Ethical guidelines and Institutional Review Board
Topic 3 DQ 1
Discuss the ethical guidelines that would need to be implemented when conducting translational research. What are the ethical and legal considerations related to translating research into practice? Discuss what steps you would take as a member of a translational research team in order to establish ethical guidelines for conducting translational research.
Sample student answer One
Translational research is intended to create significant impact on population health outcomes. Therefore, the ramifications are dire in the event that ethical guidelines are not adhered to. When dealing with human participants in translational research, the ethical guidelines that govern nursing practice needs to be adhered to; that is beneficence and non-maleficence, justice and respect for patient autonomy (Olson & Stokes, 2016). These guidelines provide a direction and benchmark through which legal and ethical considerations need to be adhered to when implementing translational research.
According to Mandal et al. (2017), translational research needs to ensure that the interventions implemented poses as little harm to the participants as possible. Any research that has high potential for harm, without putting in place the necessary safeguards are considered unethical and could also lead to legal ramifications. Likewise, the translational researchers also need to ensure that the participation is voluntary, with approved informed consent from the participants.
Doing any research without disclosing the same to the participants is considered unethical. Other considerations include maintaining patient confidentiality and anonymity in accordance with the HIPAA rules and regulations.
Some of the steps that I would take to as a member of the translational research team to establish ethical guidelines for conducting translational research include informing the team members on the relevant research guidelines involved in implementing such a research. I would also ensure that all stakeholders involved in the research are identified and properly notified on the ongoing translational research and their roles in the research. I would also advocate for a periodical review to assess compliance of legal and ethical guidelines involved in translational research.
References
Mandal, J., Ponnambath, D. K., & Parija, S. C. (2017). Ethics of translational medical research. Tropical parasitology, 7(2), 62–64. https://doi.org/10.4103/tp.TP_47_17
Olson, L. L., & Stokes, F. (2016). The ANA code of ethics for nurses with interpretive statements: Resource for nursing regulation. Journal of Nursing Regulation, 7(2), 9-20. https://www.nursingworld.org/practice-policy/nursing-excellence/ethics/code-of-ethics-for-nurses/
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Sample student response two
There are several ethical consideration in translational research. As a healthcare professional, we have an obligation to do no harm and our actions are to promote good. Researchers have this same moral obligation for their research participants. Protecting human rights in research studies is outlined in The Belmont Report. There are three basic ethical principles that are set as guidelines for research studies involving human subject.
Respect of persons, beneficence and justice are the three basic ethical principles (OHRP, 2018). Respect of persons is divided into two separate moral considerations: individuals should be treated as autonomous agents and a requirement to protect those with diminished autonomy (OHRP, 2018). Beneficence is treating each participant in an ethical manner by respecting their decisions and protecting them from harm. The last ethical principle of justice is making sure all participants are treated in a fair and equal manner.
As part of a translational research team, I would first read the The Belmont Report to help guide the steps and decisions made when it comes to protecting the rights of the study participants. Setting guidelines for participate selection is another important step. I would consider the risk and benefits to participants and obtain informed consent before the start of any research study. It is important that participants have all the information provided to them to be able to make an educated decision to participate.
Reference:
Office of Human Research Protections (OHRP). (2018, January 15). Read the Belmont report. HHS.gov. Retrieved December 11, 2021, from https://www.hhs.gov/ohrp/regulations-and-policy/belmont-report/read-the-belmont-report/index.html
Topic 3 DQ 2
Discuss the role of the Institutional Review Board. Discuss ethical guidelines and research considerations specific to population health. How are respect for the persons, potential benefits and burdens of the research, and justice kept in balance? Provide an example.
Sample student response one
The Institutional Review Board (IRB) has been given the mandate under the Food and Drug Administration (FDA) regulations to approve or disapprove research. The review al studies involving human subjects to ensure that their rights, safety, and welfare are safeguarded They accomplish this by using a group process to review research protocols and related materials to safeguard human rights and welfare during research (U.S. Food and Drug Administration, n.d.). Therefore, through the regulatory mandate given to the board, they ensure that ethical considerations involving human research are adhered to during the entire research process.
Ethical considerations need to be adhered to at all times when conducting research, especially research that involves human subjects and have implications on population health outcomes. One of the ethical research considerations specific to population health as noted by DeCamp et al. (2018) is non-maleficence and beneficence. When commissioning any research that involves population health, the research team needs to ensure that the research is done for the benefit of the population with as little harm as possible.
Any unnecessary harm of situations that may lead to unintended harm needs to be considered with proper interventions taken to avoid them. Another consideration is respect for persons, where the research team recognizes that the participant is autonomous, with the right and capacity to decide (DeCamp et al., 2018). Third consideration is justice and fairness where the benefits of the research needs to be shared across the entire population, which can be achieve by objective selection of the participants in the research.
The ethical considerations are kept in balance by strictly following the recommended research protocols and regulatory guidelines. For example, selection of participants needs to be unbiased with equal treatment of all participants in the same research group to ensure the elements of justice and respect of persons is kept in balance. Respect of persons can be realized by providing the participants informed consent and informing them all through on the activities involved in the research.
Reference
DeCamp, M., Pomerantz, D., Cotts, K., Dzeng, E., Farber, N., Lehmann, L., Reynolds, P. P., Sulmasy, L. S., & Tilburt, J. (2018). Ethical Issues in the Design and Implementation of Population Health Programs. Journal of General Internal Medicine, 33(3), 370–375. https://doi.org/10.1007/s11606-017-4234-4
U.S. Food and Drug Administration (n.d.). Institutional Review Boards Frequently Asked Questions. https://www.fda.gov/regulatory-information/search-fda-guidance-documents/institutional-review-boards-frequently-asked-questions
Sample student response two
Ethical guidelines in research are put in to place to protect the participants taking part in the research. These guidelines also protect the integrity of the data gathered during the research process. The institutional review board (IRB), or a research ethics committee must approve all research studies involving human participants to ensure that ethical regulations and standards are being followed and met (Oermann, Barton, Yoder-Wise, & Morton, 2021).
When conducting research, ethical guidelines must be adhered to. Ethical considerations concerning population health can vary depending on the population being served. Cultural considerations must be respected. Respect for the persons, potential benefits and burdens of the research, and justice are kept in balance by the research team respecting patient rights. When the patient’s rights are honored, those things will be met (Acadia, 2016).
An example of this could be modifying a patient’s diet during a research trial to adhere to the patient’s dietary restrictions. As long as this does not jeopardize the integrity of the research, it is a great way to respect the person.
References
Acadia, S. (2016). Knowledge translation and ethics in public and population health from a knowledge management perspective. Ethics, Medicine and Public Health, 2(2), 302–309. https://doi-org.lopes.idm.oclc.org/10.1016/j.jemep.2016.04.012
Oermann, M. H., Barton, A., Yoder-Wise, P. S., & Morton, P. G. (2021). Research in nursing education and the institutional review board/ethics committee. Journal of Professional Nursing : Official Journal of the American Association of Colleges of Nursing, 37(2), 342–347. https://doi-org.lopes.idm.oclc.org/10.1016/j.profnurs.2021.01.003
Jermaine Byrant
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