Revamping the US Federal Common Rule: Modernizing Human Participant Research Regulations.
نویسندگان
چکیده
On January 19, 2017, the Office for Human Research Protections (OHRP), Department of Health and Human Services, and 15 federal agencies published a final rule to modernize the Federal Policy for the Protection ofHumanSubjects (knownas the “CommonRule”).1 Initially introduced more than a quarter century ago, the CommonRulepredatedmodern scientificmethodsand findings, notably human genome research. Research enterprises now encompass vast multicenter trials inbothacademiaandtheprivatesector.The volume, types, andavailabilityofpublic/privatedataand biospecimenshaveincreasedexponentially.Federalagenciesdemandedmoreaccountability,researchinvestigators sought more flexibility, and human participants desired morecontroloverresearch.Mostrulechangesbecomeeffectivein2018,givinginstitutionstimeforimplementation.
منابع مشابه
Protection of human participants in health research - a comparison of some US Federal Regulations and South African Research Ethics guidelines.
In response to criticism of ethical review of a South African clinical trial, we contrast aspects of the United States Common Rule with South African research ethics requirements. In the USA the Common Rule does not apply to all health research and allows many exemptions from ethics review and waivers of informed consent. At a structural level research ethics review in South Africa is in many c...
متن کاملWho's watching the watchdogs? Responding to the erosion of research ethics by enforcing promises.
For more than thirty years, federal regulations--collectively known as the "Common Rule"--have governed all federally funded medical research involving human subjects. The Common Rule requires, inter alia, that any research facility receiving federal funds submit a Federal Wide Assurance (FWA) to the department or agency from which funding is sought. The FWA is a contract in which the research ...
متن کاملEthical Values and Legal Regulation
UNTIL THE EARLY 1970S, R. J. REYNOLDS, DOW Chemical, the US Army, major pharmaceutical companies, and other sponsors conducted a wide variety of research on prisoners—a captive, vulnerable, and easily accessible population. During that time, approximately 90% of all pharmaceutical research was conducted on prisoners, who also were subjected to biochemical research ranging from testing diet drin...
متن کاملReforming the regulations governing research with human subjects.
In the wake of the scandal surrounding the Tuskegee syphilis study, Congress established the National Commission for the Protection of Human Subjects of Biomedical and Behavioral Research. The commission investigated and made recommendations regarding basic ethical principles guiding research with human beings and the special principles relating to research with fetuses, prisoners, and children...
متن کاملProtecting human research participants in the age of big data.
Facebook’s experimental manipulation of newsfeed content and the subsequent PNAS publication of significant findings from it (1) have drawn attention to the regulation of human participation in academic research and to the differences between commercial and academic research. Those events were recognized in an Expression of Concern in PNAS (2). In commerce and on the Internet, experimentation i...
متن کاملذخیره در منابع من
با ذخیره ی این منبع در منابع من، دسترسی به آن را برای استفاده های بعدی آسان تر کنید
برای دانلود متن کامل این مقاله و بیش از 32 میلیون مقاله دیگر ابتدا ثبت نام کنید
ثبت ناماگر عضو سایت هستید لطفا وارد حساب کاربری خود شوید
ورودعنوان ژورنال:
- JAMA
دوره 317 15 شماره
صفحات -
تاریخ انتشار 2017