How effective are the resources in your community for the vulnerable populations we have discussed over the past 2 weeks (homeless, low income, mental illness, etc)? In which areas is there room for improvement?
Case Study: Late and Later Documentation:
The following is a case study in which documentation played a role in the practice breakdown of nursing care. The story is encapsulated for the reader with a sample of the actual documentation provided by the nurses involved. The reader is encouraged to question whether the documentation truly reflects the story presented. According to what you learned from chapter 3 critique the documentation presented by the healthcare provider and provide examples of whether the nurse follow or did not follow documentation requisites
PRACTICE BREAKDOWN IN DOCUMENTATION
Ms. Amy Jones was a 55-year-old woman being treated for depression at a mental health facility. She was alert, oriented, ambulating without difficulty, and interacting appropriately with staff. The patient’s family was scheduled for a meeting with her treatment team in the afternoon. During the day Ms. Jones met with her psychiatrist, Dr. Ian Smith, in Ms. Jones’s room. When her roommate came in, Dr. Smith suggested that they complete their session in his office, and Ms. Jones accompanied him to that space. On the way, she complained that she felt weak but could make it. During the session, she reported that she had a headache, which Dr. Smith attributed to anxiety. He went to look for a nurse to provide medication for Ms. Jones. On his return with Ms. Mary Sullivan, a registered nurse, Ms. Jones was on the floor on her knees vomiting. A physician working across the hall came and assisted Dr. Smith and Nurse Sullivan with Ms. Jones, who was now quite somnolent, into a wheelchair. Dr. Allen, the primary care physician, ordered that Ms. Jones be given Phenergan IM for the vomiting and that the nursing staff monitor her bowel sounds. Dr. Allen reported that she was not informed of Ms. Jones’ complaints of headache or loss of bowel control. Dr. Allen thought that she was dealing with gastrointestinal symptoms so she had the nurses check for bowel sounds and softness of the patient’s belly. She reports that she received a second callback and was told bowel sounds were normal, the patient’s stomach was soft, and the patient was resting comfortably. Ms. Jones was bathed and returned to her bed. She took the prescribed Phenergan after which she vomited several more times during that shift. She was incontinent of stool once. No one considered conducting neurologic checks because the staff thought Ms. Jones was suffering from a virus.
When Ms. Jones’s family members arrived, the nurses advised them that their mother was sick and was sleeping, and would not be able to attend the meeting. The family members could not arouse the patient. The staff said that Ms. Jones had been administered Phenergan for vomiting and would be awake by evening. Family members returned that evening and found the patient still unresponsive with vomit in her mouth. The family checked Ms. Jones’ pupils and found them unequal. The family reported to the registered nurse at the desk, and another nurse checked Ms. Jones’ vital signs and reported them to be normal. The family telephoned Ms. Jones’ primary care physician, Dr. Allen, and the nurse gave him a report. Soon after this call, an ambulance transported Ms. Jones to the hospital for evaluation. Ms. Jones subsequently died at the hospital.
Ms. Jones’ daughter stated that the registered nurse did not assess her mother; on arrival in the unit, the EMT assessed Ms. Jones. Ms. Jones’ daughter did not believe that her mother had been adequately monitored from noon to 6:30 PM. She also complained that the nurses were laughing at the family’s concerns about the condition in which they found their mother.
Ms. Cherie Hoffman, a registered nurse, had been employed at the facility for 25 years. She began her career as a nursing assistant, a title she held for 7 years. She then served as a licensed practical nurse for 10 years and then as a registered nurse for the past 6 years. She was familiar with all of the policies and procedures of the facility. On the day of the event Ms. Hoffman was working as the charge nurse; she noted that it was a particularly busy day. She returned from lunch and was informed by Nurse Sullivan that Ms. Jones was ill and had vomited. She was bathed, and the staff had documented her vital signs, completed the Glucoscan, and medicated Ms. Jones with Phenergan per Dr. Allen’s order. The family was not notified of a change in Ms. Jones’ condition because they were expected for a family conference at 3 PM, and Nurse Sullivan hoped that Ms. Jones would feel better by then and could participate in the conference. Nurse Hoffman assisted Nurse Sullivan in monitoring Ms. Jones throughout the rest of the shift. Nurse Hoffman had understood that Ms. Jones had not been sleeping well and thought it would be good to let her sleep. Nurse Hoffman thought Nurse Sullivan had last assessed Ms. Jones at 7 PM.
Nurse Hoffman states she was never informed that Ms. Jones had collapsed prior to vomiting or that she had a headache, or that Ms. Jones was somnolent after the episode. She reported that Ms. Jones had a history of headaches, nausea, and dizziness, all of which had been attributed to medications.
Nurse Sullivan recalls reporting everything to Nurse Hoffman. Nurse Sullivan said she had checked bowel sounds as directed. Ms. Jones was incontinent of stool at 2 PM. and was bathed and repositioned. Around 6 PM. Nurse Sullivan straightened Ms. Jones in bed and said that Ms. Jones looked comfortable. Nurse Sullivan said that she did not feel anxious about the patient, as she thought Ms. Jones was sleeping. Ms. Jones was not on 15-minute checks, but Nurse Sullivan recalled checking on Ms. Jones frequently throughout the shift to assess for vomiting.
Competency
Apply the principles and practices of operations management to improve performance outcomes of a healthcare organization.
View the grading rubric for this deliverable by selecting the “This item is graded with a rubric” link, which is located in the Details & Information pane.
You are the new project manager for the operations unit of Charleston General Hospital. The hospital is facing challenges of long wait times at the ED resulting in a high number of patients leaving without being seen (LWBS) and long admission holds in the ED. Upon initial assessment, you determine that the two challenges are related and are caused by inefficiencies in process flow.
Develop a process map to evaluate and suggest a redesign of the current challenges. Process maps are graphical depictions of a process. The process map (flow chart) shows the sequence of tasks, decisions, and all other related activities that results from inputs and outputs.
Your map should include a visual illustration of different processes that can be employed by Charleston General to improve the flow of operations in the ED. Attach a summary of the proposed changes reflected in the process map to explain how the changes can improve performance outcomes for the ED.
Review the description below.
· Describe why the healthcare Justice ethical principle is important.
· 100 words.
Justice
The justice principle can be broadly defined as “fairness.” It is exemplified by the Aristotelian ideal that people in similar situations ought to be treated similarly, and people in different situations should be treated differently. A distinction is sometimes made between distributive justice, which refers to the allocation of resources, and procedural justice, the fairness and transparency of processes by which decisions are made. The Belmont Report: Ethical Principles and Guidelines for the Protection of Human Subjects of Research, prepared by the National Commission for the Protection of Human Subjects of Biomedical and Behavioral Research (1979), offers guidelines on ethical principles; it states that “[a]n injustice occurs when some benefit to which a person is entitled is denied without good reason or when some burden is imposed unduly” (p. 5). This may occur in the clinic or in research. For example, there is some evidence that persons who are poor and thus have less access to care and information about options may also have less access to clinical trials. They also have less access to the benefits of findings and to drugs that are approved as a result of such studies. Charges of injustice regarding access to research involving women have also been made (Mastroianni, 1998); women have proportionately been less often represented as research subjects. Data also indicate that persons belonging to some racial groups are treated differently when they appear at an emergency department (James et al., 2005; Selassie et al., 2003). Statistics have consistently shown differences in life expectancy by socioeconomic status (National Center for Health Statistics, 2012).
In 1971, the leading American political philosopher of the 20th century, John Rawls (1921– 2002), wrote A Theory of Justice, a highly influential book that advances the idea that the best principles of justice are those that we would all agree to if we were all impartially situated as equals. This he arrives at through his famous thought experiment “the veil of ignorance,” in which we are asked to imagine an “original position” from which no one was better situated than anyone else (or at least that we’d be ignorant of any inequalities in such a utopian state-of-affairs).
A Rawlsian approach to distributive justice and health care ethics is one based on fairness. Therefore, even in cases where not everyone will have access to a certain good because it is scarce, there needs to be fair opportunity of access to the benefit. For Rawls, fair access was ensured by formal procedures that were themselves required to be fair. This leads us to the concept of procedural justice.
In order for the justice principle’s requirements to be met, any formal procedures or mechanisms by which people attempt to decide dilemmas must be fair and just, or equitable. Procedural justice requires that policy makers craft regulations, laws, and formal procedures that are free from bias that would render them inaccessible to some, or that would unduly restrict the chances of fair treatment for others. For example, a policy that recognizes employees’ rights to opt out of procedures when they have a strong conscientious objection states that employees must provide documentation in writing to the supervisor at least two weeks prior to the event. But given the nature of acute care, in which the unexpected happens routinely, how can a nurse know in advance that something will be demanded of her that strongly violates her conscience? When this issue came up in a local hospital, human resources had the policy rewritten to accommodate reality. Hospitals and nursing homes have to be clear about nurses’ rights and duties. For example, a policy might state that a nurse who has a strong moral objection to terminal extubations could be transferred to a unit where this procedure will not likely occur. Other policies might call for less supportive measures such as unpaid leave; such options could trigger a union dispute.
Justice is a fundamental principle for health care administrators and practitioners—particularly in their responsibilities to make resource allocation decisions—and among those who work toward eliminating health inequities. The justice principle impacts many other day-today decisions that health care managers make. Examples include policies regarding unionization, working conditions, and staffin
Who Am I? Project Manager for Operations @ Hospital
(Selected Health Organization) Facility: Hospital
CHALLENGES: A. Long wait times in the ED B. LWBS C. Long Admission Holds In ED
CAUSES: BAD WORKFLOW (PROCESS) = INEFFICIENCIES = LONG WAIT TIMES IN THE ED
RESULTS/EFFECTS = LWBS + LONG ADMISSION HOLDS IN ED
YOUR TASK: REDESIGN OF CURRENT CHALLENGES (REDESIGN FLOW – ED Flow/ PROCESSES)
ADD PROCESSES TO EXPLAIN CHANGES THAT CAN IMPROVE PERFORMANCE OUTCOMES
SEARCH: (PROCESSES THAT IMPROVE PERFORMANCE OUTCOMES IN ED) + Long wait times + LWBS + Long Admission holds
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Case Study
You are a manager of the Child Specialty Clinics at a major University Hospital Center. You are also a member of the Ethics Committee. Today is your monthly Ethics Committee Meeting. The Committee consists of the Committee Chair, a recording Secretary, an ICU doctor, three nurses, a social worker, a Nurse Practitioner, the CNO, the Chief Medical O�cer, the Chaplain, a public member, a nurse from the pediatric ICU, and a doctor from the Pediatric ICU.
After gathering lunch, reading and approving the minutes of last month’s meeting, the Chairman states that there is an urgent case to discuss.
There is a situation in the Neonatal Intensive Care Unit (NICU). A Baby Bundle was born yesterday with anencephaly. Because he had trouble breathing, he was placed on a ventilator and is in the NICU.
For our public member I will explain: Anencephaly in this child is a congenital neural tube defect where a major portion of his brain, skull, and scalp are missing. The brain stem is the only part of the brain that is present. The brain stem supports the autonomic functions and re�ex actions, but he remains permanently unconscious because he lacks his cerebrum. The cerebrum is important because it sets us apart as humans. Not only
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is the cerebrum the largest part of the brain in humans, but cerebrum also enables speech, thinking and reasoning, judgment, problem-solving, emotions, and learning. It also serves to initiate and coordinate movements and initiate movement. Anencephaly is always fatal. The children almost always die within a few days, although there have been a very few exceptions. Parents of children with anencephaly are often approached by the transplant team to donate various organs from their child.
Thus, Baby Bundle has no cognitive abilities or awareness, and cannot hear or see or otherwise interact with his environment. Baby Bundle’s brain stem supports his autonomic and re�ex actions, but he is permanently unconscious because he lacks a cerebrum. The issue we are looking at today is the father wants to terminate Baby Bundle’s treatment.
The mother wants to continue medical treatment. The doctors have informed the parents of the dismal future for the child and advise termination of treatment. The nurses feel that the child feels pain and is suffering when they suction his ventilator tube and take blood work. Mr. and Mrs. Bundle have been married for 5 years and this is their �rst child. Mr. Bundle is an accountant and Mrs. Bundle works for NASA but is now on maternity leave for 6 months.
QUESTIONS TO CONSIDER
MEDICAL INDICATIONS
What is the patient’s medical problem? History? Diagnosis? Prognosis?
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PATIENT PREFERENCE
What has the patient expressed about preferences for treatment (e.g. advanced directives)?
Has the patient been informed of the bene�ts and risks, understood and given consent?
Is the patient mentally capable and legally competent? What is evidence of incapacity?
If incapacitated, who is appropriate surrogate? Is surrogate using appropriate standards?
In sum, is the patient’s right to choose being respected to every extent possible in ethics and law?
QUALITY OF LIFE
What are the prospects, with or without treatment, for a return to the patient’s normal life?
Are there biases that might prejudice the provider’s evaluation of the patient’s quality of life?
What physical, mental, and social de�cits is the patient likely to experience if treatment succeeds?
Is the patient’s present or future condition such that continued life might be judged undesirable by them?
Is there any plan and rationale to forgo treatment?
What plans are there for comfort and palliative care?
CONTEXTUAL FEATURES
Are there family issues that might in�uence treatment decisions?
Are there provider (physicians and nurses) issues that might in�uence treatment decisions?
Are there �nancial and economic factors?
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Are there religious, cultural factors?
Is there any justi�cation to breach con�dentiality?
Are there any problems of allocation of resources?
What are legal implications of treatment decisions?
Is clinical research or teaching involved?
Any provider or institutional con�ict of interest?
500 words, formatted and cited in current APA style with support from at least 2 academic sources
Ritter, L.A., Graham, D.H. (2017). Multicultural Health (2nd ed.). Burlington, MA: Jones and Bartlett Learning.
ISBN: 9781284021028
Chapters 7 and 9
Yale University
CASE 3
IRB CASE 3: REASONABLE RIGHT TO PRIVACY FOR PATIENTS ACCESSING HOSPITAL SERVICES
Type of Institution: Community Hospital
Type of IRB: Biomedical/Socio-behavioral
Type of Case: Biomedical/IRB Operational
Author: Chairman of the IRB
From the Editors:
When research involves hospital patients, part of the IRB’s risk/benefit analysis of a study often involves weighing the impact of subject recruitment methods on the rights of hospital patients to maintain the confidentiality of their hospital medical information. This case illustrates a number of important regulatory and administrative IRB issues that intersect with ethical and regulatory considerations regarding subject recruitment, respect for confidentiality of patient records and the public’s perception of the hospital in the community it serves.
Background
The recent publicity regarding the epidemic of obesity in the United States has led a number of funders, including the National Institutes of Health, to support a variety of research approaches to studying this issue. The ability of a number of herbal and naturopathic compounds to aid in weight reduction, ameliorate insulin resistance and in other ways facilitate metabolic changes aimed at decreasing BMI are being extensively tested around the world. There has been discussion for some time about the use of chromium as a dietary supplement as one approach towards weight reduction through its impact on the alteration of glucose metabolism. This study involved the use of chromium in subjects with impaired glucose tolerance (IGT) and was designed to test the hypothesis that dietary supplementation with chromium could improve impaired glucose tolerance and possibly prevent progression to Type 2 diabetes.
Study Design
The researchers planned to recruit subjects with impaired glucose tolerance (IGT) and test the efficacy of chromium as a dietary supplement along with dietary counseling compared with subjects who received only counseling. The outcome measures included a number of metabolic parameters including weight, glucose tolerance, lipids, and several other related tests of therapeutic efficacy.
Recruitment
Normally, this research group has little difficulty in recruiting subjects to participate in its studies, relying on its well-publicized research platform in the community and strong hospital and community support for its work. Their recruitment efforts have generally consisted of advertising in local newspapers, the hospital newsletter, referrals from local physicians and clinics, and sending informational letters to individuals who have participated in one or more of their previous studies and have provided the research organization with permission to be contacted for possible participation in future research efforts.
In order to participate, subjects were required to meet the standard American Diabetes Association definition of impaired glucose tolerance (IGT) defined as a 2-hour plasma glucose measure of between 140 – 199 mg/dl on a 75-gram oral glucose tolerance test (OGTT). A 2-hour test result greater than 200 defines Type 2 diabetes.
The size of the potentially eligible group was limited to those individuals who
· had undergone 75-gram oral glucose tolerance testing AND
· had results consistent with IGT AND
· who knew their diagnosis AND
· could be notified of the existence of the study.
The recruitment strategies for the study that were initially approved by the IRB involved the standard techniques employed by this research group with an expectation of reasonable enrollment. The researchers discovered, however, that while the results of many oral glucose tolerance tests performed at the hospital were consistent with a diagnosis of IGT, many individuals tested were unaware their results met the definition of IGT and still fewer understood the significance of the diagnosis. This greatly limited direct recruitment from within the local community. Local physicians did not refer many eligible subjects to the researchers as the relationship between the investigators and community primary care providers was found to be less than optimal. Finally, the standard advertising approach and use of the organization’s database of previous study participants failed to substantially enhance enrollment.
Request to Amend Recruitment Methods
Midway through the first year of study implementation, the investigators approached the IRB with this enrollment problem and proposed the study be amended in the following manner. They requested the IRB grant the researchers a Waiver of HIPAA Research Authorization in order to permit direct access to the hospital’s laboratory database. They wished to be provided with an identified list of outpatients who had glucose tolerance testing performed at the hospital lab in the prior 18 months with results that met their inclusion criterion definition for impaired glucose tolerance. The researchers then planned to take the minimum amount of Protected Health Information (PHI) from the laboratory database necessary to mail a letter to each of these individuals informing them that, on the basis of their glucose tolerance testing performed in the hospital laboratory, they were candidates for participation in a study being conducted by the research organization and were requested to call if they would like more information regarding the study. Patients who enrolled in the study would be required to sign the standard informed consent and HIPAA Research Authorization forms in order to participate in the study.
Amendment Discussion
Although the initial study met all Office of Human Research Protection (OHRP) criteria necessary for expedited review, it was not reviewed on an expedited basis but rather was presented to the full IRB for formal consideration. The decision whether or not to expedite a study was made solely by the Chairman of the IRB who often was also the primary reviewer of the protocol as in this case. However, it was the custom in this IRB that all pertinent study documents provided expedited review and approval by the Chairman be presented to the full IRB at the next meeting, even though this is not required by OHRP regulations.
When the request to amend this protocol was received by the IRB office, it was reviewed by the Chairman of the IRB who determined that the amended protocol would still meet all OHRP criteria necessary to permit expedited review. He deemed that the study was not greater than minimal risk and met Research Category #5 of the OHRP Categories of Research that May Be Reviewed by the IRB through an Expedited Review Procedure. He therefore approved the amendment, including the Waiver of HIPAA Research Authorization , on an expedited basis with full knowledge that this amendment would be submitted to the full IRB committee for formal review at the next meeting.
When the committee met, most members strongly disagreed with the Chairman’s expedited approval on the grounds that granting the amendment and thus providing the researchers with identified patient laboratory data without their express authorization constituted an unacceptable breach of patient privacy according to the members’ interpretation of local privacy standards. The committee voted not to approve the amendment request and as a consequence, the Chairman agreed to work with the researchers to create alternative approaches to enhance study enrollment.
Ethical/Regulatory/Operational Issues
The request by the investigators for access to the hospital laboratory database for use as a tool in directly recruiting subjects for participation in the study raised several important operational and ethical considerations for this IRB.
· How much protection should be afforded patients’ PHI in a research hospital? Does a hospital have the right to establish rules for use and disclosure of PHI in its institution that are more stringent than those proposed by the Privacy Rule? What are the considerations that govern disclosure of PHI?
Granting a Waiver of HIPAA Research Authorization to allow researchers to access patient PHI certainly constitutes a breach of patient privacy, yet is routinely performed both ‘…preparatory to research’ and during the course of certain types of studies, and is provided to investigators in accordance with HIPAA regulations as codified in Section 45 of the Code of Federal Regulations, Parts 160 and 164. Here the Office of Civil Rights defines Protected Health Information (PHI) and delineates regulations that govern individual and institutional access to and use of such protected information. It also explicitly describes criteria that must be met for an IRB to alter some or all of the elements that govern how researchers may and may not use PHI in activities related to research. These regulations also differentiate access to PHI in preparation to conducting research (‘preparatory to research’), as well as during the conduct of the study.
Frequently, for example, investigators request and are provided with an identified list of hospital patients who all have the same diagnosis so that researchers may determine the prevalence of the disease entity they wish to study at that hospital. However, researchers’ access to identified patient lists in directly recruiting subjects for study participation without patient authorization depends on the ability of the investigators to successfully argue that their study meets the four criteria necessary to qualify for a Waiver of HIPAA Research Authorization.
These are:
· The research could not practicably be conducted without access to and use of the protected health information.
· There is an adequate plan to protect the identifiers from improper use and disclosure.
· There is an adequate plan to destroy the identifiers at the earliest opportunity consistent with the conduct of research
· There are adequate written assurances that the protected health information will not be reused or disclosed to any other person or entity, except…for authorized oversight of the research project…
While all IRB’s are provided rough guidance in their decision-making by the language in the HIPAA regulations, they often must be sensitive to local community-defined privacy standards. They are also obliged to consider pertinent patient forms that often delineate important hospital policies concerning payment for hospital services, access to patients’ PHI, and other practice information the hospital deems vital for the patients to know.
IRB Decision
The IRB determined that patients who access routine services at this hospital have a reasonable expectation their PHI will be kept private by the hospital and disclosed only under certain specific conditions as detailed in the hospital’s privacy notice, the hospital admission forms or in some other documents provided to patients. The Patient Acknowledgement forms in use at this hospital include a check box that gives patients the ability to permit or deny hospital researchers the right to use their de-identified information for the purposes of research. Additionally, while the hospital’s Notice of Privacy does inform the patients their PHI may be used for research purposes, it does not state whether it can be used in an identified manner such as for recruitment.
While the IRB recognized they had the legal authority to grant the requested waiver, the hospital’s Notice of Privacy and the two Patient Acknowledgement forms (outpatient and inpatient) did not satisfy the committee’s concerns that hospital patients receive adequate notification regarding how, when and why their medical information might be disclosed for use in research. Specifically, the committee concluded that patients utilizing hospital services should be informed of the possibility their identified PHI might be used or disclosed for use in research. The IRB also expressed concern that disclosing patient PHI to researchers for use in direct subject recruitment without patient authorization might result in a public relations problem for the hospital in the community it serves and should be taken into account in its decision-making regarding the granting of the Waiver. In addition, concerns were voiced that the CEO of the hospital would share these public relations fears. The committee decided, given the language in use in the pertinent hospital documents and the public relations concerns, not to affirm the expedited approval of the amendment by the Chairman.
· How should an IRB judge researchers’ claims they have exhausted all standard recruitment avenues in their enrollment efforts when they are requesting a Waiver of HIPAA Authorization in order to cast a wider and often easier net for eligible subjects?
The investigators provided the IRB with a summary of the range of recruitment efforts conducted by the research team in an attempt to make the case to the IRB that they had, indeed, made good faith efforts at subject enrollment through their usual means and had nonetheless failed. They also expressed concerns to the committee that the need for increased expenditure of time and funds to improve recruitment using the standard approaches would likely jeopardize their relationship with the funder for this and future projects. Finally, they reminded the IRB of the importance of the study given the epidemic of obesity and Type 2 diabetes and the promise of chromium as a potentially important tool in combating these problems.
IRB Decision
Despite the researchers’ arguments and notwithstanding the committee’s thorough understanding of the potential importance of the study, the IRB felt the investigators had not yet worked sufficiently hard in their recruitment efforts and therefore had not met the first element for alteration or waiver of HIPAA authorization:
· The research could not practicably be conducted without access to and use of the PHI.
The committee felt that the study could practicably be conducted without the Waiver and without direct access to patient PHI through enhanced enrollment efforts on the part of the researchers. Despite the committee’s understanding that the Privacy Rule does provide IRB’s the ability to grant investigators access to identified patient information for the purpose of subject recruitment ‘…preparatory to research,’ this IRB defined such access as an unacceptable breach of patient privacy particularly since the hospital forms did not specifically inform patients their identified information might be used for research purposes. The IRB voted to insist that the investigators work harder at subject recruitment and denied them access to the hospital’s lab database.
· What is the obligation of the committee to take into account the expedited approval of the Chairman under such circumstances?
Prior to the full IRB meeting, the Chairman had reviewed the amendment requested by the investigators and had provided them with approval to access the lab database for the recruitment purposes described. A copy of the sample letter to be sent to prospective subjects was submitted as well and also granted expedited approval for use. However, as per the routine of this IRB, all study documents granted expedited approval are submitted for review by the full IRB committee for affirmation of the Chairman’s approval. The committee, however, has the freedom to vote to disapprove the documents or to approve them pending receipt of requested modifications.
IRB Decision
As was the custom in this IRB, the full committee met, reviewed the investigator’s request for the Waiver of HIPAA Research Authorization as well as the Chairman’s expedited approval and overwhelmingly rejected this request by not affirming the decision of the Chairman to grant this amendment expedited approval. It was then the responsibility of the Chairman to inform the investigators that the amendment had not been approved and to discuss with them alternate approaches to improve subject recruitment.
· What actions can the Chairman of an IRB take in helping investigators improve study design and implementation?
The Chairman believed that the IRB had erred in its conclusions regarding the request for a Waiver of HIPAA Research Authorization. He considered the IRB mistaken by confusing ‘protection of human subjects’ with ‘protection of the hospital.’ Clearly, the committee had denied the request for the Waiver, in part, due to concerns regarding potentially negative community responses to receiving investigator letters inviting study participation without first having provided the researchers with permission to access their hospital data. Accordingly, the Chairman sought to revisit the discussion of the Waiver at the next meeting in order to encourage the IRB to reverse itself and approve the amendment . In preparation for the next meeting, he attempted to defuse the IRB’s community relations concerns as well as find ways to support the investigators in creating alternative approaches to subject recruitment.
He took the following actions prior to the next meeting of the IRB committee:
· He reviewed this issue of the potential for a negative public reaction from the community with the hospital CEO who concluded that the potential problem resulting from providing the researchers with access to the laboratory database without patient authorization would likely be nominal, although he agreed that the final decision regarding granting the Waiver rested with the IRB. The hospital CEO also recommended the Chairman of the IRB work with the hospital Privacy Officer to revise the Notice of Privacy and the Patient Acknowledgement forms to inform patients utilizing routine hospital services of the possibility their identified information might be used in research conducted at the hospital.
· The Chairman of the IRB met with the researchers to discuss alternative approaches to enhance subject recruitment using changes in inclusion criteria as well as in working differently with local physicians.
IRB Decision
When the IRB met the following month, the Chairman discussed his conversation with the hospital CEO and requested the committee re-consider its prior decision by removing potentially negative hospital community relations concerns from its consideration of the Waiver. However, at the same meeting, the committee was also presented with a revised amendment submitted by the investigators requesting approval of expanded study inclusion criteria and revised recruitment efforts through improved relations with several local physicians. The IRB again rejected the original Waive r request but did approve the new inclusion criteria as well as the new plans for subject recruitment. The IRB clearly believed the investigators’ new proposal supported their original contention that the researchers had not yet worked hard enough at subject enrollment. The IRB stated again that the criteria for approval of a Waiver of HIPAA Research Authorization had not yet been met since the researchers had not yet proven that the study “…could not practicably be conducted without access to and use of protected health information.” The committee recommended the investigators continue to pursue all possible avenues of subject enrollment but left open the possibility of revisiting the Waiver request at a future meeting should these new recruitment efforts still prove to be inadequate. The IRB members made it clear to the researchers, however, of their very high threshold for performing ‘due diligence’ in recruitment efforts which, if reached but still without adequate enrollment, might lead to a reconsideration of the Waiver request.
Evidence Matrix Table
| Article | References | Purpose Hypothesis Study Question(s) | Variables Independent(I) Dependent(D) | Study Design | Sample Size & Selection | Data Collection Methods | Major Finding(s) |
| 1 (SAMPLE ARTICLE) | Smith, L. (2013). What should I eat? A focus for those living with diabetes. Journal of Nursing Education, 1 (4) 111-112. | How do educational support groups effect dietary modifications in patients with diabetes? | D-Dietary modifications I-Education | Qualitative | N- 18 Convenience sample-selected from local support group in Pittsburgh, PA | Focus Groups | Support and education improved compliance with dietary modifications. |
| 1 | |||||||
| 2 | |||||||
| 3 | |||||||
| 4 | |||||||
| 5 |
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