How You are Protected in a Clinical Trial
There are many measures that are in place now to ensure that mistakes of the past are not repeated. Federal law requires that patients who want to join a clinical trial are advised of all risks or harms as well as benefits involved in any kind of medical research to protect study participants before they join.
Three basic principles are particularly relevant to the ethics of research involving human subjects. These are the principles of respect for persons, beneficence and justice.
This principle incorporates two ideas. The first idea is that individual persons should have the ability to make their own decisions about what to do and should not be influenced by anyone or told what to do. This principle respects the patient's autonomy - the right to decide what is best for themselves. To respect a patient’s autonomy, researchers consider a person’s opinions and choices, Researchers do not discount or block the patient's opinions.
Patients are free to act on
their personal judgements and no information is withheld to influence the patient’s judgement.
The second idea is protecting people who are not capable of making decisions for themselves. Some individuals, like children, are too young to make mature decisions. Other people with mental disability, illness, and other circumstances, lose their ability to think about and decide what is best for themselves.
Beneficence means doing or producing good. The principle of beneficence in research has two rules: 1) do no harm, and 2) maximize the possible benefits and minimize the possible harms. Under the principle of beneficence, patients are provided with information about all possible harms and risks, not just the possible benefits, to allow them to make decisions about study participation.
The principle of justice is about who receives the benefits of research and who bears its risks and burdens. Injustice happens when the benefits of research are denied to certain persons or groups of people with no good reason or when the risks of research are placed on some persons or groups more than is necessary, acceptable, or reasonable. Our section above medical mistrust gives examples of injustice in research. Justice demands that research subjects are scrutinized to determine whether disadvantaged groups like the poor, under-educated, certain racial and ethnic groups are being selected for reasons other than the problem that is being studied. Justice also demands that the benefits of the research not be given to only those who can afford them.
Source: The Belmont Report: Ethical principle and guideline for the protection of human subjects of research. https://www.hhs.gov/ohrp/regulations-and-policy/belmont-report/read-the-belmont-report/index.html#xbasic
In research involving human subjects, respect for persons demands:
Persons volunteer to participate in research.
Persons are provided with all the necessary information to make a decision about participation
The purpose of the study
The procedures involved
The timeline – when things will happen
The risks and benefits
Office for Human Research Protections
The Office for Human Research Protections (OHRP) provides leadership in the protection of the rights, welfare, and wellbeing of human subjects involved in research conducted or supported by the U.S. Department of Health and Human Services (HHS). OHRP is part of the Office of the Assistant Secretary for Health in the Office of the Secretary of HHS.
Develops educational programs and materials
Oversees regulation compliance
Provides advice clarification, and guidance on ethical and regulation issues in clinical and behavioral research
OHRP also supports the Secretary's Advisory Committee on Human Research Protections (SACHRP), which advises the HHS Secretary on issues related to protecting human subjects in research.
Source: Office for Human Research Protections: https://www.hhs.gov/ohrp/index.html
The FDA is responsible for protecting public health by regulating human drugs and biological products, animal drugs, medical devices, tobacco products, food (including animal food), cosmetics, and electronic products that emit radiation.
New drugs and biological products for people must be FDA approved before they are marketed in interstate commerce. This means that a company must demonstrate that its drug or biological product is safe and effective for the intended use, and that it can manufacture the product to federal quality standards. If the FDA grants an approval, it means the agency has determined that the benefits of the product outweigh the risks for the intended use.
U.S. Food and Drug Administration (FDA)
Some examples of biological products that require approval are therapeutic proteins, vaccines, allergenic products, cellular and gene therapies, and products manufactured from plasma. Manufacturers must also prove that they are able to make the drug or biological product according to federal quality standards.
The FDA does not develop products before approving them. Instead, FDA experts conduct a careful evaluation of the results of laboratory, animal, and human clinical testing done by manufacturers.
Source: U.S. Food & Drug Administration.
Institutional Review Boards
An Institutional Review Board (IRB) is group of individuals required by the FDA to review and monitor biomedical research involving human subjects. Each institution the conducts research must, by law, have that research reviewed by an IRB. An IRB has the authority to approve, require modifications in, or disapprove any research with human subjects. The IRB serves an important role in the protection of the rights and welfare of human research subjects.
The purpose of IRB review is to assure, both in advance and by periodic review, that appropriate steps are taken to protect the rights and welfare of humans participating as subjects in the research. To accomplish this purpose, IRBs use a group process to review research protocols and related materials (e.g., informed consent documents and investigator brochures) to ensure protection of the rights and welfare of human subjects of research.