Expert answer:respond to discussions
Expert answer:I have attached some discussion including my original post that you helped me with also two others. I need you to respond to number 2 an 3 with at least one reference each
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1) The Research Ethics Committee
The course is very educative and enlightening. It gives insight to the learner about the
actual responsibilities of the Research Ethics committee. Also, the learner can get
detailed guidelines offered by the council in a given medical facility. I work in one of the
acute care facilities in the downtown of history, and in this facility, the research process
that involves human participants is conducted in several ways by the REC that has been
established in the institution (Humphreys, 2016). The committee holds meetings
frequently and may call upon some researchers to attend these meetings which provide
their research procedures to them. In some cases, the board carries out some interviews
with human participants to get the required information. The said Committee then
reviews every single proposal on human subjects ensuring that all participants are
protected regarding safety and their welfare (Humphreys, 2016). Before subject
recruitment and information gathering at the St Joseph Centre, all the subject researches
are reviewed and approved by the IRB.
The REC in the facility is composed of several scientists and some lay members
who do the reviewing of the frequent activities of the institution. It is essential that the
lay persons are available to be able to offer more information about the concerns of the
society and deliver their opinions on the issue in discussion (Humphreys, 2016).
The members of the Research Ethics Committee at St Joseph’s Medical
Centre do meet according to the required Federal Guidelines because they can review the
proposals brought before them on time. Also, with regards to the issues raised, they can
ensure reduction of the risks that the participants are exposed to (Humphreys, 2016).
Equally, they make sure that the participants’ benefits are well distributed. Through
them, the privacy of participants is provided, and the required information is obtained.
References
Humphreys, S. (2016). Research ethics committees: The ineligibles. Research Ethics,
174701611246697. http://dx.doi.org/10.1177/1747016112466979
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2)
The NIH “Protecting Human Research Participants” discusses how
humans are being protected when participating on research. There are ethical
principles and a law, National Research Act (Pub. L. 93-348) that has to be
followed. Basic ethical principles include: Respect for persons, Beneficence, and
Justice. Respect for persons by respecting their self-autonomy and selfdetermination, upon participating on any research or making any kind of decision,
a person should be respected no matter what the decision and outcome maybe.
Beneficence comes in place when decisions was not only made but also protect or
make effort to securing the safety of the well-being. Justice, “fairness in
distribution” should always take place and that every single one of patients should
be treated equally.
I currently work as a full-time employee on an Assisted Living Program. It is in between
Independent Living and Assisted Living Residence. Our residents are cared for based on
their level of care assessments and are treated fair and equally. As a Director of Nursing I
make sure that all our residents are provided with HIPAA (Health Insurance Portability
and Accountability Act) which is “a set of national standards for protection of certain
health information” We may not have or use IRB, HIPAA is used to protect the safety of
our residents information most especially the ones who are affected by any mental or
neurological problems.
3) We have all heard the saying where there is good there is evil. With that being said the
NIH “Protecting Human Research Participants informs on measures in place to protect
participants from harm while participating. It is unethical to use participants as a means
to an end and not consider their welfare. The relationship between those conducting the
study and those participating should be based on honesty, respect, and trust. I was
shocked to learn of the Nazi Medical War Crimes. I had never heard of this before and I
was appalled that physicians would subject human beings to this kind of torture in the
name of research. I also learned through the course what the first international standard
for conduct of research was. This was the Nuremberg Code. This code provided ten
directives when experimenting on humans. Some of the studies this course discusses just
angers me that people would be so cruel and heartless in the name of medical
advancement. The Willowbrook study sticks out in my mind. Totally unethical to subject
children to this type of experimentation and to coerce the parents into thinking allowing
their children’s participation would be a good thing was immoral. As I continued the
course I was surprised that so many regulations and changes have been made to protect
individuals from harmful testing. I was also amazed that some of these regulations are
really in-depth trying to tackle many different angles and aspects involved in medical
testing.
I currently work at a local outpatient dialysis clinic. I work through Fresenius Medical
Care and they are worldwide. I am not aware of how they conduct current research. I did
however do a google search and found some informative information concerning the
company. In North America alone, Fresenius Medical Care‘s research efforts involve the
contributions of more than 1,200 employees, and the company’s contract clinical
research division comprises a network of over 450 principal investigators at more than
260 sites representing 160 medical practices (Business Wire). Frenova traces its
beginnings back to 2000, when Fresenius Medical Care North America (FMCNA), the
world’s largest provider of dialysis services for patients with end stage renal disease,
centralized the clinical research function to orchestrate all research activity in its facilities
(Frenova Renal Research). The research this company conducts focuses on chronic
kidney disease and adjacent medical conditions. There are seven aims for research with
Fresenius. They include using science and technology to characterize and improve patient
outcomes driving advancements in management paradigms through value based care
models, using predictive modeling for clinical decision support and better outcomes,
characterizing the impacts of CKD options education on outcomes and modality
selection, leveraging coordinated care initiatives to improve patient outcomes, defining
outcomes related to the management of bone mineral metabolism in renal disease, and
identifying the influences of social determinants of health on clinical measures (Business
Wire). I am unsure if Fresenius has an IRB but they do have an ethics committee. The
clinical science and epidemiology group consist of Norma Ofsthun, PhD, Vice President
Data Analytics-Reporting, Algorithms & Research, Len Usvyat, PhD, Vice President
Integrated Care Analytics & Research and Kevin Chan, MD, Senior Director, Analytical
Research. The Frenova Research Leadership consists of Kurt Mussina, BS, MBA, Vice
President, General Manager, Ann Mooney, MSN, RN, CNN, Senior Director,Clinical
Operations; Brigid Flanagan, MS, RN, CCRC, Senior Director, Clinical Development,
Russell Smith, BS, MBA, Senior Director, Business Operations, Christina Marie Kahn,
BS, CCRP Director, Frenova Site Innovation. They do meet federal guidelines in their
research.
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