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Research with Human Subjects:
Published in Lynne M. Bianchi, Research during Medical Residency, 2022
Lynne M. Bianchi, Joyce Babyak, Robert Maholic
The U.S. Office for Human Research Protections (OHRP) offers a Human Protections Training course, consisting of four lessons. These are free online training modules that may be used at some institutions.
Conduct of an inquiry into alleged misconduct
Published in Frank Wells, Michael Farthing, Fraud and Misconduct in Biomedical Research, 2019
In many countries, there are national bodies involved in the investigation of research fraud and misconduct that can advise and support the relevant institutions; these are covered in more detail in Chapter 17. But it is still the responsibility of the institutions or companies to whom allegations of fraud or misconduct have been made to carry out a full investigation and to take action against those found to have acted dishonestly. The national bodies in some countries, such as the USA and France, can themselves take direct action. For example, the US Office for Human Research Protections (OHRP) can order the closure of institutions, as can the Food and Drug Administration (FDA), which can also circulate the names of the wrongdoers on their ‘Black List’, and the Office of Research Integrity (ORI) can also recommend federal funding be withdrawn.
The imperative to publish healthcare improvement
Published in David P. Stevens, Writing to Improve Healthcare, 2018
The Office for Human Research Protections (OHRP), a U.S. federal oversight agency, was formally established in 2000. At that time, OHRP policy considered healthcare improvement studies to be under the rubric of clinical research. Improvement professionals, on the other hand, argued that healthcare improvement did not involve new experimental therapy, but rather the implementation of variations on “usual care” [17]. The variety of approaches to quality improvement at this time employed a variety of definitions of improvement methodology. This added to the conflict surrounding research ethics policy at both the local institutional levels and at the national oversight levels.
Sex-specific correlates of metabolic syndrome risk in college-aged young adults
Published in Journal of American College Health, 2022
Simon Higgins, Alexandra N. Smith, Ewan R. Williams, Bhibha M. Das, Michael V. Fedewa, Ellen M. Evans
This cross-sectional study included a convenience sample of 425 full-time, first-year students, who lived on-campus at a large southeastern U.S. university. The reported sample includes 379 students (67.3% female; 70.2% white, 18.3 ± 0.5 y/o) with complete data for all outcomes of interest. Recruitment took place via printed and digital advertisements and emails to university accounts. Individuals were excluded if they were pregnant, planning on becoming pregnant, or had given birth in the past 12 months. Athletes, as well as those who had been previously diagnosed with a cardiovascular, metabolic, or renal disease, were also excluded from the sample. The University’s Institutional Review Board (IRB) approved all aspects of the protocol and the study complies with the Office for Human Research Protections Common Rule. All participants provided written informed consent prior to participation.
When Professional Meets Personal: How Should Research Staff Advertise on Social Media for Research Opportunities?
Published in The American Journal of Bioethics, 2021
Liza-Marie Johnson, Devan M. Duenas, Benjamin S. Wilfond
As part of the regulatory review process, both the Food and Drug Administration (U.S. FDA 1998) and Office for Human Research Protections (OHRP) (U.S. Department of Health and Human Services [HHS] 2013) have issued guidance stating that institutional review boards (IRBs) should review and approve direct advertising to study participants. Research opportunities advertised online, and specifically through social media, would be included in this requirement. The FDA considers recruitment via direct advertising for study participants to be the start of the informed consent and subject selection process. Advertisements should be included in the IRB review to assure that they are not unduly influential and do not promise any expectation of cure beyond what is described in the consent materials and the protocol. This is especially critical when a study may involve participants who are likely to be vulnerable to undue influence. The previously published directives from federal agencies predate the widespread use of social media platforms as a method of health communication and participant recruitment and are largely silent on the potential blurring of personal and professional boundaries when study staff members advertise through their personal social media platforms. For example, should there be any concern if a team member simply shares an IRB-approved advertisement from an institutional account to their personal twitter or Facebook news feeds? What if they attach a comment to the retweet or share?
When Is It Ethical for Physician-Investigators to Seek Consent From Their Own Patients?
Published in The American Journal of Bioethics, 2019
Stephanie R. Morain, Steven Joffe, Emily A. Largent
The Office for Human Research Protections (OHRP), which provides federal leadership on human subjects research, cautions against dual-role consent, noting that “patients might feel obligated to participate in research if their physician is also the investigator” (Office for Human Research Protections 2017). OHRP instructs IRBs to “use their discretion [and] … consider whether the prospective subject may feel pressured.” The U.S. Food and Drug Administration (FDA), in non-binding draft guidance, identifies the potential for conflicts of interest (COIs) and threats to voluntariness “when the investigator is also the prospective subject’s physician” (Food and Drug Administration 2014). Yet the draft guidance implicitly allows dual-role consent so long as the physican-investigator is “careful.”