IRB forms and materials to be submitted …
WHEN I WANT TO: I NEED TO SUBMIT: {for CIRB studies, see the specific FAQ}
1
Request a determination as to whether AHC is the appropriate IRB of record (i.e. is AHC “engaged?”) or Request a determination about whether the project requires IRB review, i.e. “Is it Human Subject Research per FDA/DHHS definitions or QA/QI, Process Improvement, etc?”
HRP-211 Initial Review form
A comprehensive, written research plan (scientific protocol, grant application, QA/QI plan)
An email or short cover letter requesting a determination about whether the project requires IRB review
Scan or pdf the signed form 211 and e-mail all materials to IRBMail@advocatehealth.com with a subject line of “Request for initial determination”
2
Request that a protocol be waived to the oversight of another IRB instead of reviewed by Advocate’s IRB
(Potentially applicable to commercially sponsored studies and academic consortia wherein the lead site has agreed to be the IRB of record for participating sites)
Waiver will only be considered to IRBs that are accredited by AAHRPP; verify the accreditation status before submitting.
Enclose the following:
1. A cover letter noting that the submission is a request for waiver with a statement of the rationale for waiver (might include sponsor letter or materials)
2. Completed forms HRP-211 and HRP-226 (as with CIRB, future personnel changes still require an AHC Mod before implementing) 3. If already approved by the other IRB, include that IRB’s current
letter of approval
4. The complete, current research protocol
5. The current approved consent form (and HIPAA Authorization if it’s not part of the consent); if not yet approved, include the sponsor’s template consent
6. The contract/research agreement final version or current draft 7. The other site’s waiver acceptance form (IAA - IRB Authorization
Agreement)
8. Current CITI training certificates must be on file or attached for all study personnel
9. Assemble a complete packet of attachments and submit to the AHC IRB by internal mail with a subject line of “Request for Waiver” Email only to AHC-IRB-Admin@advocatehealth.com
10. If there are no questions the AHC IRB will forward you an AHC IRB protocol number, a letter of approval to seek external review, a signed IAA and the requirements to add site-specific language to the consent
11. Note: Despite the waiver of review, Sponsors remain responsible for AHC IRB administrative fees
3 Submit a research study for initial review
3 collated sets of the following materials, submitted by internal snail-mail HRP-211 Initial Review form
Non-AMG attending doctors acting as Principal Investigators should complete and include an Independent Investigator Agreement(needed for each protocol unless arrangements have been made with the IRB; this
documentation is evolving; Research Dept can advise on its necessity)
HRP-226 form - Department Chair Certification with Local Oversight and support Dept. sign-offs
HRP-503 form - Template Protocol and, if applicable, the accompanying master protocol
All subject materials – advertising/recruiting flyers, surveys, etc. HRP-502 form - Template Consent Document (if applicable; if not
applicable follow instructions in 503 for waiver requests or alteration of informed consent)
Sponsored / funded studies should include a copy of the research contract (Trial Agreement) as submitted to the Legal Dept. All study personnel must have completed the Research Conflict of
Interest statement and must include copies of current ethics training certifications
Fee waiver request explanation, if relevant
After the submission has been checked for completeness, the IRB will e-mail a study number (and request an electronic copy of the consent if relevant)
________________
The Dept. of Research is responsible for protocol review for institutional compliance (scientific integrity, budget, legal & internal authorizations such as the Local Oversight approval) prior to IRB review. You can contact them for support at:
advocateresearch@advocatehealth.com or 630.929.6129
4 Modify an already approved research project
HRP-213 Modification form
Revised protocol and any supplementary materials provided by a sponsor
If applicable, the revised AHC approved consent with track-editing of the changes
Waived studies require a local Mod for personnel/site changes; all other amendments are a matter for the IRB of record; their response should be submitted when received
For details refer to
http://www.advocatehealth.com/documents/IRB/AHCIRB_Modificati on-Guide.pdf
and for submission instructions, refer to
http://www.advocatehealth.com/documents/IRB/AHCIRB_e-file-Procedures.pdf
5
To report an adverse event, submit a protocol deviation or study related materials that do not alter the protocol or consent – e.g. a DSMB report, a
sponsor’s annual recruitment report, new safety information
HRP-214 form - Reportable New Information
Other information as applicable, e.g., a corrective plan of action for a deviation, a sponsor communication, etc.
Waived studies should submit an RNI with a copy of the report to the IRB of record and submit their response when received
For submission instructions, refer to
http://www.advocatehealth.com/documents/IRB/AHCIRB_e-file-Procedures.pdf
6
Report the progress of an approved study for applicable interval and either close or renew the study
(For studies that were approved to be waived to an external IRB, see the AHC IRB’s original letter of waiver for required documents at the time of renewal/closure)
HRP-212 form - Continuing Review
Other forms as applicable: HRP-213; HRP-214
Reports and documents as applicable, e.g. DSMB report, new publication, sponsor communication, revised (track edited) consent Other than CIRB protocols, which have their own arrangements,
internal snail-mail all Cont. Rev. materials 6 weeks in advance of the study approval expiration date to:
IRB – Downers Grove SC
Non-HSR determinations vs Approval as Exempt
The term “Exempt” is often confused with a “non-human subject research” determination. It is important to understand the difference. The term “non-human subject research” refers to activity that does not meet the federal (FDA and OHRP) definitions of research that requires IRB review.
As defined in federal law, the term Exempt refers to a protocol that: is Human Subject Research
must be approved by an IRB
meets one of a set of minimal risk criteria (as opposed to Expedited or Full review criteria) requires a normal review submission (which at Advocate includes submission of 3 copies, ethics
certifications for all, Departmental and local site Protocol Review Committee approval, a form 503 protocol, etc.)
does not require (is exempt from) Continuing Review
”Exempt” means exempt from ongoing review, not exempt from any IRB review and approval. Activity that
qualifies for “exempt” status IS human subject research, HAS been reviewed by the IRB, and the IRB has determined that the study falls under one of the criteria defined by law for “exemption” from ongoing IRB review.
A request for non-human subject determination (Item 1 above) is appropriate when you are uncertain whether a project requires any IRB review at all. IF you are confident that your project is HSR then you should submit the materials in the normal manner for review; you cannot receive IRB approval of HSR that is Exempt via a submission under Item 1 above. If you request an HSR determination and the IRB responds that the project qualifies as Human Subject Research, you will be instructed to complete a submission for IRB review; the IRB will determine which category of review is appropriate (exempt, expedited, or full review). The documentation required for IRB submission is listed in Item 2 above.
In summary, following the steps outlined in Item 1 of this document will result in one of the following IRB determinations:
A letter from the IRB that your project does not meet the federal definition of research that requires IRB review, therefore no further correspondence with the IRB is required unless the nature of your project changes;
OR
A letter from the IRB informing you that your project IS research as defined by law and therefore you will need to follow the submission guidelines set forth in Item 2 above.
Discussion and examples
To reference federal definitions and consideration of how the IRB determines whether individual projects require IRB review refer to the IRB website document: HRP-310 WORKSHEET Human Research Determination. For federal definitions/criteria for “Exempt” and “Expedited” review of research by the IRB refer to: HRP-312 WORKSHEET Exemption Determination and HRP-313 WORKSHEET Expedited Review.
As a general rule, most protocols approved as Exempt fall under the criterion for the collection of data that will, from the time of collection, remain completely anonymous. Examples: a truly anonymous survey (i.e., impossible to identify respondents via e-mail addresses or any information in the survey); or analysis of data obtained from the NIH’s National Trauma Database, an archive of completely de-identified patient data.
In its review of human subject research the IRB considers the research plan for protecting the privacy and confidentiality of subjects. Most retrospective studies (e.g. chart reviews) require some access to or recording of Private Health Information (PHI, such as name, MRN, birthdate or date of care fields, etc.) and thus the data cannot be considered anonymous. In many studies some identifiers are necessary, for example PHI may be recorded:
simply to avoid accidentally duplicating cases in the research data set
because it may be necessary to link data fields over time (course of care and outcomes over multiple visits) to link locations of care (in-patient vs out-patient) or,
because it is prudent to use MRN or name as an identifier in case data values need to be double checked or more variables need to be recorded in the future.
The designations of “exempt” and “expedited” IRB review of research are based on the level of risk posed to research subjects. In both designations the level of risk must be “no greater than minimal.” The criteria for “exempt” research covers “minimal risk” studies where the likelihood of harm to subjects is exceedingly low (as in the study using information from the NIH National Trauma Database: the research team receives patient
information that has already been stripped of all identifiers, thus negating the risk that confidentiality will be breached). The criteria for “expedited” research address “minimal risk” studies where the risk to subjects is higher than studies that are “exempt” although still relatively low (for example a study that receives information from patient charts with identifiers but protects confidentiality by keeping identifiers separate from information using a carefully guarded code, encrypting stored data and so forth).
The operational difference for investigators between exempt and expedited is that an “exempt” approval of a study does not require continuing review and in most instances does not require any other ongoing reporting to the IRB. A study that has qualified for “expedited” review does, by law, require continuing review at least once yearly and there is an ongoing obligation during the study to notify the IRB of protocol, consent and personnel changes (see HRP-213 Modification), deviations from the protocol and other events that occur during the study (see HRP-214 Reportable New Information).
