Essay Sample Trying to Determine Boundaries to Informed Consent

Are there boundaries to informed consent?

According to Grady (2015), informed consent has been accepted by the researchers and the bodies mandated to govern research studies as a legal, ethical, and regulatory requirement for most studies (Yip, Han, & Sng, 2016). Informed consent is comprised of eight key elements which the participants are required to be aware of before agreeing to participate in the research. The informed consent informs potential participant about the purpose of the study, the length of the study, freedom to withdraw from the study without any consequences, factors that are important in their decision to participate or not, benefits of the research or incentives, confidentiality, and contact information regarding their rights (Patel, Moore, Craver, & Feldman, 2016). For a research study to be considered to have adhered to all the informed consent requirements, the prospective research participants should be able to have confidence that all the eight elements have been adequately addressed by the researcher.

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Failure of researchers to obtain inform consent from the potential participants may result in lawsuits should something go wrong during the research process (Turillazzi & Neri, 2015; Grauberger et al., 2017). For instance, if the participants end up being emotionally and psychologically distressed as a result of being part of the study they were not fully briefed on, they may seek compensation through available legal channels. Despite being an essential part of the research process, past studies have shown that the present strict boundaries of informed consent may sometimes hinder rather than enable the research process. For instance, it has been reported that confidentiality assurances in informed consent may sometimes make the prospective research subjects to be apprehensive of the research process and thus less likely to participate in the study (Walkup & Bock, 2008). Moreover, it has been reported that when confidentiality is over-emphasized, the participants shy away from the study because they believe their personal data may land in the wrong hands.

Walkup and Bock (2008) also established that not all the eight elements of informed consent are regarded by the participants as necessary. That is, information considered vital by one research (such as confidentiality) subject before undertaking the study may be unnecessary for another participant. Consequently, I believe that the existing boundaries on what information a research participant should be made aware of should be scrapped. Accordingly, as highlighted by D'Abramo, Schildmann, and Vollmann (2015), offering a choice to the potential research subjects for an individualized consent should be considered.

Situations When Withholding Information from Research Subjects is Acceptable

Withholding information from research subjects is considered a violation of the ethical principles of research involving human subjects. However, there are situations where the researchers may be forced to deny the participants information pertaining to a particular research study. For instance, according to University of California Los Angeles Office of the Human Research Protection Program (2014), incomplete disclosure of information or deception may be appropriate in some studies because of its ability to enhance scientific validity because it enables the researchers to get unbiased data regarding participants' attitudes and behavior in situations where truthful disclosure could possibly lead to biased responses by research subjects.

Additionally, a researcher may be given an approval to proceed with a study involving withholding of information from the participants if the Institutional Review Board considers the research as a minimal risk (University of California Los Angeles Office of the Human Research Protection Program, 2014). For instance, in a study intended to explore the relationship between laughter and stress, it is not necessary to divulge a lot of details to the researcher since failure to provide such information may not lead to physical or emotional distress on the affected individuals.

Similarly, the University of Nevada, Reno (2018) agrees that researchers who are planning to withhold some information from the participants must supply the IRB with sufficient information to explain why failure to disclose information is needed for the conduct of the research. Moreover, non-disclosure of information is also allowed if it does not lead to increased risks beyond what the research subjects would agree if full-disclosure of all research aspects was made. On the other hand, if the research study has greater than minimal risk, complete disclosure or deception is not used. Furthermore, a researcher can be allowed to use deception if the purpose of the study is to assess the behaviors or responses that are likely not to be the same if the participants had full information pertaining the study.

The researchers are also allowed to use deception if withholding research information does not have a negative impact on the rights and welfare of the participants. In this arrangement, the subjects are provided with all the information about the study after participation. Lastly, it is worth noting that a researcher will be allowed to withhold information if they do not cheat the participants on significant aspects of the study that is likely to have an effect on their willingness to participate (Swarthmore College, 2018).

References

D'Abramo, F., Schildmann, J., & Vollmann, J. (2015). Research participants' perceptions and views on consent for biobank research: a review of empirical data and ethical analysis. BMC Medical Ethics, 16(1), 60.

Grady, C. (2015). Enduring and emerging challenges of informed consent. New England Journal of Medicine, 372(9), 855-862.

Grauberger, J., Kerezoudis, P., Choudhry, A. J., Alvi, M. A., Nassr, A., Currier, B., & Bydon, M. (2017). Allegations of failure to obtain informed consent in spinal surgery medical malpractice claims. JAMA Surgery, 152(6), e170544-e170544.

Patel, N. U., Moore, B. A., Craver, R. F., & Feldman, S. R. (2016). Ethical considerations in adherence research. Patient Preference and Adherence, 10, 2429.

Swarthmore College (2018). Deception, incomplete disclosure, and debriefing. Retrieved from https://www.swarthmore.edu/institutional-review-board/deception-incomplete-disclosure-and-debriefing

Turillazzi, E., & Neri, M. (2015). Informed consent and Italian physicians: change course or abandon ship-from formal authorization to a culture of sharing. Medicine, Health Care and Philosophy, 18(3), 449-453.

University of California Los Angeles Office of the Human Research Protection Program (2014). Guidance and procedure: deception or incomplete disclosure. Retrieved fromora.research.ucla.edu/OHRPP/Documents/Policy/8/Deception.pdf

University of Nevada, Reno (2018). Informed consent and incomplete disclosure or deception. Retrieved from https://www.unr.edu/research-integrity/human-research/human-research-protection-policy-manual/342-informed-consent-and-incomplete-disclosure-or-deception

Walkup, J., & Bock, E. (2009). What do prospective research participants want to know? What do they assume they know already? Journal of Empirical Research on Human Research Ethics: JERHRE, 4(2), 59-63.

Yip, C., Han, N.-L. R., & Sng, B. L. (2016). Legal and ethical issues in research. Indian Journal of Anaesthesia, 60(9), 684-688.