Most of the clinical trials that are aimed at developing new interventions are often carried out in stages. During the early phases, novel interventions are often tested using a small group of individuals with the aim of evaluating its effectiveness and safety (Emanuel, Wendler & Grady, 2000). After determining that the intervention is highly efficient, it then moves to later testing phases with more subjects to gather more data on the efficiency and potential side effect. Any trial would thus proceed through the following major stages:
Phase I Clinical Trial- At this phase, the trial is conducted to test a potential intervention using a smaller number of participants ranging from 20 to 80. It is often carried out to examine the safety of the study, for instance, the determination of the safe dosage range and at the same time determine potential side effect (Emanuel, Wendler & Grady, 2000) .
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Phase II Clinical Trial - the clinical trial at this stage is undertaken to evaluate a given intervention on a large number of participants which might entail of several hundred to determine its efficacy and assess its overall safety.
Phase III Clinical Trial- at this stage, the trial is undertaken to determine the effectiveness of the proposed interventions using a larger number of subjects, and this might range from hundreds to thousands by making a comparison between the interventions to other standard or even experimental interventions (Emanuel, Wendler & Grady, 2000) . Further, the trial is undertaken to examine the potentially undesirable effect and gather data that might allow for a safe utilisation of the intervention.
Phase IV Clinical Trial- The trial at this phase is conducted once the proposed intervention has been thoroughly marketed. The study is specifically designed to check the overall intervention's efficacy among the subjects carefully and to gather data on a potential adverse effect associated with a widespread use over a long time. Further, the trial examines the prospective use of the proposed intervention. Pharmaceutical firms tend to have numerous companies with objectives which entail comparing the proposed drug with the rest of the drugs in the market. Lastly, this phase will help in the determination of the substantial long-term impact on the target patient’s life quality (Emanuel, Wendler & Grady, 2000).
THE FOUR PHASES OF A CLINICAL TRIAL DIAGRAM
Figure 1-Phases of a Clinical Trial
2. THE FOUR ETHICAL PRINCIPLES IN RESEARCH
Core principles must guide all ethical clinical research. There are four distinct ethical principles in research that are critical when carrying out a clinical trial including, justice, nonmaleficence, respect and even beneficence.
Non-maleficence- This policy revolves around the duty of the researcher to cause no harm to the subjects, and it can be traced back to the Hippocratic Oath (Emanuel, Wendler & Grady, 2000). One of the primary ethical issues within clinical research is whether the trial’s outcome can be expected to offer greater benefit to the society without causing any potential harm to the participants.
Informed consent- Respect for the subjects is established in the informed consent, and it dictates that information should be exhaustive but must be provided in such a manner that it can be understood. The subjects should participate in the trial voluntarily and further, all the information gathered must be held in confidence.
Beneficence- This is shown through carrying out the benefit and risk assessment. The benefits that the participants would receive in the study can be altruistic, the director even collateral. According to Emanuel, Wendler & Grady, (2000), the risks that might be experienced in the survey can be in socioeconomic, psychological or even psychological terms. Any ethical clinical trial must be supported by a body of scientific proof that will justify the exposure of the individual to risks of trial. There is the need to weigh the benefit and risks to all the participants regarding safety and effectiveness of the proposed intervention.
Justice- This principle, on the other hand, takes into consideration the entire process used in selecting the participants to make sure that the results from the study benefit the entire community (Emanuel, Wendler & Grady, 2000) . Further, it outlines the need for the researchers to avoid any action that might exploit the most vulnerable population or take advantage of them.
3. CLINICAL TRIALS DATABASES
Clinical trials are often undertaken to gather information with regards to the safety and the efficacy of the proposed intervention or a new drug. The clinical trials will thus go through four stages, and the information would be used to develop a drug or any device to be sold in the market for consumption. The clinical trial for the drug or intervention thus would begin with extensive research on the clinical databases to gather vital information on the trial (Emanuel, Wendler & Grady, 2000) . The clinical trial database contains in-depth information that would give the research a broad background of the proposed intervention and its potential consequences. Therefore, when used appropriately, the clinical trial database would help guide the research and point specific areas that should be focused. Further, using the database, the clinicians might be able to understand what is required to complete the trial hence saves time and resources.
4. THE 14 AREAS OF THE INFORMED CONSENT PROCEDURE
In a clinical trial, when a researcher seeks for the informed consent of the potential participants, the following are the critical information that should be provided to the subjects:
First, is the statement that the study entails a research which will explain the purpose of the survey and duration of participation of the subjects (Emanuel, Wendler & Grady, 2000) . Further, it is comprised of the in-depth description of the procedure and identification of the innovative products. The statement is vital in the clinical research since the patient-physician and subject-investigator relationships are different.
The second element is the description of the potential risk of discomfort to the participants. All relevant information on the risk of procedure in a clinical study has to be explained in the consent form. According to Emanuel, Wendler & Grady, (2000), s ome of the risks in all clinical trials include social, physical, psychological or even physical harm and all should explained particularly to the clinical trial that might carry risks of mortality.
The third aspect is the description of potential benefits to volunteers that is reasonably expected to a clinical trial. It is important that in any clinical trial, the benefits must not be overstated and if there is no direct benefit, it must be stated in the informed consent.
The fourth element is the disclosure of the most appropriate alternative procedure that might be of benefit to the participants (Emanuel, Wendler & Grady, 2000) . Further, to have a rational choice of the volunteers, the subjects must be aware of the diverse options that are available to them. It explains all available alternatives for them to make an informed decision.
The fifth component is a statement that describes the extent to which confidentiality of the records that identify the participants will be maintained and notes that an external regulatory agency like Food and Drug Administration might inspect the records (Emanuel, Wendler & Grady, 2000). The subjects ought to thus be told how the researcher intends to maintain the confidentiality of the data that identify the participants. It is also important that the subjects are informed that the regulatory agency might inspect the study records.
The sixth element states that for a clinical study that involves a higher than minimal risk there must be an explanation whether there would be any form of compensation or medical treatment that would be offered in the event of injury, their nature and if more information would be gathered.
The seventh component is the explanation of a person that should be contacted for answers to the pertinent questions related to the study and the rights of the participants. In a clinical study, there must be the contact of the person that will be reached in case of research-related injury to the participants (Emanuel, Wendler & Grady, 2000). Therefore, the consent document of a clinical will contain the name of the person to be contacted, related injury and the rights of the subjects.
The eighth element is the statement that the participation to the study would be voluntary. In a clinical study, participation should be voluntary with no penalty or the loss of benefit for refusing to participate.
The ninth element is the statement that the procedure might entail risks to the unforeseeable subject such as the fetus or embryo especially when dealing with pregnant women. In a clinical trial a statement, which explains potential unforeseen risks to the embryo or fetus must be supported with sufficient animal data that predicts potential risk to the human fetus (Emanuel, Wendler & Grady, 2000).
The tenth component is the anticipated event when the participant’s involvement might be terminated by the researcher with having the consent of the subjects. In a clinical trial, the subjects must be informed possible situations when their participation might be terminated without their consent particularly when they fail to follow the instructions as given to them by the researcher.
The eleventh element states that all additional costs to the participants that would be incurred in the process of involvement in the study should be explained (Emanuel, Wendler & Grady, 2000) . A clinical trial should explain the extra cost that a subject might incur during the research to ensure that they prepare themselves adequately.
The twelfth factor outlines the consequences of the decision of the participant to withdraw from the trial. The clinical trial should describe a procedure for effective termination of subject involvement, especially where withdrawal might have deleterious effects on the s health or welfare of the participant (Emanuel, Wendler & Grady, 2000).
The thirteenth element is the statement that new outcome developed from the study which might relate to the willingness of the volunteers to continue participation will be offered to the participants. In a situation where it is expected that the new conclusions might be relatable to the participant’s continuous involvement are probable, then IRB must establish a plan must present information to the members.
The last element is the approximate number of the participants in the trial study. In a clinical trial, the participants must be informed the total number of the subjects and reasons behind that specific number, for instance, a smaller number might compromise the confidentiality.
5. HIPAA PRIVACY AND SECURITY RULES
HIPAA limits how the researchers should utilize or even disclose any information that is protected for any probable function. Privacy law established a health information category that is known as PHI that might be used or even disclosed to other people only within specific situations or condition. It strictly authorizes the researcher to appraise the health record for the pre-trial purposes as long as there is no PHI that would be revealed to any sponsor (Emanuel, Wendler & Grady, 2000) . Additionally, the Privacy Rule will allow the researcher to share the “de-identified” information without any form of constraint.
Secondly, privacy law allows the researcher to recruit patients for instance through an email or a letter to the potential subjects who are qualified to be enrolled in the study or even through talking about the recruitment when visiting the organisation. In a situation where a CRO desires to make use of a medical practitioner to enroll subjects, then the researcher is required to obtain HIPAA’s partial waiver approval from IRB (Emanuel, Wendler & Grady, 2000). It is a requirement that a researcher should acquire an HIPAA research approval to be allowed to recruit subjects in the trial study. The research site which in this case is the covered entity has to ensure that they supply the HIPAA authorization. Further, HIPAA authorization plays a vital role where they inform the patients on ways to revoke the authorization. Once the revocation has been done, the researcher might utilize the new PHI of the patient to maintain the overall integrity of the study.
HIPAA further continues to apply in a situation where the study results from a clinical trial are published or even presented to a particular audience. Therefore, a clinician is required to obtain a written HIPAA authorization before paper’s publication or even making any form of presentation that is comprised of the PHI (Emanuel, Wendler & Grady, 2000) . Further, it is a requirement that all materials that involve any highly publicized case, photographs or even a rare disease must be critically reviewed with utmost care.
6. EXEMPT RESEARCH AND EXPEDITED RESEARCH OF IRB SUBMISSIONS .
Figure 2-Exempt Research and Expedited Research
B. A SURVEY PACKET TO GATHER APPROPRIATE RESPONSES
1. A COVER LETTER
Dear Sir,
RE: Request to perform a clinical in your organisation
Introduction-
I am writing to express my interest in carrying out a clinical trial in your organization. Various studies have focused on work related stress and job burnouts.
Research question -
Are increased nursing turnover among the major risk factors that affect the quality of care in most hospital care?
Purpose-
The primary purpose of the current clinical trial is to evaluate whether the increased nursing turnover in healthcare institutions affects the healthcare quality.
Importance of the study-
Increased nursing turnover has been a major area of concern in the contemporary world because with increased turnover, the quality of care deteriorates worsening the patient’s condition. With the rising nursing turnover, to the productivity of the available nurses that attends to patients critical needs have been limited.
Participant’s Importance-
The participants in this clinical trial will play a crucial role by providing appropriate information on the benefits that the participants. The participants will thus provide vital information that would help to determine the effectiveness of an intervention for human consumption.
Sponsors-
The primary sponsors of the current research comprise of the government’s health policy makers who wish to improve the quality of care in hospitals and increase the number of clients served which would improve the nation’s wellbeing.
Time frame-
The trial will take approximately five months. Therefore, it will run between September 21, 2017, and March 21, 2018.
Contact Information-
The contact person is Mark Luke who is the primary clinical research nurse. Mark has Bachelor of Science in Nursing from Ohio State University, Cincinnati, OH – 2004. He can be reached through email markluke@gamil.com and phone number +44-2617282429
Survey Instructions-
The subject will respond to the eight questions that focus on various areas of nurse turnover and how it impacts the quality of care. The participant must be able to comprehend the core issues as related to the research topic and how they will contribute to the process of gathering information and the research topic. The participants would be required to respond to the questions as asked by the researcher and ask for clarification whenever the concept is not clear.
2. Survey question
Do changes to nurse staffing improve patient care outcomes?
What do you think contributes towards increased nursing turnover?
How could you define your workplace environment?
Are you satisfied with your career choice?
Yes
No
What are the chances of being promoted in the organisation?
Very high
Minimal
None
Do you think that the type of care provided to patients is of higher quality?
Yes
No
The health management of the organisation are highly supportive
True
False
I would wish to continue working in my current organisation
True
False
I am satisfied with current wage and salary
True
False
2. STATISTICAL METHODS TO EVALUATE THE SURVEY RESULTS
The data analysis process in this study will be conducted using diverse strategies. The interview will also be recorded with the utilisation of the audio devices, therefore; the data will be transcribed (verbatim). Further, the data gathered from the interviews conducted will be the transcript, read and evaluated for possible universal insightful and conception of perfect background (Emanuel, Wendler & Grady, 2000). Further, information collected will be compiled then later on ordered systematically to ensure that they match up with the questions of the researcher. Specific codes will be developed for categorization of all reoccurring themes in addition to the universal trends that might repeatedly surface in the transcript. Codes will be assigned to phrases and words that might reoccur in the transcriptions of the interview. Evaluation of the information obtained will have to be found on the question developed in the survey.
3. BENEFITS OF CONDUCTING INTERVIEWS WITH SURVEY .
A. APPROPRIATENESS OF INTERVIEWS
Conducting interview would be appropriate for the survey above. Interviews have been shown to be the most suitable tools to gather data for the study. The interviews as instruments for the collection of vital and in-depth information are flexible which means that they can be used to collect data on the different phenomenon, based on the interests of the researcher (Emanuel, Wendler & Grady, 2000). Additionally, interview instruments will allow the researcher to specifically focus on distinct ideas, feelings, and experiences of the participants and how they contribute to the study. Further, the researcher would be able to change the nature of questioning which would help to suit a particular setting and in the process gather in-depth information. Interviews are cost efficient and further; they have the potential to save on costs where each will be performed within a period of 20 minutes.
References
Emanuel, E. J., Wendler, D., & Grady, C. (2000). What makes clinical research ethical?. Jama , 283 (20), 2701-2711.
