internal and external governing entities

The writer will have to read each of this articles and react to them by
commenting, analyzing and supporting with relevant pear review articles. The
writer will have to read carefully before giving constructive comments on the
article. APA and in text citation must be use as each respond to the 3 articles
must have in text citations with a pear review article to support your
comments. The writer will provide a reference at the end of each comments.
They will be a minimum of 1 reference for each respond to the 3 articles.
Please refrain from just using “ I agree or this is a good article”, but offer
constructive and informative comments that can contribute to the articles.
Article 1

Implementing Change

What internal and external governing entities (individuals, groups) must approve the
change prior to implementation?

This is a private organization which is own and operated by one physician. According to Smith
(2000), governing bodies of regulatory entities are referred to in numerous ways in various
jurisdictions. Some of the most common terms are “boards” and “councils.” (para. 1). Because
this is a private practice, the physician is the only one needed to approve this practice change.
The information could be brought to the office manager which is then conveyed the physician. If
the physician believes this change will be beneficial for his practice, then he would make the
final decision on whether to move forward or not.

Is an IRB required? Why or why not?

This modification in the policy will not be drastic. The change lies in how the elderly patients are
screened for hypertension and the monitoring of these patients after the antihypertensive therapy

have commenced. This is not a complete change of policy, but an addition of stricter guidelines.
Therefore, an IRB is not required. According to American Public University System (2016), the
purpose of the IRB is to ensure that all human subject research be conducted in accordance with
all federal, institutional, and ethical guidelines. This practice change has already been researched
and has shown to be effective in lowering the blood pressure of elderly patients, while reducing
the risk of adverse reactions.

Approximately how long will it take to gain approval to implement your plan?

This proposal is not an extreme change to the current policy. It also does not pose any threat to
the patient or the organization. For this reason, I believe it would take one week to gain approval
to implement this practice change proposal.

What aspects of your plan might be of concern to governing bodies? Why?

The aspect of this proposal that might be of concern to governing bodies includes the cost of
implementing this plan. Although this project will not be too costly for the organization, we must
be sure that it fits it the budget. Leadership may be hesitant to spend money on initiating a plan
that may not work. According to Gesme & Wiseman (2010), resistance to change usually comes
from fear, on one of three levels—what will happen to me in my world, how will my relations to
my colleagues change, or how our practice and our patients will be affected. This new practice
change is evidenced based. It is not an experiment but rather an improvement on the current
practice. Therefore, there should be little if any apprehension to implementing change.

References

Include the one paragraph comments hear using a pear review article to support your
comments. Also include in text citations in APA.

Article two

Internal governing entities that must approve the change of incorporating pharmacogentetic
testing as a routine diagnostic lab for patients 65 years and older include the Chief Executive
Officer/President, the Senior Medical Director and the President of the Clinical Services.
External governing entities include the Centers for Medicare and Medicaid Services (CMS).
CMS as federal government insurance systems that would provide health insurance coverage for
these older adults to cover the cost of testing.
Since my EBP is not as a research project, approval from the IRB would not be necessary.  The
IRB is a federally mandated body established under the Department of Health and Human
Services regulations for the protection of human subjects to protect the rights of human subjects
recruited to participate in research studies (Keele, 2011).   If the goal of undertaking this as a
research study was to create new knowledge that could be generalized to other populations, and
human subjects were involved, then the clinical study/research will have to abide by IRB
standards and guidelines. Additionally, confidentiality agreement about the results must be
adhered to and the patients must provide consent prior to testing. 
Obtaining approval for projects that require review by the IRB can be very time consuming. 
Therefore, if an IRB approval was needed, it would take  approximately six months to gain
approval to implement the plan.  However, since the approval will come from both internal and
external entities, the timeframe to gain approval would be approximately 3 to 4 months.
“Adherence to the details of the organization’s operations and approval processes ensures a
smooth and speedy integration of the change into the organization’s standard of care”. (Larrabee
and Rosewrum (1999) as cited in Stevens, 2013).

The cost of the plan might be one aspect of concern to governing bodies.  Some might be
concerned about costs (such as, out-of-pocket payments), insurance coverage or premiums, and
reimbursement related to pharmacogenomics tests.  Others might be concerned about the ethical
implications of pharmacogenetics testing.  For one thing, the clinical use of pharmacogenetics
drugs will require that a sample of a patient’s DNA be tested before a drug is prescribed, and
therefore informed consent and privacy of pharmacogenetics test results should be considered. 
Another aspect of concern is discrimination based on the testing results.  According to the World
Health Organization (WHO, 2016). “the targeting of specific populations may result in the unfair
discrimination against some groups, for instance, pharmacogenomics knowledge could be linked
with specific racial or ethnic indicators, making it tempting to assume a biological linkage
between race and responsiveness to particular medications, which could lead to inappropriate
decisions about treatment”.
Reference
Keele, R. (2011). Nursing research and evidence-based practice. Ten steps to success. Sudbury,
MA: Jones & Bartlett Learning
Stevens, K., (May 31, 2013) The impact of evidence-based practice in nursing and the next big
ideas. OJIN: The Online Journal of Issues in Nursing, 18, (2).
World Health Organization (2016). Ethical, legal and social implications (ELSI) of human
genomics. Retrieved from http://www.who.int/genomics/elsi/pharmacogenomics/en/
Include the one paragraph comments hear using a pear review article to support your
comments. Also include in text citations in APA.

Article 3

The agencies that would need to approve of my proposed practice change to use teach back with
patients to avoid miscommunication, misunderstanding and possible hospital admissions would
be the physician who owns the practice based of the time it would take away from other patients’
scheduled appointments that would create a back log in productivity. On any given day, my
preceptor alone has 35+ patients scheduled and she takes walk ins. The highest number of people
I have seen on her daily roster has been 45. Increase that exponentially to the two additional
physicians and one MA in the practice; patient teaching takes a back seat to the time it takes to
ensure a patient is educated.
For this study on medication adherence, the researcher would have face to face conversations
with the clients, or do telephone follow up interviews with the patients an IRB could be
designated to review and monitor biomedical research involving human subjects. In accordance
with FDA regulations, an IRB has the authority to approve, require modifications in (to secure

approval), or disapprove research. This group review serves an important role in the protection of
the rights and welfare of human research subjects (fda.gov).
The purpose of IRB review is to assure, both in advance and by periodic review, that appropriate
steps are taken to protect the rights and welfare of humans participating as subjects in the
research. To accomplish this purpose, IRBs use a group process to review research protocols and
related materials (e.g., informed consent documents and investigator brochures) to ensure
protection of the rights and welfare of human subjects of research and that no HIPPA laws are
violated.
Despite the large number of patients seen at this office, it is an independent entity that does not
receive any funding or grants, therefore, a formal IRB would not be necessary, however a
spreadsheet with the patient’s age, gender, formal diagnosis, and a yes/no column denoting if the
patient is taking their medication as prescribed would be sufficient to collect the appropriate data
while keeping the patient’s personal health information private. This is HHS: the HHS Protection
of Human Subjects Regulations describe “private information” as information which has been
provided for specific purposes by an individual and which the individual can reasonably expect
will not be made public (for example, a medical record). Under the HHS Protection of Human
Subjects Regulations, private information must be individually identifiable (i.e., the identity of
the subject is or may readily be ascertained by the investigator or associated with the
information) in order for obtaining the information to constitute research involving human
subjects unless data are obtained through intervention or interaction with the individual.
Based on the good that will come of doing this research, the providers running this practice
would not object as it the same routine they currently have in place: it is called follow up. The
main concern, as I pointed out in Unit 2, would be the language barrier. If the caller spoke a
language different that the person being called, information could get into the wrong hands. At
this point it would be up to the governing individual to designate ab assistant n collecting data
that would lead to the conclusion that understanding equals adherence which in turn leads to
good patient outcomes (Brown & Brussell, 2011).
Brown, M. and Brussel, J. (2011) Medication adherence: WO cares? Mayo clinical proceedings. 
84(4):pp 304-314 doi 10.4065/mcp.2010.0575
Regulatory information: Institutional review boards.

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