The Code of Federal Regulations are general and permanent rules which have been published by the Executive departments and Federal Government agencies in the Federal Register. CFR’s Title 21 has been reserved for the Food and Drug Administration rules. The Protection of Human Subjects is in part 50 of the CFR Title 2. This part involves all the clinical investigations involving research or marketing and regulated by the Food and Drug Administration. It involves foods that feature dietary supplements and nutrient content and health claims, infant formulas, human drugs, medical devices for human use, food and color additives and human use biological products.
General Requirements for Informed Consent (Section 50.20)
This part requires that no investigator or research shall involve human being subject in a research covered by the Food and Drugs regulations. This is unless the researcher/investigator obtains a legal and effective informed consent from the human subject or the subject’s legal representative. The investigator/researcher is supposed to seek the consent only under the conditions that he has provided the prospective human subject prospective or the legal representative with adequate opportunity to consider whether to take part in the research or not. This is to minimize any possibility of the subject being coerced or participating under undue influence (FDA, 2017) . The investigator should also provide sufficient information to the subject or the representative in a comprehensive language. Informed consent, whether oral or written shall only be legal when the liability for negligence is squarely placed on the investigator/sponsor/institution and also when subject’s legal rights have been respected.
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Basic Elements of Informed Consent (Section 50.27)
When seeking informed consent from human subjects, the code of rules has provided the basic information which should be provided to every subject. This includes a statement and explanation of what the research involves, the duration of the subject’s participation as well as a description of the procedures which will be followed especially if experimental. The investigator is also supposed to provide a description of any foreseeable risk or discomfort which may affect the subject in addition to benefits to the subject and beneficiaries to be expected due to participation in the research (FDA, 2017) . The investigator shall also disclose the alternative procedures or treatment which might be beneficial to the subject.
A statement indicating the extent to which confidentiality of the subject’s records will be maintained must also be provided. This does not rule out the possibility of these records being inspected by the FDA. For research involving high risks, the investigator shall explain to the subject the compensation plan and medical treatments available in case of an unfortunate incident. A statement by the investigator that the participation is voluntary and that decline of participation will not involve any loss of benefits or penalty to which the subject is entitled is also a requirement. Discontinued participation lack of penalties or loss of benefits should also be included under this statement (FDA, 2017)
Documentation of Informed Consent (Section 50.25)
Informed consent shall be documented only by using a written consent form which has been approved by the IRB. The form should have the subject’s signature and date or the subject’s legal representative during the time of the consent. The form should contain the elements of informed consent documented in section 50.25 (FDA, 2017) . The investigator may read the form to the subject or the subject’s legal representative and ensure that they been give adequate opportunity to read it before it is signed.
References
FDA. (2017, April 1). CFR - Code of Federal Regulations Title 21: PART 50 PROTECTION OF HUMAN SUBJECTS . Retrieved from US Food and Drugs Administration: https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfcfr/CFRSearch.cfm?CFRPart=50&showFR=1
