Therapeutic Misconception

Misconception with equipoise will make the barrier between therapeutic and research null. Its goal in producing reliable and generalizable knowledge is coiled in with ethical difficulty. That’s why on an ethical standpoint, benefiting a collective group needs to be weighed with the rights of the participant patients in the clinical research. However, the goal of equipoise is beneficial since its main priority is extracting epistemic information from the randomized clinical trials. The useful information is needed since equipoise follows the principle of having “a state of genuine uncertainty.” This affects both theoretical and clinical. So, trials that are redundant can be marked out by taking equipoise into account since the trials have already been run where there is already certainty of the outcome. So, to detail what equipoise allows underneath the principle of “non-exploitation” is that there will be no exploitation of participants or patients with a needless trial that holds no useful outcome. Equipoise becomes a necessary condition in order for a trial to become ethical since trials must be reviewed to be deemed of value. But, there’s an underlying factor that equipoise’s uncertainty trials do not bring about and that is the health of the patients. Participant patients will undergo trials of uncertainty so there is a possibility that the patient may be harmed during the process. If the trial proceeds, then the health of the patients will be even more at risk, disregarded and exploited in order to grasp epistemic information. The moral principles between medical therapy and those that guide clinical research is different. Though, equipoise is valuable in a collective sense – it is exploitative of participant patients by failing to consider the balance with the subject and societal

Our country is one where every day, new medical treatments and medicines are being discovered and being approved to help Americans battle all of the different diseases and conditions that affect us. In order for us to be able to get access to those medications and treatments, many people agree to become part of clinical trials, they are the first to receive the treatments, this helps to understand how the body will be affected and if the medication will be effective. People who are part of these clinical trials, go through extensive medical testing, and they must be of sound mind and

Some of the research the IRB reviews involves medical and administrative record data, research that uses leftover tissue, health service research, survey research, behavioral research, biomedical and other clinical research, and many more. The IRB has the authority to approve, require modifications in, or disapprove research. “The IRB require that information is given to the participants as part of informed consent is in accordance with appropriate laws, regulations, and international standards (https://www.irb.cornell.edu/responsibilities/).”

Interestingly, IRBs are set up mainly to confirm that a clinical trial is ethical and that the process will not harm patients. Whether or not the clinical trial is constructed properly or not is commented upon, but may not be a major focus of the review. For this reason, many institutions also require a concurrent review by an institutional “Office of Clinical Research” and a regular meeting of supervising clinicians during the

The HHS is required to oversee IRBs in order to ensure that they are functioning properly. Institutional Review Boards cannot function properly without being overseen by the HHS, and therefore lack of oversight would lead to weakened protection of human participants. An Institutional Review Board may not fulfill its purpose without the HHS’s close oversight. Two agencies within the Department of Health and Human Services, the Office for Protection from Research Risks (OPRR) and the FDA, are both tasked with reviewing IRBs. The OPRR utilizes an assurance document to oversee how IRBs are functioning. All IRBs using HHS funding must have an assurance document on file with the OPRR. Coleman adds, “The assurance is a written statement of an institution’s requirements for its IRB and human subject protections” (Coleman et al. 170). Meanwhile, FDA uses research investigators to determine whether IRBs are functioning in an effective manner. The OPRR and the FDA share the task of oversight of IRBs, and do so through documentation and research investigators respectively. Without this system of review, Institutional Review Boards would not be checked by any part of government, and thus would have free reign to do as they please. Thus, the interests of human participants

Medicine is often called an art rather than a science. While I do not agree with this assessment entirely, because I believe in the value of empirically-gathered evidence, I do understand why many patients are frustrated by what often seems like contradictory studies supporting different health treatments. One week it seems as if there is an article in the newspaper stressing that preventative screening is valuable; the next week there is an article stating that too much testing can yield too many false positives. One week exercise is stressed as a means of weight loss, the next week a healthy diet. From a layperson's and even a provider's perspective, this can seem confusing. There is also an unfortunate degree of confusing chatter from the commercial purveyors of medicine, promoting specific drugs or treatments.

Institutional Review Boards (IRBs) are groups that are formally designated by an institution to protect the rights and the welfare of human subjects. This is done by reviewing, approving and monitoring the medical research (Layman & Watzlaf, 2009). However, in order to do this efficiently, there are 3 ethical theories that the IRB must rely on. The first theory is beneficence which means “do no harm/promote good”. The second theory is autonomy, and the third theory is justice. Furthermore, IRBs review all the research that is conducted via data sources regarding human participation (i.e. medical records, tumor registry, and Medicare data). That said, IRBs are important because they help protect the rights and welfare of those participating

The IRB is a way for participants in research to make sure that their rights as participants are protected and represented fairly in different research projects. The demands of the IRB are simple. The three demands are respect for persons, beneficence and justice. These characteristics are in place to protect the participants in every way possible. The first demand, respect for person, not only means to have respect, but also to be able to provide the utmost protection for the person in a research study depending on the risk factors in the study. Beneficence is the ethics behind the treatment of the participants of the study. This includes the safety and the minimizing any risk factors there may be in the research study. Justice refers to the benefits of the study, meaning the equal treatment of everyone in the study. These are needed as guidelines for researchers to make sure that all researchers are protected in any and every situation they may be put in. As researchers, it is their responsibility to make sure that their participants are protected and the IRB has placed these guidelines so the researchers and the participants know their rights during

I would not conduct the child custody evaluation for him because this would be a dual role or multiple relationship. Since I have already been counseling this client, and already have a relationship and opinion (that he is a good person who loves his kids) with him, this may make it hard to remain objective if I were to conduct the child custody evaluation. Also, there are two sides to every story, thus even though the client seems nice and loving while in therapy, that may not be the case outside of therapy. Also, entering into a multiple relationship is against the American Psychological Association (APA) (2010) Ethical Principles. Ethical code 3.05 states that therapists should avoid multiple relationships because being in one can impair their competence, effectiveness, objectivity and can put the client at risk for harm or exploitation. The APA ethical principle of avoiding harm also applies to this scenario (APA, 2010). If I was to do the custody evaluation for my client, and find that he should not have custody, this would ruin our therapeutic alliance and greatly harm the client. Although some therapists may belief that they would be competent and objective enough to conduct the child custody evaluation for their current client, they should stay on the side of caution, not take the risk and refer the client to a different professional who is competent in these evaluations.

My view of Human Nature is to speak with true honesty and to understand my view I would have to share the personal aspects within my life. There is an agreeance stated in Carroll College (2016), that “Normative implications for human existence (How should we live): Is dependent within success or failure in life, on either getting medical help, therapy, or being psychologically analyzed in order to escape our pasts, or at least prevent it from turning into a affliction”. This way we can aid the Ego in its fight against the Id and the Superego. I have had many traumas involving being abused by a babysitter and intimate relationships, sexually assaulted, raped at the age of 12, parents divorced at 12, Depression, loss of an unborn child, emotional

In their research, Cohen, et al. (2001) and colleagues suggest that randomized controlled trials conducted in research settings, may not provide the whole picture about the most

The author believes that biomedical research is the way of better understanding medicine and without randomized clinical trials the field of medicine will have insufficient information. He argues that randomized clinical trials are the most scientifically sound and ethically correct means of evaluating new therapies. The belief of a physician being unethical when running randomized clinical trials is rejected by this article because previous trials on patients can have a better outcome on future patients. This article stresses that randomized clinical trials must be carefully designed that has an intended purpose of gathering data to improve the wellbeing of patients. If the patient is to endure a clinical trial he/she must be properly informed of the risks of the trial and the health of the patient should be high priority. Overall this article explains the importance of randomized clinical trials and debunks the idea of randomized clinical trials as being unethical. This article uses a utilitarian point of view and gives reasons why these trials can be in the best interests for both the patient and society.

Provider’s participation in clinical trials as an investigator is critical in development and advancement in treating diseases with new medicines, devices or protocols. Advantages of participation include; professional development, recognition as a leader in the medical community, potential for increased compensation and personal satisfaction. It should be noted not ALL studies provide physician compensation. There is also an advantage to patients whose physician is also a clinical investigator, they can have confidence you will have the ability to consider any

Federn (1961) states that individuals separate their internal experience from the external world through psychological boundaries. In addition, these boundaries allow an individual to maintain the distinction between oneself and others (Mahler, Pine, & Bergman, 1975). In the context of therapy boundaries between the therapist and client provide an environment that fosters safety and trust enabling exploration. This dynamic places mental health professionals in a position of power over the client (Simon, 1992). This power differential creates a responsibility for the therapist to create and maintain appropriate, professional boundaries. When speaking about departures from commonly accepted clinical practice it is necessary to distinguish between boundary crossing and boundary violations. Whereas boundary crossing may or may not benefit the client, boundary violations have the potential to seriously harm the client or the therapeutic process (Simon, 1992). It is important to note that either the client or the therapist has the ability to cross or violate boundaries. However, the duty to put the client’s therapeutic care and goals first lay with the clinician alone.

Due to the fact that because drug trials were poorly regulated in the early 1970’s Phase I research was conducted on prisoners. The FDA was granted authority to monitor research that involved humans in the 1978; at which time, the FDA ordered each institution to devise an Institutional Review Board (IRB). The IRB was to generate and monitor the rules of the trials on all studies done within the universality. The IRB was comprised of faculty members who volunteered to evaluate their colleagues’ studies. Unfortunately, before 2005, FDA inspectors’ primary focus was on verifying the clinical trial data, not the human subjects involved in them.