Ethical Issues in Research Design

Research in any area of the sciences is fraught with ethical considerations. Whether research involves the social sciences or “hard sciences” such as biology, physics or medicine, similar ethical issues arise. This is particularly true when the research involves human participants.

Validity

Research studies must be designed to answer specific research questions. The methods of assessing the questions must relate specifically to the questions. The conclusions of the study must be directly correlated with the results found during the course of the research.

Voluntary Participation

An individual’s participation in a study should be voluntary rather than coerced. In the past, studies involved captive populations, such as prison inmates or hospital patients. In the 21st century, involuntary human participation in research studies is considered unethical. In addition, researchers must refrain from using any deception to gain an individual’s participation in a study.

Closely related to voluntary participation is informed consent. The subjects must give their consent to be involved in the study based on thorough knowledge of the procedures and possible risks of the study. This consent should be obtained in the form of written and witnessed documentation from the participant.

Risk of Harm

Researchers are ethically bound to avoid harming participants in their studies. Studies, particularly in medicine, must be weighed carefully for the risk to benefit ratio. If the potential risks outweigh the benefits, the study should be redesigned or abandoned. As studies progress, researchers should continually assess the risk of harm to the participants.

Confidentiality and Anonymity

Confidentiality is integral in any study. An individual’s participation, consent and study results must be kept absolutely confidential. Ideally, participants’ identities should be unknown to even the researchers. Furthermore, if a study surrounds a controversial social issue, even researchers may prefer to remain unidentified. The study itself and the results must be kept confidential until the responsible entity releases the results to the public. It is highly unethical for individuals involved in the study to discuss preliminary findings with any outside entity.

Right to Service

True experimental design requires a control group. That is, a cluster that receives no experimental treatment. Particularly in medical trials, studies may have to go forward with no control group. The Tuskegee Syphilis Studies are an example of unethical studies that violated the patients’ rights to service. In these studies, penicillin shots were withheld from the infected patients. These shots would have saved the patients’ lives. Researchers allowed the subjects to suffer in order to study the late stages of the disease. This study was unethical for many reasons. In addition to the violation of a patient’s right to service, the involuntary participants were not even aware they were part of a study and did not give consent. Many of the Tuskegee airmen were not even informed that they had syphilis, nor were they informed of the treatment available for their condition. Unethical, inhumane studies such as this were the catalyst for the creation of independent institutional review boards.

Institutional Review Board (IRB)

IRBs are independent entities with no vested interest in a study. The responsibility of the IRB is to appraise a research design for ethical issues. If the study does not pass the IRB process, the researchers must redesign the study to meet the ethical guidelines.