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.
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 do I obtain a list of FDA audits of IRBs?
You may send a Freedom of Information Act request to 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 IRBs required to have Federalwide Assurances?
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.
Schulman reviews most new research site submissions, recruitment and study-related materials, as well as some amendments and new study submissions using expedited review.
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 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 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.
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 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 3D and SiteAccess 1.0.
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?
Please contact Schulman IRB 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. For more information, please review Additional Protection for Children.
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
- Institutional review boards
- 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 informed consent?
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 IRB may have access to the subjects’ Personal Health Information (PHI) in relation to its responsibilities as an Institutional Review Board.
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 otherwise. The most recent approval or reapproval letter to determine 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.
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.
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 document to Schulman for review and approval?
No. This is not necessary as long as the separate consent does not contain study specific information.
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.
Is a sponsor/CRO closeout visit required prior to submitting a Final Report to Schulman?
Schulman does not require a sponsor/CRO closeout visit prior to receiving a Final Report. However, please verify with the sponsor/CRO whether your site can be closed with the IRB prior to submitting your Final Report to Schulman.
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.
Does my Federalwide assurance number cover federally funded research only or is all of the non-exempt research at my site/institution covered by our Federalwide assurance?
What is different about Department of Defense (DoD) research?
DoD follows the Common Rule, however 32CFR219 adds other requirements. Each DoD component may apply different policies, such as the DoD Addendum to FWA, to address those requirements. Call us, contact the funding point of contact, or reference the following web sites for more information: