IRB-SBS Researcher Guide

Moving Forward in 2019: iProtocol and Revised Common Rule

Designed in accordance with new federal regulations (Revised Common Rule), iProtocol will help researchers navigate IRB regulations and submit compliant protocols that will be efficiently reviewed by our staff, taking advantage of new exemption flexibility, etc. iProtocol’s protocol development tools will help researchers build and maintain protocols, communicate with our office, and organize all the essential elements of a compliant protocol in one secure and easily accessible place.

While iProtocol and the Revised Common Rule won’t change the essential elements of the IRB ethical review process, the IRB-SBS will modify how protocols are received and processed in our office. In general, the changes will create more efficiency for researchers and staff alike. The following section will provide additional details regarding the Revised Common Rule and how it will affect new protocols in 2019 as well as previously approved protocols.

Please note that we will be assessing protocols on a case-by-case basis and if you have any concern as to what is the best course of action for your protocol, please contact our office directly. As our office navigates this transition period, we appreciate your patience and support.

# Office Procedure Revised Common Rule Pre-2018 Regulations
1 Protocol submission and maintenance Use iProtocol: online application for protocol submission and review Word forms submitted via email
2 Exempt Review Expanded categories; exempt review conducted by our staff with no requirement for continuation. Modifications to the protocol need to be submitted for review and a study closure form will be submitted at study completion. Fewer categories; exempt review conducted by board member through expedited process
3 Continuation Review for Expedited Studies No change to categories; continuation no longer required; initial review conducted by board member through expedited process. Modifications to the protocol need to be submitted for review and a study closure form will be submitted at study completion. Annual continuation required; review conducted by board member through expedited process
5 Other changes Minor adjustments to waiver of consent requirements and consent form templates

Protocols that were approved under the pre-2018 Common Rule regulations can continue to be approved under the old regulations. However, our office will no longer maintain paper protocols after January 2020 and we will require all active protocols to transition to iProtocol. At this point in the transition to iProtocol we are recommending previously approved protocols transition to iProtocol with a few minor exceptions. If you have questions about your previously approved protocol, contact the IRB-SBS to consult with us regarding your protocol.

iProtocol is an online application designed to facilitate the IRB-SBS protocol submission and review process. Using iProtocol, researchers will:

  • Efficiently create and submit protocols—includes uploads for all relevant materials (consent forms, instruments, etc.);
  • Experience an online review process—eliminates the need for paper forms;
  • Submit electronic signatures collected using Netbadge;
  • Reuse previously developed materials—approved protocols can be copied and used as templates for future protocols;
  • Interface with the IRB-SBS—reviewed protocols display review comments and revisions;
  • Comply with the most current IRB regulations—Revised Common Rule as well as AAHRPP review standards.

CFR 45:46 is the section of the Federal Register that governs IRBs. Referred to as the “Common Rule” because of the multiple agencies that ascribe to its precepts, new revisions (“Revised Common Rule”) were recently accepted which take effect January 21, 2019. In order to continue to be in compliance with CFR 45:46, UVA’s HRPP standard operating procedures and review policy will also be revised. Overall, the essentials that make research involving human participants ethical will not change; rather this is an opportunity to streamline processes and modernize them in accordance with ever evolving research practices. IRB-SBS’s new online submission and review application, iProtocol, is designed to assist researchers and IRB-SBS reviewers with the newly revised procedures.

The Revised Common Rule (RCR) includes changes in the following areas:

  • Exemption categories
  • Consent requirements
  • Continuation requirements

The most significant change that will affect IRB-SBS researchers is the expanded exemption categories. Exempt categories can be found on the OHRP website.

Exemption means that a qualified research study isn’t required to follow the specific requirements defined by the regulations and the researcher is allowed more flexibility. Exemption status is determined by the IRB-SBS and requires protocol submission and review. Researchers conducting exempt studies need to submit a protocol using iProtocol. The new regulations allow for greater flexibility and some reviews can be done by the staff rather than needing board member approval, etc; coupled with the benefits of using iProtocol as a review tool, exempt protocols will be reviewed in a timely manner. Exempt protocols do not require yearly continuation review but if the protocol is modified, the modifications need to be submitted for review. When the study is completed, it is important that researchers submit a study closure form. iProtocol will help researcher accomplish modifications and study closure.

Revised Common Rule Exemption Categories Comparison with Pre-2018 Exemption Categories
Pre-exemption text: Studies that focus primarily on incarcerated participants (prisoners) cannot be exempt. Some exemption categories cannot be applied to minors. New: Not allowing prisoner studies to qualify for exemptions Stays the same: Some exemption categories can’t be applied to minors
Normal Educational Practice (NEP): • Conducted in commonly accepted educational setting • Research involves NEP not likely to adversely impact students’ opportunity to learn required educational content or disrupts educators’ ability to teach or adversely impact their employability • NEP research includes research on regular and special education instructional techniques, effectiveness of or the comparison among instructional techniques, curricula, or classroom management methods. New: NEP research can’t adversely impact students’ opportunity to learn educational content or disrupts educators

Interactions, educational tests, survey procedures, interview procedures, or observation of public behaviors:

  • Research is limited to the above categories
  • Educational tests defined as: cognitive, diagnostic, aptitude, and achievement tests
  • Observation of public behavior includes visual or auditory recording
  • One of the following criteria needs to be met in order for the exemption to apply:
    • Participant cannot be identified
    • Disclosure of data won’t result in criminal or civil liability or be damaging to the participants' financial standing, employability, educational advancement, or reputation
    • If participant can be identified, the study is reviewed by the IRB.
Studies involving minors can only qualify for exemption if identities are not collected and if the study involves educational tests or observation of public behavior (i.e., the researcher can’t interact with the participants)
New: more specific definition for educational tests and observation of public behavior; additional criteria that need to be met in order for exemption to apply. The pre-2018 regulations included an additional clause for exempting studies using educational tests, surveys, et al., when the study involved an elected public official or if confidentiality was maintained. This additional clause was eliminated in the 2018 Revised Common Rule.

Benign Intervention with Adults:

  • Benign intervention is defined as: brief in duration, harmless, painless, not physically invasive, not likely to have a significant adverse lasting impact on the subjects, and the investigator has no reason to think the subjects will find the interventions offensive or embarrassing. Examples include: playing an online game, solving puzzles under various noise conditions, or deciding how to allocate a nominal amount of received cash between themselves and someone else.
  • Participant must provide consent
  • One of the following criteria needs to be met in order for the exemption to apply:
    • Participant cannot be identified
    • Disclosure of data won’t result in criminal or civil liability or be damaging to the participants' financial standing, employability, educational advancement, or reputation.

If participant can be identified, the study is reviewed by the IRB.

  • Unless the participant can be informed that there is an element of deception in the study, deception studies cannot qualify under this category of exemption
This exemption category cannot be applied to studies involving minors
New: This is a new exemption category and should have broad application for many social and behavioral science studies.

Secondary research for which consent is not required: Secondary research uses of identifiable private information or identifiable biospecimens if at least one of the following is met:

  • Data are publically available
  • Data are not linked to identifiers, researcher does not contact participants and will not re-identify subjects
  • Data are identifiable health information for the purposes of health care operations or research, or for public health activities
Research for a federal department using data not collected for research purposes.
New: This category broadens to include not only archival data but the secondary use of prospective data as well.

Research conducted or supported by a Federal department or agency and that are designed to study, evaluate, improve, or otherwise examine public benefit or service programs:

Federal departments or agencies will have an online list of exempt research and the exempt study needs to on that list. 
New: More specific definition of what qualifies as an exempt study under this category as well as a new requirement to post exempt studies online.

Taste and food quality research: must qualify for one of the below:

  • Wholesome food with no additives
Additives must meet FDA, EPA, or Dept. of Agriculture standards.
No changes from previous regulations

Our updated website and templates will provide further guidance regarding new consent form requirements.

  • Lengthy consent forms are required to have a “key points” summary at the beginning of the consent form. Most social and behavioral sciences studies tend to have shorter consent forms but if your consent form is four pages or longer, consider adding a key points section at the beginning of the consent form.
  • Include a statement about potential future use of the data, whether it is identifiable or de-identifiable.  

Protocols reviewed and approved by the full board will require an annual continuation review in order for the researcher to continue the study. However, protocols that are deemed “expedited” either in the initial review or as the protocol progresses (either due to modifications or the fact that the protocol is no longer enrolling participants) will no longer require an annual continuation review. Exempt reviews don’t require continuation reviews as well. If a protocol is modified, modifications need to be submitted and reviewed. Study closure forms need to be submitted when the study is completed.