Case Study 2

Balance of Risk and Benefits of Research

Risk and Benefits to the Researcher

When a researcher selects a population to work with for research there are always risks involved. With the group selected in this case study prisoners present an inherited risk. Many inmates have mental and behavior health conditions that may present struggles to communicate in a level that is required for the research. This may place the researcher at risk for not properly getting informed consent due to lower level of education or the inmate just not understanding the information but agreeing to the research anyway. Many individuals with a history of incarceration have a manipulative behavior and might try and use the research in their favor to try and get something. This is also a concern and a risk that might be placed in the hand of the researcher. As always, when working with a population that is contained as has had rights taken away a change for physical hard is always present (Chapter 4: Assessing Risks and Potential Benefits and Evaluating Vulnerability, 2016). At a higher risk due to trauma and stress.

The benefits for the researcher are the collection of data to help improve the care of the participant as well as society. The goal for most people working in this field is to make a better life for those around them. Collecting this data and being able to provide information to possible resources to help improve the lives of others is a large benefit to this research. Also, many research projects are funding through grants and require continuing research and show of growth and information to continue the funding. A small trial made lead way to more trials and larger trials due to the information collected.

Risk and benefits to the participant

Due to the concern for the research participants in 1979 the Belmont Report was produced to help researches with guidelines to protect all participants in research studies as well as making sure that those who are completing the research are providing an environment that is as safe as possible. With our study population some of the risks that would be of concern would be that of autonomy. These individuals are incarcerated, many levels of their autonomy have been taken away from them. They may feel like they do not have a choice but to participate in the study. With this concern the informed consent must be sought from each individual with the understanding that they do not have to participate and may withdraw at any time (Chapter 4: Assessing Risks and Potential Benefits and Evaluating Vulnerability, 2016 ). When considering looking at past experiences and how they affect and individual this poses a risk for traumatic emotions to be brought up. Researchers need to make sure that we work to minimize the risk to our participant by assessing and attempting to monitor for early indicators of harm before, during, and after our research. If at any time the level of risk becomes to high, we need to stop the research to protect the individual.

The benefits to a study such as this is that also due to the Belmont Report, (1979) and just the theory of medicine in general is that medical providers do not want to harm out patients. Researchers and medical professionals must try at all levels to prevent this, however if harm has occurred making sure that help is provided to reduce the trauma and work through any harm caused. Due to the topic of beneficence researchers must make sure that there is help provided to our research participants, if needed, during and after the research has been completed. The use of prisoners who are usually classified as low socioeconomic status may have made it more difficult for them to be able to access help for certain conditions such as PTDS or other mental health services. By participating in this research, researchers are expected to help them process the trauma that we as researches may open up. Which means thet for the first time they may have access to services that were not accessible to them before (Department of Health, Education, and Welfare, 1979). This may also provide and eye-opening experience to the individual to seek help or change habits, which is a promotion benefit to the individual to make changes for a better personal outcome.

Risk and Benefits to society

When looking at risks and benefits to society we must look at society as a whole. However, also the society that our research participants live in. As discussed above some situations may cause a traumatic memory to arise causing participants to behave differently or lash out. This may cause a concern for the safety of the others who live in their community of this prison system. Are we placing those who live and interact daily with the research participants at a higher risk due to something that we may invoke during our research? It is our job to not only protect ourselves and the participants but also those around them. Monitoring the behavior and possible reactions of our participants for signs of aggression or self-harm which could have a negative affect on others is important to be done.

On the alterative, we have to look at how this research may play out to be of benefit to the population living with the research participate as well as society as a whole. Will this research provide a new treatment or preventative measure and if so, we have to weigh that against any harm at any level that might appear (Chapter 4: Assessing Risks and Potential Benefits and Evaluating Vulnerability, 2016). With this in mind we need to do our best to prevent any harm to the researchers, participants, and the society in which is interactive to try and collect the best data to provide the best information to help the most people in the long term. Considering the changes that be happening in the research participant form self-awareness and change, this may encourage others around them to also participate in other research trials or in self help to improve their daily lives, their chances of succeeding outside of prison, and thus society as a whole.

Level of IRB approval required

According to John Carroll University in their online document STEP ONE: Before you Begin (n.d.) any research that includes a human will require an IRB review.

John’s Carroll University states that:

human subject is defined as a living individual about whom an investigator conducting research obtains (1) data through intervention or interaction with the individual, or (2) identifiable private information about a human subject, which includes a subject’s opinion on a given topic. Intervention includes both physical procedures by which data are gathered and manipulations of the subject or the subject’s environment that are performed for research purposes. Interaction includes communication or interpersonal contact between investigator and subject.

Thus, the research being obtained in the correctional facility falls under this definition and will require a review by the IRB board. There are three types of IRB reviews, these review types are exempt, expedited, and a full board review (STEP ONE: Before You Begin: INVESTIGATORS’ GUIDE. (n.d.).) Due to our research study participates being a classified group that are at a higher level of possible coercion and concern for their protection as they in a group that has a higher chance of being taken advantage of, due to their incarcerations status our research in this case study would require a full board approval. (STEP ONE: Before You Begin: INVESTIGATORS’ GUIDE. (n.d.).).

 

Bibliography:

Chapter 4: Assessing Risks and Potential Benefits and Evaluating Vulnerability (Research Involving Human Participants V1). (2016, February 1). Retrieved from https://www.onlineethics.org/cms/8033.aspx

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

STEP ONE: Before You Begin: INVESTIGATORS’ GUIDE. (n.d.). Retrieved from https://jcu.edu/research/irb/investigators-guide/step-one-you-begin

 

2 Responses

  1. adcriger at |

    One thing that seems questionable in this study is that they only used incarcerated participants in one Midwestern correctional facility. According to the Belmont Report of 1974, Justice in research focuses on the duty to assign the burden and benefits of research fairly. This study failed to do that. The purpose of the study was to analyze the relationship between traumatic childhood experiences and the effect on interpersonal relationships in adulthood. By choosing only incarcerated participants justice was not adhered to. There are many other resources to find patients that have had traumatic experiences (Moon and Khin-Maung-Gyi, 2009).
    Another issues that questions the validity of this study is the sample size of thirty participants. A sample size of thirty is not a valid research study.

    References:
    Khin-Maung-Gyi, F. and Moon, M. (2009). The History and Role of Institutional Review Boards. American Medical Association Journal of Ethics, Volume 11 (Number 4,) 311-321.

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