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Vulnerable Subjects

Additional safeguards may be requested by the IRB to avoid undue influence and coercion of vulnerable subjects. There are specific requirements and exceptions to the consent requirements in specific situations.

Children/Pediatric Research

Federal regulations [21 CFR Parts 201, 312, 314 and 601 and 45 CFR 46 (OHRP) subpart d.401-409] specify that any research involving children or pediatric subjects in any manner must have specific approval for their protection. For information, visit the web link of the American Academy of Pediatric Policy Statement for the Guidelines for the Ethical Conduct of Studies to Evaluate Drugs in Pediatric Populations (RE9503) at

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 certain conditions are met. When the question of competence is unclear, competency is commonly judged by subjects evidencing a choice regarding research participation, by factual understanding of the 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.

Non-English Speaking Subjects

To meet the requirements of 21 CFR 50.20, the informed consent document should be in language understandable to the subject (or his/her authorized representative). When the consent interview is conducted in English, the consent document should be in English. When the study subject population includes non-English speaking people or the clinical investigator or the IRB anticipates that the consent interviews will be conducted in a language other than English, the IRB should require a translated consent document to be prepared and assure that the translation is accurate. As required by 21 CFR 50.27, a copy of the consent document must be given to each subject. In the case of non-English speaking subjects, this would be the translated document. While a translator may be helpful in facilitating conversation with a non-English speaking subject, routine ad hoc translation of the consent document should not be substituted for a written translation.

If a non-English speaking subject is unexpectedly encountered, investigators will not have a written translation of the consent document and must rely on oral translation. Investigators should carefully consider the ethical/legal ramifications of enrolling subjects when a language barrier exists. If the subject does not clearly understand the information presented, the subject's consent will not truly be informed and may not be legally effective. If investigators enroll subjects without an IRB approved written translation, a "short form" written consent document, in a language the subject understands, should be used to document that the elements of informed consent required by 21 CFR 50.25 were presented orally. The required signatures on a short form are stated in 21 CFR 50.27(b)(2).

The FDA regulation at 21 CFR 50.20 states, "The information that is given to the subject or his/her representative shall be in language understandable to the subject or the representative."

The FDA regulation at 21 CFR 50.27 describes how informed consent must be documented (either a long form or a short form); i.e., who signs and dates the document. If a short form consent process is used, the FDA Information Sheet guidance states the following: (2) A short form written consent document stating that the elements of informed consent required by 50.25 have been presented orally to the subject or the subject's legally authorized representative. When this method is used, there shall be a witness to the oral presentation. Also, the IRB shall approve a written summary of what is to be said to the subject or the representative. Only the short form itself is to be signed by the subject or the representative. However, the witness shall sign both the short form and a copy of the summary, and the person actually obtaining the consent shall sign a copy of the summary. A copy of the summary shall be given to the subject or the representative in addition to a copy of the short form.

Illiterate Persons

Illiterate persons who understand English may have the informed consent read to them and may "mark their mark" under Ohio law. These individuals may indicate consent by placing an X on the signature line. It must be documented on the consent document and in the source document that the subject cannot read or write. Individuals may not be excluded from the study based on the inability to read or write.

Pregnant Women

Federal regulations [45 CFR 46.207] specify that any research involving pregnant women in any manner must have specific approval for their participation. Pregnancy testing is recommended for women of childbearing potential who will be involved in long-term studies of investigational drugs.

Prisoner Research

Federal regulations [45 CFR 46 Subpart C .301-.306] specify 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 people:

  • Sentenced under a criminal or civil statute
  • Detained pending arraignment, trial or sentencing
  • Detained in other facilities (e.g., for drug detoxification or treatment of alcoholism) under statues or commitment procedures providing such alternatives to criminal prosecution or incarceration in a penal institution

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 IRB to include prisoner as research subjects.

That means that a majority of the IRB members 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.

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Mount Carmel Health System  |  Columbus, Ohio

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