<P> The reviewers may also request that more information be given to subjects when, in their judgment, the additional information would add meaningfully to the protection of the rights, safety and / or well - being of the subjects . When a non-therapeutic trial is to be carried out with the consent of the subject's legally acceptable representative, reviewers should determine that the proposed protocol and / or other document (s) adequately address relevant ethical concerns and meets applicable regulatory requirements for such trials . Where the protocol indicates prior consent of the trial subject or the subject's legally acceptable representative is not possible, the review should determine that the proposed protocol and / or other document (s) adequately addresses relevant ethical concerns and meets applicable regulatory requirements for such trials (i.e., in emergency situations). </P> <P> While the Belmont principles and U.S. federal regulations were formulated with biomedical and social - behavioral research in mind, the enforcement of the regulations, the examples used in typical presentations regarding the history of the regulatory requirements, and the extensiveness of written guidance have been predominantly focused on biomedical research . </P> <P> Numerous complaints by investigators about the fit between the federal regulations and its IRB review requirements as they relate to social science research have been received . Broad complaints range from the legitimacy of IRB review, the applicability of the concepts of risk as it pertains to social science (e.g., possibly unneeded, over-burdensome requirements), and the requirements for the documentation of participants' informed consent (i.e., consent forms). Researchers have tried to determine under what instances participants are more likely to read informed consent forms, and ways to improve their efficacy in the social sciences . Social scientists have criticized biomedical IRBs for failing to adequately understand their research methods (such as ethnography). In 2003, the Office for Human Research Protections (OHRP), in conjunction with the Oral History Association and American Historical Association, issued a formal statement that taking oral histories, unstructured interviews (as if for a piece of journalism), collecting anecdotes, and similar free speech activities often do not constitute "human subject research" as defined in the regulations and were never intended to be covered by clinical research rules . </P> <P> Other federal agencies supporting social science have attempted to provide guidance in this area, especially the National Science Foundation . In general, the NSF guidelines assure IRBs that the regulations have some flexibility and rely on the common sense of the IRB to focus on limiting harm, maximizing informed consent, and limiting bureaucratic limitations of valid research . </P>

Briefly describe two ethical guidelines enforced by the institutional review board (irb)