The Institutional Review Board, or the IRB, was established by the U.S. National Institute of Health Policies and the Protection of Human Subjects in 1966. Some years later, in 1981, regulations began to require approval of the IRB for all drugs and products regulated by the Food and Drug Administration (FDA).
Nowadays, the Institutional Review Board (IRB) reviews research on human subjects funded in whole or in part by the federal government.
Here are a few key questions and answers that you should know regarding IRB and informed consent in relation to Health Economics and Outcomes Research (HEOR).
What is informed consent in HEOR?
Informed consent is a necessary and legal consent to be obtained by a researcher when performing research on human subjects. This research must meet the U.S. Food and Drug Administration prerequisites. The federal policy pertaining to the protection of human subjects is also known as the Common Rule.
In other words, informed consent in HEOR is the requirement that an investigator must obtain to get the consent of individuals before research. This protection is provided for under the HHS regulations at 45 CFR 46.
It’s worth noting that getting legally effective informed consent in urgent or emergency care settings is possible. Concerning a particular research study, the answer depends on the following:
- The expected medical condition of the prospective research participants.
- The nature of the research.
- Whether there is enough time to consider participation by the prospective individuals or their legally authorized representatives.
- Whether obtaining informed consent minimizes the possibility of coercion or undue influence.
The IRB must also consider many variables, such as the likely health and emotional condition of the prospected patient population and the potential ability during the consent procedure to process information, ask questions, and consider the risk involved.
What are the essential elements included in informed consent?
The essential informed consent requirements and elements to highlight appear in 45 CFR 46.116(a) and are as follows:
- A statement that includes the explanation of the research purposes, the expected duration of the subject’s participation, a description of the procedures, and an identification of experimental methods.
- A description of reasonably foreseeable patient risks of discomfort.
- A description of the benefits to the subject or others expected reasonably from the research.
- A disclosure of appropriate alternative procedures or medical treatment courses.
- A statement describing the extent to which confidentiality of records concerning the subject identification will be kept, like clinical trial data.
- If the medical research involves more than the minimal potential risk, an explanation as to whether any compensation and explanations are available if injury occurs, what they consist of, or where further information can be obtained.
- An explanation of whom to contact for answers to questions about the research, rights, and research-related injury to the subject.
- A statement that participation is voluntary and that refusal to participate will have no penalty or loss of benefits to the subject.
Can informed consent be passive or implied?
The informed consent process often includes terms as passive or implied that investigators or IRBs use for description purposes. However, these words are not references in the HHS regulations.
In short, regulations in the United States express that no investigator should involve a human being in any clinical research unless they can obtain legally effective informed consent from the subject or their legally authorized representative.
What additional information can be provided during the informed consent process?
An informed consent document must include one or more of the following additional elements during the process:
- The risks of a particular treatment or procedure that a research subject has.
- Circumstances in which a subject’s participation may be terminated by the investigator regardless of their consent.
- Additional costs that may result from participation in research.
- Consequences of the subject’s decision to abandon research.
- Significant new findings during the course of research that can affect the individual’s willingness to continue participation.
- An approximation of the number of subjects involved in the study.
What are the agencies and departments that have signed onto the Common Rule?
The Federal Policy for the Protection of Human Subjects in the United States, also known as the Common Rule, was published in 1991. Here are the agencies and departments that have signed onto it:
- Department of Homeland Security
- Department of Agriculture
- Department of Energy
- National Aeronautics and Space Administration
- Department of Commerce
- Social Security Administration
- Agency for International Development
- Department of Housing and Urban Development
- Department of Justice
- Department of Labor
- Department of Defense
- Department of Education
- Department of Veterans Affairs
- Environmental Protection Agency
- Department of Health and Human Services
- National Science Foundation
- Department of Transportation
- Office of the Director of National Intelligence
- Central Intelligence Agency
- Consumer Product Safety Commission
How Can We Improve Informed Consent In HEOR?
Informed consent can develop further to introduce less technical and academic terms to give it a new look and provide easier access. Jargon can be avoided, and the language simplified in order to improve consent readability. Moreover, the language of a consent form and its materials should directly target the population involved, both linguistically and culturally.
At the same time, when creating an informed consent, you should follow the American Psychological Association (APA) formatting, ensure adequate white space between paragraphs, know the correct usage of each tense, bold paragraph headers, include page numbers, and make it easier to understand above all.
How much time in advance of research can consent be obtained?
The HHS regulations don’t specify how far in advance the consent should be provided before the start of a study. Factors like the time required by a subject to make a decision would depend on the following:
- The nature of the study
- Potential benefits
- Degree of risk
- Alternatives
- Desire to consult with family members or others
Takeaway
Informed consent in medical research and HEOR in the United States is regulated and applied by several federal agencies that abide by the Common Rule.
No researcher should involve an individual in any clinical investigation unless they can obtain legally effective informed consent.
An informed consent document should be easy to understand, readable, and specific.
