HCR 561 Discussion Board 5
HCR 561 Discussion Board 5
Not all researchers are fully equipped to determine when a participant has diminished decision-making capacity. Investigators and coordinators are often trained in clinical procedures but are not trained in recognizing cognitive impairments. Laura Holtz highlights that these determinations can be made effectively by the frontline research staff, particularly the coordinators, when they are adequately trained and empowered (SOCRA, 2019). Since they continuously interact with participants, frontline research staff are in a position to see small shifts in thought and cognition, especially throughout the process of informed consent.
Impaired decision-making ability can manifest itself in confusion, failure to repeat study procedures, or lack of confidence in making voluntary choices. Another promising approach that Holtz points out includes the teach-back tactic, during which the participants will have to repeat information using their own words. This aids in checking understanding and reveals the understanding gaps.
Consent management in the context of persons who are limited in their decision-making ability should be approached carefully and on a case-by-case basis. Holtz supports the use of legal representative’s authorization (LARs) where the subject is considered incapable of consenting (SOCRA, 2019). Substituted judgment and the best-interest standard are essential ethical mechanisms in instances such as: decisions must conform to the identified values, wishes, or preferences of the participant. The record should show not just what decision was made, but also how the decision was reached. This helps respect and reflect the participant’s experience, especially when they have limited decision-making ability (“Research Involving Individuals with Questionable Capacity to Consent: Points to Consider,” 2009). In the case of partial or inconsistent capacity, researchers may want to take into account a graded consent scheme, in which people offer assent together with the legal representative’s authorization (LAR) consent, thereby maximizing dignity and autonomy. The second presenter on pediatric ethics explains that age or thinking ability should not automatically exclude someone from research. Instead, each person should be involved based on what they understand and how they best communicate (CCLG, 2016).
Ultimately, ethical research also requires a balance between protection and inclusion. Instead of excluding people just because of their age or mental condition, we should assess each person individually. This helps support their independence and ensures we follow the Belmont Report’s principles of fairness, respect, and care.
References
CCLG. (2016, June 30). Ethical considerations of involving children in research [Video]. YouTube. https://www.youtube.com/watch?v=AOyUMfI3ogo
Research involving individuals with questionable capacity to consent: Points to consider. (2009). [Dataset]. In PsycEXTRA Dataset. https://doi.org/10.1037/e651372011-001
SOCRA. (2019, November 6). Including Vulnerable Subjects with Cognitive Impairment in Research [Video]. YouTube. https://www.youtube.com/watch?v=OTO40lig1Xw
HCR 561 Discussion Board 5
