The HRPP is also implementing several additional changes to streamline processes and further reduce burden for both researchers and IRB staff. All changes are effective January 22, 2019. Here’s what you need to know:
Revised KC IRB questionnaires
The KC IRB questionnaires are the core of the IRB application and collect the information needed by the IRB to complete its review. The HRPP is continuously evaluating the questionnaires to ensure compliance with new requirements, reduce duplication of information, and collect only information truly valuable to the IRB process. Many of the questionnaires have been revised for consistency with the revised Common Rule, or to improve or correct the IRB application.
- New studies Submitted to IRB on or after 1/22/2019 will receive the revised questionnaires for completion. In addition, any new study previously Submitted to IRB and pushed back into an editable status by HRPP staff or IRB action (e.g. Return to PI, Tabled, Provisionally Approved, Withdrawn) will be prompted to update to the revised questionnaires.
- If an amendment to previously-approved research changes one of the revised questionnaires, and the amendment is Submitted to IRB on or after 1/22/2019, that questionnaire will be prompted for update.
Previously-approved research may also require updates at the time of next renewal. Specifically, you may be asked to update to the revised version of a KC IRB questionnaire in the following scenarios:
- If your study continues to rely on the old, stand-alone IRB forms (e.g. Summary Safeguard Statement, HIPAA & Recruitment Checklist, etc.), you will be expected to update to the KC IRB Questionnaires and retire the old forms. The HRPP expects to upgrade to a newer, more user-friendly version of KC IRB over the next 18-24 months. Conversion to the electronic KC IRB Questionnaire will ensure a smoother transition to the upgraded system, and ensure all studies are in compliance with current IU HRPP Policies.
- If your research is subject to FDA regulations, you will be asked to update Questionnaire B – Lay Summary & Research Design to facilitate consistent data collection and reporting on FDA-regulated research.
- If your study involves a waiver of consent for recruitment, Questionnaire D – Recruitment Methods will be updated to remove the waiver, as these waivers are no longer required by federal regulations or IU HRPP policy.
- If your study involves a waiver of informed consent, Questionnaire H – Informed Consent Process and Questionnaire J – Child Assent & Parental Consent Process (if applicable) must be updated to collect new information required for waivers of informed consent.
Any time the questionnaires must be updated, HRPP staff will make the updates for you to the best of their ability, but additional information may be required.
Revised FDA forms
Identifying research subject to FDA regulations, and ensuring compliance with those regulations, is an important part of the IRB process at IU. The KC IRB Questionnaire B – Lay Summary & Research Design has been revised to better identify research involving the study of drugs, devices, dietary supplements, foods, and cosmetics, and to collect as much information as possible in the questionnaire itself. The result is that the FDA forms (Drug and Biological Products Form, Medical Device Form) will be required in fewer circumstances, decreasing burden on study teams. The FDA forms themselves have also been revised for ease of use and understanding.
Researchers submitting new studies should read the revised Questionnaire B carefully before completing either of the FDA forms. The questionnaire will direct study teams to complete the forms only when required. Previously-approved FDA-regulated research will be prompted to update to the revised Questionnaire B at time of renewal, but the IRB-approved FDA forms will not be revised.
Revised informed consent & HIPAA authorization forms
The informed consent templates have been revised to reflect the revised Common Rule requirements. Researchers are welcome to utilize these templates for new studies going forward; however, you are strongly encouraged to utilize sponsor-created consent templates when they are available. If an informed consent template is available for your study, please use it. Please also review the IU HRPP Guidance on Informed Consent before drafting consent forms for new research.
The HIPAA authorization templates have also been revised for ease of use and understanding. Please use the revised HIPAA authorization form for all new studies going forward.
New IRB approval letters
Your IRB approval letters have a new look! Approval letters include the IRB signature and will now include more detailed information, including:
- submission and review information
- regulatory determinations
- list of documents approved with that submission
- key personnel approved to participate in research activities (NOTE: non-key personnel are not listed)
- list of approved performing organizations
The revised approval letter includes all required regulatory information for documenting IRB approval. The signed Protocol Summary Report is being phased out and, beginning January 22, 2019, will only be provided for research subject to FDA and VA regulations. Research which is not subject to FDA or VA regulations will not receive a Protocol Summary Report.
Approval letters are available on the KC IRB Protocol Actions tab, under Summary & History > History. Details about IRB approval documents, including examples and access instructions, are available at Managing Study Documents After Approval.
Change to the KC IRB Personnel tab display
Completion of research personnel requirements (e.g. CITI training, conflict of interest disclosure) is currently denoted on the Personnel Tab by color and icon. The icons and colors are changing slightly to help HRPP staff identify research personnel who have disclosed a potential conflict of interest which may need to be considered by the IRB.
- Investigators who have completed ALL investigator requirements (e.g. CITI training, COI disclosure) and have not disclosed a potential conflict of interest will appear in green with a "✔".
- Investigators who have completed ALL investigator requirements (e.g. CITI training, COI disclosure) and have disclosed a potential conflict of interest will appear in purple with a “$”.
- Research personnel that still need to complete COI or CITI requirements will appear in red with an “X”. To see the requirements which need to be met, expand the individual’s folder and click Show next to Person Details.