Case Study 1

In Case Study 1, investigators are analyzing the differences in race and HIV positive test results.  The test results are from anonymous demographic data that was collected at the point of service during initial testing.  The testing was performed, and demographic data collected at government-funded clinics in the Midwest region of the US from January 2010-December 2011.  This is retrospective data previously collected.  Analysis variables include race, ethnicity, gender, socioeconomic status, age group, and education level.

The first portion of the assignment asks us to analyze the risks and potential benefits of the research study.  This includes the risks and benefits for the researcher, participant, and society.  I have used the provided resources, as well as a few others I obtained during research for this assignment, to support my views and opinions.

Risks

The risks to the participants in the case study are minor.  The data has already been collected and will not be ongoing.  The data is also said to be anonymous, so it cannot be linked to a specific patient.  There is no risk of physical or psychological harm, since the data is demographic and was already collected at the point of service.  The investigators can minimize risks by making sure their study design is valid, and that all investigators are qualified (Online Ethics Center for Engineering, 2006).   Essentially, any investigation or any testing that might be required of the patients is finished, and researchers are now going back to study the links between HIV and race.  The risks to the researchers are minimal in this study.  As previously noted, the samples have already been collected and the data is already gathered.  The researcher does not have to interview or test any participant in the study.  There are no invasive or risky procedures involved in the study.  The researchers can minimize their risk by making sure to put together a team with enough experience to manage the research and ensuring the sample size is adequate to give advantageous results (Online Ethics Center for Engineering, 2006).  The risks to society are negligible in this study.  However, one potential risk to society in general could be found if the study were to show any links between certain races or ethnicities and HIV.  This could lead to stigmatization against these ethnic groups (Online Ethics Center for Engineering, 2006).

Benefits

The goal of research is to develop knowledge that is beneficial to society (Online Ethics Center for Engineering, 2006).  This research in the case study could potentially result in new treatments because it could be applicable to many social groups.  The variables in the study include race, ethnicity, and age group, which could influence new treatments or cures.  For example, it could be found that certain ethnicities have a higher likelihood of a positive HIV test.  Prevention could then be more targeted to that specific population to help decrease incidences of HIV.  Or, this study could lead to a future study to find out if certain HIV treatments or medications are more effective in certain populations due to genetics.

It is stated that the participants in this study are anonymous, since the study is using demographic data that was already collected.  However, in a general sense, the participants could benefit from significant information gleaned from the study.  For example, the care that is provided to certain groups with HIV (ethnicities, male/female, age categories) could change for the better after the study, or new treatments could be developed.  If this study demonstrates any link between HIV and race, ethnicity, gender, socioeconomic status, age group, and education level that is not currently known, the researchers could possibly benefit by gaining funding or resources to improve their program or enhance/continue research (Online Ethics Center for Engineering, 2006).

Level of IRB Review

The second half of the assignment involves the level of IRB review that will be needed for this particular study.  I know that an IRB review will be required, because the study involves research with human subjects.  According to the Code of Ethics by the American Nurses Association, all research must be approved by an official established and qualified review board prior to the execution of the research.  This ensures the protection of the participants in the study and moral integrity of the research (American Nurses Association, 2014).  The three levels of IRB review are Full, Expedited, and Exempt (John Carroll University Office of Sponsored Research, n.d.).  The level of IRB review needed for this study would be at the Exempt level.  There are eight different categories of Exempt studies.  Specifically, this study would be Category Four Exempt.  Category Four of the Exempt level is research relating to data, records, or specimens if the sources are publicly available, OR the information is recorded in such a way that subjects cannot be identified directly.  The data samples must already exist at the time the investigator submits the research protocol (Oregon State University, n.d.).  There is minimal risk to these study participants.  This data has been previously collected.

Category Four Exempt review has four sub-criteria, and at least one of them must be met.  The four sub-criteria are: 1) the data is publicly available OR 2) de-identified/anonymous 3) The research involves only information collection and analysis involving the investigator’s use of identifiable health information when that use is regulated, and 4) The research is conducted by, or on behalf of, the federal government or federal government agency using government-generated or government-collected information (John Carroll University Institutional Review Board, 2018).  In this particular case study, two of the four subcategories are met: Sub-category 2 and sub-category 4.  The case study specifies that the demographic data is anonymous.  It is not linked to any specific individuals.  It is also specified that the data is retrospective and has been previously collected.  Data will not continue to be gathered.  This is secondary research.  The data is anonymous, and there are no patient identifiers.  It is also stated that the data was collected at government-funded clinics.

References

American Nurses Association. (2014). Code of ethics for nurses with interpretive statements. Retrieved January 27, 2020, from https://homecaremissouri.org/mahc/documents/CodeofEthicswInterpretiveStatements20141.pdf

John Carroll University Institutional Review Board. (2018, November). Exempt research categories. Retrieved January 23, 2020, from http://webmedia.jcu.edu/research/files/2019/01/Exempt-Research-Categories.pdf

John Carroll University Office of Sponsored Research. (n.d.). Things to do and know before preparing your IRB application. Retrieved January 23, 2020, from https://jcu.edu/research/irb/investigators-guide/step-one-you-begin

Online Ethics Center for Engineering. (2006, June). Chapter 4: assessing risks and potential benefits and evaluating vulnerability (research involving human participants v1). Retrieved January 23, 2020, from https://www.onlineethics.org/cms/8033.aspx#risks

Oregon State University. (n.d.). Exempt categories table. Retrieved January 23, 2020, from https://research.oregonstate.edu/irb/types-review/exempt-review-guidance/exempt-categories-table