How it supports or doesn’t support the Belmont Report’s Respect for Persons principle

  1. Review the Belmont Report to refresh your memory on Respect for Persons.

· https://www.hhs.gov/ohrp/regulations-and-policy/belmont-report/read-the-belmont-report/index.html

  1. Find an article through the Madonna Library that addresses the research ethical principle of Respect for Persons, but specifically addressing vulnerable subjects.

· Vulnerable subjects are:

· Children

· Prisoners

· Pregnant women

· Minorities

· Economical or educationally disadvantaged

· Terminally ill

· AIDs/HIV+ subjects

  1. Write a discussion post of at least 500 words. Be sure to include the following:

· A summary of your article

· How it supports or doesn’t support the Belmont Report’s Respect for Persons principle

· The type of accommodations the researchers made to allow them to do the research

· Two questions for your peers to answer having to do with Respect for Persons. It can be specific to your posting or it can ask them about the article they chose.

· A citation of your article in 7th edition APA format

  1. Respond to at least 2 peers’ postings. Answer their questions in a posting of at least 100 words. If possible, respond to someone who hasn’t had a response yet.

Responses student 1 haley

Hi everyone,

The purpose of the article I choose was to highlight the need to protect the rights of human subjects in research and procedures to navigate through that. Previously most researchers avoided using subjects that fell under the “vulnerable group” umbrella for various reasons; difficult to access, too easy to access, or lacking proper guidelines (Ketefian, 2015). Leaving these groups ignored or treated unequally if included. There are a couple examples, highlighted in the Belmont Report such as the Tuskegee Syphilis Study where the ethical principle Respect for Persons was completely lacking. Fortunately we have come a long way in terms of guidelines and procedures to follow to prevent these types of things from happening again. Because not only does that cause harm to the participants in the study but it creates a distrust in the population regarding participating in research. Knowledge of studies blatantly ignoring important ethical principles can create a sense of hesitancy to participate in research as people may think that they may end up harmed.

The Department of Health and Human Services (DHHS) outlines the following groups as vulnerable

· Pregnant women and fetuses

· Children and minors

· Cognitively imparted persons

· Prisoners

· Terminally ill patients

· Elderly persons

· Minorities

(Ketefian, 2015)

Ketefian (2015), highlights the following guidelines for the inclusion of children and pregnant women in research. One guideline states, that in the case of pregnant women, the risk to the woman and/or fetus should be weighed against the knowledge yield. In addition, under some circumstances the father may even be asked to provide consent along with the woman. In research involving neonates, Ketefian (2015) states that both parents must give approval.

This article supports the Belmont’s Report’s Respect for Persons principle by implementing guidelines for navigating research with these different vulnerable groups. Respect for persons is what seems to be pretty straight forward. Individuals should be treated as autonomous agents and those with diminished autonomy as well as they are entitled to protection (The National Commission, 1979). An autonomous person would be defined as an individual capable of decision making regarding personal goals and health (The National Commission, 1979). Those with diminished autonomy would fall under the vulnerable group umbrella, where researchers are going to have to follow specific guidelines for including them in their research. The National Institutes of Health now requires the inclusion of such groups or will have to provide a rationale as to why these groups would not be included (Ketefian, 2015).

Two questions to my peers:

What is an example you thought of for the ethical principle respect for persons?

How can we as nurses implement this ethical principle in to our practice moving forward?

Response student 2

Respect for persons is a primary ethical principle that was outlined in the Belmont report. Respecting patients and their right to autonomy are essential for research subjects. Autonomy is an ethical principle defined by individuals’ freedom to make their own decisions (Black, 2017). When working with vulnerable populations, the researchers must aim to protect their self-determination. Vulnerable populations may include children, minorities, pregnant women, economically disadvantaged, or terminally ill individuals. According to the National Commission for the Protection of Human Subjects of Biomedical and Behavioral Research NCPHSBBR, research participation should not be coerced, and additional protection should be put into place to protect vulnerable populations. Showing respect for persons involves ensuring that informed consent (NCPHSBBR, 1978). Consent is a continuous process, and the subject has the autonomy to withdraw consent at any time.

In 1989 research was done on the Havasupai Tribe with the intent to utilize blood samples to research the increased incidence of diabetes mellitus in their tribe (Van Assche et al., 2013). The tribe’s leader approached researchers at Arizona State University, asking if they would investigate why diabetes was increasing within their tribe (Van Assche et al., 2013). The researcher Professor Martin had gained the trust of the tribe and obtained blood samples from 100 participants (Van Assche et al., 2013). Research participants were guided to believe that this study would help their community by evaluating diabetes so that they could decrease its devastating effect (Van Assche et al., 2013). One of the researchers, Dr. Markow, was more interested in the tribes’ cases of schizophrenia and proceeded with her own agenda (Van Assche et al., 2013). Researchers falsely obtained consent from tribal members and utilized their data for diabetes research as well as research on schizophrenia. Once the Havasupai tribe learned how their blood samples were being used, the tribe became distressed (Van Assche et al., 2013). To this day, many tribe members will not seek out medical treatment due to this incident (Van Assche et al., 2013).

The Havasupai tribe is in the village of Supai at the bottom of the Grand Canyon; they are a vulnerable population of 650 tribal members. Many of these individuals have English as their second language and have not obtained a high school diploma (Van Assche et al., 2013). These individuals make up a minority that is economically and educationally disadvantaged. This study contradicts the ethical principle of respect for persons as defined in the Belmont report. This tribe has diminished autonomy by being a minority group, and according to the Belmont report, should have added protection (NCPHSBBR, 1978). This research study didn’t support the group; instead, they exploited them and harmed their community. Researchers withheld information about their intentions and goals of the study; therefore, consent was falsely obtained.

Researchers were deliberate and negligent with their actions. Consent was obtained through a vague statement that wrote this research study was about the “causes of behavioral/ medical disorders” (Van Assche et al., 2013). Tribe members intended for their blood samples to only be used for research surrounding their tribe’s increased incidence of diabetes and why this was occurring (Van Assche et al., 2013). Professor Martin had worked with the Havasupai tribe before and had gained their trust (Van Assche et al., 2013). Researchers submitted separate schizophrenia and diabetes research applications on the Havasupai tribe (Van Assche et al., 2013). When consent was obtained, the tribe wasn’t made aware of the researcher’s intent. This research study unethically took place through unlawful consent, exploitation, and disrespect of persons.

Two questions to my peers:

  1. How can research be done ethically on vulnerable populations that ensures respect for persons?
  2. If you observe a colleague not having ‘respect for persons’ in a research study how would you approach that situation?

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