The Human Subjects Office (HSO) is glad to announce several changes to HSO policies and procedures effective March 29, 2018. These changes were prompted by burden-reducing provisions of the revised Common Rule, which has been delayed until at least July 19, 2018 and will reduce administrative burden for research that is not federally funded and not subject to FDA or VA regulation. Specifically, these provisions will (1) expand the opportunity for exempt research, and (2) eliminate the renewal requirement for expedited research and full board research which is in long-term follow-up or data analysis only.
Changes also include enhancements to KC IRB, revisions to KC IRB questionnaires, and revisions to the IU Standard Operating Procedures for Research with Human Subjects (IU SOPs) which will impact all research. Here’s what you need to know.
Changes to Exempt Research
Three additional exempt categories are now available to investigators for research that is not federally funded and not subject to FDA or VA regulation. The three categories, known as “flex” categories to represent the additional flexibility, expand the types of research which are eligible for exempt review. Exempt review requires a shorter application than expedited or full Board research and can usually be reviewed and granted exemption by HSO staff. All current exempt categories continue to be available as well.
What to Expect:
New research - The KC IRB questionnaires will be updated on March 29, 2018 to reflect the revised exempt categories. Many studies which are currently expedited may be eligible for exempt review under the flex categories, so please review the information about the flex categories and their impact below.
Ongoing research - Previously-approved exempt research will not be affected and will continue to be conducted under the category applied at initial approval. In rare cases, investigators submitting amendments to previously-approved exempt research may be asked to submit a new KC IRB application to ensure compliance.
Category 2 Flex
Category 2 Flex is based on an existing exempt category which allows conduct of research involving educational tests (cognitive, diagnostic, aptitude, achievement), survey procedures, interview procedures, or observation of public behavior when subjects cannot be identified via research data and/or disclosure of research responses would not place subjects at any additional risk. Additional risks include risk of criminal or civil liability or potential damage to the subjects’ financial standing, employability, educational advancement, or reputation.
Category 2 Flex expands the current category to allow exemption even when subjects can be identified and disclosure of responses may place subjects at additional risk, as long as an IRB member determines adequate protections are in place.
Category 3 Flex
Category 3 Flex is a completely new category which allows exempt review of research involving benign behavioral interventions with information collection from adult subjects, if the subjects prospectively agree to the intervention and information collection. HSO expects that a large majority of research which is currently approvable under expedited category 7 will now be eligible for exemption under this category.
Benign behavioral interventions are considered to be brief in duration, harmless, painless, not physically invasive, and not likely to have a significant adverse lasting impact on the subjects. In addition, the investigator must have no reason to think that subjects would find the interventions offensive or embarrassing. If the research involves deceiving subjects regarding the nature or the purpose of the research, subjects must prospectively agree to participate in the research knowing about the deception.
Information should be recorded so that subjects cannot be identified; or the investigator should assure that any disclosure of the subjects’ responses would not place the subjects at additional risk. If the information is recorded so that subjects can be identified, and disclosure of the subjects’ responses could pose additional risk, the study may still be exempt but will be reviewed by an IRB member to determine adequate provisions are in place.
Category 4 Flex
Category 4 Flex is a supplement to the existing exempt Category 4 which allows for research use of existing data if the data is recorded in a deidentified manner. The flex category is much expanded, allowing for exempt review of all chart reviews, many of which were previously approved under expedited category 5, regardless of identifiability of the data or when the data was created.
For more detailed information, see the HRPP Policy on Exempt Research and the HSO Guidance on Exempt Research.
Removal of renewal requirements
Renewal is no longer required for the following research (unless the IRB specifically deems it necessary for additional protection of human subjects):
- Expedited research that is not federally funded and not subject to FDA or VA regulation
- Full Board research that is not federally funded and not subject to FDA or VA regulation AND for which research procedures are limited to clinical follow-up (i.e. accessing follow-up clinical data from procedures that subjects would undergo as part of clinical care) or data analysis only
What To Expect
All study teams must submit the next scheduled renewal regardless of funding or applicable regulations. Research which is federally funded and subject to FDA or VA regulation will continue to receive annual renewal based on the current expiration date.
For research that is not federally funded and not subject to FDA or VA regulation:
- New Expedited Research will no longer be assigned an expiration date in KC IRB and renewals will not be required (unless requested by the IRB).
- Previously-Approved Expedited Research will be reviewed at time of next scheduled renewal. Upon approval, no expiration date will be assigned and no additional renewals will be required (unless requested by the IRB).
- Full Board Research in Clinical Follow-up/Data Analysis Only will be reviewed at time of next scheduled renewal. Upon approval, no expiration date will be assigned and no additional renewals will be required (unless requested by the IRB).
Additional Important Changes
Waivers of consent for FDA-regulated research
Current FDA regulations do not allow the IRB to waive informed consent for minimal risk research. In an attempt to harmonize with the Common Rule, FDA has released notification that it will allow IRBs to grant waivers of informed consent for FDA-regulated research if the criteria defined by the Common Rule are met. The KC IRB questionnaires have been updated to allow investigators to request waivers of informed consent for FDA-regulated research.
Use of information and/or biospecimens for recruitment and screening
Recent discussions with federal oversight agencies regarding the revised Common Rule have revealed that the IRB does not need to grant waivers of informed consent for investigators to utilize data and biospecimens for recruitment activities. Specifically, investigators may access medical records or stored biospecimens, or collect data directly from subjects, without informed consent for the purpose of screening, recruiting, or determining eligibility of potential subjects. The KC IRB questionnaire has been updated to remove this requirement. VA research will continue to require waivers of informed consent for recruitment.
CTSI Scientific Review
The Indiana Clinical and Translational Sciences Institute (CTSI) has provided scientific review of certain full board protocols since October 2016. Effective March 29, 2018, Indiana CTSI Scientific Review Committee review will be required prior to IRB review for full board studies which require biomedical IRB review and which have not undergone scientific review from another source such as a commercial sponsor or government funding agency. The CTSI Scientific Review Committee process should be initiated prior to IRB review. Protocols can be submitted directly to CTSI Scientific Review Committee for review by emailing the protocol to firstname.lastname@example.org.
For more information on the Scientific Review Committee review process and criteria, visit the Indiana CTSI website.
Reporting adverse events (AEs) at time of renewal
After careful review of current OHRP guidance, HSO is clarifying requirements for reporting of adverse events at time of renewal.
- Investigators will be asked to confirm whether AEs occurred at a greater frequency and/or severity than previously expected based on the current IRB-approved protocol and/or informed consent or investigator’s brochure. This consideration includes both local AEs and AEs which occurred at an external site.
- HSO expects that any AEs which meet this criteria would have been reported to the IRB as a reportable event or via amendment, and investigators should be able to simply provide confirmation at time of renewal.
- If investigators do indicate that AEs occurred at a greater frequency and/or severity than previously known, they must provide a summary of those events with an explanation.
- This confirmation should eliminate any need for the IRB to receive and review AE logs, and HSO staff will request removal if they are submitted with renewal. Investigators are responsible for assessing the ongoing safety and risk of research and should continue to log and track AEs; however, IRB review of these logs is not required.
Exempt research and Reliance Requests should now be closed by taking the “Close” action on the KC IRB Protocol Actions tab. The action will close the study in KC IRB immediately, without submission of further information to the IRB.
Revisions to KC IRB Questionnaires
In addition to revisions relevant to the additional exempt categories and elimination of renewal, many KC IRB questionnaires have also been carefully reviewed and updated to remove questions which are not applicable based on previous responses or do not provide value to the IRB. The following questionnaires are being updated with this release:
- Protocol questionnaires:
- B – Lay Summary & Research Design
- D – Recruitment
- H – Informed Consent Process
- J – Child Assent & Parental Consent Process
- L – VA Research
- Submission questionnaires:
- Reliance Request
- Closeout Report
- Reportable Events
- Not-Human Subjects Research
These changes will require you to update your previously-approved information in some circumstances.
- New studies, amendments, renewals, and FYI items created before 3/29/2018 and Submitted to IRB on or after 3/29/2018 will receive the revised questionnaires for completion.
- 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.
- For renewals, the previous questionnaire is being replaced. You may see both questionnaires on the Questionnaire tab of KC IRB, with a note that one has been deactivated. The new questionnaire will be marked as “Incomplete” and, if the renewal is submitted to IRB on or after 3/29/2018, you must complete the new questionnaire before submitting.
- If a revised protocol questionnaire is updated with an amendment Submitted to IRB on or after 3/29/2018, that questionnaire will be prompted for update.
Revised Standard Operating Procedures & Policies
Many of these changes required updates to the IU SOPs. HSO is in the process of converting the IU SOPs to HRPP Policies which describe the mandatory requirements (i.e. policy) on a topic, followed by standard procedures used to implement the policy. The following SOPs have been converted and revised with this update:
- Exempt Research
- KC IRB
- IRB Executive Committee (NEW – previously found in IRB Operations SOP)
- IRB Meetings and Minutes (NEW – previously found in IRB Operations SOP)
- IRB Membership (NEW – previously found in IRB Operations SOP)
- IRB Review Process (NEW – previously found in IRB Operations SOP)
The IU SOPs on IRB Operations and Student Projects have been retired.
HSO staff are available to answer questions about these changes. Please contact a member of the HSO staff or email email@example.com with any questions.