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As IRB offices gear up for a busy academic research year, it’s a good idea to dust off IRB templates, checklists, and other tools to revise, improve, and adapt to technology and other changes.
IRBs need to review their templates and forms at least once a year, making changes when suggested by research teams and others, says Kathryn G. Schuff, MD, MCR, professor and chair of the IRB at Oregon Health & Science University in Portland.
"We update our consent form once or twice a year," Schuff says. "We do this when we have input from our research team about parts of consent that work well or don’t work as well as a tool for the consent process. We consider feedback when tweaking the consent template itself and sharing tips that come from a research team."
IRB Advisor asked Schuff and other directors of IRB, research compliance, and human subjects protection offices nationwide to share some of their experiences and tips about improving IRB forms and templates. Here is their advice about creating new forms and modifying different ones.
After the HIPAA rule modifications, published in the Federal Register on Jan. 25, 2013, research sites were permitted to use a single authorization form for compound authorizations containing conditioned and unconditioned authorizations of personal health information related to research activities. The 2013 rule change modified exceptions for using informed consent and disclosures on the same form, Schuff notes.
After this change, the Oregon Health & Science University IRB changed its clinical research consent summary to incorporate all HIPAA-required elements, she says.
For example, to satisfy the HIPAA authorization core element of an individual’s right to revoke his or her authorization, the informed consent form states, "If you do join the study and later change your mind, you have the right to quit at any time. This includes the right to withdraw your authorization to use and disclose your health information."
The informed consent form has always had information about protecting research subjects’ privacy and confidentiality, and the separate HIPAA form was a duplication of that information, Schuff says.
"We used the required elements of an authorization and found places in the informed consent where they fit well with the required elements of the informed consent document," she explains. "We spent a lot of time trying to make it sound less legalistic and more conversational and understandable to subjects."
The resulting form had the HIPAA elements so seamlessly woven into the IC required elements that some IRB members were concerned that the IC form did not adequately address HIPAA, she notes.
"We had to explain that it was an integrated form, and we offered IRB members an informed consent template with each of the HIPAA elements highlighted and with comments about the particular authorization," she says.
The change pleased research teams, Schuff says.
"Our feedback shows that it makes more sense to subjects to just talk about HIPAA and informed consent once and have them put together [on one form]," she says. "There also is less risk of having missing signatures on the HIPAA authorization."
Medical students on rotation often conduct chart reviews or case study reports as part of their professional development, says Brian A. Gladue, PhD, CIP, executive director for the office of research compliance at the University of North Texas Health Science Center in Fort Worth.
"We wanted to provide a process for them to think through and address the issues related to activity involving a patient’s case record," he says.
"In many institutions this kind of research project would be exempt from IRB review, and most of the time it is exempt, particularly if information/research data that identify the individual subject are not recorded," he adds.
The institution needed a form that students or investigators could use to record information necessary for the IRB to approve the exempt status. With all the elements in place, the IRB could log it in as an exempt category review, Gladue says.
Before developing the form, investigators had to write a full protocol or multiple pages of documentation.
"Sometimes people inexperienced with research activities were not sure which information was relevant, so we wanted to standardize the thinking process students would need when conducting a chart review or when dealing with a single subject report," Gladue explains.
The resulting one-page form asks for basic protocol information, including the project’s title, principal investigator’s name, department, phone number, email, key personnel, and a brief description of the case study research project.
It lists these six criteria that must be met in order for the case study project to be approved as exempt:
- The case study research will involve a review of existing medical charts, clinical care charts, and/or records that have been generated as a matter of "standard of care."
- The case study will involve records for one patient.
- Patient data will be de-identified and protected under confidentiality requirements.
- All students, staff, and faculty involved in the case study must have completed appropriate human subjects research training (such as CITI).
- Only UNTHSC-affiliated institutions, hospitals, clinics, sites, and practices where medical and/or clinical records will be maintained and assessed will be involved in the case study.
- The case study will only involve the analysis and reporting of existing information (a so-called "retrospective study"). Analysis of information not yet in the medical chart and/or record is considered a "prospective" review/study and is not allowed under this procedure.
The form is then signed and certified by the investigator and co-investigators.
Even with a short form, students and investigators sometimes make mistakes or give too little information about the proposed case study, Gladue notes.
The HIPAA rule and all changes, including the Health Information Technology for Economic and Clinical Health (HITECH) Act, could be reflected in a wide range of IRB templates and forms.
For example, forms might add language pertaining to unique health identifiers, according to J. Bruce Smith, MD, CIP, director, office of human research and division of human subjects protection at Thomas Jefferson University in Philadelphia.
Thomas Jefferson University’s IRB addresses HIPAA in its record/chart review/computer database research study form with specific questions about how data will be used, including these:
- How many subject or database records will be reviewed?
- Will data be sent outside of TJU?
- If yes, where will data be sent?
- Why is it necessary to send data outside of TJU?
- How will data be sent? (Describe actual methods and include plans for coding and/or encryption.)
- Data to be used for: publication, oral presentation, other?
- Please check all categories of data that will be obtained during the record/database review: demographics, diagnosis, lab values, clinic notes, billing/charges, location of service, drug/device utilized, length of stay, radiology testing, procedures/treatment, provider of record who saw patient and signed discharge note, other?
The form also includes a list of information that is considered identifiable under the privacy rule regulations, and researchers are required to check off whether any of these will be obtained.