SCRIHS Quarterly Tips
Revisions to SCRIHS Standard Operating Procedures (SOPs) are occurring in tandem with the transition to iRIS, the SIUSM electronic IRB submission and review system. The current SCRIHS SOPs can be viewed electronically in two locations:
- SCRIHS Web page: www.siumed.edu/adrfa/scrihs_procedures.html.
- Inside iRIS: https://siu.imedris.net. Once logged in to the system, click the “Help” icon at the top right of the home screen.
The SOPs are indexed by category. Within each category, individual SOPs can be reviewed by clicking the hyperlink. New SOPs are posted upon approval by the IRB Chair or designee. If you have questions regarding current SOPs or need assistance locating SOP information, please do not hesitate to contact SCRIHS staff: Gary Fifer at email@example.com, Eric Meyer at firstname.lastname@example.org, or Alisha Mirabile at email@example.com.
SCRIHS has recently relocated offices. The new address for SCRIHS is:
SIU School of Medicine
801 N. Rutledge St., Room 1269
P.O. Box 19664
The new office location is on the first floor of the 801 building, in the southern hallway, where the CCR is currently located. The new fax number is 545-0799. Contact phone numbers will remain the same.
For the latest SCRIHS information and forms, please also visit the SCRIHS Web page at www.siumed.edu/adrfa/scrihs.html.
May 2012 - INFORMED CONSENT UPDATES
SCRIHS recently revised the Informed Consent Form (ICF) template. One of the main revisions to the ICF is the incorporation of HIPAA language. This means a separate HIPAA Authorization will no longer be required. All new protocol submissions must use this new ICF template and be entered into iRIS as Microsoft Word documents- pdfs will not be accepted. To access the new template, visit the SCRIHS Forms Web page at www.siumed.edu/adrfa/scrihsforms.html. For questions, please contact SCRIHS staff at 545-7602.
February 2012 - LIMITED DATA SET
A limited data set is a subset of protected health information (PHI) as defined by the Health Insurance Portability and Accountability Act (HIPAA) Privacy Rule. A limited data set could include the following (potentially identifying) information:
- Admission, discharge and service dates
- Dates of birth and, if applicable, death
- Age (including age 90+)
- Five-digit zip code or any other geographic subdivision, such as state, county, city, precinct and their equivalent geocodes (except street address)
The use or disclosure of a limited data set requires a Data Use Agreement. For more information, contact SCRIHS staff at 545-7602 or visit the SCRIHS Web page, at www.siumed.edu/adrfa/scrihs.html.
Does My Project Require Institutional Review Board Oversight?
Federal Regulations mandate that an Institutional Review Board (IRB) review and approve any activity that meets the definition of “research” that involves “human subjects.” At times it can be challenging for an Investigator to determine if a project includes both of these elements.
The SCRIHS Expedited Review Panel has implemented a tool to assist Investigators in making this determination. The document, entitled “When Do Activities Need Institutional Review Board (IRB) Review and Approval?” is located on the SCRIHS Web page, www.siumed.edu/adrfa/scrihs.html, under the “SCRIHS Forms” tab. It contains Regulatory definitions and guidance that aid in the process of determining if a project is “research” involving “human subjects.” If uncertainty remains after reviewing this document, the Investigator is strongly encouraged to complete a “Determination of Human Subjects Research Form” and submit it to firstname.lastname@example.org. This form is also located under the “SCRIHS Forms” tab on the SCRIHS Web page. A member of the SCRIHS Expedited Review Panel will conduct a review to determine if SCRIHS approval and oversight is required.
The SCRIHS Office welcomes any questions regarding the research determination process. Please call 545-7602 to speak with SCRIHS staff.
Also, remember that the latest forms and information can always be found on the SCRIHS Web page.
Special provisions must be provided before enrolling individuals with impaired decision-making capacity or children who have not attained a legal age as subjects for human research. When reviewing proposals with these individuals, SCRIHS is required by law to consider their unique susceptibility. Investigators should be cognizant that these individuals do not “consent” to participate in research. A parent or legally authorized representative “consents” for them. The child or cognitively impaired individual “assents” to participate. This is important when creating an informed consent document. Assent forms are available at www.siumed.edu/adrfa/scrihsforms.html. The three assent forms cover: children ages 5 to 7, children ages 12 to 17, and cognitively impaired individuals. These assent documents are “as is” and require no modification. When children and/or cognitively impaired individuals are intended to be part of a research project, assent forms are an element of the informed consent document. The appropriate assent form(s) are to be attached to the informed consent at the time they are submitted to SCRIHS for review. For questions, please contact SCRIHS staff for guidance at 545-7602.
A very common application submission is a request to conduct a retrospective chart review under 45 CFR 46.101(b)(4). These applications are accompanied by an Investigator Request for a Waiver of Authorization. Once approved, an investigator will access medical records one time to collect a specific data set. The caveat is that no identifiers (protected health information) are collected in the process. After the data collection, additional medical record queries about data outside of the originally specified set are not possible. Under this type of approval, further inquiries are not permissible. Careful protocol design will help assure that all necessary data points are collected with a single review. For additional information regarding retrospective chart reviews, please contact SCRIHS staff at 545-7602 or visit www.siumed.edu/adrfa/scrihs.html.
Federal regulations require human study investigators to obtain informed consent from research subjects. This process begins with a study-specific, IRB-approved Informed Consent and Protocol listing the individuals authorized to approach study subjects and obtain their consent to participate. SCRIHS requires two signatures on the Informed Consent: 1) the subject or the subject’s legally authorized representative, and 2) the authorized individual who obtained consent, each dated at the time the subject agrees to participate. Federal regulations further require that the original signed and dated Informed Consent document be retained in the study records. Two photocopies of the document are needed. One is given to the subject, and the second is placed in the subject’s medical record, per SCRIHS and hospital policies. If consent is obtained in a location without a photocopier, two originals of the consent form must be signed, one labeled as “Copy” and given to the subject.
Investigators and study staff will find it helpful to maintain a study log. With a study log, research personnel can easily track whether consent forms are signed, dated, and distributed appropriately. This tracking is especially helpful if a study uses multiple consent forms or if a study includes consent forms that are updated on a regular basis. For more information on informed consent, including form templates, visit the SCRIHS Web page, located at www.siumed.edu/adrfa/scrihs.html. For specific questions, contact SCRIHS staff at 545-7602.
According to federal regulations, human subjects research studies must receive continuing review (45 CFR Part 46). The interval for continuing review is based on the degree of risk determined during initial study review, “but no less often than one year.” If SCRIHS has not reviewed and approved a research study by the continuing review date, the research must stop and enrollment of new subjects cannot occur. The study investigator is responsible to submit continuing review when required. SIU-SOM, in compliance with federal requirements, has written procedures in place to conduct continuing review of human subjects research and report findings/actions to investigators and the institution. SCRIHS provides written continuing review reminders to investigators 60 days prior to study expiration. Questions about continuing review can be directed to SCRIHS staff at 545-7602.
By definition, a case report is a description of a single, novel treatment without identified protected health information or analysis. A case report, by this definition, does not meet the Common Rule definition of research per 45 CFR 46.102 (d) and therefore does not need to be reviewed by SCRIHS. Investigators are free to publish these reports.
An author of a case report should be aware of circumstances when case reports may be considered research and require SCRIHS guidance. These circumstances can include:
- The author of the case report develops a hypothesis and links other case reports to either substantiate the hypotheses or disprove the hypothesis. This type of activity may be similar to conducting a pilot study or a small epidemiological study.
- The results have become generalizable information.
- The intent is to develop generalizable information.
- The case report is part of a systematic effort to prove or disprove a point or some aspect of medicine or science.
If there is ever question as to whether a case report is or is not considered research, please contact the SCRIHS office for guidance, at 545-7602.
As a reminder, for the latest forms and information on human subjects research at SIU-SOM, visit the SCRIHS Web page at http://www.siumed.edu/adrfa/scrihs.html.
In compliance with federal regulations, SCRIHS requires all Investigators and Co-Investigators who participate in sponsored human research to report relevant financial information. Initial application submissions to SCRIHS must include the Protocol-Related Conflict of Interest Disclosure Forms. If an actual or potential conflict of interest develops after submission of the protocol to SCRIHS, the Investigators or Co-Investigators must complete and submit an updated Protocol-Related Conflict of Interest form to SCRIHS promptly.
The intent of this policy is to promote objectivity in sponsored human research by establishing standards to remove potential bias in the design, conduct, or reporting of research due to potentially conflicting relationships. By signing a SCRIHS Application for Approval of a Research Project, Investigators and Co-Investigators indicate they have read the SIU-SOM Conflict of Interest policy. All members of the SIU-SOM research community should be sensitive to the potential impacts of financial interests and/or non-financial relationships with commercial sponsors or other external entities on the conduct of research and the participation and protection of human research subjects.
For all SCRIHS-related forms, including the Application for Approval of a Research Project and the Protocol-Related Conflict of Interest Disclosure Form, please visit the SCRIHS Web page, which can be found at http://www.siumed.edu/adrfa/scrihs1.html. The SIU-SOM Conflict of Interest policy can also be found on the SCRIHS Web page.
While investigators do everything they can to avoid unexpected adverse events, these events do occur. When assessing unexpected adverse events, it is important to consider the possibility of the event being a part of a small sub-set of unexpected adverse events called Unanticipated Problems. SCRIHS defines Unanticipated Problems as events meeting all of the following criteria: 1) unexpected; 2) possibly or probably related to participation in the research; 3) placing participants and/or others at greater risk of harm; and 4) requiring revisions to study-related documents, such as protocol, consent, investigator’s brochure, etc. There is also a possibility that an event could occur that meets the Unanticipated Problem criteria even though no unexpected adverse event transpired. For example, a behavioral research study collects identifiable information about illicit drug use by surveying college students. The data is stored unencrypted on a laptop, and the laptop gets stolen. This event is unexpected, related to participation in the study, places participants and/or others at greater risk of harm, and will require revisions to study-related documents. Even though there is no adverse event, all Unanticipated Problem criteria have been met. The event should still be reported to SCRIHS. For guidance on reporting Unanticipated Problems to SRIHS, open http://www.siumed.edu/adrfa/SCRIHSManual.pdf. For additional information about Unanticipated Problems, visit http://www.hhs.gov/ohrp/policy/AdvEvntGuid.htm.
When conducting clinical research, a wide variety of circumstances exist that could result in deviation from the research protocol. These events are reported to SCRIHS using the Protocol Deviation Report form. The form is located on the SCRIHS Web page, which can be found at http://www.siumed.edu/adrfa/scrihs1.html. When reporting protocol deviations to SCRIHS, always include the following elements: subject ID number and initials, reason the deviation occurred, outcome, and an explanation of whether or not there was harm to any subjects and how future occurrences will be prevented. Completing these reports provides an opportunity for a research team to self assess their processes for adhering to a protocol, possibly presenting ways of enhancing current operations. For questions or assistance completing Protocol Deviation Reports, please feel free to contact the SCRIHS staff at 545-7602.