Ethical Issues in Conducting Research

Ethical Issues in Conducting Research

Ethical Issues in Conducting Research

“Ethics is the branch of philosophy which deals with the dynamics of decision making concerning what is right and wrong” (Fouka & Mantzorou, 2011, p. 4).  Producing research that is ethically sound is important because it ensures that participants’ rights are protected (Polit & Beck, 2017, p. 137).  A researcher’s desire to produce sound evidence may sometimes conflict with ethical requirements, but nevertheless ethical requirements should be followed to protect participants’ rights (Polit & Beck, 2017, p. 137).  Polit & Beck (2017) provide three principles which ethical standards are based upon: beneficence, respect for human dignity, and justice (p. 139).  Beneficence is concerned with maximizing benefits and limiting harm (Polit & Beck, 2017, p. 139).  Respect for human dignity includes the right to self-determination and the right to full disclosure (Polit & Beck, 2017, p. 140).  The right to self-determination ensures that study participants can voluntarily take part in research, while the right to full disclosure ensures that participants are able to make an informed decision about participation in a study by being informed about: the study itself, right to refuse, researchers’ responsibilities, and risks/benefits of participation (Polit & Beck, 2017, p. 140).   Justice concerns the right to fair treatment and the right to privacy (Polit & Beck, 2017, p. 141).  The right to fair treatment ensures equal distribution of the benefits and burdens of research; this means that participants should not be selected based upon their vulnerable status and that women and minorities should be included in research where applicable (Polit & Beck, 2017, p. 141).  The right to privacy ensures that private information, such as beliefs, attitudes, opinions, or records, will not be shared with others unless consent is given by the participant (Fouka & Mantzorou, 2011, p. 6).Ethical Issues in Conducting Research

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Recent Health-related Case with a Breach of Research Ethics

In 2013, an unethical research study was conducted on 572 patients who were to undergo cadaveric kidney transplantation at a Portland VA facility (Carome & Wolfe, 2016).   The study, A Randomized Trial of Hypothermia in Deceased Organ Donors for Protection Against Delayed Graft Function in Kidney Transplant Recipients, was a randomized trial in which patients received cadaver donor kidneys that were either normothermic (temperature of 36.5-37.5̊ C) or hypothermic (temperature of 34-35̊ C) to determine if the temperature of the donor kidney had any effect on the rate of delayed graft function in recipients (Carome & Wolfe, 2016). Delayed graft function is defined as the requirement for dialysis during the first week after transplant (Carome & Wolfe, 2016). The study was funded by the Department of Health and Human Services (HHS) (Carome & Wolfe, 2016).

This study was evaluated by the University of California, San Francisco Institutional Review Board (IRB) prior to initiation, however, the IRB found the research to represent nonhuman subjects and deemed that informed consent would not be necessary because the study posed minimal risk to the organ recipients (Nieumann et al., 2015, p. 406).  This is problematic because even though the kidney donors were deceased, the subjects who received the cadaver kidneys were not.  Human subjects are living individuals about whom a researcher obtains: data through intervention or interaction with the individual or identifiable health information (Carome & Wolfe, 2016).  Under HHS and VA regulations, an IRB may only waive the informed consent requirement if (1) the research involves minimal risk, (2) waiver does not affect rights or welfare of participants, (3) research could not be completed without the waiver, or (4) when appropriate, subjects are provided with additional relevant information after trial is completed (Carome & Wolfe, 2016).Ethical Issues in Conducting Research

Ethical Principles That Were Breached

First, the principle of respect for human dignity was violated.  Based upon the IRB evaluation, the researchers failed to acquire informed consent from the cadaver kidney recipients despite the facts that this study was performed on human subjects and that the risk of participation in the study for the kidney recipients could not be predicted to be minimal.   According to Polit & Beck (2017), informed consent involves communicating the following information to participants: difference between standard and research treatments, study goals, data to be collected, data collection and intervention procedures, nature of commitment, sponsorship information, participant selection methods, potential risks, potential benefits, alternative treatments, compensation, confidentiality pledge, voluntary nature of consent, right to withdraw or withhold information, and researcher contact information (p. 143-144).  Second, the principle of beneficence could have been violated.  Researchers did not conduct a risk/benefit assessment or ensure that participants were informed of the risks and/or benefits of the trial.  Even though participants did not suffer any known consequences from the trial and results showed decreased rate of delayed graft function, participants should have been informed of potential risks such as increased rate of delayed graft function (Carome & Wolfe, 2016).  This again was likely not done because of the IRB evaluation that determined that informed consent was not necessary, however an ethically prudent researcher should know that informed consent needs to be completed with experimentation on human subjects.

Conducting the Study Differently to Minimize Ethical Problems

First, the researchers should have sought approval from the VA or HHS IRBs prior to trial initiation so that appropriate ethical standards were followed.  Secondly, researchers should have performed the trial on animal subjects prior to performing the trial on human subjects and conducted a risk/benefit assessment post-trial to determine possible outcomes.  Third, researchers should have obtained informed consent from participants prior to study initiation. Participants should have been informed about the study (including the risks, benefits, and alternatives) and been allowed to make a voluntary decision to participate based on their understanding (Polit & Beck, 2017, p. 143).Ethical Issues in Conducting Research

How Research Can Be Done on Sensitive Issues While Protecting Subjects’ Rights

Under the principle of beneficence, study participants have the right to freedom from harm and discomfort as well as the right to protection from exploitation.  According to Polit & Beck (2017), “Protecting human beings from physical harm may be straightforward, but the psychological consequences of study participation are usually subtle and require sensitivity” (p. 139).  Participants might reveal highly personal information over the course of a study such as their personal views, weaknesses, or fears. Researchers must be aware of their intrusion on people’s psyches, especially in qualitative research where in-depth personal topics are explored (Polit & Beck, 2017, p. 139). An example of this would be asking a parent of a child with cancer what kind of coping mechanisms they use.  Probing for information from this population could be traumatic and cause great pain to participants. To minimize the risks of such a study, researchers should conduct a risk/benefit assessment which considers the risks to the participant in comparison to the benefit to society (Polit & Beck, 2017, p. 142).  The right to protection from exploitation provides that involvement in a study should not place participants at a disadvantage. An example of this would be research done on an illegal drug user.  The drug user should not fear criminal punishment for participation in the research (Polit & Beck, 2017, p. 139). A Certificate of Confidentiality may be helpful for research with this population as it allows researchers to refuse to disclose information on a participant in any court proceeding (Polit & Beck, 2017, p. 149).  Ethical Issues in Conducting Research

Under the principle of respect for human dignity, patients have the right to full disclosure which means that participants should be provided with the necessary information to make an informed, voluntary decision to participate in a study.  Covert data collection or the collection of data without participant knowledge or consent should not be done on sensitive issues such as sexual conduct or drug use (Polit & Beck, 2017, p. 140-141).  For issues such as those, informed consent should be obtained and a certificate of confidentiality should be obtained to protect the participants of the study (Polit & Beck, 2017, p. 143-148).

Under the principle of justice, study participants have the right to privacy.  The right to privacy says that researchers should ensure that participant privacy is maintained and that research is only as intrusive as it needs to be (Polit & Beck, 2017, p. 141).  Right to privacy may be protected through anonymity or confidentiality.  Anonymity occurs when a researcher cannot link data to the participant (Polit & Beck, 2017, p. 147).  When a researcher pledges confidentiality, they are promising that any information obtained will not be publicly reported or accessible to others (Polit & Beck, 2017, p. 147).

References:

Fouka, G. & Mantzorou, M. (2011). What are the Major Ethical Issues in Conducting Research? Is there a Conflict between the Research Ethics and the Nature of Nursing? Health Science Journal, 5 (1), p. 3-14.  Retrieved from the Walden Library databases.

Niemann et al. (2015). Therapeutic Hypothermia in Deceased Organ Donors and Kidney Function. New England Journal of Medicine, 373, 405-414. doi: 10.1056/NEJMoa1501969

Polit, D. F. & Beck, C. T. (2017). Nursing Research: Generating and Assessing Evidence for Nursing Practice (10th ed.). Philadelphia, PA: Wolters Kluwer.

Carome, M. A. & Wolfe, S. M. (2016). Public Citizen: Re: A Randomized Trial of Mild Hypothermia in Deceased Organ Donors for Protection Against Delayed Graft Function in Kidney Transplant Recipients.  Retrieved from https://www.citizen.org/sites/default/files/2315.pdf.Ethical Issues in Conducting Research

 

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