NUR-550 Topic 3 DQ 2 Discuss the role of the Institutional Review Board

NUR-550 Topic 3 DQ 2 Discuss the role of the Institutional Review Board

NUR-550 Topic 3 DQ 2 Discuss the role of the Institutional Review Board

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Topic 3 DQ 2

Dec 8-12, 2022

Discuss the role of the Institutional Review Board. Discuss ethical research considerations specific to population health. How are respect for the persons, potential benefits and burdens of the research, and justice kept in balance? Provide an example.

REPLY TO DISCUSSION

HK

Heather Kennedy

Dec 12, 2022, 1:39 PM

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Week 3: Optional assignment for participation credit.

Watch the 4 minute video from Christine Rabinek from Wayne State on “Ethical Considerations in Clinical Research.”  Name 3 regulatory bodies that ensure ethics is upheld in research.  Do you agree or disagree on the roles of regulatory bodies in the process?  Why?

 

https://www.youtube.com/watch?v=6_sh1ztDz8I

Rabinak, Christine. (2017, July 7). Ethical considerations in clinical research [Video]. YouTube.

            https://www.youtube.com/watch?v=6_sh1ztDz8I

REPLY

  • SF

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Regulatory bodies that ensure ethics is upheld in research include human research protection programs, institutional review boards (IRBs), federal U.S. groups like the FDA, and codes/reports such as the Belmont Report (Rabinak, 2017). I agree with the roles that these regulatory bodies have in the research process because they uphold proper and ethical/legal standards and protect the rights of research participants. Research must maintain respect for persons- which includes informed consent and confidentiality, beneficence, and justice (Rabinak, 2017). When these principles and rights are violated, it can have negative effects on the research participants as we have seen happen in the past. Having third-party regulatory bodies reviewing and guiding research studies ensures that human participants are protected and ethical standards are complied with.

Reference NUR-550 Topic 3 DQ 2 Discuss the role of the Institutional Review Board

Rabinak, Christine. (2017, July 7). Ethical considerations in clinical research [Video]. YouTube.

            https://www.youtube.com/watch?v=6_sh1ztDz8I

REPLY

  • LG

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I watched the video on ethical considerations in clinical research and I completely agree with the governing bodies role in the safety of clinical trial participants. First off the participants must know that their safety is our number one concern. After all the clinics trials ultimate outcome is to improve patient safety or patient care to the population. They need to know we will keep their participation confident. Also, they need to know that we appreciate their willingness to participate and we show that by beneficence, that the benefit will outweigh the risk. Lastly is justice, if we are not committed to being fair and honest there is really no point in doing research at all. We need our research to be valid and trustworthy in order for people to allow us to make these positive changes in their care, be it healthcare or other areas of their lives.

Rabinak, Christine. (2017, July 7). Ethical considerations in clinical research [Video]. YouTube.

REPLY

  • EP

 

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Regulatory agencies play an integral role in clinical research programs. They were developed as a result of issues that occurred in the past. Human Research Protection Agency protects the rights and wellbeing of human subjects who are involved in clinical research that are conducted by the US Department of Health and Human Services. This goal is accomplished through guidelines and protocols regulations. This is vital to the success of the research. As stated in the Belmont Report, human subjects should be voluntarily consented to being apart of clinical research after adequate information was related to them.

Rabinak, Christine. (2017, July 7). Ethical considerations in clinical research [Video]. YouTube.

            https://www.youtube.com/watch?v=6_sh1ztDz8I

REPLY

  • TW

Read

Three regulatory bodies that insure that ethical guidelines are followed during research involving human subjects are Human Research Protection Programs (HRPPs), Food and Drug Administration (FDA), and the Institutional Review Board (IRB). There is also a Office for Human Research Protections that oversees research conducted by the federal government through the Health and Human Services Department (Health and Human Services, n.d.). I feel that these regulatory bodies and the roles they play are vial in protecting people during the research process. Medical research is necessary for the development and improvement of medications, medical treatment options and procedures, but history has proven that, if not regulated, great harm can be done in the name of research.

NUR-550 Topic 3 DQ 2 Discuss the role of the Institutional Review Board
NUR-550 Topic 3 DQ 2 Discuss the role of the Institutional Review Board

References NUR-550 Topic 3 DQ 2 Discuss the role of the Institutional Review Board

 

Health and Human Services. (n.d.). Office for Human Research Protections. https://www.hhs.gov/ohrp/index.html

Rabinak, Christine. (2017, July 7). Ethical considerations in clinical research [Video]. YouTube.

https://www.youtube.com/watch?v=6_sh1ztDz8I

REPLY

TW

 

Read

The goal of the Institutional Review Board is to ensure that clinical trials are carried out in a way that is ethical, safe, and respectful of human life (United States Food and Drug Administration, 2019). One ethical dilemma surrounding population health is creating programs that are fair and equitable to all members of society in every situation. Although this goal seems unattainable, the acceptable threshold of population health programs and research studies is to find solutions to health problems that positively affect the largest group of people most of the time instead of one individual all the time. To find this balance, medical professionals must seek first to do no harm and act in a way that intentionally benefits the individual or group. They must make it a priority to ensure that all resources and opportunities provided through the programs and trials are equally and fairly distributed throughout the population. Medical professionals, public health programs and translational research trials must also recognize and respect each individual and their humanity. (Decamp et al, 2017) The homeless population of Atlanta and access to healthcare for management of chronic health conditions such as diabetes and hypertension is an area that I feel would benefit from a translational research study, but there are many ethical issues to take into consideration. For example, where would the funding for the care come from, taxpayer or private money? Should public health programs be funded by the public/ taxpayers? Most homeless individuals are not able to pay taxes or pay into social security programs. Do they deserve to be cared for by a system that they don’t contribute to? The homeless population is notoriously hard to track; how would resources and care be equally distributed and monitored?

 

References:NUR-550 Topic 3 DQ 2 Discuss the role of the Institutional Review Board

Decamp, M., Pomerantz, D., Cotts, K., Dzeng, E., Farber, N., Lehmann, L., Reynolds, P. P., Sulmasy, L. S., & Tilburt, J. (2017). Ethical Issues in the Design and Implementation of Population Health Programs.33(3), 370-375. https://doi.org/10.1007/s11606-017-4234-4.

 

United States Food and Drug Administration (FDA). (2019). Institutional Review Boards (IRBs) and Protection of Human Subjects in Clinical Trials. https://www.fda.gov/about-fda/center-drug-evaluation-and-research-cder/institutional-review-boards-irbs-and-protection-human-subjects-clinical-trials

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NUR-550 Topic 3 DQ 2 Discuss the role of the Institutional Review Board Grading Rubric Guidelines

Performance Category 10 9 8 4 0
Scholarliness

Demonstrates achievement of scholarly inquiry for professional and academic decisions.
  • Provides relevant evidence of scholarly inquiry clearly stating how the evidence informed or changed professional or academic decisions
  • Evaluates literature resources to develop a comprehensive analysis or synthesis.
  • Uses valid, relevant, and reliable outside sources to contribute to the threaded discussion
  • Provides relevant evidence of scholarly inquiry but does not clearly state how the evidence informed or changed professional or academic decisions.
  • Evaluates information from source(s) to develop a coherent analysis or synthesis.
  • Uses some valid, relevant, reliable outside sources to contribute to the threaded discussion.
  • Discusses using scholarly inquiry but does not state how scholarly inquiry informed or changed professional or academic decisions.
  • Information is taken from source(s) with some interpretation/evaluation, but not enough to develop a coherent analysis or synthesis.
  • Little valid, relevant, or reliable outside sources are used to contribute to the threaded discussion.
  • Demonstrates little or no understanding of the topic.
  • Discusses using scholarly inquiry but does not state how scholarly inquiry informed or changed professional or academic decisions.
  • Information is taken from source(s) without any interpretation/evaluation.
  • The posting uses information that is not valid, relevant, or reliable
  • No evidence of the use of scholarly inquiry to inform or change professional or academic decisions.
  • Information is not valid, relevant, or reliable
Performance Category  10 9 8 4 0
Application of Course Knowledge –

Demonstrate the ability to analyze, synthesize, and/or apply principles and concepts learned in the course lesson and outside readings and relate them to real-life professional situations
  • Posts make direct reference to concepts discussed in the lesson or drawn from relevant outside sources;
  • Applies concepts to personal experience in the professional setting and or relevant application to real life.
  • Posts make direct reference to concepts discussed in the lesson or drawn from relevant outside sources.
  • Applies concepts to personal experience in their professional setting and or relevant application to real life
  • Interactions with classmates are relevant to the discussion topic but do not make direct reference to lesson content
  • Posts are generally on topic but do not build knowledge by incorporating concepts and principles from the lesson.
  • Does not attempt to apply lesson concepts to personal experience in their professional setting and or relevant application to real life
  • Does not demonstrate a solid understanding of the principles and concepts presented in the lesson
  • Posts do not adequately address the question posed either by the discussion prompt or the instructor’s launch post.
  • Posts are superficial and do not reflect an understanding of the lesson content
  • Does not attempt to apply lesson concepts to personal experience in their professional setting and or relevant application to real life
  • Posts are not related to the topics provided by the discussion prompt or by the instructor; attempts by the instructor to redirect the student are ignored
  • No discussion of lesson concepts to personal experience in the professional setting and or relevant application to real life
Performance Category  5 4 3 2 0
Interactive Dialogue

Replies to each graded thread topic posted by the course instructor, by Wednesday, 11:59 p.m. MT, of each week, and posts a minimum of two times in each graded thread, on separate days.

(5 points possible per graded thread)
  • Exceeds minimum post requirements
  • Replies to each graded thread topic posted by the course instructor, by Wednesday, 11:59 p.m. MT, of each week, and posts three or more times in each graded thread, over three separate days.
  • Replies to a post posed by faculty and to a peer
  • Summarizes what was learned from the lesson, readings, and other student posts for the week.
  • Replies to each graded thread topic posted by the course instructor, by Wednesday, 11:59 p.m. MT, of each week, and posts a minimum of two times in each graded thread, on separate days
  • Replies to a question posed by a peer

Summarizes what was learned from the lesson, readings, and other student posts for the week.
  • Meets expectations of 2 posts on 2 different days.
  • The main post is not made by the Wednesday deadline
  • Does not reply to a question posed by a peer or faculty
  • Has only one post for the week
  • Discussion posts contain few, if any, new ideas or applications; often are a rehashing or summary of other students’ comments
  • Does not post to the thread
  • No connections are made to the topic
  Minus 1 Point Minus 2 Point Minus 3 Point Minus 4 Point Minus 5 Point
Grammar, Syntax, APA

Note: if there are only a few errors in these criteria, please note this for the student in as an area for improvement. If the student does not make the needed corrections in upcoming weeks, then points should be deducted.

Points deducted for improper grammar, syntax and APA style of writing.

The source of information is the APA Manual 6th Edition
  • 2-3 errors in APA format.
  • Written responses have 2-3 grammatical, spelling, and punctuation errors.
  • Writing style is generally clear, focused, and facilitates communication.
  • 4-5 errors in APA format.
  • Writing responses have 4-5 grammatical, spelling and punctuation errors.
  • Writing style is somewhat focused.
  • 6-7 errors in APA format.
  • Writing responses have 6-7 grammatical, spelling and punctuation errors.
  • Writing style is slightly focused making discussion difficult to understand.
  • 8-10 errors in APA format.
  • Writing responses have 8-10 grammatical, spelling and punctuation errors.
  • Writing style is not focused, making discussion difficult to understand.
  • Post contains greater than 10 errors in APA format.
  • Written responses have more than 10 grammatical, spelling and punctuation errors.
  • Writing style does not facilitate communication.
  • The student continues to make repeated mistakes in any of the above areas after written correction by the instructor
0 points lost       -5 points lost
Total Participation Requirements

per discussion thread

 The student answers the threaded discussion question or topic on one day and posts a second response on another day. The student does not meet the minimum requirement of two postings on two different days
Early Participation Requirement

per discussion thread

 The student must provide a substantive answer to the graded discussion question(s) or topic(s), posted by the course instructor (not a response to a peer), by Wednesday, 11:59 p.m. MT of each week. The student does not meet the requirement of a substantive response to the stated question or topic by Wednesday at 11:59 pm MT.

Also Read: NUR-550 Topic 3 DQ 1 Discuss the ethical guidelines that would need to be implemented when conducting translational research