17th Edition - January 22, 2019

The Human Subjects Office is now part of the IU Human Research Protection Program (HRPP). The HRPP encompasses more than just the IU IRBs. It encompasses the facilitation of all areas of human subjects’ protection, including human subjects/IRBs and the Quality Improvement Office, as well as collaboration with the Conflicts of Interests offices, the Research Integrity Office, and more. Watch for the term HRPP to replace HSO in the coming months. The IU HRPP is led by Bethany Johnson, University Director – HRPP. 

The HRPP is happy to announce several staff changes:

• Welcome to Lisa Francis, Human Subjects Research Auditor in QIO, and Audrey Williams, Research Compliance Associate on the IRB operations team.
• Avril Pitt has been named Sr. Research Compliance Consultant and now leads the team that facilitates full IRB review.
• Kara Brocious has moved from the IRB operations team to the Quality Improvement Office as QIO Consultant, and will be focused on implementing an auditing program for minimal risk research.
• Michelle Murphy has moved from the HRPP to the Office of Research Compliance IT Project Management team.

Final revisions to the Federal Policy for the Protection of Human Subjects (Common Rule) are effective January 21, 2019. The changes are intended to provide a better protection for human subjects, while decreasing administrative burden for researchers, especially for minimal risk research. 

The IU HRPP implemented early adoption of many of the changes found in the revised Common Rule in March 2018 and July 2018 (click for details), and many researchers have already benefited from the increased efficiency and reduced burden offered. Because so many of the changes have already been implemented here at IU, the actual impact of the Common Rule’s effective date should be minimal, but here’s a quick overview:

• Revised exempt categories are now available to all research (except research subject to FDA regulations). The categories expand the types of research which are considered exempt from the regulations to include studies involving benign behavioral interventions and medical chart reviews. Previously-approved exempt studies will not be affected, unless an amendment is submitted which impacts confidentiality of the data or a waiver of HIPAA authorization. In these cases, HRPP staff will request that a new exempt study be submitted. For full details about the exempt categories, see the IU HRPP Policy on Exempt Research and the corresponding guidance.
• Renewal is no longer required for expedited research and research which is now in long-term follow-up only or data analysis only, unless the research is FDA-regulated. The IRB may require renewal for research on a case-by-case basis, which should happen rarely. Studies that do not require renewal will not receive an expiration date in KC IRB but will receive an annual reminder of ongoing IRB obligations. Studies that require renewal will display an expiration date in KC IRB and will receive renewal notices as usual.
• Informed consent requirements have been revised to reflect advancements in technology and research, and the criteria for granting waivers of informed consent have also changed. For studies open to enrollment, researchers will be asked to update their informed consent documents at time of next renewal, but previously-enrolled subjects do not need to be re-consented. Research which is no longer enrolling will not be affected by these changes.

HRPP staff will work closely with researchers at time of renewal to apply burden-reducing provisions and ensure all requirements are met. Please see study-specific pre-review comments for details, or reach out to an HRPP staff member with any questions.

IRB changes for VA research

The VA is a Common Rule agency and has revised its requirements, specifically VHA Directive 1200.05, to align with the revised Common Rule. VA researchers can now take advantage of all the burden-reducing provisions offered by the revised Common Rule without having to meet additional requirements.  

Reminder for FDA-regulated research

The FDA is not a Common Rule agency and, until the FDA harmonizes its own regulations to more closely match the Common Rule, FDA-regulated research will not be able to take advantage of the same burden-reducing provisions. FDA-regulated research is not eligible for exemption and will continue to require annual renewal, regardless of level of review or study status.  

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.

The IU HRPP Policies are now easier to find and access. All IU HRPP Policies have been integrated into the IU ORC website and can now be directly accessed at IU HRPP Policies. In addition to policy statements and mandatory procedures, each policy also includes links to relevant references, including direct links to applicable IU HRPP Guidance. The online policies are printable (to PDF or directly to printer) and will always reflect the current requirements. As always, contact the HRPP at irb@iu.edu if you need a copy of a previous version. 

Minor revisions were made to many policies for consistency with the revised Common Rule. As always, please review any policies relevant to your research. Section 5.0 of each policy details the most recent revisions.

Can’t get enough of the HRPP? Join in on the monthly IRB Outreach Meetings! In addition to our newsletters, website, and KC IRB notifications, Outreach Meetings give you an opportunity to learn about regulatory and HRPP updates, as well as ask questions of HRPP staff and other study coordinators. The meetings are available in person and via teleconference. If you would like to join the invite list, please email Danielle Giltner at droessin@iu.edu. 

Although renewals have long served as a compliance check-in between the study team and the IRB, changes to the Common Rule (effective January 21) will remove the renewal requirement from most minimal risk research.  However, all human subjects research at Indiana University and its affiliates still needs to be conducted according to the applicable protocol, regulations, and/or institutional requirements. 

To assist researchers in maintaining compliance, and to ensure protection of human subjects in the absence of renewals, over the next several months the Quality Improvement Office will be creating and implementing an auditing program to review selected minimal risk projects that are either open to enrollment or closed to enrollment with continuing research interventions.  This auditing will allow the IU HRPP to verify that research is being conducted as approved, identify and resolve noncompliance issues in a timely manner, and provide additional education and training opportunities for researchers. 

More information will be communicated as the program is developed and launched throughout the coming year.  For questions or comments, please contact Kara Brocious in the Quality Improvement Office at (317) 278-7814 or krbrocio@iu.edu.

The National Science Foundation (NSF) requires that each institution submitting a proposal certify that it has a plan to provide appropriate training and oversight in the ethical conduct of research to all undergraduates, graduate students, and postdoctoral researchers who will be supported by NSF to conduct research.  This policy requires that Institutions are responsible for verifying training has been received.                

To meet the NSF RCR training requirement, undergraduates, graduate students, and postdoctoral researchers receiving NSF funding need to successfully complete IU’s two-part program:

• Successful completion of the Responsible Conduct of Research (RCR) course of the online program hosted by Collaborative Institutional Training Initiative (CITI); and
• Discipline-specific mentoring by the principal investigator and lead investigators during the course of the grant.

The Office of Research Compliance will conduct audits of online completion of CITI RCR training and will notify individuals when they are non-compliant. Notifications are sent via email to the Principal Investigator, undergraduate students, graduate students, and postdoctoral researchers, and the grant account Fiscal Officer. The schedule of notifications provides 30 days to complete the online RCR requirement. If the requirement has not been met at 15 days, a second (reminder) notification will be sent. If the requirement has not been met at 25 days, a third (final) notification will be sent. Undergraduates, graduate students, and postdoctoral researchers supported by NSF funding, who have not completed the online CITI RCR training within 30 days from the initial notification, will have compensation charges removed from the grant.   

If you have any questions about this requirement, please contact our office at researchcompliance@iu.edu.