Conducting research with strong ethical principles is a critical component of being an effective nurse researcher.
- In the research simulation activity, which character(s) did you play?
- What did you learn about ethical principles in research?
- Are ethics in research clear cut, or do you think there are some gray areas?
- Provide examples from the simulation activity.
Steps to complete this assignment
- Open the website https://ori.hhs.gov/research-clinic(Links to an external site.) and click “Play Full Video.”
- Watch the introductory video, and then select the character you want to play. You may play as many characters as you like.
- Click “Jan Klein, RN” to play the simulation from a nurse perspective.
- Complete the simulation and answer the discussion prompt.
In the research simulation activity, which character(s) did you play?
Jan Klein, RN a clinical research coordinator (CRC)
What did you learn about ethical principles in research?
Research involving human subjects is regulated by the Institutional Review Board (IRB), a regulatory body that oversees the research to ensure that the rights and welfare of research participants are maintained. Before any research involving human subjects can be conducted, IRB has to be consulted to approve the study. One of the major ethical principles in research is informed consent. It involves providing comprehensive information to the participants before deciding whether they want to enroll in the study or not. While some participants may not be attentive and might prefer to skip the process, it is the role of the CRC to ensure that all the information is given and the participant understands the benefits, risks, and the treatments in the research before they are allowed to sign the informed consent form. Any irregularities observed by the CRC should be reported to the supervisors for further investigations. The CRC should also ensure that all research team members are aware of the purpose of the study, protocols to be followed, such as inclusion and exclusion criteria, regulatory requirements, acceptable standards of practice, and other factors (The Office of Research Integrity, 2021).
Are ethics in research clear cut, or do you think there are some gray areas?
Research ethics are clear-cut since there are established protocols, guidelines, and support systems to ensure that studies, including human subjects, adhere to specific regulations. For example, when Dr. Sowers, the PI, approaches Klein to include a patient into the first phase of the study, she insists that IRB has not yet approved the study protocol and response of Dr. Sowers indicates he is aware of the step only that he is trying to ignore it. This indicates the ethics are regulations are clear. Annie Bailey, also CRC, is captured reading the updated guidelines on new protocols, which confirms that ethics in research are clear without grey lines. Also, there are established lines of reporting whenever a CRC notes irregularities. For example, when Klein suspected data falsification, she was required to report it to the regulators, who then investigated the issue to confirm whether the research adhered to the set guidelines. The several support systems placed at every research project stage show that ethics are clear cut in research (The Office of Research Integrity, 2021).
Response 1: Herman
Clinical research aims to advance human health by making new treatment discoveries and ensuring that medications used for therapy provide adequate benefits to the general public. However, when conducting research, the researchers need to ensure that they observe the established ethical guidelines to maintain the integrity of the participants. The initial step to conducting clinical research is acquiring IRB approval, a regulatory body tasked with ensuring the welfare and integrity of research participants is maintained. Dr. Sowers, however, seemed not to be mindful of the requirement. For a study to be approved by IRB, it must show that subjects will be exposed to minimal risks relative to the expected benefits, there was equitable subject selection, data will be collected adequately and safely, among others. (Research Administration, 2021).
Response 2: (Jean)
Among the ethical principles of research is informed consent, which requires that research subjects decide whether to participate or not without any coercion; for participants to make the decision, they have to be fully informed. The CRCs are usually tasked with explaining to the subjects the methods, purpose, benefits, and risks associated with the research process. The CRC should also inform the participant of other alternatives if they choose not to participate in the study. The process is of informed consent is usually tiring for both the participant and the CRC; however, all details must be explained and participants’ understanding assessed before they can be allowed to sign an informed consent form. The CRC has other roles such as documentation and coordinating the research effort among all those involved to ensure that all ethical principles are followed (National Institutes of Health, 2021).
Institutional Review Board (IRB) is the institution tasked with ensuring that research involving human subjects adheres to the set regulation. It was founded in 1974 after the national research act was signed into law. Among the ethical principles of research is informed consent, which requires that the patients are fully informed before they can make an independent decision whether to participate or not. A favorable risk-benefit ratio requires that patients are exposed to minimum risks throughout the research and maximize potential benefits. For example, Jan Klein, RN a CRC, refused to enroll participants who did not meet the criteria since they were more likely to be harmed than benefit from the trial. While investigators can ignore some of the regulations, it is the responsibility of the CRC to ensure that all the regulations are followed and where they are violated, they can report to their institution supervisor so that the issue is addressed (Spellecy & Busse, 2021).
National Institutes of Health, (2021) Guiding Principles for Ethical Research: Pursuing Potential Research Participants Protections Retrieved from: https://www.nih.gov/health-information/nih-clinical-research-trials-you/guiding-principles-ethical-research
Research Administration, (2021) Guidance: Requirements for IRB Review and Approval Retrieved from: https://ora.research.ucla.edu/OHRPP/Documents/Policy/12/IRB_Review_Requirements.pdf
Spellecy, R., & Busse, K. (2021). The history of human subjects research and rationale for institutional board review oversight. Nutrition in Clinical Practice. https://aspenjournals.onlinelibrary.wiley.com/doi/abs/10.1002/ncp.10623