Week 6: Assignment – Human Subjects Protection.

Web Page You have viewed this topic Points: 50 | Due Date: Week 6, Day 7 | CLO: 3 | Grade Category: Assignments Assignment Prompt This course is designed to prepare investigators involved in the design and/or conduct of research involving human subjects to understand their obligations to protect the rights and welfare of subjects in research.Week 6: Assignment – Human Subjects Protection.

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The course material presents basic concepts, principles, and issues related to the protection of research participants. Evidence based research involving human subjects requires that researchers be cognizant of and adhere to the important tenets necessary to protect subjects from abuse, harm, injury, and/or other undesirable outcomes resulting from the research process. Based on this fact, write a minimum of 2 pages (Title page and Reference not included in page count) of an APA formatted paper answering the following questions with a minimum of 3 “short” sentences for each question: Historical background of human subjects protection? (10 points) Find and discuss at least one historical incident of human subjects abuse in research and what human right was violated. (10 points) What steps will you take to minimize risks on human subjects? (10 points) What populations are considered vulnerable populations and why? (10 points) What are appropriate ways to recruit subjects? (10 points) How would you properly obtain consent? (10 points) What are the elements of a properly executed consent? (10 points) What committees are responsible for monitoring the protection of human subjects? (10 points) Scoring Scheme: Total points for questions/content: 80 points Title page and a minimum of 2 References: 10 points Minimum of 3 “short” sentences to answer each question: 10 points TOTAL POINTS: 100 (the gradebook will re-weight this total as 50 points or 5% of the course grade) NOTE: This is a written APA formatted assignment and “NOT” a YES or NO answer assignment. You are expected to answer each question with at least 3 short sentences, points will be deducted for using a single sentence. Title and Reference pages are required.Week 6: Assignment – Human Subjects Protection.

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Historical background of human subjects protection

Historically, guidelines in human subjects protection and medical ethics were developed partly as a result of violations in ethical conduct of research. Research ethics emerged from the vestiges of the Holocaust, where the Nazi physicians performed sadistic and notorious medical experiments, typified by a total lack of ethical practice and informed consent. Lioke (2019) explains that, in response to the atrocities by Nazi physicians, the Nuremberg Code was drafted in 1948 by the judges who arbitrated the in the Nuremberg Trial of Nazi doctors charged with offenses against humanities, with the Code outlining some of the essential legal guidelines entailing voluntary informed consent, right to withdraw from a research study without repercussions and favorable risk versus benefit analysis.

A historical incident of human subjects abuse in research and the human right that was violated

The Tuskegee study, conducted between 1932 and 1972 involved researchers from Alabama’s Tuskegee Institute and the public health service withholding penicillin, a recognized effectual treatment for syphilis from participants (Negro males). The researchers were investigating the natural course of syphilis.   The informed consent was not obtained from participants and the aim of the study was not explained to them.  Even after penicillin was made the treatment of choice in 1947, the medication was not administered to the participants (Mick, 2019). The right to self-determination was violated because individuals were used as subjects and were exposed to a medical intervention under study without them knowing.

Steps that I will take to minimize risks on human subjects

I will minimize risks on human subjects by weighing the risks and benefits of the research study by performing a risk assessment that will consider nonphysical and physical harm. I will also safeguard vulnerable study participants by ensuring their welfare and rights are not violated.  As indicated by Mick (2019), vulnerable study participants have diminished autonomy and less capability of defending themselves in a certain situation or setting

Populations that are considered vulnerable populations

Research participants may be vulnerable due to mental or legal incompetence, confinement to an institution, terminal illness, or age.  Infants, children, and human fetuses as well as mentally or physically disabled individuals and people with terminal illnesses are vulnerable populations because they have diminished autonomy and are less likely to defend themselves. Workers or residents of an institution in which study is being carried out are vulnerable because they might face risks related to employment. (Mick, 2019).

Appropriate ways to recruit subjects

Appropriate recruitment of study subjects is the one that is equitable, with fair treatment of all participants during the study.  According to Mick (2019), the researcher should distribute benefits and among groups of individuals by reflecting on who will bear the risk and burden of taking part in the study and the individual who will benefit from the findings of the study. Participants should be chosen equitably and fairly without a group of individuals that will not gain from research findings being exploited.Week 6: Assignment – Human Subjects Protection.

How I would properly obtain consent

Consent is properly obtained when the informed consent form is written in a language that the study subjects easily understand.   Informed consent also involves presenting research-related information to enable individuals to make voluntary decisions on whether or not to become research subjects. Study subjects should be offered enough time to consider participation (Manti & Licari, 2018).Week 6: Assignment – Human Subjects Protection.

Elements of a properly executed consent

The deliberate provision of consent by an individual who is competent along with sufficient disclosure of information about the study are vital components of the process of informed consent.  Manti and Licari (2018) emphasize that competent subjects capable of comprehending the information related to research must personally choose and offer consent to participate in research. The process of obtaining informed consent should minimize the probability of undue influence or coercion.Week 6: Assignment – Human Subjects Protection.

Committees responsible for monitoring the protection of human subjects

Independent ethics committees also known as Institutional Review Board s (IRBs) review and disapproves or review, and also monitor study involving human subjects. According to Mick (2019), IRB is primarily responsible for safeguarding the rights and welfare of human subjects. IRBs carry out a preliminary review of proposed research studies and also continually assess, at least yearly, for studies progressing for over one year.Week 6: Assignment – Human Subjects Protection.