Science & Research
Protection of Human Subjects; Informed Consent (12/22/95)
WAIS Document Retrieval[Federal Register: December 22, 1995 (Volume 60, Number 246)]
From the Federal Register Online via GPO Access [wais.access.gpo.gov]
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
21 CFR Parts 50 and 312
[Docket No. 95N-0359]
Protection of Human Subjects; Informed Consent
AGENCY: Food and Drug Administration, HHS.
ACTION: Proposed rule.
SUMMARY: The Food and Drug Administration (FDA) is proposing to amend its current informed consent regulations to require that the written consent form signed by the subject or the subject's legally authorized representative, be dated by the subject or the subject's legally authorized representative at the time consent is given. FDA is proposing this requirement because the agency has had problems on occasion verifying that informed consent was obtained from a research subject prior to participation in a study because the consent document was not dated. The agency believes that by explicitly requiring that the consent form be dated at the time it is signed, the agency will be able to help ensure that informed consent was, in fact, obtained prior to entry into the study as required by FDA regulations. FDA is also proposing to amend its regulation on case histories to clarify what adequate case histories include.
DATES: Written comments by March 21, 1996.
ADDRESSES: Submit written comments to the
Dockets Management Branch (HFA-305),
Food and Drug Administration, 12420 Parklawn Dr., rm. 1-23,
Rockville, MD 20857.
FOR FURTHER INFORMATION CONTACT: Glen D. Drew, Office of Health Affairs (HFY-20), Food and Drug Administration, 5600 Fishers Lane, Rockville,
MD 20857, 301-443-1382.
I. Description of the Proposed Rule
Except as provided in FDA regulations, no investigator may involve a human being as a subject in research covered by part 50 (21 CFR part 50) unless the investigator has obtained the legally effective informed consent of the subject or the subject's legally authorized representative. Section 50.20 requires the investigator to seek informed consent only under circumstances that provide the prospective subject or the representative sufficient opportunity to consider whether or not to participate and that [[Page 66531]]
minimize the possibility of coercion or undue influence. In past audits of clinical investigations, FDA has had problems on occasion verifying that consent was obtained prior to participation in the study because a number of the consent documents were not dated. By explicitly requiring that the consent form be dated at the time it is signed, the agency will be able to help ensure that informed consent was obtained prior to entry into the study and will be able to verify that the investigator has fulfilled his or her obligation. Thus, FDA is proposing to amend
Sec. 50.27(a) to explicitly require that the consent form be dated by the subject or the subject's legally authorized representative at the time that it is signed.
II. Request for Comments
Interested persons may, on or before March 21, 1996, submit to the Dockets Management Branch (address above) written comments regarding this proposal. Two copies of any comments are to be submitted, except that individuals may submit one copy. Comments are to be identified with the docket number found in brackets in the heading of this document. Received comments may be seen in the office above between 9 a.m. and 4 p.m., Monday through Friday.
III. Environmental Impact
The agency has determined under 21 CFR 25.24(a)(8) that this action is of a type that does not individually or cumulatively have a significant effect on the human environment. Therefore, neither an environmental assessment nor an environmental impact statement is required.
IV. Analysis of Impacts
FDA has examined the impacts of the proposed rule under Executive Order 12866 and the Regulatory Flexibility Act (Pub. L. 96-354). Executive Order 12866 directs agencies to assess all costs and benefits of available regulatory alternatives and, when regulation is necessary, to select regulatory approaches that maximize net benefits (including potential economic, environmental, public health and safety, and other advantages; distributive impacts; and equity). The agency believes that this proposed rule is consistent with the regulatory philosophy and principles identified in the Executive Order. The Regulatory Flexibility Act requires agencies to analyze regulatory options that would minimize any significant impact of a rule on small entities. This rule simply adds a requirement that consent forms be dated at the time that they are signed in order to permit the
agency to verify that informed consent is obtained prior to an individual's entry into a research study. Because the majority of consent forms are currently dated at the time that they are signed, the agency certifies that the proposed rule will not have a significant economic impact on a substantial number of small entities. Therefore, under the Regulatory Flexibility Act, no further analysis is required.
V. Clarifying Amendments
Along with this proposal to require that consent forms be dated at the time they are signed, FDA believes that a number of related changes to the regulations for human drugs and biologics are warranted. FDA is proposing to revise Sec. 312.53(c)(1)(vi)(d) (21 CFR 312.53(c)(1)(vi)(d)) to expressly recognize that the informed consent referred to be in accordance with 21 CFR part 50 and that institutional review board review and approval referred to be in accordance with 21 CFR part 56. Also, FDA is proposing to revise Sec. 312.62(b) (21 CFR
312.62(b)) to clarify that adequate case history records include the case report forms and supporting data, including, for example, signed and dated consent forms and medical records.
List of Subjects
21 CFR Part 50
Human research subjects, Informed consent, Prisoners, Reporting and recordkeeping requirements, Safety.
21 CFR Part 312
Drugs, Exports, Imports, Investigations, Labeling, Medical research, Reporting and recordkeeping requirements.
Therefore, under the Federal Food, Drug, and Cosmetic Act and under authority delegated to the Commissioner of Food and Drugs, it is proposed that 21 CFR parts 50 and 312 be amended as follows:
PART 50--PROTECTION OF HUMAN SUBJECTS
1. The authority citation for 21 CFR part 50 continues to read as follows:
Authority: Secs. 201, 406, 408, 409, 502, 503, 505, 506, 507, 510, 513-516, 518-520, 701, 721, 801 of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 321, 346, 346a, 348, 352, 353, 355, 356, 357, 360, 360c-360f, 360h-360j, 371, 379e, 381); secs. 215, 301, 351, 354-360F of the Public Health Service Act (42 U.S.C. 216, 241, 262, 263b-263n).
2. Section 50.27 is amended by revising paragraph (a) to read as follows: Sec. 50.27 Documentation of informed consent.
(a) Except as provided in Sec. 56.109(c), informed consent shall be documented by the use of a written consent form approved by the IRB and signed and dated by the subject or the subject's legally authorized representative at the time of consent. A copy shall be given to the person signing the form.
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PART 312--INVESTIGATIONAL NEW DRUG APPLICATION-
3. The authority citation for 21 CFR part 312 continues to read as follows:
Authority: Secs. 201, 301, 501, 502, 503, 505, 506, 507, 701 of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 321, 331, 351, 352, 353, 355, 356, 357, 371); sec. 351 of the Public Health Service Act (42 U.S.C. 262).
4. Section 312.53 is amended by revising paragraph (c)(1)(vi)(d) to read as follows:
Sec. 312.53 Selecting investigators and monitors.
* * * * *
(c) * * *
(1) * * *
(vi) * * *
(d) Will inform any patients, or any persons used as controls, that the drugs are being used for investigational purposes and will ensure that the requirements relating to obtaining informed consent (21 CFR part 50) and institutional review board review and approval (21 CFR part 56) are met;
* * * * *
5. Section 312.62 is amended by revising paragraph (b) to read as follows: Sec. 312.62 Investigator recordkeeping and record retention.
* * * * *
(b) Case histories. An investigator is required to prepare and maintain adequate and accurate case histories that record all observations and other data pertinent to the investigation on each individual treated with the investigational drug or employed as a control in the investigation. Case histories include the case report forms and supporting data including, for example, signed and dated consent forms and medical records.
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Dated: December 12, 1995.
William B. Schultz,
Deputy Commissioner for Policy.
[FR Doc. 95-31154 Filed 12-21-95; 8:45 am]
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