Researchers from multiple disciplines, including criminology, carry out studies. These studies often necessitate the participation of persons, often referred to as “human subjects.” Ethical standards guide researchers so that whenever they involve human subjects in their research, they must take steps to ensure that their study minimizes harm to those persons and protects their rights.
To ensure that studies protect human subjects, U.S. government agencies sponsoring research require that the proposal (or protocol) for the study be examined by an institutional review board (IRB). The goal of an IRB is to assure that proposed research will protect human subjects in the study from undue physical or psychological harm. The importance of the IRB in protecting human subjects is evidenced by the fact that many organizations now require an IRB review for all research studies, and not just those sponsored in some way by the U.S. federal government.
Structure and Process
All universities and colleges and many research organizations have established their own unique IRB processes. The main mission of the IRB is to conduct a risk-benefit analysis to determine whether the proposed research should be carried out and what alterations should be made to protect human subjects. In the United States, the federal Department of Health and Human Services (DHHS) authorized IRBs to oversee research with human subjects.
By law, an IRB must be made up of at least five members. The required backgrounds are diverse, but at least one scientist and one nonscientist must be on the IRB. In addition, one member external to the research institution or university must be on the IRB. An IRB has the authority to approve research, and it can also require modifications before approval to reduce the likelihood of potential harm to human subjects. The IRB can also disapprove of research under its operating authority. Further underscoring the importance of the IRB is its power to suspend or terminate research that violated approved study requirements or resulted in unexpected serious harm to human subjects. No federally sponsored research involving research subjects may proceed without IRB approval.
An IRB generally reviews research at meetings attended by a majority of members. The IRB must approve research by a majority of those present at the meeting and then notify investigators in writing of its decision. An approved research study must be reviewed again by the IRB one year later.
Investigators proposing research submit a “protocol” to the IRB that outlines their study and includes a description of planned data collection and analysis and copies of planned surveys or interview instruments. The point person for the IRB reviews the protocol and determines whether it meets the definitions for research involving human subjects and whether it should receive a full or expedited review, or whether it is considered exempt. A full review is one that is examined by all members of the IRB and for which a quorum of members must vote. An expedited review is sent to one to two members for examination and approval. Exempt studies mean they can proceed without an IRB review. An IRB not only approves a study, but also requires continual review, usually annually, to ensure the study continues to meet ethical standards.
History
The IRB is the product of concern with ethical standards and the improper practice of research. Although biomedical and social science research have helped improve overall well-being in society, there have been several ethical abuses in the name of science. The most egregious of these were the scientific experiments carried out in Nazi concentration camps prior to and during World War II. Nazi scientists did experiments that showed no concern for the well-being of human subjects, including using people incarcerated in concentration camps in studies to determine how long it would take a person to freeze to death in cold water. A commission during the Nuremburg war crimes trials examined this mistreatment of human subjects at the hands of the Nazi scientists. The result was the Nuremburg Code, which has been influential in establishing ethical standards for research involving human subjects, including the voluntary consent of anyone participating in a study and their ability to opt out of a study at any point.
Another landmark example of the violation of the rights of human subjects that greatly influenced the move toward protecting persons from unethical research was the Tuskegee Syphilis Experiment. In Tuskegee, Alabama, from 1932 to 1972, biomedical researchers from the U.S. Public Health Service enrolled disadvantaged rural black men in a study of the natural progression of syphilis. Some men had syphilis, others did not. Those that had syphilis did not know they had the disease and were not told. Penicillin was found to be an effective remedy for syphilis as early as the 1940s; yet, this treatment was intentionally withheld from the infected men in the study. The researchers’ actions led to some of the men dying from syphilis and their spouses and newborn infants contracting it. These violations of ethical standards propelled the U.S. government to pass the National Research Act, which led to the requirement for IRBs at institutions receiving any federal funding.
The Nazi scientific studies using concentration camp victims and the Tuskegee Syphillis Experiment were among the most egregious examples and helped propel ethical standards for research forward, including the IRB. Another important development in the creation of ethical standards for human subjects research and, eventually, the IRB, were several commissions and documents. For example, the Declaration of Helsinki, developed in 1964 by the World Medical Association, was the first intentional effort by the medical research community to establish a set of ethical standards. Such standards included the primacy of the well-being of the patient and holding physicians responsible for the patient’s wellbeing in medical studies.
Perhaps the most influential document in the history of ethical standards is the 1978 Belmont Report. This report provides an analytical framework for the resolution of ethical dilemmas that arise during the course of human subjects research. The National Commission for the Protection of Human Subjects of Biomedical and Behavioral Research was charged by the Department of Health, Education, and Welfare to revise and expand the current regulation for research involving human subjects. It set out the three principles to use in determining the cost and benefit of research to research: respect for persons, beneficence, and justice.
Federally funded research in the United States now adheres to the Federal Policy for the Protection of Human Subjects, better known as the Common Rule. The Common Rule requires the establishment of IRBs to review and monitor research projects with human participants at higher educational institutions and research organizations, defines what studies meet the standard for involving human subjects, and sets out the conditions for the types of research that must receive a full IRB review, an expedited one, or are exempt altogether from the IRB’s purview.
What Is Research With Human Subjects?
Not all investigation that researchers undertake meets the definitions in the ethical standards for what constitutes research on human subjects. The Common Rule, for example, defines research as “a systematic investigation, including research development, testing and evaluation, designed to develop or contribute to generalizable knowledge.” Thus, investigations like program audits, which are designed to provide formative feedback solely to a client, would generally be viewed as not meeting this definition. The Common Rule also defines a human subject as a “living individual about whom an investigator (whether professional or student) conducting research obtains (1) data through intervention or interaction with the individual; or (2) identifiable private information.” A study involving examination of publicly available documents or inanimate objects would not meet the definition of a study of human subjects under the Common Rule.
The Common Rule also establishes guidelines for research that is considered exempt from IRB oversight. These categories are: (1) studies conducted in established educational settings involving normal education practices and/or assessments; (2) studies of existing data sources in which the data on human participants are de-identified; (3) research and demonstration projects conducted by or subject to the approval of department or agency heads, which are designed to study, evaluate, or examine public benefit or service programs, procedures for obtaining benefits or services under service programs, possible changes in or alternatives to those programs or procedures, or possible changes in methods or levels of payment for benefits or services under those programs.
Respect for Persons
The Belmont Report underscored that all research should have as a priority the respect of persons. Respect for persons involves treating each individual as an autonomous agent capable of making his or her own decisions about whether to participate in research. If a person has diminished capacity such that he or she cannot function autonomously, they are entitled to greater protection from undue harm. This has led to a number of ethical standards that govern the conduct of research. For example, no study should impede upon an individual’s right to act on his/her considered judgments to participate or not in research. Information about the study should not purposefully be withheld from persons that would permit them to make decisions about participation unless there are compelling reasons to do so. Research studies involving persons with diminished capacity, including children, are often provided more protection including exclusion from the study or additional consultation to obtain informed consent. Participants have the right to withdraw from a study at any point.
The issue of informed consent warrants more attention. Each person should be provided the opportunity, to the extent possible, to choose what does or does not happen to them. This means that a participant should have the ability to choose whether or not to participate in research. Three criteria must be satisfied for proper informed consent for research. The first condition is that the information that is relevant must be made available to the participant. This information should include the research procedure, purpose, risks and opportunities, alternatives, and a statement of the voluntariness of participation. The IRB, during its review, will often spend considerable time reviewing consent procedures and helping investigators determine what level of information is necessary and appropriate to present to potential participants before the study begins. Researchers must also take special care to deliver the information to potential participants in an appropriate and accessible language. The IRB also reviews whether a research study provides assurance that participants who have given consent to participate have done so voluntarily without unjustifiable pressure to do so.
Beneficence
The Belmont Report also established the principle of beneficence. This ethical standard prioritizes that research maximize possible benefits while simultaneously minimizing possible harms. Essentially, IRBs must examine whether research presents a risk of harm that is worth the reward for the participants and for those populations for which the results would be generalized to and potentially benefit. Determining beneficence is not always clear cut, particularly when more than minimal risk is present and the study’s participants do not stand to benefit directly from the research.
The IRB applies this principle in a number of ways. Before a study begins, investigators proposing research with human subjects must present a careful consideration of potential risks and benefits. An IRB then weighs whether or not the research is justified according to a cost-benefit analysis. Risks not only include the likelihood that harm will occur, but also the degree of harm possible and whether that harm is psychological, physical, legal, social, or economic.
It is up to the IRB to decide whether or not the balance of risk and benefit means that the research is justifiable. Although this balancing can be murky, there are some scenarios that automatically tip the scales in favor of risk, such as the inhumane treatment of human subjects. The IRB will require that risk to human subjects be reduced to what is absolutely necessary to achieve the research objective. When the risk presented by research is significant, the IRB must be insistent on the justification of the risk, particularly when vulnerable populations are involved.
Justice
The final principle established by the Belmont Report is that of justice. This standard underscores that research should benefit the population involved in the study. There should also be a fairness of distribution of benefits in proportion to the amount of burden placed on the population. The Belmont Report recognizes that human populations may not all benefit equally from a research study, but researchers should take care to see that all affected are benefitted appropriately.
To apply the principle of justice, an IRB must assure that researchers not expose research participants to any more or less risk based on their socioeconomic status. In addition, the principle of justice applies in the selection of populations for a study. An IRB must decide that a study appropriately selects a population to assure that already burdened or at-risk populations are not put at additional risk by being included in the study if another population will serve the same purpose. For example, adults should be selected for a study before children, if adults could reasonably serve the purpose of appropriate research subjects. An IRB must also decide if at-risk populations are being taken advantage of for no other reason than convenience. For example, a study of a general population may serve the same purpose as a study of prisoners or the mentally ill; in such cases, researchers should opt for a study with the general population and not those who are in a disadvantaged position.
IRB Challenges
IRBs are generally viewed as being overloaded, underfunded, and hard pressed to fully carry out their responsibilities. An IRB is usually responsible for overseeing a number of studies simultaneously. This presents challenges to the IRB in providing the appropriate review, so that research proposals that require the most intensive review receive adequate attention. Furthermore, modern technological advances are placing burdens on IRBs to become more adept in how information and data can be accessed, stored, and compromised. Although IRBs are guided by the same ethical principles, these can be subjectively interpreted and can lead to different rulings by different IRBs about the appropriateness of the same study.
Bibliography:
- National Commission for the Protection of Human Subjects of Biomedical and Behavioral Research. “The Belmont Report: Ethical Principles and Guidelines for the Protection of Human Subjects of Research.” (1979) http://hhs.gov/ohrp/humansubjects/guidance/belmont.html (Accessed April 2013).
- National Research Council. Protecting Participants and Facilitating Social and Behavioral Sciences Research. Washington, DC: National Academy Press, 2003.
- Vaugn, Michael G., Carrie Pettus-Davis, and Jeffrey J. Shook. Conducting Research in Juvenile and Criminal Justice Settings. Oxford: Oxford University Press, 2012.
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