Wednesday, June 01, 2005

Not what I call "minimal risk" or remotely ethical

In an update to this story in which NYC's Administration for Children's Services (ACS) is alleged to have implemented procedures that are in direct contrast with all applicable Federal Regulations related to enrollment of subjects from vulnerable populations in clinical trials, The Alliance for Human Research Protection (AHRP) has posted it's May 18th testimony in front of the House Ways & Means Committee. According to this month's Guide to Good Clinical Practices, ACS has hired the Vera Institute of Justice to conduct an independent review of the agency's policies and practices related to enrollment of HIV positive foster children into Phase I & II clinical trials between the 1980s through 2001. According to the blurb, Vera will review the case & medical records of the study subjects and conduct follow-up to determine their current clinical status; a public report will be issued detailing the institute's findings.

There is, unfortunately, no reference to independent investigation into the alleged ACS mandated violations of CFR protections or punitive action to be taken against those involved (which should include any industry professional/IRB member who was aware subjects were being enrolled under these circumstances), but an independent committee will provide oversight of ACS' current policies and make recommendation for new policies.

Clinical Trials have become big business for Physicians/Research Centers and, unfortunately, some folks put their bottom line before their ethical obligations to patients and/or clinical judgment. There is an inherent potential conflict of interest for physicians conducting clinical trials for any study that is enrolling subjects for the purposes of evaluating effectiveness for the treatment or prevention of a condition; for this reason, I generally require the following statement (or a similar one) in the introduction of the Informed Consent Form (ICF) of these studies:
Your healthcare provider may be an investigator for this study, and as an investigator, is interested both in your clinical welfare and in the conduct of this study. Before you enter this study or at any time during the study, you may ask for a second opinion about your care from another doctor who is in no way associated with this study. You are not under any obligation to participate in any research study offered by your doctor. Please read this carefully and do not hesitate to ask your doctor any questions about this form and/or the information about the study provided below.
Participation in any clinical trial is voluntary. You may refuse to participate or may stop participation at any timeduring the study without penalty or loss of benefits to which you are otherwise entitled. If you decide to discontinue participation in a clinical trial, the study center may ask you to complete certain follow up safety procedures (e.g. physical exam, ECG, lab tests) as described in the ICF you signed (the research center is required to supply you with a copy of the form), you can refuse these procedures but it's generally a good idea to complete end of study safety procedures. If you have any questions about your rights as a research participant, the ICF will include the contact information so you can direct your questions to the IRB (the ethics committee that approved the clinical trial being conducted at the research center).

The basics of what you need to know about participating in clinical trials can be found at the following:

CenterWatch clinical trial background info for patients
FDA- clinical trials


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