Level of IRB Review – There are three levels of IRB review: full, expedited, and exempt review (John Carroll University, 2020).  The level of IRB approval needed for this case study is a full board review because it involves research with prisoners.  In this case study, thirty participants from a Midwestern correctional facility were chosen to be interviewed.  Therefore, a full board review is required.

 

The ethical principle and guideline for research involving human subjects assures that research involving human subjects should be carried out in an ethical manner.  The three basic principles relevant to the ethics of research involving human subjects are the principles of respect of persons, beneficence, and justice (Department of Health, Education, and Welfare, 1979).

 

Risks and Benefits to Researcher:

Investigators are obliged to give forethought to the maximization of benefits and the reduction of risk that might occur from the research investigation (Department of Health, Education, and Welfare, 1979).  The investigators must examine whether the proposed research is properly designed.

 

Risk to researcher could be physical harm such as injury, illness, pain, suffering, or discomfort from conducting this research at a correctional facility and interviewing incarcerated individuals about a sensitive subject such as traumatic childhood experiences.  There may be legal harm against the researcher for an improper research design, minimization of benefits, and maximization of risk in the research investigation.

 

Research institutions may benefit from enhanced capacity to conduct research or by receiving resources to improve a program as a result of a research study (National Bioethics Advisory Commission, 2016).

 

Risks and Benefits to Participant:

The principle of respect of persons state that prisoners should not be deprived of the opportunity to volunteer for research (Department of Health, Education, and Welfare, 1979).  However, prisoners may be subtly coerced or unduly influenced to engage in research activities for which they would not otherwise volunteer (Department of Health, Education, and Welfare, 1979).  Therefore, prisoners need to be protected.  Prisoners must enter into the research voluntarily and with adequate information.  The prisoners must give informed consent and be given the opportunity to choose what shall or shall not happen to them.  The prisoners must be given sufficient information and must comprehend clearly the range of risk and the voluntary nature of participation.  Prisoner’s informed consent must be free of coercion and undue influence.

 

The general rule of the principle of beneficence is to do no harm, maximize possible benefits, and minimize possible harms (Department of Health, Education, and Welfare, 1979).  One should not injure one person regardless of the benefits that might come to others (Department of Health, Education, and Welfare, 1979).  The researchers should not harm the prisoners.  The researchers should maximize the benefits for the prisoners and minimize any possible harms toward the prisoners.  The prisoners should not be injured regardless of the benefits that might arise to society.

 

The principles of justice state that the burden and benefit of research should be distributed fairly.  The formulations of distributing burdens and benefits are each person should have an equal share, each person according to individual need, each person according to individual effort, each person according to societal contribution, and each person according to merit (Department of Health, Education, and Welfare, 1979).  An injustice would occur if some benefit to which a prisoner is entitled is denied without good reason or when some burden is imposed unduly.  Selection of research subjects needs to be scrutinized in order to determine whether prisoners are being systematically selected simply because of their easy availability, their compromised position, or their manipulability, rather than for reasons directly related to the problem being studied (Department of Health, Education, and Welfare, 1979).

 

Prisoners should assess whether or not to participate in the research.  Prisoners are burdened to accept the risk, but the outcome of the research may likely benefit society at large.  Prisoners may be easy to manipulate as a result of their socioeconomic condition.

 

There is a risk of psychological harm to the prisoners during this research about traumatic childhood experiences.  They may experience emotional suffering, anxiety or shame, or aberrations in thought or behavior (National Bioethics Advisory Commission, 2016).  The participants may experience distress, anger, or guilt related to the disclosure of sensitive or embarrassing information (National Bioethics Advisory Commission, 2016).  Social harms involve the negative effects on one’s interactions or relationships with others (National Bioethics Advisory Commission, 2016).  There is a risk of social harm in that research findings may expose participants to social stigmatization.  Participants may also suffer from dignitary harm when they are not treated as persons with their own values, preferences, and commitments, but rather as mere means not deserving of respect (National Bioethics Advisory Commission, 2016).

 

Potential benefits to participants may include receiving clinically significant information about the effect on interpersonal relationship of traumatic childhood experiences and receiving standard treatments or interventions as part of the research, such as counseling and testing.  Another benefit for the prisoners is increased social contact, sharing information with another person, or gaining personal satisfaction from participating in the research (National Bioethics Advisory Commission, 2016).

 

 

Risks and Benefits to Society:

Members of society are obliged to recognize the longer-term benefits and risks that may result from the improvement of knowledge and from the development of novel medical, psychotherapeutic, and social procedures (Department of Health, Education, and Welfare, 1979).  The importance of the knowledge to be gained may increase when significant new findings are expected; when it may result in new products, treatments, or cures; or when it is applicable to many different social groups (National Bioethics Advisory Commission, 2016).

 

Communities can benefit through improved access to programs or through the emergence of programs targeted to specific groups within the community (National Bioethics Advisory Commission, 2016).  The anticipated benefit to society is the knowledge to be gained from the research of the relationship between traumatic childhood experiences and the effect on the interpersonal relationships in adulthood.  New programs may emerge from the research investigation.

 

 

 

Department of Health, Education, and Welfare. (1979, April 18). The belmont report.  https://www.hhs.gov/ohrp/regulations-and-policy/belmont-report/read-the-belmont-report/index.html

 

John Carroll University. (2020). The institutional review board. https://jcu.edu/research/irb/investigators-guide/step-one-you-begin

 

National Bioethics Advisory Commission. (2016, February 1). Assessing risks and potential benefits and evaluating vulnerability. https://www.onlineethics.org/cms/8033.aspx