Does a study being conducted in a hospital have to be reviewed by the hospital's IRB?
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 Overview.
How will Schulman interact with my local IRB or research office?
Schulman will work closely with the institution to ensure that institutional requirements (informed consent language, reporting requirements, etc.) are appropriately addressed. Additionally, Schulman can provide the local IRB/research office with access to all approval documents via our SiteAccess portal. Other support and training services are also available.
What should an institution do to begin working with Schulman?
How does Schulman ensure that it provides meaningful consideration of relevant local factors for communities from which research subjects will be drawn?
Schulman relies on the documentation provided by the institution regarding local considerations. Additionally, the Board composition represents a diverse spectrum of expertise and perspectives that contribute to a thoughtful and meaningful review for the protection of human subjects.
What are the requirements for submitting a federally funded research or research otherwise being conducted under an FWA?
Submission requirements for federally funded research or research otherwise being conducted under an FWA are available under Submit FWA Study.
Do I need to submit an IRB Authorization Agreement?
If the research being proposed is either federally funded, or the current FWA covers all research conducted at your institution (regardless of funding), an IRB Authorization Agreement must be included in the submission
If an IRB disapproves a study, can the principal investigator submit the study to a second IRB?
Yes. FDA states, however, that the investigator should inform the second IRB that another IRB previously disapproved the study.
How do I obtain a list of FDA audits of IRBs?
You may send a Freedom of Information Act request to obtain a list of the dates and results of FDA audits of IRBs. Upon request, Schulman will provide you with information on our FDA audit history.
Are IRBs required to have Federalwide Assurances?
Is Schulman registered with the Office of Human Research Protections (OHRP) and the Food and Drug Administration (FDA)?
Can Schulman accept electronic submissions?
Schulman’s Secure Electronic Submission System (eSubmission) can be used to submit most study documents. For additional information, please refer to the applicable submission form.
What is the deadline for submission of a new study?
New study submissions must be received one week prior to the intended Board meeting. See Get Started for details.
What is the usual turnaround time for review of a new study?
The usual turnaround time for full-Board review of a new single-site or institutional research study is five business days. Turnaround time is dependent upon complete and accurate submission of study documents and may be extended if the Board, upon review, requires further information.
When may I expect to receive notification of the status of the review of a new study?
A Schulman representative will contact you within one business day after the Board’s initial review of the study. This notification will include a statement of the Board’s decision.
Why might the Board request modifications of the IC?
Under federal regulations, the Board has the authority to request modifications to the submitted IC. The Board may seek modified language to ensure that the document includes the required elements of informed consent. The Board may also suggest changes to an IC to make it easier to read and/or more understandable to a study subject.
What is the deadline for submission of an additional site for a previously reviewed protocol?
There is no deadline to submit an additional site for an existing or new study. Additional sites are eligible for expedited review and are processed daily.
Must each research site submit an IC?
Additional research sites conducting a protocol previously reviewed by the Board are not required to submit a copy of the IC. However, sites with institution-specific language are invited to provide their required text to Schulman with their site submission so that we may incorporate that text appropriately into the IC. Schulman will provide each approved research site with a site-specific IC.
What could slow the approval process for my study?
- Incomplete Submission Documents: Please refer to the Forms library to ensure that you are submitting all required documents for the review of new studies and additional sites.
- Study Placed on Hold: The Board may identify areas of concern with the protocol and place a study on hold or conditionally approve a study pending receipt of further information.
- Delays in Finalization of IC: After formal Board review, additional Schulman-internal or sponsor/CRO review of the IC may be required prior to finalization. Approval documents will not be sent to sites until the IC is finalized.
- Board Concerns with Site Submission Information: Upon review of additional sites conducting a previously approved protocol, the Board may note an area of concern with the site’s responses on the submission documents. If concerns are noted or the compensation for participation information is unclear, a Schulman representative will contact the site. The site must provide satisfactory resolution of the identified issues before the approval process can be completed.
- Site-Specific IC Revisions: If a site submits a request for additional site-specific revisions, a Board member must review the requested revisions to determine appropriateness
What items can an IRB review by expedited review?
Research that presents no more than minimal risk. These categories are listed in National Institutes of Health Guidance; and
“Minor changes” to previously approved research during the period (one year or less) for which approval is granted.
What is the cost of the review?
Please request a copy of Schulman’s current Fee Schedule.
Who has to sign and date the IC?
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.
Can informed consent be obtained from a legally authorized representative (LAR) over the telephone?
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 LAR by facsimile or other means, 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.
How does Schulman evaluate compensation for subjects participating in research?
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.
Does the Board approve investigator brochures (IBs)?
The Board does not approve IBs; however, an acknowledgement of receipt is provided to the submitting party.
How are investigator brochures (IBs) acknowledged?
Acknowledgement of receipt for revised IBs will be provided to the sponsor/CRO and sites via Schulman’s WebPortal 3D and SiteAccess 1.0.
How can I contact Schulman with questions, to express concerns, or to convey suggestions regarding Schulman’s human research protection program?
Contact us by telephone at 513.761.4100 or complete the Feedback form
What is a child's assent? Is it required under FDA Regulations?
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.
Can a child's assent ever be waived?
What state/provincial laws should IRBs, sponsors, CROs and clinical investigators be familiar with that relate to the conduct of clinical trials?
- 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
- Investigational drugs
- Vulnerable subjects
- Medical practice and delegation of authority to perform procedures
If a site enrolls a subject who cannot read and understand English, does the IC need to be translated into the subject’s native language?
Yes. The IC must be provided in a language understandable to the study subject.
What information should an independent, central IRB obtain about a research site?
Information 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 Schulman. In certain situations, the Board may request that a site visit be conducted.
Can a research site use a screening consent for screening tests and procedures prior to having subjects sign a study-specific consent document?
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.
Does subject information need to be redacted (blacked out) when submitting signed ICs with a Study Status Report?
No. The Board is listed on the Authorization to Use and Disclose Personal Health Information as having access to subjects’ Personal Health Information.
What are the differences between a legally authorized representative (LAR) and a caregiver?
When am I required to submit a Study Status Report?
Study Status Reports are generally required every 12 months, unless the Board determines more frequent reports are required. The most recent approval or reapproval letter will state 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.
Does Schulman provide sites with approved HIV Consents when HIV testing is explicitly required by the protocol or when the protocol allows for HIV testing at the investigator’s discretion?
No. It is Schulman’s expectation that the PI/QI 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 U.S. 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.
If a site intends to use a separate document to obtain consent for HIV testing as part of a study, is it necessary to submit that document to Schulman for review and approval?
No. This is not necessary as long as the separate consent document does not contain study specific information.
Does the Board review pregnant partner consents?
Yes. When, during the course of a study, a pregnant partner is identified, Schulman will work with the client to develop an appropriate form of consent and Board approved consent process suited to the individual case.