- Explain how research involving humans and animals is regulated
Today, scientists agree that good research is ethical in nature and is guided by a basic respect for human dignity and safety. However, as you will read in the Tuskegee Syphilis Study, this expectation has not always been the case. Modern researchers must demonstrate that the research they perform is ethically sound. This section presents how ethical considerations affect the design and implementation of research conducted today.
Research Involving Human Participants
Any experiment involving the participation of human subjects is governed by extensive, strict guidelines designed to ensure that the experiment does not result in harm. Any research institution that receives federal support for research involving human participants must have access to an institutional review board (IRB). The institutional review board (IRB) is a committee of individuals often made up of members of the institution’s administration, scientists, and community members (Figure 1). The purpose of the institutional review board (IRB) is to review proposals for research that involves human participants. The IRB reviews these proposals with the principles mentioned above in mind, and generally, approval from the IRB is required in order for the experiment to proceed.
An institution’s IRB requires several components in any experiment it approves. For one, each participant must sign an informed consent form before they can participate in the experiment. An informed consent form provides a written description of what participants can expect during the experiment, including potential risks and implications of the research. It also lets participants know that their involvement is completely voluntary and can be discontinued without penalty at any time. Furthermore, the informed consent guarantees that any data collected in the experiment will remain completely confidential. In cases where research participants are under the age of 18, the parents or legal guardians are required to sign the informed consent form.
While the informed consent form should be as honest as possible in describing exactly what participants will be doing, sometimes deception is necessary to prevent participants’ knowledge of the exact research question from affecting the results of the study. Deception involves purposely misleading experiment participants in order to maintain the integrity of the experiment, but not to the point where the deception could be considered harmful. For example, if we are interested in how our opinion of someone is affected by their attire, we might use deception in describing the experiment to prevent that knowledge from affecting participants’ responses. In cases where deception is involved, participants must receive a full debriefing upon conclusion of the study—complete, honest information about the purpose of the experiment, how the data collected will be used, the reasons why deception was necessary, and information about how to obtain additional information about the study.
Dig Deeper: Ethics and informed consent
In October 1998, 36-year-old Joseph Santana, a patient at the state-run Bronx Psychiatric Center, died during a trial of antipsychotic drugs. His cries for help were ignored as he was considered delusional. The next month, another ethical concern was raised after the University of Maryland, the University of California at Los Angeles, and the National Institute of Mental Health in Maryland violated federal regulations during drug trials because they did not get the proper consent from patients—some were taken off of medication for schizophrenia that had been improving their condition.
As a result of the investigation, the institutions changed their practices. The Office of Protection from Research Risk is designed to protect research subjects. Informed consent is permission granted in the knowledge of the possible consequences, typically that which is given by a patient to a doctor for treatment with full knowledge of the possible risks and benefits.
You be the judge: Can a patient suffering from a severe mental disorder give informed consent? How were the participants in these drug trials harmed as a function of the research?
Below are links to FDA regulations governing human subject protection and the conduct of clinical trials:
Research Involving Animal Subjects
This does not mean that animal researchers are immune to ethical concerns. Indeed, the humane and ethical treatment of animal research subjects is a critical aspect of this type of research. Researchers must design their experiments to minimize any pain or distress experienced by animals serving as research subjects.
Whereas IRBs review research proposals that involve human participants, animal experimental proposals are reviewed by an Institutional Animal Care and Use Committee (IACUC). An Institutional Animal Care and Use Committee (IACUC) consists of institutional administrators, scientists, veterinarians, and community members. This committee is charged with ensuring that all experimental proposals require the humane treatment of animal research subjects. It also conducts semi-annual inspections of all animal facilities to ensure that the research protocols are being followed. No animal research project can proceed without the committee’s approval.
debriefing: when an experiment involved deception, participants are told complete and truthful information about the experiment at its conclusion
deception: purposely misleading experiment participants in order to maintain the integrity of the experiment
informed consent: process of informing a research participant about what to expect during an experiment, any risks involved, and the implications of the research, and then obtaining the person’s consent to participate
Institutional Animal Care and Use Committee (IACUC): committee of administrators, scientists, veterinarians, and community members that reviews proposals for research involving animal participants
Institutional Review Board (IRB): committee of administrators, scientists, and community members that reviews proposals for research involving human participants
- Mosher, Loren L. (1999) Psychology Today. https://www.psychologytoday.com/us/articles/199909/are-psychiatrists-betraying-their-patients ↵