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. |
Schulman must receive all new study submissions no later than 3:00 p.m. EST one week before the intended meeting date. The Board routinely meets to review new studies Mondays, Wednesdays and Fridays. For holiday schedules, please check the Board’s schedule of meetings. |
The usual turnaround time for review of a new study is approximately ten (10) business days. This allows five (5) days for administrative processing and circulation to the Board for review, and five (5) days after the Board meeting for preparation and transmission of study documents to the submitting party. Turnaround time is dependent upon complete and accurate submission of study documents and may be extended if the Board, upon review, requires further information. For more information, please see Turnaround Time. |
The submitting party will be contacted regarding the status of a new study within one (1) business day after the Board’s initial review of the study. This notification will include a statement of the Board’s decision regarding the review of the study. For more information on Board decisions, please see Board Response. |
When the Board approves a new study, the draft IC will be sent to the submitting party within four (4) to six (6) business days following the initial review and approval. |
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. For more information, please see Informed Consent Template. |
The submission deadline for an additional site of a previously approved protocol is 4 p.m. EST. If a site submission is received after the 4 p.m. EST deadline, it will be recorded as received on next business day.
|
Additional research sites conducting a protocol previously reviewed by the Board are not required to submit a copy of the IC. Schulman will provide each approved research site with a site-specific IC. |
- Incomplete Submission Documents: Please refer to the Schulman Submission Forms 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 Approval of IC by Board and Client: Upon approval of a study, Board requested modifications (as applicable) to the IC are provided. A draft of the IC is forwarded to the submitting party for review and response. Approval documents will not be sent to sites while the draft IC template is still in review.
- 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 revision(s) to an IC, a Board member must review the requested revision(s) to determine appropriateness of the requested revision(s).
|
Schulman’s WebPortal provides a downloadable PDF version(s) of the study’s IC(s). After approval documents have been sent to the appropriate parties, Schulman provides the sponsor/CRO with a protected Microsoft Word version of the IC template(s) with the Track Changes feature enabled. This file is provided for future revisions requests due to amendments, etc. Schulman will send an unprotected Microsoft Word version of the IC template(s) upon sponsor/CRO request describing the intended use. |
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. |
|
Yes. For multi-center studies, centralized billing is the preferred method for the Board’s review of protocol-related items for all sites.
|
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. |
|
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").
|
Per regulations, Schulman’s Board can provide expedited review for:
2.) "minor changes" to previously approved research during the period (one year or less) for which approval is granted.
Schulman reviews most new research site submissions, recruitment and study-related materials, as well as some amendments and new study submissions using expedited review. |
Yes. However, FDA states that the sponsor/CRO should inform the second institutional review board that another institutional review board previously disapproved the study.
|
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
|
|
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. |
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. For additional information about LARs, please refer to (LAR Guidance doc hyperlink).
|
Study Status Reports are normally required every 12 months, unless the Board determines otherwise. Please refer to the most recent approval/reapproval letter to determine when the 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. |
Approximately six to eight weeks prior to the expiration date of the study to allow adequate time for Board review of the study. For more information, please see Protocol Continuing Review. |
|
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. |
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. |
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 does not contain study specific information. |
Please contact Schulman Associates IRB by telephone at 513-761-4100![]( "Call: 513-761-4100") or by completing the Feedback form. For a list of specific team contacts, please visit Contact Us. |
When registering study at ClinicalTrials.gov, Schulman suggests the following responses:
- 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
![]( "Call: 513-761-4100")
For more information, please refer to item #3 on the ClinicalTrials.gov Definitions page. |