Research is considered to be a planned activity and emergency consent is not often an issue. Thus, waiver requirements are intentionally strict. Waivers are prospective for the study rather than individual to any particular subject.
The FDA and the DHHS rules differ significantly. As NGHS policy accepts the Common Rule as the minimum standard, all studies will need to meet this standard first.
The IRB may approve a consent process that does not include some or all of the elements of informed consent or may waive the process. Generally, there are three sets of circumstances under which the regulations give the IRB authority to waive the required informed consent, provided the IRB finds and documents that the study/research meets criteria identified by regulations:
Public Benefit or Service Programs Research
The research or demonstration project is to be conducted by or subject to the approval of state or local government officials and is designed to study, evaluate or otherwise examine:
- Public benefit or service programs,
- Procedures for obtaining benefits or services under those programs,
- Possible changes in or alternatives to those programs or procedures, or
- Possible changes in methods or levels of payment for benefits or services under those programs, and
The research could not practicably be carried out without the waiver or alteration.
45 CFR 46.116(c)
Waiver for Minimal Risk Studies
- The research involves no more than minimal risk to subjects, and
- The waiver or alteration will not adversely affect the rights and welfare of the subjects, and
- The research could not practicably be carried out without the waiver or alteration, and
Whenever appropriate, the subjects will be provided with additional pertinent information after participation.
45 CFR 46.116(d)
Unless all four conditions are met, informed consent shall be deemed feasible. If time permits, the investigator and an uninvolved physician must certify to the above in writing before processing. If time does not allow, such certification must be made within five days thereafter. Certification must be sent to the NGHS IRB within 5 working days.
Treatment of individual subjects/patients with an investigational test article (i.e. investigational drug, biologic product or medical device) in an emergency situation is allowed by DHHS, FDA and Georgia State Law. The obtaining of informed consent shall be deemed feasible unless, before the use of the test article, both the investigator and a physician who is not otherwise participating in the clinical investigation certify in writing all of the following:
- The subject is confronted by a life-threatening situation,
- Informed consent cannot be obtained from the subject because of an inability to communicate with or obtain legally effective consent from the subject,
- Time is not sufficient to obtain consent from the subject's legal representative, and
- There is no available alternative method of approved or generally recognized therapy that provides equal or greater likelihood of saving the life of the subject.
If immediate use of the test article is required to preserve the life of the subject and time is not sufficient to obtain an independent opinion from a physician not involved in the study, then the investigator may proceed. However, within five (5) working days following the emergency use of the article, a physician who is not otherwise participating in the research must conduct a review and evaluation of the articles used and document his/her findings.
The documentation shall be submitted to the IRB Office within five (5) working days after the article's use. Neither prior approval nor a response by the IRB is indicated, as this is not a "research protocol".
Subsequent use of the test article must be reviewed by the IRB
21 CFR 50.23(a)(b)(c)
21 CFR 312
21 CFR 812