Three fundamental principles guide the ethical conduct of research involving human subjects. These principles come from The Belmont Report, a statement of basic ethical principles and guidelines that assist in resolving the ethical problems that surround the conduct of research with human subjects.
These three principles shape how research is reviewed:
Respect for Persons (autonomy)
Individuals should be treated as autonomous agents, capable of deliberating and making decisions on their own.
Researchers are obligated to minimize possible harm and maximize possible benefits.
Research participants should be treated fairly and risks and benefits evenly distributed.
Applying these principles leads us to the following requirements:
The risks to research subjects posed by participation in research should be justified by the anticipated benefits to the subjects or society.
This requirement is clearly stated in all codes of research ethics and is central to the federal regulations. The major responsibility of review is to assess the risks and benefits of proposed research.
The first part of the review process considers the risks and benefits within the proposed research activity. There are five steps in the analysis.
1. Identifying risks
Risk is the probability of harm or injury (physical, psychological, social, or economic) occurring as a result of participation in a research study. The proposed research is reviewed to identify any possible risks; all phases of the research are considered, from the initial contact with subjects through data collection and storage.
Research can involve exposure to minor pain, discomfort, or injury from invasive medical procedures or activities designed to test biomechanical or ergonomic performance.
IRB Analysis: Risks are very specific to the study; this is why IRBs need to see a detailed account of all of the tasks investigators will be asking subjects to perform and the environment in which they will be performed.
What IRBs may require: The IRB will want to review supporting evidence of a device’s commercial application and basic operating information from the manufacturer.
These run from temporary anxiety and distress to relapse and precipitation of behavioral disorders.
IRB Analysis: Discomfort may be associated with the questions in a survey or interview. The IRB considers the range of reactions that are possible in response to the research and will ask researchers to design the study in a way that provides an adequate level of protection.
What IRBs may require: Giving subjects information on available counseling services and telephone hotlines.
Federal regulations permit but establish limitations on the use of deception in research. Deception in research occurs when subjects are intentionally mislead or when information about the nature of the experiments is withheld.
What IRBs may require: IRBs will require that subjects are fully debriefed after the experiment is conducted. Investigators will submit a debriefing document for review. Subjects are given the opportunity to ask questions about the new information and given the chance to withdraw. It is not permissible to use deception to obtain participants
Confidentiality of data concerns safeguarding information that has been given voluntarily by one person to another. A breach of confidentiality may result in psychological harm to individuals (in the form of embarrassment, guilt, stress, and so forth) or in social harm.
Some invasions of privacy and breaches of confidentiality may result in embarrassment within one’s business or social group, loss of employment, or criminal prosecution.
IRB Analysis: Areas of particular sensitivity are information regarding alcohol or drug abuse, mental illness, illegal activities, and sexual behavior. Some social and behavioral research may yield information about individuals that could “label” or “stigmatize” the subjects. Confidentiality safeguards must be strong in these instances. For example, the fact that a person has participated in HIV-related drug trials or has been hospitalized for treatment of mental illness could adversely affect present or future employment, eligibility for insurance, standing in the community, and/or relationships with family members.
2. Minimal vs. greater than minimal risk
Once the risks have been identified, the question of whether the research presents greater than minimal risk is asked. “A risk is minimal where the probability and magnitude of harm or discomfort anticipated in the proposed research are not greater than those ordinarily encountered in daily life or during the performance of routine physical or psychological examinations or tests.”
3. Are risks minimized?
Next, the reviewer considers whether risks will be minimized to the extent possible. Precautions, safeguards, and alternatives can be incorporated into the research activity to reduce the probability of harm or limit its severity or duration.
4. Are risks reasonable in relation to benefits?
The reviewer looks at the anticipated benefits and then considers whether the risks are reasonable in relation to the anticipated benefits and the importance of the knowledge to be gained; this is called a risk/benefit ratio.
Evaluation of the risk/benefit ratio is an ethical judgment that is made when reviewing research proposals. The risk/benefit assessment is not a technical one valid under all circumstances; rather, it is a judgment that often depends upon prevailing community standards and subjective determinations of risk and benefit. Consequently, different reviewers, Institutional Review Boards, and Institutions may arrive at different assessments of a particular risk/benefit ratio.
5. Adequate provisions for the continuing reassessment of risks?
Finally, the reviewer considers whether there are adequate provisions for the continuing reassessment of the balance between risks and benefits. This is accomplished when investigators submit to a continuing review process at least once a year on the anniversary date of approval, and sometimes more often if required.
Selection and Recruitment of Subjects
Reviewers are looking to see that the selection and recruitment of subjects is equitable.
Participants should share equally in foreseeable risks and benefits.
A specific determination is made that the selection of subjects is equitable and that the burdens and benefits of research will be fairly distributed.
To ensure fairness, two concepts are considered:
The manner in which subjects will be recruited, making sure that subjects have an equal chance of being selected.
Ways to reduce the pressure to participate on certain classes of subjects –for example, with research conducted in a classroom setting, what steps has the researcher taken to ensure that participants don’t feel they are being coerced (or pressured) to take part.
The reviewer evaluates what information is provided to potential subjects in light of the risks and benefits of the proposed research procedures.
The information provided to prospective subjects must be correct, adequate, and clear. The information is viewed from the subject’s perspective.
Most importantly, the reviewer expects to see that the information is presented to prospective subjects in a manner they can understand.
Privacy and Confidentiality
The protocol acknowledges and makes plans for protecting the privacy of the participants and the confidentiality of their data.
Privacy can be defined in terms of having control over the extent, timing, and circumstances of sharing oneself (physically, behaviorally, or intellectually) with others.
Confidentiality means the treatment of information that an individual has disclosed in a relationship of trust and with the belief that it will not be revealed to others without permission.
In some cases, an invasion of privacy or breach of confidentiality may present a risk of serious harm to subjects (e.g., when the researcher obtains information about subjects that would, if revealed by the researcher, jeopardize their jobs or lead to their prosecution for criminal behavior).
Under less dramatic circumstances, an invasion of privacy or breach of confidentiality can be a moral wrong, or provide cause for legal action against a researcher or institution.
Monitoring and Observation
The reviewer expects to see that a researcher has developed checks and balances for monitoring data collection so that any unexpected risks or potential adverse events will stand out before a participant is harmed.
This is important because preliminary data may indicate the need to change the research design, change the information presented to subjects, or even to terminate the project.
Researchers should provide a description of their plans for analyzing the data during the collection process. This allows for the identification of flaws in the study design early in the project and the reevaluation of the risks to human subjects to assure that they are no greater than initially predicted.
Additional Safeguards for Vulnerable Participants
Federal regulations strictly limit research on the following vulnerable populations when it is considered to be more than minimal risk:
Fetuses and pregnant women
Research involving prisoners
Research involving children
Research involving institutionalized or incapacitated persons
Part of the review process is to determine whether the proposed subject population would be more sensitive or vulnerable to the risks posed by the research as a result of their general condition or disabilities.
Incentives for Participation
The reviewer considers whether paid participants in research are recruited fairly, informed adequately, and paid appropriately. To make this determination, who the subjects will be, what incentives are being offered, and the conditions under which the offer will be made must be thoroughly explained.
Although payments are usually monetary, volunteers may be offered other rewards in lieu of or in addition to money. The rewards must not add up to excessive inducement. To determine this the subjects’ medical, employment, and educational status, as well as their financial, emotional, and community resources will be considered.
One of the primary responsibilities of review is to ensure that a subject’s decision to participate in research is truly voluntary. An offer that is hard to refuse is essentially coercive, and coercive incentives may be troublesome because offers that are too attractive may blind prospective subjects to the risks or impair their ability to exercise proper judgment; and they may prompt subjects to lie or conceal information that, if known, would disqualify them from enrolling in a research project.
Considerations of Research Design
The federal regulations guiding research with human subjects require that the risks to subjects are reasonable in relation to the importance of the knowledge that may reasonably be expected to result.
The value of research depends upon the integrity of study results. One of the ethical justifications for research involving human subjects is the social value of advancing scientific understanding and promoting human welfare.
If a research study is so methodologically flawed that little or no reliable information will result, it is unethical to put subjects at risk or even to inconvenience them through participation in such a study.