Staph Meeting 13

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Biology

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Dec 6, 2023

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Thunderbirds Episode 13: Staff Meeting - Thunderbirds Case Study 1. A pharmaceutical company conducts 10 different phase I studies on a new drug to establish its safety in health individuals. Five of these studies had a P-value less than 0.05, indicating significant results; five had a p-value greater than 0.05, indicating non-significant results. As it so happens, undesirable side effects were observed in four of the studies with the nonsignificant results. None of the studies with significant results had a significant proportion of side effects. The researchers report these results to the FDA and in a publication, but they donot mention the side effects that occurred in the studies with the higher p-values. ● Is there an ethical responsibility to report all of the data? ● Does it make a difference in reporting if the subjects were not human (i.e. animals)? ● What are the responsibilities of the researchers in this company, to themselves, and to society? ● Should there be a federal mandate to report all side effects? A. There’s an ethical responsibility of the researchers to report all findings and results in a timely manner that is also understandable in order for the community to fully benefit. B. If subjects were not humans, then it wouldn’t be unethical to make reports public because it would not necessarily cause any harm or take benefits away from humans. Results should still be published for the scientific community for further review. C. The responsibilities of these researchers include taking on the role as advocates to represent communities that would be affected, researchers must exhibit cultural competency when communicating with communities. Responsibilities within the experiment involve getting the consent of participants and protecting the wellbeing and privacy of the subjects. Rules and regulations regarding proper ethical behavior and unethical conduct must be shared with any colleagues and any practicing scientists involved must D. There shouldn’t be a federal mandate to report side effects until the post-licensing evaluation of the vaccine. Case study #2 Two physicians in a department of emergency medicine reviewed the medical records of all patients admitted for diabetic crisis to the hospital in the last 5 years. They correlated several different variables, such as length of hospital stay, survival,cost of care, rehospitalizations, age, race, family history, and so forth. If they found any statistically significant trends (p-values of 0.05 or less),they planned to publish those results,and they planned to ask a statistician to help them determine if any of their correlations are significant. • Do you see any potential methodological or ethical problems with this study design? Yes, there are some methodological and ethical problems with this study design because the physicians did not have the best interests in their patients. They need to follow the

Thunderbirds major principles for research which are respecting the people, beneficence, and justice • Would it be ethical for the researchers to publish their results if they do not makeit clear in the paper that they have mined the data for specific trends? No, they have to provide informed consents from the patient themselves. The informed consent should include the purpose of the information, comprehension, voluntariness, and documentation. In addition the physicians need to go through an institutional review board to ensure everyone involved in the study are treated fairly • Would you be more confident in their research if they had a hypothesis prior to conduction the study? Why? No, even if they have a hypothesis they would need to conduct the study following correct protocols. Case Study 3. An announcement in the newspaper and radio encourages people to enroll in research Protocols to test a new anti-flumedication. The announcement emphasizes that subjects Will receive a free physical exam, free healthcare for 60 days and $400 compensation. The New drug is very promising in either stopping the full-blown symptoms of the flu or Preventing it all together. Theprotocol has already been approved by an IRB. • What questions would you ask if you were a potential subject? If I were a potential subject I would ask has anyone else tested the anti-flu medication? What makes this new drug promising from all the rest of the flu medications or vaccine? Does this new medication cause any other health problems? • Should the IRB have approved the protocol? Why? I do not feel as if IRB should have approved this protocol because first off they are still doing research to see if it actually works that is why they want people to enroll in the research and because they are bribing the people with a free physical exam, healthcare for 60 days and $400 compensation. What if this new drug doesn’t work and affect the person’s health. Case Study 4. The aim of a study is to better understand condom use among adolescents and the psychosocial factors that increase or decrease condom use. The study is a survey of adolescent attitudes and beliefs about sexuality. It will include many different questions about sexuality as well as questions about alcohol and drug use, violence, musical tastes and religion The subjects will not be told the exact purpose of the study when they take the survey, but they will be told the results of the study. Subjects will be recruited from three local high schools. Personal identifiers will be removed. High school health education teachers will help administer the survey. Taking the survey will suffice as proof of consent. Subjects may refuse to take the survey without penalty. Parents will be notified about the study and may refuse to allow their children to participate. ● How would you protect the privacy of subjects? ● Why should the parents be involved? ● Should there be any concern for the community

Thunderbirds A. Once consent is given by parents, I would continue administering surveys that are to be collected without names and birthdates on them to conceal identifying information. Students would have to fill out information regarding their demographics. Once information is collected, proper measures such as collection, storage and analysis of the data would be carefully handled by researchers to keep all information private. B. Parents should be involved to avoid and ensure there is no coercion or persuasion occurring with the study. Parents should be included for “informed consent” because most high schoolers are considered minors and dependents and can not legally consent to participating in studies. C. The results should be published for the safety of the high school community. Studies are done to inform the public of important affairs and Case Study 5. A research proposal and its informed consent forms were submitted to an IRB of an independent nonprofit research facility in San Francisco. The protocol deals with 300 drug addicts, of whom 20% are also suspected of having HIV. The protocol is a survey of social habits of these addicts. The surveyor will follow the addicts around in their daily routine for one week to register their food intake, drugs used, sexual habits, and so forth. The researcher considered the study to be a minimal risk study and said so on the proposal submitted to the IRB. · What should the IRB do? o Carefully review the study protocol. Even though they are addicts, they have rights as people. Consent forms must be superb and inform the subjects of the risks that they are taking along with exposing others that they interact with while engaging in their lifestyle. o All recruitment material, surveys, timelines and background information must be looked into and made sure that all confidentiality and privacy assurance are in place and the researcher has in place a detailed understanding of risks and benefits of the study available to subjects. · What should the informed consent contain? o To cover the bases, the informed consent should include; Purpose, procedures, possible risks and benefits, contact information, meaningful discussion, personal consideration of characteristics or factors, in written form and approved by IRB with a copy given to the subject after signed. o But the consent form should definitely press on the private information vs. confidentiality. Confidentiality can only go so far, if there is a case of a lawful investigation some of their actions could incriminate them, and or others they associate with. They need to know that information would not be shared unless

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Thunderbirds the researcher had no lawful choice but as far as for the purposes of the research and the study they would be protected from identification. · Should confidentiality of information be dealt with in the informed consent form? o Yes, because this kind of study includes the observations of actions that aren’t always lawful and the subject needs to know how the risks of their actions could affect them in the worst-case scenario of information having to be revealed. · Is this research of minimal risk? Why? o This is not a minimal risk study being that we are dealing with human beings and their lifestyle and how their habits affect that lifestyle. Some of the elements being studied are dangerous and the sheer number of 300 creates larger concern. For example, we are observing subjects take unmeasured and unregulated drugs that can have an extreme effect on them including death. We are observing sexual patterns that can put the subject or unknown partners at risk yet we can’t inform others that this subject has had sex for money or 4 other people today because it would interfere with the study. Yet, would it even be ethical not to inform them or ethical to observe in either situation because 20% of the subjects have HIV? It’s hard to say for sure or how its justified. Especially when, last but not least, it isn’t a clear reason for this study stated. What are we trying to accomplish with this study?

Staph Meeting 13

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