IRB Case Study 1, Module 2-3
Risk and Benefits related to the Researcher
Benefits related to the researcher are that there are minimal risks and low experimentation due to the fact that only information is being gathered and is anonymous. There are no experimenting factors that make this a risky trial that I can see. This should make it easier to meet the demands of an IRB approval. Another benefit of the researcher is that is little to no chance that physical harm can come to those participating from the case study if protocols and anonymity are followed. These reasons should allow the case study to be less complicated for the researcher. Also, the researcher may find it beneficial that the information gathered will lead to securing funds or grants for this particular case study. Risks for the researcher may include the variables that are listed in the case study that may effect the case study outcome. Since the case study is limited to a certain region it may not be beneficial to other parts of the country where the demographics of the variables like race, ethnicity, gender, age, society status, and education level may be completely out of comparison.
Risk and Benefits related to the Participant
Benefits are that the participants remain anonymous. The National Bioehtics Advisory Commission states under approval of IRB research that, “When appropriate, there are adequate provisions to protect the privacy of subjects and to maintain the confidentiality of data.” The National Bioehtics Advisory Commission continues on to state benefits of participant are, “For example, 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 and testing, or gaining access to experimental therapies that may improve the participant’s health status.” In case study 1, the information gathered may lead to the participants and others in that region with benefits such as these. Not to mention that benefit of how it may make the participants in the study feel when they have a person to talk to about their diagnosis, they may feel support during the discussion or study, it may feel therapeutic in nature, or offer a sense of personal satisfaction just by participating. A risk for the participants would be if the data does not remain anonymous and private vulnerable information may be identified and used against an individual, or they could be targeted, breaching the laws of HIPPA. As it may be beneficial for some to be a part of a study it may bring up traumatic emotions in others that can have a negative impact on a participant.
Risk and Benefits related to Society
Benefits that are related to society from case study 1 would be the ability to track trends of HIV cases in the areas of society the case study is being done in. In this case, the Midwest region from the time frame of January 2010 to December 2011. The trends and data collected will allow this region to be better supported by the government and or state in terms of funding, resources, and whatever other support may be needed for the demand the case study shows. Also, it allows local demographics to understand the needs of people in their society who this case study pertains to. Risk related to society are that some may feel or notice a change in their society in regard to the case study and the outcome it may produce drawing people who the study does not pertain to away from that society or become not supportive out of fear.
The Need for IRB Approval
The level of IRB needed for this case study starts with Chart 1: Is an activity research involving human subjects? Yes. Are the human subjects covered by regulations? Yes. Go to chart 2: Is the human subjects eligible for exemption? HHS has not prohibited the subjects of human research (prisoners and children) in this case involves patients with HIV a non prohibited group. Is research involving collection or study of existing data? Yes. Go to chart 5: Does exemption 45 CFR 46.101 apply? Moving through this chart to if the investigator gathering data or information will be done so in such a manner that the subjects cannot be verified directly (in this case study they are anonymous) or to identifiers linked to the subject, than the research is eligible for exemption under 45 CFR 46.101(b)(4) from 45 CFR part 46 requirements. This means this study may be exempt from an IRB approval(Hhs. gov 2019). Initially I thought of course they would have to have IRB approval because they are human subjects.
This is my interpretation of the charts and algorithms provided, however I could be extremely wrong. I feel as if I am trying to make sense out of something I am barely understanding at this point.
American Association of Public Opinion Research. (n.d.). IRB FAQs for Survey Researchers. Retrieved from https://www.aapor.org/Standards-Ethics/Institutional-Review-Boards/IRB-FAQs-for-Survey-Researchers.aspx#question4
CDC. (2019, October 30). Surveillance Overview. Retrieved from https://www.cdc.gov/hiv/statistics/surveillance/index.html
Hhs.gov. (2019, June 18). Human Subject Regulations Decision Charts. Retrieved from https://www.hhs.gov/ohrp/regulations-and-policy/decision-charts/index.html
National Bioethics Advisory Commission (2020). Exhibit 4.2: using the framework to assess risks and potential benefits. Report of Ethical and Policy Issues in Research Involving Human Participants Volume 1 – Report and Recommendations. Retrieved from https://www.onlineethics.org/cms/8033.aspx#exhibit4-2