RESEARCH WITH HUMAN SUBJECTS
The issues concerning research with human subjects involve topics ranging from voluntary participation in research to fair selection and justice. This variety makes the topics surrounding research ethics with human subjects a challenging but important charge.
Respect for Persons – Informed Consent:
Informed consent exists to ensure that all research involving human subjects allows for voluntary participation by subjects who understand what participation entails. Informed consent means that people approached and asked to participate in a research study must:
a) Know what they are getting involved with before they commit;
b) Not be coerced or manipulated in any way to participate; and,
c) Must consent to participate in the project as a subject.
The Belmont Report of 1979 outlines the three requirements for informed
consent. The first requirement is that information disclosed to research participants must include, “research procedure, their purposes, risks and anticipated benefits, alternative procedures (where therapy is involved), and a statement offering the subject the opportunity to ask questions and to withdraw at any time from the research.”
The second requirement for informed consent is comprehension. The concept of comprehension requires researchers to adapt information to be understandable to every participant. This requires taking into consideration different abilities, intelligence levels, maturity, and language needs.
Finally, the third requirement for informed consent is voluntariness. Informed consent can be neither coerced nor improperly pressured from any participant.
Respect for Persons – Privacy and confidentiality:
Privacy and confidentiality are very important components for research involving human subjects. People have a right to protect themselves, and information gathered during research participation could harm a person by violating their right to keep information about themselves private. The information gathered from people in biomedical studies has a unique potential to be particularly embarrassing, harmful, or damaging.
Recently, a number of research projects have focused on unlocking genetic
information. Genetic information may violate a person’s right to privacy if not adequately protected. The very fact that genetic information contains information about identity provides a unique challenge to researchers. Many genetic experiments may seem harmless, but during the process of
collecting genetic information on, for example, breast cancer, a researcher will inevitably collect a wealth of other identifiable information that could potentially be linked to research participants as well.
Risk benefit and beneficence:
Beneficence is a principle used frequently in research ethics. It means, “doing good.”. Biomedical research strives to do good by studying diseases and health data to uncover information that may be used to help others through the discovery of therapies that improve the lives of people with spinal cord injuries or new ways to prevent jaundice in infants. The core of this issue lies in the fact that uncovering information that may one day help people must be gathered from people who are living and suffering today. While research findings may one day help do good, they may also cause harm to today’s research participants. For example, research participants in an AIDS study could be asked to take an experimental drug to see if it alleviates their symptoms. The participants with AIDS take on a risk (ingesting the experimental drug) in order to benefit others (information on how well the drug works) at some time in the future. Researchers must never subject research participants to more risk than necessary, be prepared to cease research if it is causing harm, and never put participants at a level of risk disproportionate to the anticipated benefits.
Particular interest has been paid lately to preventing the overburdening of some populations in order to apply research findings to other groups. Populations under consideration with particular potential for exploitation may include but not limited to the following:
1. MINORITY GROUPS
3. MENTALLY IMPAIRED INDIVIDUALS
5. FINANCIALLY DISADVANTAGED INDIVIDUALS
7. THE DECEASED
Source: Guide to Research Ethics the University of Minnesota’s Center for Bioethics to read more go to library: Ethical Challenges of Research