Human subjects training

I completed my annual Protecting Human Research Participants training today. Clinical research involving human participants has resulted in invaluable advances, but has also been scarred by horrifying abuses and cruelty in the name of medicine and science. PHRP training is intended to provide researchers with a background in human subjects ethics, as well as familiarity with the NIH and Health and Human Services regulations and the role of Institutional Review Boards, or IRBs.

The training itself is not exactly thrilling, consisting of lots of regulation-reading, multiple choice quizzes, and a few case studies. I’ve heard many researchers groan about the whole process, about the IRB requirements, and the general beaurocracy involved in human subjects research. After all, it’s kind of a pain, and we all know better than to treat our participants in unethical ways, right? 

However, the regulations are actually more complex than just ‘common sense’. For example, tissue taken from living donors (even as surgical waste) does count as human subjects research, but that tissue or data about it may be used for later studies without informed consent IF there is adequate anonymization. Minors (under 18) may or may not be subject to additional regulations as ‘children’ depending on the legal age for consenting to various medical treatments in different states and the regulating agency. But, from my understanding, for NIH funded studies anyone under 21 is classified as a child. There are seemingly endless rules in place with the overarching goals of promoting respect, beneficence, and justice.

 The research that I’m currently becoming involved in employs widely accepted interventions and, as such, is less ethically complex than research that involves higher risk to participants. However, the main ethical principles are no less important even in ‘minimal risk’ intervention studies. 

For me, the most motivating part of the PHRP training is the history section. It provides a painful walk through the abuses put upon human subjects, particularly vulnerable populations such as prisoners, institutionalized children, minorities, and those with too few socioeconomic resources to fight intimidation, deceit, and coercion. Many of these maltreatments were probably not fueled by simple evil or maliciousness, but by some twisted logic in the pursuit of ‘successful’ research with no consideration for the cost to those involved. The current system of IRB review is not infallible, but at least provides a relatively objective outside interpretation of whether the benefits of the proposed research truly outweigh the risks to the participants. 

I’ll be writing more on this just as a way to think through the concepts & become more familiar with the regulations, and to cover some current happenings that bring certain aspects of the requirements for respect, beneficence, and justice (and the actuality of those principles in clinical research) to the forefront. 

** I’ve been a research participant multiple times in studies requiring and exempt from formal informed consent/IRB recruiting procedures (exempt studies kind of crack me up since I’ve been recruited for two by being essentially pounced on by desperate PhD students roaming the halls of the mechanical engineering building in search of female participants). I do feel like I’m at an advantage over many participants as far as protecting myself, since I have some research background and am generally participating in research conducted by my peers/fellow students/lab mates and don’t feel as much intimidation as I might have if I’d been interacting with an unfamiliar or authority figure.

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