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Special Research Concerns

Emergency Use of a Test Article or Procedure

OVERVIEW:
In extreme cases of emergency (as defined below), a physician may use a test article or procedure to treat a patient who could not otherwise receive the experimental intervention as part of a research study. Nonetheless, when a physician uses a test article or procedure in an emergency situation, the patient may not be considered to be a research subject. Furthermore, such care may not be claimed as research, nor may the outcome of such care be included in any report of a research activity. In other words, emergency use of a test article or procedure is not equal to Human Research Review Board approval of a research protocol or research activities.

DEFINITION:
Emergency use, for purposes of compliance with human subjects research regulations and policies, is defined as the use of a test article (e.g., investigational drug, device, or biologic) or procedure on a patient in a life-threatening situation in which no standard acceptable treatment is available and in which there is not sufficient time to obtain regular Human Research Review Board approval. Except as noted below, ("Emergencies for Which Informed Consent is not Feasible"), the Investigator is still required to obtain informed consent under circumstances which qualify as emergency use. This definition of emergency use will be interpreted very strictly and should not be confused with deviation from a protocol, or instances where expedited Human Research Review Board approval may be warranted.

PROCEDURE FOR EMERGENCY USE:
When a physician identifies a need for emergency use of a test article (drug, device, or biologic) or procedure, the following must occur:

1. Prior to performing the emergency experimental treatment, the Investigator must complete the form, "REPORT OF EMERGENCY USE OF A TEST ARTICLE". [Please note that completion of the form requires the signature of an additional physician with no research or other interest in the test article or procedure.]

2. Prior to performing the emergency experimental treatment, the Investigator must obtain the informed consent of the patient or his/her legally authorized representative unless both the investigator and a physician who is not otherwise participating in the clinical investigation certify in writing all of the following [21 CFR.50.23(a)].

3. After performing the emergency experimental treatment, the Investigator must notify the Baptist Health System Human Research Review Board of the one-time emergency use of the test article within five (5) working days [21 CFR 50.23(c)].

Please note: Any subsequent use of the test article or procedure requires full Human Research Review Board review and approval. "Subsequent use" means any use of the test article that occurs after its initial emergency use (even on the same patient). Should the Investigator see a subsequent need to use the test article, a complete, formal application must be submitted for Human Research Review Board consideration.

EMERGENCIES FOR WHICH INFORMED CONSENT IS NOT FEASIBLE:
In some emergency circumstances, it may not be feasible to obtain informed consent prior to using the test article or procedure. The regulations provide an exception for informed consent requirements for such situations. For the exception to apply, both the Investigator and a physician who is not otherwise participating in the clinical investigation must certify in writing all of the following:

1. the patient is confronted with a life-threatening situation necessitating use of the test article; and
2. the patient is unable to provide effective consent; and
3. there is insufficient time in which to obtain consent from the patient's legal representative; and
4. there is no available alternative method of approved or generally recognized therapy that provides an equal or greater likelihood of saving the patient's life.

Use of Children as Research Subjects


CHILDREN AS A RESEARCH POPULATION:
Children are considered a vulnerable research population because their intellectual and emotional capacities are limited and they are legally incompetent to give valid informed consent.

The Baptist Health System Human Research Review Board has taken the position of prohibiting children under the age of 19 (legal age of majority in Alabama) to be considered as subjects for research purposes.

Use of Fetuses, Pregnant Women and Human In Vitro Fertilization

While pregnant women may be involved in several categories of research, studies involving the human fetus raise special concerns. Research involving pregnant women, fetuses and human in vitro fertilization are subject to special Federal regulations that guide IRB deliberations on such studies. Investigators proposing to conduct research with pregnant women, fetuses or genetic material used for in vitro fertilization must abide by these additional regulations [45 CFR 46 subpart B]. In addition, Investigators are encouraged to consult with the Human Research Review Board office prior to submitting a protocol application that includes pregnant women as research subjects.

Use of Cognitively Impaired Subjects

COGNITIVELY IMPAIRED PERSONS AS A RESEARCH POPULATION:
People with mental retardation, Alzheimer's disease, dementia, and some forms of mental illness are considered cognitively impaired. Cognitively impaired persons are considered a vulnerable research population because their mental disability may compromise their capacity to make a reasoned decision about participation in a study. In addition, some people with mental impairments may be residents of institutions, which may further compromise their ability to exercise free choice.

LEGAL INCOMPETENCY:
All adults (including those with cognitive impairments) are presumed competent to consent unless legally judged to be incompetent.

In cases where a cognitively impaired adult has been judged incompetent, legally authorized representatives (i.e., persons with court appointed Guardianship or Power of Attorney with Healthcare Proxy) may consent for research on the impaired adult's behalf. Next-of-kin may not consent for a cognitively impaired person.

OBTAINING ASSENT:
When consent will be obtained from a legally authorized representative, the Human Research Review Board requires that the assent of the cognitively impaired subject be obtained. Assent is defined as affirmative agreement to participate in research. Failure to object does not qualify as assent.

Use of Prisoners as Subjects


PRISONERS AS A RESEARCH POPULATION:
Prisoners are considered a vulnerable research population because the very fact of incarceration may make it difficult for them to give truly voluntary informed consent.

FEDERAL REGULATIONS:
To protect this study population, Federal regulations stipulate that the only studies that may use prisoners are those with an independent and valid reason for involving them (e.g. studies on the effects of incarceration). In addition, IRB's are required to have at least one member who is a prisoner or a prisoner advocate when reviewing protocols proposing to use prisoners. Therefore, the Baptist Health System Human Research Review Board prohibits prisoners as research subjects.

Use of Baptist Health System Staff, Residents and Employees as Subjects

HUMAN RESEARCH REVIEW BOARD'S ROLE:
The Human Research Review Board is responsible for protecting the rights and welfare of all human subjects, including Baptist Health System staff, residents, and employees who participate in research.

Baptist Health System personnel asked to volunteer as human subjects in a researcher's study may feel some pressure to agree to participate, especially if the requesting researcher is their supervisor or someone who might be in a position to influence their future.

POLICY:
To protect against even the appearance of coercion, when a Baptist Health System research investigator wishes to include Baptist Health System medical staff, residents, and employees (i.e., administrative, clerical, nursing, lab, house staff, etc.) as human subjects, s/he must first request approval for inclusion of one or more of these populations by either including this information in the cover letter for initial review or by requesting an amendment to the approved protocol.

If those populations are approved for inclusion by the Human Research Review Board, the Investigator may not actively recruit the subjects from within his/her own department or practice. However, this does not preclude members of the Investigator's department or practice from freely volunteering to participate. For example, anyone is free to respond to general recruitment advertisements (posters, ads in publications).

Researchers who include subordinates in research are urged to exercise great caution to avoid even the appearance of pressuring or coercing potential subjects into enrollment or continued participation. In addition, researchers should guard against the potential for compromised objectivity and/or confidentiality when including subordinates in a study.

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