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SECTION 25 Vulnerable SubjectsAdditional safeguards may be requested by the Human Assurance Committee (HAC) to avoid undue influence and coercion of vulnerable subjects. There are specific requirements and exceptions to the consent requirements in specific situations and the research team should inquire to the HAC administrative office at 706-721-3110/1482 or via email: hac@mail.mcg.edu for detailed direction. Children/Pediatric Research
Federal regulations [21 CFR Parts 201, 312, 314 and 601and 45 CFR46 (OPRR)
subpart d .401-409] stipulate that any research involving children or
pediatric subjects in any manner must have specific approval for their
participation. The children’s assent document (CAD) must be completed
along with a parental/guardian informed consent document (ICD).
Protocols that involve children as research subjects require full review
of amendments, advertisements, etc., although some can be reviewed at
the expedited level. The HAC Chairman determines the level of review.
There are specific requirements and exceptions to the consent
requirements in these situations and the research team should inquire to
the HAC administrative office for detailed directions. For more
information, visit the web link of the American Academy of Pediatrics
Policy Statement for the Guidelines for the Ethical Conduct of Studies
to Evaluate Drugs in Pediatric Populations (RE9503) at
http://www.aap.org/policy/00655.html.
Mentally Incompetent A research subject must be competent to give informed consent. For incompetent subjects, a surrogate whose primary interest is the patient's welfare may give informed consent if conditions are met. When the question of competency is unclear, competency is commonly judged by subjects evidencing a choice in regard to research participation, by factual understanding of issues, by rational manipulation of information, and by appreciation of the nature of the research project. If competency is an issue, it must be acknowledged in the research proposal and the procedures used to evaluate competency must be described in detail. The HAC may request that a physician not affiliated with the study review and document the competency of the potential subject. There are specific requirements and exceptions to the consent requirements in these situations and the research team should inquire to the HAC administrative office at for detailed directions. Non-English Speaking Subjects Federal regulations stipulate that any research involving non-English speaking subjects in any manner must have specific approval for their participation. If these subjects will be a targeted part of the subject pool, the study must be explained in a language that is understandable to the subject [21CFR46 50.20]. Issues such as informed consent documents, children assent documents, subject diary cards, medication and dosing instructions so that the continual process of informed consent may be addressed to ensure that the subject can fully understand the study. Individuals may not be excluded from the study based on the inability to speak, read or write in English. The investigator must submit the English language version of all documents to the HAC for approval. After the HAC approves the English language version of the documents, then the investigator must submit a translated document in the foreign language with a certification statement by the individual or professional translation service who performs the translation for approval by the HAC. The costs associated with the professional translation service are to be borne by the investigator, either through negotiation with the sponsor or other funding source. The department will be responsible for these costs if the investigator does not have any external funding. Below is a listing of translations service companies We do not recommend these sites, these are primarily for your information.
Translations Service
Companies Illiterate Persons Illiterate persons who understand English may have the informed consent document read to them and may “mark their mark” under Georgia law. These individuals may indicate consent to participate by placing an X on the signature line. It must be documented on the consent document and in the source documents that the subject cannot read or write. Issues such as subject diary cards, medication and dosing instructions and the continuing process of informed consent must be addressed so that the subject can fully understand the study. Individuals may not be excluded from the study based on the inability to read or write. Additional safeguards may be requested by the HAC to avoid undue influence and coercion. There are specific requirements and exceptions to the consent requirements in these situations and the research team should inquire to the HAC administrative office for detailed directions. Pregnant Women Federal regulations [45 CFR 46.207] stipulate that any research involving pregnant women in any manner must have specific approval for their participation. There are specific requirements and exceptions to the consent requirements in these situations and the research should inquire to the HAC administrative office for specific directions. Women of Childbearing Potential The HAC recommends monthly pregnancy testing for women of childbearing potential that will be involved in long-term dosing of investigational medications. Prisoner Research Federal regulations [45CFR 46 Subpart C .301-.306] stipulate that any research involving prisoners in any manner must have specific approval for their participation. A prisoner is an individual involuntarily confined in a penal institution, including persons:
Note: If a subject is participating in a study and becomes a prisoner as outlined above, then all study related activities must stop until a protocol amendment is submitted to and approved in writing by the HAC to include prisoners as research subjects. That means that the majority of the HAC shall have no association with the prison and that one member (voting member) shall be a prisoner or a prisoner representative with appropriate background and experience to speak on behalf of prisoners. Next the HAC must find that the study meets one of the categories of research that is allowed under the regulations and that the additional duties of the HAC at 46.305(2-7) are met. Under 45 CFR 46.305(c), the institution responsible for conducting research involving prisoners that is supported by HHS shall certify to the Secretary (through OHRP) that the HAC has made the seven findings required under 45 CFR 46.305(a). The institution must send to OHRP a certification letter to this effect, which should also include the name and address of the institution and specifically identify the research protocol in question and any relevant HHS grant application or protocol. HHS conducted or supported research involving prisoners as subjects may not proceed until OHRP issues its approval in writing to the institution on behalf of the Secretary under 45 CFR 46.306(a)(2). Under its authority at 45 CFR 46.115(b), OHRP requires that the institution responsible for the conduct of the proposed research also submit to OHRP a copy of the research proposal so that OHRP can determine whether the proposed research involves one of the categories of research permissible under 45 CFR 46.306(a)(2), and if so, which one. The term "research proposal" includes the HAC-approved protocol, any relevant HHS grant application or proposal, any HAC application forms required by the HAC, and any other information requested or required by the HAC to be considered during initial HAC review. Prisoner research certification letters should be mailed to:
Attention: OHRP Prisoner Research Contact Person
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OHRP | Research | Medical
College of Georgia February 20, 2007 |