The most fundamental condition for the conduct of research involving human subjects is the condition that all subjects participate voluntarily, after giving truly informed consent.
Obtaining informed consent is, first and foremost, the Investigator's responsibility. Lack of informed consent will expose the Investigator to a claim of medical malpractice (and in some settings, possibly to a claim of assault and battery). In the research arena, however, the IRB is also charged with oversight responsibility for the consent process, which is exercised by (i) approving the informed consent documents to be used, (ii) obtaining the Investigator's certification that informed consent will be obtained and documented in every case, and (iii) reserving the right to audit the consent process and documentation in any case. In addition, for studies involving federal funding or FDA drugs or devices, federal regulations define the necessary elements of informed consent for human research, and require a much more extensive consent document than typically used for non-research medicine and surgery. Consent documents which meet the federal regulatory requirements are generally expected by the IRB, even for studies which are not subject to the regulations.