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Bezzdna [24]
2 years ago
9

A 46-year-old man is currently enrolled in a Phase 2 study of a drug for severe diabetic neuropathy. While the study is on-going

, a new drug becomes commercially available that may have equal or greater benefit to the subject. The investigator should do which of the following?
(A) Tell the subject about the new drug but discourage him from switching treatment until the study is completed.
(B) Withhold this information to avoid confusing the subject with other treatment options or alternatives.
(C) Give the subject comprehensive information about the new drug, including its side effects, discuss the pros and cons of both investigational drug and commercially available drug and then allow the subject to decide whether to withdraw from the research to take the new drug.
(D) Dont tell the subject about the new drug since phycian have the right to try our new treatments with their new patients.
Health
2 answers:
irinina [24]2 years ago
5 0

Answer:

C

Explanation:

The investigator should give the subject comprehensive information about the new drug, including its side effects, discuss the pros and cons of both investigational drug and commercially available drug and then allow the subject to decide whether to withdraw from the research to take the new drug.

It is subject's will that he would either take that research treatment or would try the new treatment, but it is the investigator's duty to tell the subject all about the new drug, about its side effects and benefits, its costs and all other benefits or drawbacks.  

Soloha48 [4]2 years ago
3 0

Answer:

(C) Give the subject comprehensive information about the new drug, including its side effects, discuss the pros and cons of both investigational drug and commercially available drug and then allow the subject to decide whether to withdraw from the research to take the new drug.

Explanation:

Whenever a study is done the researcher must follow ethical and moral values and always value the health and health of the study participants. In the case shown in the question above, the study participant has a serious illness and is testing the effects of a drug being produced by the researcher. When a new drug appears that may have the same or better effects than the one being produced, the researcher must be ethical and act to allow the well-being of the study participant. For this reason, the researcher should provide the participant with comprehensive information about the new drug, including its side effects, discuss the pros and cons of the experimental drug and the commercially available drug, and allow the participant to decide whether or not to withdraw from the research for further research. take the new medicine.

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Alenkasestr [34]

Answer:

This is the banking of red cell units from the patient before planned surgery.

PAD was stimulated by concerns about viral transmission by donor blood, especially during the HIV epidemic of the early 1980s. With a red cell storage-life of 35 days at 4°C, most healthy adult patients can donate up to three red cell units before elective surgery. Patients may be given iron supplements, sometimes with erythropoietin, to prevent anaemia or allow more donations to be collected. The Blood Safety and Quality Regulations (BSQR, 2005) require that donations for PAD must be performed in a licensed blood establishment, rather than a routine hospital setting. The donations must be processed and tested in the same way as donor blood and are subject to the same requirements for traceability.

Given the current remote risk of viral transfusion-transmitted infection by donor blood in developed countries, the rationale, safety and cost-effectiveness of routine PAD has been severely questioned (see 2007 British Committee for Standards in Haematology (BCSH) Guidelines for Policies on Alternatives to Allogeneic Blood Transfusion. 1. Predeposit Autologous Blood Donation and Transfusion – https://b-s-h.org.uk) and the procedure is now rarely performed in the UK. Although PAD may reduce exposure to donor blood, it does not reduce overall exposure to transfusion procedures or protect against wrong blood into patient episodes due to identification errors at collection from the blood bank or at the bedside. Indeed, the availability of autologous blood may increase the risk of unnecessary transfusion. Most Jehovah’s Witnesses will decline PAD (see Chapter 12). Clinical trials of PAD are mainly small and of low quality and do not provide strong evidence that the risks outweigh the benefits. The BCSH guideline on PAD only recommends its use in ‘exceptional circumstances’, and lists the following indications for PAD:

Patients with rare blood groups or multiple blood group antibodies where compatible allogeneic (donor) blood is difficult to obtain.

Patients at serious psychiatric risk because of anxiety about exposure to donor blood.

Patients who refuse to consent to donor blood transfusion but will accept PAD.

Children undergoing scoliosis surgery (in practice, most specialist units now use other blood conservation measures).

PAD should only be considered in surgery with a significant likelihood of requiring transfusion, operation dates must be guaranteed and the patient’s ability to donate safely must be assessed by a ‘competent clinician’, usually a transfusion medicine specialist. Adverse events and reactions associated with PAD (or other autologous transfusion systems) should be reported to the Serious Hazards of Transfusion (SHOT) haemovigilance scheme and the Medicines and Healthcare Products Regulatory Agency (MHRA).

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