Analogous to
clinical ethics consultation, Research Ethics Consultation (REC) describes a formal way for researchers to solicit and receive expert ethical guidance related to
biomedical research
Medical research (or biomedical research), also known as experimental medicine, encompasses a wide array of research, extending from "basic research" (also called ''bench science'' or ''bench research''), – involving fundamental scientif ...
. The first REC service was established at the
National Institutes of Health
The National Institutes of Health, commonly referred to as NIH (with each letter pronounced individually), is the primary agency of the United States government responsible for biomedical and public health research. It was founded in the late ...
(NIH) Clinical Center in 1997. Today, most REC services are found at academic institutions, and the majority of current services were originally launched in response to the 2006 NIH
Clinical and Translational Science Award Clinical and Translational Science Award (CTSA) is a type of U.S. federal grant administered by the National Center for Advancing Translational Sciences, part of the National Institutes of Health. The CTSA program began in October 2006 under the au ...
program, as applicants to that program were required to have procedures in place to address ethical concerns raised by their research.
While still a young discipline with no explicit standards, individuals serving as
research ethics
Research is " creative and systematic work undertaken to increase the stock of knowledge". It involves the collection, organization and analysis of evidence to increase understanding of a topic, characterized by a particular attentiveness ...
consultants are expected to be familiar with
research ethics
Research is " creative and systematic work undertaken to increase the stock of knowledge". It involves the collection, organization and analysis of evidence to increase understanding of a topic, characterized by a particular attentiveness ...
and ethical analysis; knowledgeable about the applicable regulations, laws, and policies; and ideally also have some
biomedical research
Medical research (or biomedical research), also known as experimental medicine, encompasses a wide array of research, extending from "basic research" (also called ''bench science'' or ''bench research''), – involving fundamental scientif ...
experience and scientific expertise.
REC is distinct from related services, such as those of
Institutional Review Boards
An institutional review board (IRB), also known as an independent ethics committee (IEC), ethical review board (ERB), or research ethics board (REB), is a committee that applies research ethics by reviewing the methods proposed for research to ens ...
, in that it is typically available at any point during a study (planning, conducting, interpreting, or disseminating results), and can relate to any ethical question. While little is known about the range and distribution of topics put forth for REC, such services may be particularly important and useful for studies of known regulatory and ethical uncertainty (e.g. assessment of minimal risk in pediatric studies) and frontier research for which there is little if any regulation or expert consensus.
[{{cite journal, last=Havard, first=M, author2=Cho MK , author3=Magnus D , title=Triggers for research ethics consultation, journal= Sci Transl Med, date=25 Jan 2012, volume=4, issue=118, pmid=22277965, doi=10.1126/scitranslmed.3002734, pages=118cm1, doi-access=free] The recommendations that result from the consultation are non-binding, meaning that the researcher may choose to follow the recommendation, or to pursue a different approach.
See also
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Institutional Review Board
An institutional review board (IRB), also known as an independent ethics committee (IEC), ethical review board (ERB), or research ethics board (REB), is a committee that applies research ethics by reviewing the methods proposed for research to ens ...
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Ethics Committee (European Union) The ethics committee, according to Directive 2001/20/EC, is an independent body in a member state of the European Union, consisting of healthcare professionals and non-medical members, whose responsibility is to protect the rights, safety and well b ...
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Human experimentation in the United States
Humans (''Homo sapiens'') are the most abundant and widespread species of primate, characterized by bipedalism and exceptional cognitive skills due to a large and complex brain. This has enabled the development of advanced tools, culture, a ...
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IRB: Ethics & Human Research
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Informed consent
Informed consent is a principle in medical ethics and medical law, that a patient must have sufficient information and understanding before making decisions about their medical care. Pertinent information may include risks and benefits of treatme ...
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Data Monitoring Committees
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Office for human research protections
The Office for Human Research Protections (OHRP) is a small office within the United States Department of Health and Human Services (DHHS), specifically the Office of the Assistant Secretary for Health in the Office of the Secretary of DHHS, that d ...
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Ethical problems using children in clinical trials
In health care, a clinical trial is a comparison test of a medication or other medical treatment (such as a medical device), versus a placebo (inactive look-alike), other medications or devices, or the standard medical treatment for a patient's c ...
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References
Research ethics
Consulting