A recap of human research protections and ethics for clinical research professionals
All clinical research professionals receive extensive training on Good Clinical Practice and other processes to be followed in their work. A topic that is only superficially covered is why those processes are required.
“Many of today’s clinical trial regulations were designed to protect against repeats of past research abuses,” states James Riddle, MCSE, CIP, CPIA, CRQM, Vice President, Research Services and Strategic Consulting, Advarra. “These historical lessons underpin many of the checklists of activities involved in clinical research—from obtaining informed consent, to documenting clinic visits, to filling out delegation of authority logs.”
In the United States, key regulations come under the Department of Health and Human Services’ Food and Drug Administration (21 CFR Parts 50 & 56) and Office of Human Research Protections (45 CRF 46 or “Common Rule”). Major historical documents include the Nuremberg Code, Belmont Report, and the Helsinki Declaration.
“Compared to other industries, regulations within clinical research can feel overly burdensome, but they are there for good reasons,” notes Riddle. “Intended to advance the principles of respect for persons, beneficence, and justice, these regulations can help us define when clinical research is ethical.”
Core principles of respect for persons, beneficence, and justice
The informed consent process is a good example of ensuring “respect for persons.” Often treated as being solely a documentation exercise, this involves telling clinical trial participants what is involved in the study and gaining their autonomous consent. Since participants can withdraw their consent at any time and leave the study, this is not a one-off exercise but a process that continues throughout the study lifecycle from first contact with the patient to study completion.
The concept of “beneficence” is reflected in the relative potential risks and benefits of study participation, usually compared to the contemporary standard of care. This is debated by ethics committees (ECs) and institutional review boards (IRBs) when making decisions on whether a study can go ahead.
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The principle of “justice” is also applied during EC/IRB discussions. One example is the need to avoid excluding particular populations from clinical studies for reasons that are not scientifically justified. Ensuring that choice of study participants is equitable involves sponsors through their role in protocol design and clinical research professionals through selection of individuals to enroll in a particular study.
“The framework of regulations and contemporary oversight from ECs and IRBs are designed to set guard rails and provide broad protections for research subjects,” says Riddle. “However, each one of us—from the newest clinical research professionals to the most experienced—must make our own judgements of when it is ethical to experiment on humans. Everyone in clinical research should always keep this question at the back of their minds.”