Health Medical Homework Help

Reply:

Peer 1: What is the purpose of the Declaration of Helsinki?

“To provide ethical principles  and guidance to physicians and other participants in medical research involving human subjects”.  (WHO, 2001).

Discuss considerations when balancing risks, burdens, and benefits of medical research.

The Institutional Review Board(IRB) is responsible for “evaluating the potential risks and weighing the probability of the risks occurring and the magnitude of harm that may result.  It is then they must judge whether the anticipated benefits, either of new knowledge or of improved health for the research subjects, justifies inviting any reason to undertake the risks.  The IRB can not approve research in which the risks are judged unreasonable in relation to the anticipated benefits”. (“Risks, and Benefits of Research”, n.d.).

By knowing the requirements for research on human subjects, what regulations that it falls under and ensuring the risks are minimal: “by using procedures that are consistent with sound research design and do not unnecessarily expose subjects to risk, and using procedures already been formed on the subject for diagnostic or treatment purposes, and lastly risk to subjects are reasonable in relation to anticipated benefits”.   (“Risks, and Benefits of Research”, n.d.).

Next you will complete the application process of identifying all procedures that will be conducted for research purposes as directed by the study protocol: “analysis of information or specimens collected for reason other than the project (medical records, student records, analysis of left-over specimens, etc); collection of blood by fingerstick, heel, ear stick or venipuncture; use of xrays or microwaves”.  (“Risks, and Benefits of Research”, n.d.).

By applying research protocols: “describing known risks related to participate in research; actions taken to minimize risks; clearly stating which procedures are being done solely for research purposes, and which are done as standard of care or normal practice; describing any anticipated benefits the relation to the research subjects may receive from participation in the research, and compensation for participation in research may not be tasked as a benefit”.  (“Risks, and Benefits of Research”, n.d.).

Common types of risks researches are responsible for identifying and minimizing the risk are “economic risks, loss of confidentiality, legal risks, physical risks, psychological risks, and social risks.  Along with risks researches must all identify the benefits which can be direct benefits, indirect benefits and aspirational benefits”.  (“Risks, and Benefits of Research”, n.d.).

What is a goal of informed consent? 

The goal of informed consent is to “ensure the participant has been explained the purpose of the research, including what their role would be, and how the trial will work”. (“Informed Consent to Clinical Trails”, n.d.).

In conclusion IRB boards have a checks and balances of every step needed to ensure risks, burdens and benefits are identified, and a plan is in place to minimize any risks to keep research participants as safe, informed and protected as possible.

References

Informed Consent to Clinical Trials (n.d.). Retrieved from https://www/fda.gov/patients/clinical-trials-what-patients-need-know/informed-consent-clinical=trials#:~:text=Informed%20consent...

Risks and Benefits of Research (n.d,).  Retrieved from https://research.ucdavis.edu/[policiescompliance/irb-admin/researches/project-guidance/risks-and-benefits/

World Medical Association Declaration of Helsinki (2001).  Retrieved from https://www.who.int/bulentin/archives/79(4)373.pdf 

Peer 2:

What is the purpose of the Declaration of Helsinki?

The Declaration of Helsinki was developed by the World Medical Association in 1964 and is “considered to be one of the most influential documents in research ethics” (Goodyear, Krleza-Jeric, & Lemmens, 2007, pg. 624, par. 1).

The purpose of the Declaration of Helsinki is to safeguard the health of participants involved in biomedical research. It involves providing instruction and guidance to physicians, researchers as well as participants in appropriate and ethical standards in conducting medical research on human subjects.

Discuss considerations when balancing risks, burdens, and benefits of medical research.

When performing medical research, the researchers must balance risk, burdens and benefit of the research. This is accomplished by ensuring that the research participant’s well-being has a higher preference over any other interest accomplished by the research. Also, the research subject’s participation should only be conducted in the research if the benefits outweigh the risks and burdens on the participant.

What is a goal of informed consent? 

The goal of informed consent is to inform the participant in the research of all the facts involved in the medical research. It gives the participant the opportunity to understand the facts, risks and implications that may occur in the study. The participant can then make the informed decision whether or not to participate in the research. 

Informed consent is the process where a participant is informed about all aspects of the trail, which are important for the participant to make a decision and after studying all aspects of the trial, the participant voluntarily confirms his or her willingness to participate in a particular clinical trial and significance of the research for advancement of medical knowledge and social welfare (Nijhawan, et. al, 2013, pg. 1, para 1).

References

Goodyear, M. D., Krleza-Jeric, K., & Lemmens, T. (2007). The Declaration of helsinki. Mosaic tablet, dynamic document, or dinosaur? BMJ, 624-625. doi:10.1136/bmj.39339.610000.BE

Nijhawan, L. P. (2013). Informed consent: Issues and challenges. Journal of Advanced Pharmaceutical Technology & Research, 134-140. doi:10.4103/2231-4040.116779