in research studies usually have no idea about all the protections that exist on their behalf. It seems as if the beginning of a new year is an appropriate time to take this step back and appreciate the good that happens behind the scenes.

The safety of clinical research participants was not always the primary concern that it is today. In fact, it is the historical incidents that often underly the concerns that people have. And trust once lost is very hard to restore. But that trust can begin to be restored by examining the historical events and learning how those failures to respect human life will be prevented from ever happening again.

Medical research does have a horrific past - sadly, there is a long tortuous history of medical experimentation on humans. Usually, the subjects, or really victims, were somehow considered to be lesser individuals; servants, slaves, prisoners or the “feeble minded.” This of course was not the norm, but bad things did happen to a few people. What were once rare, isolated activities came to the world’s attention after World War II during the Nuremburg trials of widespread Nazi atrocities. Many of the Nazi crimes against humanity involved experiments done in the guise of medical research. If you are at all squeamish, don’t go looking these up. The outcome of these trials exposed these horrors to the world and resulted in the Nuremberg Code. This code broadly outlined the basic requirements for conducting clinical research that respect the rights of all people. The United States, however, did not codify the elements of the Nuremburg Code into law and instead deferred to the Hippocratic oath and professional ethics.

Although the Nuremberg Code brought awareness to the ethical principles that should be applied to medical research; relying on professional ethics alone did not ensure the ethical treatment of all research participants. Then Tuskegee happened. The Tuskegee syphilis study (1932–1972) was one of a handful of US medical research atrocities and the most publicized. The goal of this study was to determine the long-term effects of syphilis infection. The study enrolled black men in Tuskegee, Alabama who were infected with syphilis. At its onset, it was a reasonable study. But several years after it began a treatment for syphilis was discovered. The study participants were never offered the opportunity to be treated. In fact, some study participants thought they were receiving treatment because they were in the study and being evaluated by doctors. However, they were not offered, nor told that a treatment existed, and this was the unethical turn of events. When the results of this study became public, we finally learned that we can’t just rely on the goodwill and ethical standards of medical researchers. Regulations and laws needed to be put in place to ensure the ethical treatment of research participants.

It took until 1974, when The National Research Act of 1974 established the National Commission for the Protection of Human Subjects of Biomedical and Behavioral Research. The Commission authored a report published in 1978 outlining the basic principles of biomedical and behavioral research involving human subjects. The report, called the Belmont Report (https://www.hhs.gov/ohrp/regulations-and-policy/belmont-report/index.html) described the basic principles that should underly all such research:

·        Respect for persons

·        Beneficence

·        Justice

This report and the resulting Federal regulations established Institutional Review Boards, usually just referred to as IRBs, or human subjects ethics boards. These boards review research protocols before the start of the research project. IRBs ensure the scientific rationale is sound, the risks to subjects are minimal and the benefits are maximized. All medical research studies conducted in the US must be reviewed and approved by an IRB. Once begun, studies are reviewed annually by the IRB at the federally-certified institution where the study is taking place. The consequences for failing to comply with the regulations can be severe (depending on the nature of the non-compliance) and could even include termination of employment for the investigator or suspension of all research at their university or hospital. Hence, everyone involved in any aspect of research does their very best to comply with all the regulations.

As much as we all (sometimes including myself) grumble about government regulations in general, we do know that they protect us - especially the vulnerable. While these regulations protect everyone, the primary benefit is to the under-resourced, under-educated and disenfranchised among us. These regulations especially protect the valuable members of our society who, due to the circumstance of their birth – about which they have no control –are particularly vulnerable such as those living with a chromosome 18 abnormality.

There is much that happens before, during, and after research projects that participants don’t even see directly. One of these protections is the ethics training that all research personnel must take, and then re-take every 2 years. This applies to physicians, scientists, nurses, study coordinators, research assistants; everyone who deals with human participants or even just human data or blood samples.

As a research participant, everything you need to know about your participation is described in the consent forms, which must be signed by each participant before study participation begins. Participants are asked to read these forms, ask questions if they need clarification, and sign attesting that they understand the information. One important aspect of research consent forms is that they are not traditional contracts in that, even after you have signed, you can always change your mind and ask more questions or even decide to withdraw from the study.

If you are a research study participant, all the questions you have, and the questions posed at the beginning of this article, should all be addressed in the consent forms. If not, just ask. The principles of the Belmont report are not just the foundation of the regulations, but moreover, have been instilled into the culture of all who are involved in the medical research enterprise. And really, these principles, respect for persons, beneficence, and justice, are principles for all aspects life as well.