Case Study 2
The first step is to determine whether the project requires the review of the Institutional Review Board (IRB). All research involving human subjects require the review of the IRB (John Carroll University, 2019). Because this case study involved participants incarcerated in a correctional facility, the investigators would undergo a review by the IRB.
The next step is for anyone engaged in the research activity to complete an online training course about Research with Human Subjects (John Carroll University, 2019). The course is valid for three years (John Carroll University, 2019). The IRB will not review any application where any of the investigators or sponsors have not completed the course (John Carroll University, 2019). There is no information about whether the investigators or sponsors in this case study completed the course on Research with Human Subjects.
Level of IRB Approval:
All human subjects research projects are classified into one of three types of review categories: Exempt, Expedited, and Full Board (John Carroll University, 2019). No research activity can begin until the IRB has issued a Notice of Exemption or Notice of Approval for the application (John Carroll University, 2019). Initially, it seemed that this research would be classified as exempt because it involved a face-to-face interview of a detailed questionnaire. It seemed that it was a minimal risk survey or interview. However, after reading the description of a Full Board category, this criterion would be the appropriate level of IRB approval needed because it involves research with prisoners.
The principle of beneficence requires that investigators attempt to maximize possible benefits and minimize possible harms (National Bioethics Advisory Commission, 2016). The types of harms include physical, psychological, social, economic, legal, or dignitary.
Risk to Researcher:
A risk to the researcher is physical harm. Physical harm includes injury, illness, pain, suffering, or discomfort (National Bioethics Advisory Commission, 2016). Because the researcher has to enter the environment of a correctional facility, that environment poses certain dangers and risks to the investigator. Additionally, these interviews are conducted face-to-face with incarcerated individuals. These individuals have been deemed by the justice system to have posed a danger to society. These individuals may impose physical harm upon the researcher when asked about traumatic childhood experiences.
Risk to Participant:
One risk to the participant is psychological harm. This includes distress, anger, or guilt related to the disclosure of sensitive or embarrassing information (National Bioethics Advisory Commission, 2016). This research can cause psychological harm to the incarcerated participant because they have to answer questions face-to-face with an investigator about traumatic childhood experiences. Depending on the experience, the detailed questionnaire could cause distress, anger, and guilt related to this sensitive information.
Another risk to the participant is social harm. Social harms involve the negative effects of one’s interaction or relationship with others (National Bioethics Advisory Commission, 2016). In this case, research findings may damage the incarcerated participant’s interpersonal relationship with others.
Lastly, a risk to the participant is dignitary harm. Dignitary harms are those incurred when individuals 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). In this research, the investigator may impose dignitary harm upon the participant because the participant is incarcerated and therefore not deserving respect. The researcher may believe that because the participant is incarcerated, the participant is not worthy of being respected.
Risk to Society:
Perhaps a risk to those other than the participant or researcher is the legal risk by the person or persons who bestowed the traumatic experience upon the incarcerated participant as a child. Legal harms are legal actions that could be taken against that individual or individuals (National Bioethics Advisory Commission, 2016). The disclosure of sensitive information about childhood trauma may pose a legal risk to the individual who imposed that trauma upon the incarcerated participant.
Benefit to Researcher:
Research institutions, social groups, or communities can benefit from research (National Bioethics Advisory Commission, 2016). Institutions 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). 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). In this case, the researcher may be part of an institution conducting this research and may receive resources to improve programs that resulted from this study. Additionally, the result of the study between traumatic childhood experiences and the effect on interpersonal relationships in adulthood may bring about programs in the community targeted to individuals who have experienced trauma as a child.
Benefit to Participant:
Individuals may directly benefit from participation in certain types of research, such as studies designed to offer interventions or procedures that offer a prospect of benefit (National Bioethics Advisory Commission, 2016). Potential benefits include receiving clinically significant information that could be used to influence the care provided, receiving standard treatments or interventions as part of the research, such as counseling or testing, or gaining access to experimental therapies that may improve the participant’s health status (National Bioethics Advisory Commission, 2016). In this research, the participant may seek therapy or counseling to overcome the traumatic childhood experience. Additionally, the participant may learn better ways to interact with people and have better relationships from the awareness gained by the effects of the traumatic childhood experience. Other benefits might be the experience of increased social contact, sharing of information with another person, or gaining personal satisfaction from participating in the research (National Bioethics Advisory Commission, 2016). In this research, incarcerated individuals may enjoy the social contact with the researcher, may enjoy sharing the information about the past experience, and may feel a sense of personal satisfaction by taking part in the research.
Benefit to Society:
The goal of research is to develop knowledge that is beneficial to society (National Bioethics Advisory Commission, 2016). The IRB must be able to clearly identify what might be learned from the research and decide whether the gain in knowledge justifies the exposure of participants to harm (National Bioethics Advisory Commission, 2016). In this research, learning about how traumatic childhood experiences affects interpersonal relationships in adulthood can be beneficial to society. If people learn about how traumatic childhood experiences affects interpersonal relationships in adulthood, it could be better understood and decrease the incidences of traumatic childhood experiences.
John Carroll University. (2019). Things to do and know before preparing your IRB application. Retrieved from https://jcu.edu/research/irb/investigators-guide/step-one-you-begin?_ga=2.39043363.1009771939.1580600399-681300779.1580179266
National Bioethics Advising Commission. (2016). Report on ethical and policy issues in research involving human participants volume I report and recommendations. Retrieved from https://www.onlineethics.org/cms/8033.aspx
Hello Ditas,
Your blog was informative and easy to follow.
I do agree with your full board review. STEP ONE: Before you Begin, under the Full Board heading tells us that prisoners are to be included in this category.
I would like to touch about the risks to the participant. You wrote about one of the harms being a “dignitary harm” and lack of respect as a person with his/her own values, preferences and commitments due to their incarceration. I came across a study in my research: “The National Commission for the Protection of Human Subjects of Biomedical and Behavioral Research (NCPHSBBR),who addressed the ethics of research involving prisoners. The commission focused on 1) respect for persons and 2) justice. One of the issues also was whether prisoners bear a fair share of the burdens of research and receive a fair share of the benefits.
The NCPHSBBR gave discussed pro’s and con’s to the use of prisoner in research. Dr. Olga Grinstead, PH.D. argued that when it comes to equity or the issue of justice, there is benefits to participants from the prison population. She opines “they are motivated to give back and they want to be included in research and want want access to innovative intervention programs. They want to change”. On the opposing side is Dr. Daniel Murphy, PH.D, who himself is a former prisoner but is now a professor in the Department of Political Science and Justice Studies at Appalachian State University. He questions why the attraction to using prisoners in research, if not for the fact that it is a “controlled population” Dr. Murphy informs us that there are 275 million people in the U.S. as compared to 2 million prisoners and why not use the 275 million since those numbers are far greater.
After doing your research do you have an opinion as to the use of prisoners in research? I for one believe that we should be using prison incarceration for rehabilitation as well as punishment. If prisoners have the desire as Dr. Grinstead suggests than I believe with the correct oversight from the IRB’s that it is something that society as well as the participant could benefit from.
Thanks for your blog post,
Loretta Gayle Bergman
Hello Loretta. Thank you for reading and responding to my post. I did mention that prisoners are included in the Full Board review: “However, after reading the description of a Full Board category, this criterion would be the appropriate level of IRB approval needed because it involves research with prisoners.”
Good question as to whether incarcerated individuals should be used in research. After reading your comment that there are more people in the general population of 275 million to use rather than the 2 million prisoners, that made sense to me. Why limit the research to a small segment of the population?
However, prisoners should not be deprived of the opportunity to volunteer for research (Department of Health, Education, and Welfare, 1979). Prisoners need to be protected when it comes to research. Incarcerated individuals 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). Prisoners are persons with diminished autonomy and therefore are entitled to protection (Department of Health, Education, and Welfare, 1979).
If prisoners are subject to research, the principle of beneficence should be strictly followed. The general rule is to do no harm and maximize possible benefits and minimize possible harms (Department of Health, Education, and Welfare, 1979).
The ethical principle of justice is also to be considered and followed. The selection of research subjects needs to be scrutinized in order to determine whether some classes 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). In this case, prisoners are readily available. No difficulty finding them. They will be in the building somewhere. Prisoners are in a compromised position. They have limited choices. Some say, prisoners are easily manipulated because their freedom is limited. Therefore, simply offering a prisoner a luxury item such as cigarettes or a hamburger might convince them to participate in a research.
Overall, researchers should try to perform their research on the general public. However, if there is a specific research about prisoners and their life, then it makes sense to study this population. However, it should be kept in mind that the IRB must approve it first.
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#xbasic
Great job on your blog post. I do agree with your points you have mentioned. This case does meet the criteria for a Full Board review. This does pose a risk for the researcher. The court has obviously deemed these prisoner’s a risk to society or they would not be in prison. This case study being face-to-face deems even more of a risk since the researcher is in direct contact with the prisoner. It’s also important to think about how manipulative these prisoner’s can be, and how this could influence their answers. Prisoner’s could answer questions to benefit them more so than being honest about their traumatic childhood experiences, if indeed they even had any. This type of research also takes an experienced researcher. “The standards and requirements for studying inmates are different from other types of human subjects research. Interviewing in prison present unique sets of obstacles and methodological landmines of which inexperienced researchers may be unaware.” (Issues in Interviewing Inmates, 2009). This research is very vital for programs for people that have experienced traumatic childhood experiences. With mental health becoming more and more of an issue, this type of research is critical. All your points you addressed were very good. This could also be beneficial to the prisoner’s in getting more programs in place inside the prison system to help these prisoner’s overcome these negative experiences. Great job.
Issues in Interviewing Inmates (2009). Navigating the Methodological Landmines of Prison Research. Retrieved from citeseerx.ist.psu.edu.
Thank you for reading and commenting on my post. You are correct, this type of research requires an experienced investigator/researcher. I would also think that the investigator/researcher is a subject matter expert on traumatic childhood experiences so that he/she will not be easily manipulated or be gullible about the answers provided. There is a spotlight on mental health and lack of mental health services. Having a mental illness is not something to be ashamed of. It can happen to anyone and at anytime. More research is needed to help provide the services people need. You are correct again in that this type of research is critical.