Assignment: Protecting Human Subjects

Assignment: Protecting Human Subjects

Assignment Details

Unit 6 assignment: Ethics Handout

Purpose: The Purpose of this assignment is for you to learn the principles of ethical conduct in research as defined in the Belmont Report, the role of the IRB, and the role of the RN in protecting human subjects in research.

Outcomes addressed:

NU310-4: Determine the ethical principles necessary to protect human subjects and avoid scientific misconduct in research.

PC 2.3: Demonstrate integrity through the application of relevant codes of conduct and social responsibility within one’s profession.

Ethics Handout Project:

For this assignment you will create a colorful handout that you will post on a bulletin board in your staff lounge or disseminate to work colleagues to inform them of ethical conduct in human research and protection of participants.

Be creative with the handout using color and make it interesting.

I. Content of the Handout:

1. Include a brief historical overview of ethics and the need for human protection

(for example the Belmont Report and how it came about).

1. Include legal and ethical issues relevant to nursing research.
2. Briefly state the role of the Institutional Review Board (IRB).
3. Procedures for protecting individuals:
   1. Informed consent.
   2. Identify vulnerable or at risk participants and explain special considerations.
   3. Privacy and confidentiality issues.
   4. Justice and fair treatment of research participants.
   5. The RN’s role in protecting human subjects.
4. Section containing frequently asked questions concerning protection of human subjects with answers provided.

II. Presentation of Handout

1. Name and credentials at the bottom.
2. The handout should have attractive formatting that is legible and well-organized and is presented with a mix of interesting graphics along with text.
3. Handout should be colorful and interesting and well organized.
4. Spelling, grammar, and punctuation should be correct throughout the document.
5. Provide at least 5 scholarly references and list them in APA format on a separate document.

EXAMPLE PAPER

1. Historical background of human subject’s protection?

The Nuremberg Code’s three basic elements – voluntary informed consent, favorable risk/benefit analysis, and right to withdraw without repercussions – is the basis for subsequent ethical codes and research regulations. The Declaration of Helsinki, constructed on the principles of the Nuremberg Code was discharged by the World Medical Association in 1964. The first legislation to protect the rights and welfare of human subjects by the congress was the National Research Act of 1974, which later on lead to the National Commission for Protection of Human Subjects of Biomedical and Behavioral Research. This institution postulated the Belmont Report which has three fundamental principles for conducting human-subjects research: respect for persons, beneficence, and justice (Rice, 2008)

1. Find and discuss at least one historical incident of human subject’s abuse in research and what human right was violated.

The CIA’s Mind Control Program, also known as Project MKUltra is an illegal program of experiments on human subjects, conducted and performed by the United States (CIA). Its aim was to establish drugs and procedures to be utilized in investigation and persecution to compel admissions of the weakened individual through manipulation of their minds. It began in the 1950s and officially stopped in 1973. It used inadvertent U.S. and Canadian citizens as human subjects, which lead in to the questioning of its authenticity (Russell, 2008). The right to voluntary informed consent, favorable risk/benefit analysis, and right to withdraw without repercussions were all violated. Administration of medications and other chemicals, , , isolation,  and , as well as various forms of  were the methods to maneuver people’s mental states and change brain functions.

1. What steps you will take to minimize risks on human subjects?

I have thought of three steps to minimize risk on human subjects. It is necessary that the subjects are provided with comprehensive and detailed information in the protocol related to the design of the experiment and the reason behind the proposed research, to include the outcomes of preceding researches. The procedures should also be in line with the study’s design and does not carelessly expose participants to risk. An inclusion and exclusion criteria that will limit the study only to a specific population of interest should be developed.

1. What population are considered vulnerable population and why?

Special considerations should be exercised for vulnerable populations.

“Vulnerable populations are at risk for disparate healthcare access and outcomes because of economic, cultural, ethnic or health characteristics” (Waisel, 2013). Pregnant women, fetuses, and neonates; prisoners; elderly; racial or ethnic minorities; minors; and socioeconomically disadvantaged persons are considered vulnerable population.

1. What are appropriate ways to recruit subjects?

According to the US Department of Health and Human Services (2018), appropriate recruitment can be done by employing a variety of strategies to make potential participants aware of the projects. This includes disseminating letters or postcards; displaying flyers, pamphlets, brochures, and/or posters; asking patients one-on-one in their primary care provider’s office or local community clinic; participating in health fairs and/or other community outreach activities; calling phones, sending messages or emails through patient portals or listservs; and placing advertisements in university newsletters, local newspapers, radio, or television stations. Assignment: Protecting Human Subjects

1. How would you properly obtain consent?

There are requirements to obtain an informed consent. Some are as follows:  “The investigator or a person designated by investigator must obtain informed consent; it must be obtained before non-routine screening procedures are performed and/or before any change in the subject’s current medical therapy is made for the purpose of the clinical trial; the subject/subject’s legally acceptable representative should not be forced to sign on consent or participate/continue to participate in the trial; and the subject/legally acceptable representative and individual obtaining consent must personally sign with date the form.” (Nijhawan, et al., 2013) These steps are recommended in order to be able to acquire a consent in the right manner.

1. What are the elements of a properly executed consent?

The Belmont Report in 1979, identified three ethical principles for biomedical research. One principle, “Respect for Persons” discussed the topic about informed consent. Three basic elements were defined for a consent to have validity: “(1) comprehensive and important information for decision making, (2) comprehension, and (3) voluntariness.” (Koonrungsesomboon, et al., 2013).  Adequate information should be given to the participants, they should be able to understand the information, and make a conscious decision without intimidation.

1. What committees are responsible for monitoring the protection of human subjects?

Institutional Review Boards were created to ensure that the research subjects are protected. “The Common Rule became widely accepted as the way to oversee human research that is funded by federal agencies, or used in FDA submissions” (Breault, 2006). Operating through the Secretary of DHHS, the Office of Human Research Protections, made federal-wide assurances with groups that are federally funded. It has been agreed upon that the same ethical rules should be the basis no matter which funding source is used.

 

 References

, J.L. (2006). Protecting human research subjects: the past defines the future. The Oshner Journal 6(1): 15–20. doi:  []

, N., , J., and , J. (2015). Understanding of essential elements required in informed consent form among researchers and Institutional Review Board members. 43(2): 117–122. doi: []

, L.P., , M.D., , B.S., B,K.M., Bairy, K.L., Udupa, N., and , P.B. (2013). Informed consent: issues and challenges. Journal of Advanced Pharmaceutical Technology and Research 4(3): 134–140. doi: []

Rice, T. (2008). The historical, ethical, and legal background of human-subjects research [ Abstract].  Respiratory Care Journal, 53 (10) 1325-1329. Retrieved from

Russel, D. (2008). On the trail of JFK assassins: a groundbreaking look at America’s most infamous conspiracy. Retrieved from

U.S. Department of Health and Human Services. (2018). Participant recruitment for research. Retrieved from

Waisel, D. (2013). Vulnerable populations in healthcare. Current Opinion in Anaesthesiology . doi: 10.1097/ACO.0b013e32835e8c17