No, it does not. The hospital can assign jurisdiction to another IRB, but it must be done in writing. For more information, please see Institutions. |
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No. Only institutions that receive federal funding for human subject research are required to have Federalwide 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 and the standards set forth in the federal regulations at 45 CFR 46. |
Per regulations, Schulman’s Board can provide expedited review for:
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; and 2.) "minor changes" to previously approved research during the period (one year or less) for which approval is granted. Schulman reviews most research sites, recruitment and study-related materials, as well as some amendments using expedited review. |
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 IC. |
A verbal approval does not satisfy the requirement for a signed consent, as outlined in 21 CFR 50.27(a). However, it is acceptable to send the IC to the legally authorized representative (LAR) by facsimile and conduct the consent interview by telephone when the LAR can read the consent as it is discussed. If the LAR agrees, he/she can sign and return the signed IC to the clinical investigator by facsimile. |
Yes. FDA states, however, that the investigator should inform the second IRB that another IRB previously disapproved the study.
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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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The Board does not approve IBs; however, an acknowledgement of receipt is provided to the sponsor/CRO and sites via Schulman's WebPortal 3D and SiteAccess 1.0. For more information, please see IBs and PPIs. |
The Board will acknowledge receipt of all IBs included with the initial protocol submission. Acknowledgement of receipt for revised IBs will be provided to the sponsor/CRO and sites via Schulman's WebPortal 3D and SiteAccess 1.0 if the Product Safety Submission Form is used. To obtain a hard copy acknowledgment of receipt by mail, you must submit two (2) copies of the Product Safety Report Form and a self-addressed stamped envelope or pre-paid courier envelope. For more information, please see IBs and PPIs. |
Please contact Schulman Associates IRB by telephone at 513-761-4100![]( "Call: 513-761-4100") or complete the Feedback form. For a list of specific team contacts, please visit Contact Us. |
In pediatric studies, the investigator must obtain, in addition to written permission from the child subject's parent(s) or legal guardian, 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 the concepts involved in the research 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. Under the FDA regulations, the Board must determine that adequate provisions are made for soliciting the assent of the children when in the judgment of the Board the children are capable of providing assent. For more information, please review Additional Protection for Children. Additionally, you can download Schulman’s assent template. |
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; and
(b) the waiver will not adversely affect the rights and welfare of the subjects; and
(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. |
IRBs, sponsors, CROs and clinical investigators should be familiar with state/provincial 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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Information that is relevant to an independent, central IRB about a research site includes the education and training of all study personnel, the site's history and experience in conducting clinical research, federal agency inspection reports, type of demographics the site will encounter, and safeguards for vulnerable subjects. Please refer to the Research Site Submission Form for complete information required by the IRB. In certain situations, the Board may request that a site visit be conducted. |
Yes. A screening consent 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 IC must be given to the subject. |
No. The Institutional Review Board is listed on the Authorization to Use and Disclose Personal Health Information as having access to subjects’ Personal Health Information. |
A LAR "stands in the shoes" of the decisionally-impaired person and makes decisions on his/her behalf. Who may act as a LAR varies with the law of the state/province in which the research is being conducted. Therefore, the research staff should be familiar with its own state/provincial law in this area.
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/province’s law.
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Study Status Reports are generally required every 12 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 within 8 weeks prior to the due date to allow time for processing. For more information, please see Study Status Reporting. |
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No. It is Schulman’s expectation that the Principal Investigator will assume the responsibility of being aware of and assuring compliance with state/provincial laws and/or regulations regarding HIV testing when HIV testing is explicitly required by the protocol or when the protocol allows for HIV testing at the Investigator’s discretion. Schulman recommends that Canadian sites consult with their provinces’ health officials and/or legal counsel to assist in determining the provinces’ laws and/or regulations pertaining to HIV testing. Schulman recommends that US sites consult with their states’ departments of health and/or legal counsel to assist in determining the states’ laws and/or regulations pertaining to HIV testing. |
No. This is not necessary as long as the separate consent document does not contain study specific information. |