February 23, 2017
The Human Subjects Office (HSO) is releasing several updates to IRB processes and procedures, including enhancements to KC IRB, effective February 23, 2017. These changes are the result of recommendations by two research community working groups, as well as feedback received from investigators, accreditation site visitors, and external auditors. The release includes a new submission process for reportable events as well as the consequent retirement of two related IRB forms, publication of three new guidance documents for investigators, revisions to several KC IRB questionnaires, and revisions to the IU Standard Operating Procedures for Research with Human Subjects (IU SOPs). Here’s what you need to know:
Reportable Events: new requirements, new KC IRB submission process
Requirements and processes for reporting post-approval events to the IRB, such as adverse events and instances of noncompliance, have been simplified. Based on feedback from accreditation site visitors, the HSO has consolidated the Prompt Reporting Form and Noncompliance Reporting Form into a single submission for “promptly reportable events” which require reporting to the IRB within five business days. Incidents which are not promptly reportable, including instances of minor noncompliance, are reported at time of next renewal. Please see the new guidance on Reportable Events for a detailed list of events considered to be promptly reportable and those which should be reported at time of renewal. This information is also detailed in the SOP on Reportable Events (replaces the previous SOP on Unanticipated Problems and Noncompliance).
As a part of this change, promptly reportable events are now communicated to the IRB via a new KC IRB questionnaire. In order to submit notification of a promptly reportable event, take the “Notify IRB of a Reportable Event” action in KC IRB, then navigate to the Questionnaire tab to complete the new smart form. Be prepared to provide details about the event, corrective measures to resolve the issue, preventive measures to prevent recurrence, and any plans for notifying sponsors, subjects, etc.
These changes are meant to simplify the process for reporting events to the IRB and consequently improve the quality of information considered by the IRB to aid in human subjects protections. As always, please contact a member of HSO staff with any questions regarding whether an incident should be promptly reported.
Amendments: new submission timing requirement, revised KC IRB questionnaire
To ensure IRB members and study subjects are provided with accurate information about studies, amendments which are initiated by a sponsor or external PI and update risks, benefits, or study procedures must be submitted for IRB review within sixty (60) days of receipt by the study team. Additionally, minor revisions to the KC IRB Amendment Questionnaire have been implemented to better facilitate personnel updates and collect more specific information regarding notification of changes to subjects.
Study Closure: new submission requirement
Based on feedback from a recent FDA audit of the IU IRBs, closure of studies involving greater than minimal risk research (i.e. full board) and FDA-regulated research MUST be reported to the IRB. These studies will no longer be allowed to simply expire, and failure to report study closure prior to expiration will be considered noncompliance. Information regarding final subject enrollment, study results, and reportable events is submitted via the Study Closure Report and reviewed by an IRB member. Study closure will be reported to the IRB via the Study Closure Report (previously Closeout Report) which can be downloaded from HSO Forms & Templates and submitted via email to email@example.com.
Reporting study closure of minimal risk research will still be permitted; however, failure to submit closure information is not required and will consequently not be considered noncompliance. Researchers may allow minimal risk, non-FDA regulated studies to expire, and the expiration will be treated as a study closure.
Research with individuals lacking consent capacity: new guidance
At the request of the IRB Executive Committee, a working group of investigators, Human Research Protection Program (HRPP) staff, IRB members, and other community members met during 2016 to discuss conduct of research with cognitively/decisionally impaired subjects, including inpatient psychiatric subjects. This population can be especially vulnerable to coercion, so ensuring research with this population includes appropriate safeguards is especially important. The working group produced a comprehensive guidance document on conducting research with this population which defines best practices for assessing consent capacity, identifying individuals who can consent for subjects lacking consent capacity, and documenting consent procedures with this population. See the new Research with Individuals Lacking Consent Capacity guidance for details.
In addition to providing best practices, the working group felt strongly that the IRBs’ current terminology of “cognitively/decisionally impaired individual” is inappropriate, as vulnerability of this population is related specifically to individuals’ ability to provide consent to research, not their cognitive abilities. As such, the HSO and IRBs will be referring to this vulnerable population as “individuals lacking consent capacity” and all HSO/IRB documentation is being revised to reflect this new paradigm.
Research with prisoners: new guidance
View the new Guidance on research involving prisoners, created by HSO staff and based on current regulations and requirements.
Enhancements to KC IRB
HSO took this opportunity to make several enhancements to KC IRB, including implementation of new processes which allow discontinuation of two IRB forms. In addition, several KC IRB questionnaires have been revised for clarification and ease of use.
- Revised language from “cognitively/decisionally impaired” to “individuals lacking consent capacity” throughout the system.
- Questionnaire B – Lay Summary & Research Design: new question regarding use of OnCore to help facilitate use of OnCore.
- Questionnaire G2 – Individuals Lacking Consent Capacity: revised “cognitively/decisionally impaired” to “individuals lacking consent capacity;” revised questions based on feedback from the working group on consent capacity.
- H – Informed Consent Process: revised “cognitively/decisionally impaired” to “individuals lacking consent capacity;” revised questions relating to this population based on feedback from the working group on consent capacity.
- Questionnaire M – ClinicalTrials.gov: incorporation of final NIH policy requirements; see below for more information.
- Amendment Questionnaire: streamlined process for personnel updates and revised questions to collect specific information about notification of changes to subjects.
- Renewal Questionnaire: clarified language throughout; revised questions regarding data safety monitoring.
- Reportable Events Questionnaire: new questionnaire associated with “Notify IRB of a Reportable Event” action; replaces Prompt Reporting Form and Noncompliance Form.
These changes will require you to update your previously-approved information in some circumstances.
- New studies, amendments, renewals, and FYI items submitted to IRB on or after 2/23/2017 will receive the revised questionnaires for completion. Any of these submissions which were created prior to 2/23/2017 and Submitted after this date will be prompted to update to the revised questionnaire.
- If a revised questionnaire (i.e. Questionnaires B, G2, H, or M) is updated with an amendment Submitted to IRB on or after 2/23/2017, that questionnaire will be prompted for update.
- Any submission previously Submitted to IRB and pushed back into an editable status by HSO staff or IRB action (e.g. Return to PI, Tabled, Provisionally Approved, Withdrawn), will also be prompted to update to the revised questionnaires. In these circumstances, HSO staff will make the update for you to the best of their ability but may require additional information from you.
If an update is required, you will see a prompt in the KC IRB questionnaire which indicates “A newer version of the questionnaire has been published. An update is required.” Simply choose “Copy the answers from the old version of questionnaire to the new one. Only questions that have been changed in the new version will have to be answered,” then click Update. You may need to click Save at the bottom of the page to display all new questions.
Some of these changes, such as the revised process for reportable events, required substantive revisions to the IU SOPs. Additionally, several SOPs received minor revisions to reflect new language or ensure consistency. View current IU SOPs on the HSO website.
SOPs with substative revisions
|SOPs with only minor revisions for language/consistency|
• Informed Consent: clarification of signature requirements; revised procedures for subjects who cannot read due to blindness, illiteracy, or other.
• Investigator Responsibilities: addition of IU and NIH GCP training requirements, amendment submission requirements and study closure requirements.
• IRB Operations: addition of IRB review of study closure.
• Reportable Events: revised list of promptly reportable events.
• Vulnerable Populations: revised for consistency with recommendation from consent capacity working group.
• Auditing Human Subjects Research
• Data Management
• Emergency Use of Investigational Test Articles
• Humanitarian Use Devices
• KC IRB
• Planned Emergency Research
• Research with Investigational Test Articles
• Safety Monitoring
• Transnational Research
For questions about HSO the HSO updates, or to request a departmental training session, please contact us at firstname.lastname@example.org.
Revised ClinicalTrials.gov Questionnaire Available in KC IRB
Changes to ClinicalTrials.gov compliance for both the Food and Drug Administration (FDA) and the National Institutes of Health (NIH) took effect on January 18, 2017. Several key changes to the IU ClinicalTrials.gov Compliance Program were implemented to address these requirements, including revisions to KC IRB Questionnaire M - ClinicalTrials.gov to reflect the new compliance requirements and allow for ease of data entry. Previously-approved protocols should only amend Questionnaire M and complete the revised questionnaire if the previous responses are inaccurate.
For more information on the changes to ClinicalTrials.gov compliance, please review the NIH News Release on the FDA final rule and the NIH policy. IU ClinicalTrials.gov Compliance Program updates can be reviewed on the IU ClinicalTrials.gov Compliance Program webpage. For questions, concerns or to request a departmental training session, please email email@example.com.