A Master of Science in Regulatory Affairs from Northeastern University helps prepare these professionals to manage the product life cycle in industries such as biotechnology, pharmaceuticals, and medical devices while better understanding the laws and standards that apply to each step of that life cycle. They, as well as people who have experienced major injury, illness or disability that interferes with the quality of their lives, might be traumatized by unskillful interviewing. Public attention to ethics in research involving human subjects typically emerges from shocking scandals. It is also wise to only gather sensitive information if absolutely necessary for the research. They may feel compelled to participate in research because of their relationship to the researcher or because their freedom is curtailed. 4. One of the emerging trends in biotechnology is the personalized treatment of rare diseases, made possible through highly targeted treatment plans and therapies that are, in some cases, based on a patient’s genetic and molecular makeup. However, the actual studies may cover a number of ethics issues and you are advised to look at other studies as these may also highlight issues that they are of your concern. Over the past decade, there has been an increase in the volume of qualitative health services research published in the mainstream medical journals1 and a growth of interest amongst health service researchers in qualitative research methods.2 However, with few exceptions,3,4 articles about qualitative methods in health services research have not dealt with ethical issues. Research that involves actively deceiving participants about research activities presents ethical problems. A mix of national regulations and international declarations offer numerous principles for human subjects research ethics. Empirical–ethical studies have argued that both the ethical concept and the current legalistic practice of informed consent should be adapted to the complexity of the clinical environment. from Northeastern University helps prepare these professionals to manage the product life cycle in industries such as biotechnology, pharmaceuticals, and medical devices while better understanding the laws and standards that apply to each step of that life cycle. The ethical and legal issues in research are the most important considerations for every researcher. If numbers appear to be off, they must further investigate to see if the issue is with the way the device collects and reports data—as with a heart rate monitor in a smartwatch that’s worn incorrectly—or is indicative of a problem that requires medical attention. Parents of sick children in an emergency room or intensive care unit are under immense emotional distress and approaching them with a request that their child participate in research may only increase that distress. According to the FDA, certain adverse events must be reported to an IRB, while others do not—but all require investigators to intervene on behalf of a patient’s health and safety. Some research activities may require IRB review, others may not. Under FDA rules, a clinical trial that requires human subjects must have a consent form that is reviewed and approved by an Ethics Committee or Institutional Review Board (IRB). Both students and faculty at Lehigh University are encouraged to become involved in the research life of the University. Lehigh’s IRB is required to review all projects that are considered human subjects research under the federal regulatory definition of research: “a systematic investigation, including research development, testing and evaluation, designed to develop or contribute to generalizable knowledge.” (45 CFR 46.102(d)). Members of vulnerable groups – excepting those who are identified as spokespeople – should not be asked sensitive questions, by which we mean questions that could re-traumatize them or that, if responses were revealed outside the research, could put respondents at risk. Learn more about Northeastern University graduate programs. The conclusions of the study must be directly correlated with the results found during the course of the research. Ethical Considerations. “The IRB wants to make sure they are not unduly influencing patients or making promises that the drug will work,” Dronitsky says. Adherence to Data Protection Act (1998) if you are studying in the UK. Other vulnerable populations:  Cognitively impaired individuals might not have the intellectual capacity to consent to research participation. This roadblock presents safety and ethical issues because organizations must avoid enrolling participants who do not qualify. 64% of regulatory affairs professionals hold an advanced degree. In highly regulated industries such as medical devices, pharmaceuticals, biotechnology, and food safety, companies must constantly balance the demands of bringing new products to market quickly while also testing those products in a safe manner. Ethical issues in research is a topic worth discovering because it helps a person conducting a study to do their job in a quality way. Departmental honors and capstone courses, as well as a number of campus fellowships and programs, offer opportunities for students to learn the skills of research and present their results. 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