Case Study 2

Investigators studied the effect of traumatic experiences on incarcerated males. 30 individuals who were incarcerated  in Midwestern prisons were the participants. A detailed questionnaire was given concerning personal characteristics (e.g., age, education, and place of work), type of trauma experienced, and interpersonal relationship behaviors.

Risk/benefits for Investigator-

According to the Belmont report, in order to assess the risk and benefits for the investigator “The investigator examines whether the proposed research is properly designed”(Department of Health, Education, and Welfare, 1979). The investigator uses the ethical principle of beneficence. “Persons are treated in an ethical manner not only by respecting their decisions and protecting them from harm, but also by making efforts to secure their well-being” (Department of Health, Education, and Welfare, 1979). The risk to the investigator can come from the participant in the study. The investigator will be giving the detailed questionnaire to the participants who may react with violence in  physical or verbal altercations. The investigator could be hurt physically or mentally from their responses, or from hearing the trauma experienced by the participants. The benefit for the investigator can be a link between participants in the study finding a program to help them in the future.  This could also lead to an increase in funding for more of the investigators studies.

Risk/benefits for participant-

The participant must be informed giving them an assessment of what is going to be used or talked about in the study. “The assessment will assist the determination whether or not to participate”(Department of Health, Education, and Welfare, 1979). The participant must be well informed to stay within ethical standards. An example is the use of the justice principle.  The principle of justice state that the burden and benefit of research should be distributed objectively and without prejudices. “Almost all commentators allow that distinctions based on experience, age, deprivation, competence, merit and position do sometimes constitute criteria justifying differential treatment for certain purposes”(Department of Health, Education, and Welfare, 1979). These formulations are: to each person an equal share, to each person according to individual need, to each person according to individual effort, to each person according to societal contribution, and to each person according to merit (Department of Health, Education, and Welfare, 1979). This means an incarcerated individual participating must be allowed the same reward, or no reward for participating the study. As well as any accommodations are made for individuals who are unable to interpret the questionnaire.  An injustice would occur if some benefit to which a prisoner is entitled is denied without good reason.  Selection of research subjects needs to be determined whether prisoners are being systematically selected by their easy availability, their compromised position, or their obedience, rather than for reasons directly related to the problem being studied (Department of Health, Education, and Welfare, 1979). The risk to the participant is anxiety and depression from bringing up the past trauma of their youth. This can lead the participant to have the emotions from that time period coming back. There can also be a benefit for the participant because they are older and in a controlled environment that can help them express their feeling appropriately.

Risk/benefit for society –

Because none of the research procedures offer the prospect of direct benefit, the risk/potential benefit analysis involves judging whether the risks are reasonable in relation to the potential gains in knowledge for society. 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).

level of IRB-

IRBs should independently weigh the risks and potential benefits of each type of procedure. The risks associated with individual procedures offering the prospect of direct benefits are justified in relation to their potential to benefit the participant in addition to their potential to generate knowledge. Those procedures designed solely to answer the research question(s) are justified in relation to their potential to generate knowledge (National Bioethics Advisory Commission, 2016). This means the IRBs job is to stay impartial and review the study as an unbiased party.

Concerns of the IRB should be threats to privacy, breaches in confidentiality, and psychological risks such as distress. The sample size may result in individuals being identified even if no direct identifiers are maintained. Investigators might argue that participants might feel better after the interview and derive some satisfaction from talking about their experiences. However, these types of indirect benefits should not be taken into consideration in the risk/potential benefit analysis. Based on the analysis of the components of this study, it should receive full IRB review because some components pose more than minimal risk. The IRB should be particularly aware of the special problems of research that involves subjects who are vulnerable to coercion or undue influence, such as children, prisoners, individuals with impaired decision-making capacity” (John Carroll University,2020).

References

Department of Health, Education, and Welfare. (1979, April 18). The belmont report. Retrieved March 30, 2020,  https://www.hhs.gov/ohrp/regulations-and-policy/belmont-report/read-the-belmont-report/index.html

John Carroll University. (2020). The institutional review board. Retrieved March 30,2020. 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 vulnerabilityhttps://www.onlineethics.org/cms/8033.aspx

 

2 Responses

  1. aadeyiga at |

    I enjoyed reading your Case Study II. I thought you talked well on the measure that should be taken for the safety of the participants. The privacy of the participants should be respected and they should be well informed by giving them an assessment of what will be discussed.

  2. aadeyiga at |

    I enjoyed reading your response to case study 2, you explained it just the way it should be explained. In case study 2, the participants are aware of the survey and the researchers must be very detailed with the participant so they are aware of the risk involved when they agree to participate. The IRB will not approve the research to conduct this study until all the protocols are followed and the participant’s privacy and confidentiality are protected. These volunteers should also be guarantee protection from any harm. However, these surveys will help the participants and others that are in a similar situation in the future and it will increase funding for the investigators.

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