Ethical Considerations in Medical Research
The push for the medical research to evaluate the efficacy of new emerging health care practices and technologies have also led to the question of ethical considerations in the medical research. With the changes in population profiles and ever emerging public health issues, there is even a bigger push and need for medical research to allow for efficient, cost effective and ethical delivery of medical care.
Researchers have to be careful not to be influenced by the external forces such as vested interest of the funding sources or get blinded by their own biases. Researchers have an ethical responsibility to conduct meaningful research, that is based on sound and fair ethical principles and the goal should be to deliver honest and unbiased results. The research should be based on rational, theoretical principals and conducted according to the appropriate standards of research guidelines. Researcher should be careful to minimize the personal biases during the sample selection and data collection. Statistical procedures should be valid and should not be used to manipulate the data with the intention of getting significant or expected outcomes.
The main objective of any clinical research is to verify the efficacy of any medical intervention and our patients or subjects are the most essential and indispensable part of the whole clinical research process. It is not ethical to involve patients in a study with potential harm to them. It is imperative to protect the rights and dignity of patients or subjects during any clinical or research study. [1]
Guiding Principles for Medical Ethics
The first and the foremost duty of any researcher involved in the clinical or scientific research, is to adhere to the set of principles that outline the safe and fundamental values involved when conducting research on the human subjects.
There are Five Principles of Medical Ethics that set standards for the code of conduct in the fields of medicine and research. These principles allow for defining safe and respectful research practices while keeping human subjects free of harm and protect their rights.
Following are the 4 main ethical principles in research: [1] [2]
1. Autonomy: Refers to patients or subjects being allowed to make their own choices. No controlling influences should be exercised and subjects should be able to make informed decisions based on their own beliefs and personal values. In case of the subjects being cognitively impaired or when children are involved, the researcher is obliged to make sure that surrogate or parents are involved that are able to make rational decisions in favor of the subject without compromising the interest of the subjects.
2. Beneficence: Refers to the obligation to ensure the wellbeing of the individuals involved. All who participate in the clinical research are bound by the rule “Maximize possible benefits and minimize possible harm”. A careful analysis of risk and benefit must be done before proceeding with the subject involvement and proceeding with the trial.
3. Non-Maleficence: Refers to “Do no harm”. Many consider that this should be the main ethical consideration in clinical research, that it is more important not to harm your patient, than to do them good. If a treatment causes more harm than good, then it should not be considered.
4. Justice: Refers to fairness or equitable distribution of risks and benefits in the research process. This is often one of the hardest ethical principles. Justice can be applied in many terms for example fair selection of subjects from the target population, the subjects should not be discriminated on the grounds of some irrelevant criteria or personal or organizational biases. Everyone involved in the research should be treated alike regardless of need, situation, external influences or biases.
Regulations for the Conduct of Research Involving Human Subjects
Declaration of Helsinki
The Declaration of Helsinki was created in 1964 by the World Medical Association (WMA). The WMA was established seventeen years before in 1947, and was created to handle the growing concern of unethical medical practice which became more apparent during and after World War II. The WMA is an international representative organization for members of the medical community including doctors, researchers, dentists, and more. While the WMA is a well-respected body which is cited by health organizations around the world, it does not have any legal authority. Therefore, the Declaration of Helsinki is an ethical guideline, rather than a document with international legal implications. The Declaration set the standard for ethical human experimentation conducted by researchers.
Throughout history, the Declaration of Helsinki has had significant influence on many medical governing bodies and guidelines including the International Conference on Harmonization’s Good Clinical Practice Guidelines, the U.S. FDA, the Council for International Organizations of Medical Sciences’ Guidelines for Biomedical Research, and the United Nations Education, Scientific, and Cultural Organizations’ Declaration on Bioethics and Human Rights. The document was created to set a balance between the interests of humanity and individual patients who are part of clinical trials. The basic principles include respect for individuals, the right to make informed decisions, recognition of vulnerable groups, and more.
The Declaration of Helsinki has been revised six times, in 1975, 1983, 1989, 1996, 2000, and 2008. The fifth revision, in 2000, caused considerable controversy regarding issues such as whether the document should be revised at all, the restating of Article 29 which dealt with placebo use, and what the medical community should be required to do to treat patients after they have undergone a medical trial. After this revision, the U.S. FDA refused to refer to the new version and instead continued using the document from 1989. In 2006, the U.S. FDA discontinued referring to the Declaration at all. Also, the European Commission only uses an older version from 1996. This lack of cohesion has weakened the Declaration of Helsinki’s influence over the years. However, it is still viewed as a pioneering effort to ensure that patients involved in clinical trials are treated with the fairness around the world.
To access the Declaration of Helsinki, click on the link below:
The Institutional Review Board
According to the federal regulations, any research studies or projects involving human subjects that are funded through federal resources must be reviewed by an institutional committee or board prior to implementation to ensure that the rights of the research subjects are protected. An IRB is a committee that reviews research proposals. These proposals are reviewed before a project is submitted to a funding agency to determine if the research project follows the ethical principles and federal regulations for the protection of human subjects. The IRB has the authority to approve, disapprove or require modifications of these projects.
According to federal regulation, an Institutional Review Board (IRB) must consist of at least five members of different backgrounds. It may not consist of all males or all females, or all members from one professional group. IRB members should have the professional experience to provide appropriate scientific and ethical review. An IRB must have at least one scientist member and at least one member whose primary concerns must be non-scientific issues like a lawyer, clergyman or ethicist. Additionally, there must be one member who is not otherwise affiliated with the institution (a community representative). There should be fair representation of gender, race and cultural heritage as well. [1]
Institutional Review Boards (IRBs) and Protection of Human Subjects in Clinical Trials | FDA
Institutional Review Boards Frequently Asked Questions | FDA
Review of Proposals
The primary responsibility of IRB is to review the research proposals to approve, disapprove or require a modification to the existing proposal. To make a decision, IRB will take into account scientific merits of the project, competency of the investigators, the risk to the subjects, and the feasibility of the study based on the identified resources. The board members will consider all the evidence and facts that the risks and harms to the subjects have been minimized and the benefits of the research study significantly outweigh these risks and harm to the human subjects. This is qualified as the risk-benefit ratio. The board also reviews sampling procedures to recruit subjects. It will also ensure that participation of the subjects is voluntary and based on the informed consent outlining the clear description and disclosure of the study and confidentiality.[1]
Informed Consent
Informed consent is one of the founding principles and the most important ethical doctrines of research ethics. Its purpose is to ensure that human participants can take part in the research voluntarily with full information and understanding about what it means for them to take part in the research, and that they give consent before they enter the research.
The informed consent and all its components must address the basic ethical principles of autonomy, beneficence, justice and confidentiality.
Consent should be obtained before the participant enters the research, and there must be no undue influence on participants to consent. [1]
Elements of Informed Consent
1. Purpose of the research project
· A clear explanation of the reason for doing the study and why it is important
· Reasoning for selecting this particular individual
2. Procedures
· A clear, detailed explanation of what will be done to or by the individual.
3. Risks and discomforts
· Truthful and inclusive statements of risks that may result, and discomforts that can be expected
4. Benefits
· A description of potential benefit to the individual participant, to the general knowledge, or to future administration of health care
5. Alternative to participation
· A description of reasonable alternative procedures that might be used in the treatment of this individual when a treatment intervention is being studied
6. Confidentiality
· Statements of the procedure used to ensure the anonymity of the individual, in collecting, storing and reporting the information and who (persons or agencies) will have access to the information
7. Request for more information
· A statement that individual may as questions about or discuss participation in the study at any time, naming an individual to contact
8. Refusal or withdrawal
· A statement that the individual may refuse to participate or discontinue participation at any time without prejudice
9. Injury Statement
· A description of measures to be taken if injury occurs as a direct result of the research process
10.Consent Statement
· A confirmation that the individual consents to participate in the research project
11.Signature
· Participant
· Parent or guardian (for the care of minors)
· Assent of minors over age 7 years
· Witness
What is Bioethics?
According to Wikipedia “Bioethics is both a field of study and professional practice, interested in ethical issues related to health (primarily focused on the human, but also increasingly includes animal ethics), including those emerging from advances in biology, medicine and technologies. It proposes the discussion about moral discernment in society (what decisions are "good" or "bad" and why) and it is often related to medical policy and practice, but also to broader questions as environment, well-being and public health. Bioethics is concerned with the ethical questions that arise in the relationships among life sciences, biotechnology, medicine, politics, law, theology and philosophy. It includes the study of values relating to primary care, other branches of medicine, ethical education in science, animal, and environmental ethics, and public health.
Bioethics is a multidisciplinary field of study that analyzes and addresses ethical, social, and legal issues that arise in biomedicine and biomedical research. With the advancement in the medicine and biomedical research, overlapping concerns and conflicts from other disciplines are bound to overlap often raising bioethical questions.
Medical ethics focuses on issues in the health care. Clinical ethics is a discipline that works to resolve ethical questions or disagreements that arise in the practice of health care. Clinical ethicists work to identify, analyze, and resolve conflicts that arise when clinicians, patients or their families and surrogates cannot come to best ethical course of action. For example, patients or their surrogates may refuse recommended medical treatment, that raises a conflict against the clinician’s medical opinion. Clinical ethicists in this situation can help to identify and clarify ethical questions and help find ethically acceptable solution to the conflict.
Some other areas covered under bioethics are as follows:
Resource Allocation
Assisted reproductive techniques and their use
Genetic testing and screening
Sexuality and gender
Clinical research ethics
Environmental ethics
Consent, vulnerability, and/or coercion
Mental health illness, treatments, and care for patients
Ethical treatment of research subjects in clinical trials
Public health ethics
Genetic ethics
Research ethics
[1] From Portney L and Watkins M, Foundations of Clinical Research; Applications to Practice, 2nd Edition, Pages: 33-45
[2] https://clinicalcenter.nih.gov/recruit/ethics.html
[3] What Is Bioethics? (msu.edu)