Does Schulman provide a copy of the California Experimental Research Subject's Bill of Rights?
Does Schulman require the California Experimental Research Subject's Bill of Rights to be signed?
Yes, including any versions of the California Experimental Research Subject’s Bill of Rights documents that do not have signature lines.
California’s “Protection of Human Subjects in Medical Experimentation Act” and California Health and Safety Code, Section 24173 (a) requires that the California Experimental Subject’s Bill of Rights be given to subjects prior to conducting the initial protocol-specific consent process and that it is signed and dated.
Does a California Experimental Research Subject's Bill of Rights need to be signed again when a consent document is revised?
No, it only needs to be provided and signed at the time of initial consent, prior to conducting the initial protocol-specific consent process.
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?
See our Turnaround Times.
What is the usual turnaround time for review of a new study?
See our Turnaround Times.
When may I expect to receive notification of the status of the review of a new study?
We 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.
When may I expect to receive a draft of the IC for review?
If draft review is required, after the Board approves a new study, the draft IC will be sent to the submitting party within 1-2 business days.
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 additional sites 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 to the IC. Schulman will provide each approved research site with a site-specific IC.
What could slow the approval process for my study or site?
- Incomplete Submission Documents: Please refer to the Forms library to ensure 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 their appropriateness.
Can I receive an electronic copy of the informed consent (IC)?
Schulman’s WebPortal provides a downloadable PDF version(s) of the study’s IC(s). If a sponsor or CRO is obtaining a translated consent(s) for its sites, Schulman will send an unprotected Microsoft Word document version of the IC(s) upon request. After approval documents have been sent to the appropriate parties, Schulman provides the sponsor/CRO with a protected electronic version of the IC, with Track Changes enabled, for future revisions due to amendments, etc. An unprotected electronic version of the IC template can also be provided upon request.
If the study is approved, will Schulman provide the sponsor/CRO with an approval letter?
Yes. Schulman will provide an approval letter for the study and a copy of the approved template IC(s) directly to the sponsor/CRO via Schulman’s WebPortal.
What is the cost of the review?
Please request a copy of Schulman’s current Fee Schedule.
Does Schulman provide centralized billing?
Yes. For multi-center studies, centralized billing is the preferred method for the Board’s review of protocol-related items for all sites.
Does a study being conducted in a hospital have to be reviewed by the hospital's IRB?
No, a hospital may defer review of research conducted at the hospital to another IRB, but the deferral must in writing. For more information on using a central IRB instead of a local IRB, please see Institutions Overview.
How do I obtain a list of FDA audits of IRBs?
You may send a Freedom of Information Act request to the FDA 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 all IRBs required to have Federalwide Assurances?
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). IRBs reviewing research must be registered with OHRP and FDA.
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.
If an IRB disapproves a study, can the sponsor/CRO submit the study to a second IRB?
Yes. However, FDA states that the sponsor/CRO should inform the second IRB that another IRB previously disapproved the study.
What state/provincial laws should IRBs, sponsors, and clinical investigators be aware of 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 informed consent need to be translated into the subject’s native language?
Yes. The informed consent document 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
What are the differences between a legally authorized representative (LAR) and a caregiver?
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.
When are sites required to submit a Study Status Report?
Study Status Reports are normally 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.
When are sponsors/CROs required to submit the Protocol Continuing Review Form?
Approximately six to eight weeks prior to the expiration date of the study to allow adequate time for Board review of the study.
Is Schulman registered with the Office of Human Research Protections (OHRP) and the Food and Drug Administration (FDA)?
Yes. Schulman’s IRB Organization number is IORG0000635. Schulman’s IRB registration number is IRB00000971. To view Schulman’s registration information, please visit US Department of Health and Human Services.
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. See FDA Guidance on Paying Research Subjects.
Does the Board approve Investigator Brochures (IBs)?
The Board does not approve IBs; however, an acknowledgement of receipt is provided to the sponsor/CRO and sites via Schulman’s WebPortal and SiteAccess systems.
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 and SiteAccess systems.
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 consent to obtain consent for HIV testing as part of a study, is it necessary to submit that consent to Schulman for review and approval?
No. This is not necessary as long as the separate consent does not contain study specific information.
How can I contact Schulman with questions, to express concerns, or to convey suggestions regarding Schulman’s human research protection program?
Please contact Schulman IRB by telephone at 513.761.4100 or by completing the Feedback form.
Are all clinical trials registered on ClinicalTrials.gov?
No. Only “applicable” clinical trials require registration. See ClinicalTrials.gov FAQs for the definition of which trials require registration and which trials are generally excluded from registration.
For a ClinicalTrials.gov registration, what information should I enter about Schulman IRB?
- Board Approval – select one of the following as applicable
- Request not yet submitted
- Submitted, pending
- Submitted, approved
- Submitted, exempt
- Submitted, denied
- Submission not required
- Approval Number – Enter the Schulman approval date (mm/dd/yyyy)
- Board Name – Schulman Associates IRB
- Board Affiliation – Independent
- Board Contact – 513.761.4100
.What is the difference between continuing review and periodic review?
Continuing review describes the study protocol reapproval process and periodic review describes the research site reapproval process
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.
My study is federally funded. Does Schulman review federally funded studies?
Schulman IRB reviews federally funded studies. Federally funded studies have additional submission requirements.
How can I find my Federalwide assurance number?
Please visit the OHRP Federalwide assurance (FWA) database here, and follow the instructions provided.