Investigator FAQs

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No, it does not. The hospital can assign jurisdiction to another IRB, but it must be done in writing. See Institutional Deferral Letters

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Yes. You may send a Freedom of Information Act request to FDA to obtain a computer generated list of the dates and results of FDA audits of IRBs.

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No. Only institutions that receive federal funding for human subject research are required to have Federal-Wide Assurances ("FWAs") on file with the Office for Human Research Protections ("OHRP"). An FWA is a written document by which an institution agrees to comply with appropriate ethical standards (such as The Belmont Report and The Declaration of Helsinki) and the procedural standards set forth in the federal regulations at 45 CFR 46.

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1.) Research that presents no more than minimal risk and is listed in a National Institutes of Health guidance document as an "adjunct" to the DHHS and FDA regulations;
2.) "minor changes" to previously approved research during the period (one year or less) for which approval is granted; and
3.) some materials used for subject recruitment.

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Under FDA Regulations, the subject must sign and date a consent document. According to the International Conference on Harmonisation (ICH) Guidelines, the subject and the person conducting the consent discussion and, if applicable, an impartial witness must sign and date the informed consent document.

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Under certain circumstances, a legally authorized representative (LAR) may provide consent over the telephone. Please review Consent via LAR by Telephone for the proper way to conduct the consent discussion via LAR by telephone.

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Yes. FDA states, however, that the investigator should inform the second IRB that another IRB previously disapproved the study.

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In pediatric studies, the investigator must obtain, in addition to written permission from the child subject's parent(s) or legally authorized representative, the child's affirmative agreement or "assent" before the child may participate in the study. (A child's mere failure to object is not assent.) Assent must be obtained from children who are capable of understanding and should usually be obtained from any child with an intellectual age of seven (7) years or more. Thus, in addition to explaining the study to the parents, the investigator must explain the purpose, risks and benefits to the child at a level appropriate to the child's intellectual age, and the child must affirmatively agree to participate. Assent is required under the FDA Regulations.

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Yes, assent may be waived if the IRB determines: (a) that the capability of some or all of the children is so limited that they cannot reasonably be consulted; or (b) the research presents a prospect of direct benefit that is important to the health or well-being of the child or children and is available only in the context of the research study. The IRB may also waive assent of children who are capable of assenting if: (a) the clinical investigation involves no more than minimal risk to the subjects; (b) the waiver will not adversely affect the rights and welfare of the subjects; (c) the clinical investigation could not practicably be carried out without the waiver; and (d) when appropriate, the children will be provided with additional pertinent information after participation.

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State laws that relate to:

• age of consent/children's assent
• capacity to consent/legally authorized representatives
• HIV/STD reporting requirements
• confidentiality of medical records
• informed consent
• clinical research
• genetic research
• referral fees
• recruitment methods
• Institutional review boards
• investigational drugs
• vulnerable subjects
• medical practice and delegation of authority to perform procedures

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Yes. The informed consent document must be provided in a language understandable to the study subject.

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Information that is relevant to a non-local IRB about a research site includes the education and training of all study personnel, the site's history and experience in conducting clinical research, FDA inspection reports, type of demographics the site will encounter, and safeguards for vulnerable subjects. This information is captured on the Research Site Submission Form. The Board may request, in certain situations, a site visit be conducted.

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Yes. A screening consent document may be used only for screening procedures such as a physical exam, blood draw, chest x-ray, and medical history. If a potential subject qualifies after the screening procedures, a study specific consent document must be given to the subject.

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No.

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An LAR is an individual or judicial or other body authorized under applicable state law to consent on behalf of a prospective subject to the subject's participation in the procedure(s) involved in the research.

For a study in which the IRB determines an LAR is appropriate for decisionally-impaired adults, it is, initially, up to the Investigator to determine that an adult is, in fact, decisionally-impaired and, therefore, unable to consent to study participation. This determination must be documented in the individual's study record. The LAR may then participate in the informed consent process and, when fully informed, decide whether or not to consent on behalf of the potential subject.

An LAR "stands in the shoes" of the decisionally-impaired person and makes decisions on his/her behalf. Who may act as an LAR varies with the law of the state in which the research is being conducted. Therefore, the research staff should be familiar with its own state law in this area. In general, a person who has been appointed by the subject (when the subject was competent) under an advance directive, such as a durable power of attorney for health care, may consent to the procedures to be performed in a research study. Also, most states would recognize a person who has been appointed legal guardian of the potential subject to consent to such procedures. Many states have laws that set forth a hierarchy of persons who may consent to medical procedures when an individual is unable to consent for himself/herself. The hierarchy generally includes a person named under an advance directive, a majority of adult children reasonably available, parents, majority of adult siblings, etc., in order of priority.

A research study may require the involvement of the subject's caregiver. The caregiver may or may not be the subject's LAR . It is the Investigator's responsibility to determine if the caregiver has the authority to act as a decisionally-impaired subject's LAR under your state's law.

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Study Status Reports are normally required every 6 months, unless the Board determines otherwise. Please refer to your most recent approval / reapproval letter to determine when your next Study Status Report is due. Study Status Reports should be submitted 8 weeks prior to the due date to allow time for processing.

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Yes. Schulman's OHRP registration number is 00000971.

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Yes. For some forms, a guide to completing the form is also available. Please see the Forms for these guides.

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Compensation is evaluated by the Board on a study-by-study basis. Please review the schedule of visits outlined in the protocol before deciding compensation amounts. Compensation should be pro-rated and based on time and inconvenience to the subject.

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IBs are not approved by the Board, therefore only an acknowledgement of receipt is provided. Acknowledgement of receipt will be provided for all IBs included with the initial protocol submission. Acknowledgment of receipt for revised IBs is provided to the submitting party in the same method the IB is received. If an IB is received by hard copy, a self-addressed stamped envelope or pre-paid courier service envelope must be included with the submission in order to receive acknowledgement of receipt. If an IB is received by fax, a fax number must be indicated on the accompanying Product Safety Submission Form. If an IB is received via Email or Secure Electronic Submission, acknowledgement of receipt will be provided via email.

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Acknowledgements of receipt of IBs are provided to the submitting party in the same method the IB is received. If an IB is received by hard copy, a self-addressed stamped envelope or pre-paid courier service envelope must be included with the submission in order to receive acknowledgement of receipt. If an IB is received by fax, a fax number must be indicated on the accompanying Product Safety Submission Form in order to receive acknowledgement of receipt. If an IB is received via Email or Secure Electronic Submission, acknowledgement of receipt will be provided via email.