REVISED COMMON RULE

This page will be updated regularly with information about the Revised Common Rule, including an overview of key changes, which regulations will apply to your research, training sessions available, and how the changes will affect research reviewed by the OU Norman Campus IRB. 


Click on the links below to view a description of each major change affecting research reviewed by the OU Norman Campus IRB.

Exempt Categories

There are several changes to the exemption categories that will affect research submitted to the Norman Campus IRB. However, all studies will still need to be initially reviewed and approved by the IRB before the start of any data collection activities can begin. If you are unsure whether your study requires review, please submit a Determination of Human Research Worksheet for official determination. The key changes that will affect social/behavioral research reviewed by the Norman Campus IRB are noted below. For a complete list of all exemption categories, please click HERE.

Category 1

This category covers research conducted in established or commonly accepted educational settings. It has been revised to include a statement noting that the research cannot impact students’ opportunities to learn the required educational content, or negatively impact the assessment of educators who provide the instruction. This change is based on concerns about whether the conduct of some research projects of this type might draw too much time and attention away from the delivery of regular educational curriculum, and may then have a detrimental effect on student achievement.

This means that research conducted by department or program chairs who also hold responsibility for the evaluation of faculty would not qualify for this exemption category. Research involving the assignment of students to either a proven educational technique or a novel educational technique would also not qualify for this exemption.

Category 2

This category is intended for research involving the use of educational tests, surveys, interviews, or observations of public behavior. It previously covered most survey studies, and some interview studies where audio/video-recordings were not included.

The revised category covers research that includes educational tests, surveys, interviews, or observations of public behavior, and INCLUDES visual or auditory recordings, if at least one of the following criteria is met:

  1. The information obtained is recorded by the researcher in such a manner that the identity of the participants cannot be readily ascertained, directly or through identifiers linked to the participants;  
  2. Any disclosure of the participants’ responses outside of the research would not reasonably place the participants at risk; OR
  3. The information obtained is recorded by the researcher in such a manner that the identity of the participants CAN readily be ascertained, directly or through identifier linked to the participants, and an IRB conducts a “limited IRB review” of the project.   

Since the OU IRB already reviews and approves all exempt studies, the “limited IRB review” provision will not add an extra review to the process. Instead, our standard review will satisfy the requirement for “limited IRB review.”

It is also important to note that this does not apply to studies involving children or participant interventions. For example, if a research study were to randomly assign students to different interventions (take a survey in a quiet room, take a survey in a noisy room, eat a snack, or don’t eat a snack), it would not qualify for this exemption category.

Category 3

In the past, this category covered research involving elected or appointed public officials or candidates for public office, and was rarely utilized by the OU IRB. It has been completely replaced with a new Category 3 related to behavioral interventions. The new category covers research involving benign behavioral interventions in conjunction with the collection of information from adult participants through verbal or written responses (including data entry) or audio/visual-recording in the subject prospectively agrees to the intervention and data collection, and at least one of the following criteria is met:

  1. The information obtained is recorded by the researcher in such a manner that the identity of the participants cannot be readily ascertained, directly or through identifiers linked to the participants;  
  2. Any disclosure of the participants’ responses outside of the research would not reasonably place the participants at risk; OR
  3. The information obtained is recorded by the researcher in such a manner that the identity of the participants CAN readily be ascertained, directly or through identifier linked to the participants, and an IRB conducts a “limited IRB review” of the project.   

Once again, the “limited IRB review” requirement will be satisfied with our standard review process. It applies only to studies with adult participants, and does allow for the inclusion of deception as long as the participants authorize its use in the consent form. “Authorized deception” occurs when the initial consent form includes a warning that the participant may be deceived as part of the study design. Please contact the IRB office for more information regarding “authorized deception” consent language.

For the purpose of this provision, benign behavioral interventions must be brief in duration, harmless, painless, not physically invasive, not likely to have a significant adverse lasting impact on the participants, and there is no reason to think that the subjects will find the interventions offensive or embarrassing. Examples of such interventions would include having participants play an online game, having them solve puzzles under various noise conditions, or having them decide how to allocate a nominal amount of received cash between themselves and someone else.

Category 4

This category covers the secondary use of data in which consent is not feasible or required. The existing category has been expanded to note that at least one of the following criteria must be met:

  1. The identifiable private information or identifiable bio-specimens are publically available;
  2. Information, which may or may not include information about bio-specimens, is recorded by the researcher in such a manner that the identity of the participants cannot be readily ascertained directly or through identifiers linked to the participants, the researcher does not contact the participants, and the researcher will not re-identify the participants;
  3. The research involves only identifiable health information already protected under HIPAA regulations; OR
  4. The research is conducted by, or on behalf of, a Federal department or agency using government-generated or government-collected information obtained for non-research activities, so long as the research adheres to specified privacy standards (described in full category definitions document link above).

This exemption does not cover any primary collections of either information or bio-specimens. It only covers pre-existing data. However, the data does not need to be pre-existing at the time of approval. Data can be both retrospective and prospective, as long as it is not directly obtained by the researcher.

Continuing Review

One of the most significant changes from the Revised Common Rule is the elimination of Continuing Review requirements for certain studies. The circumstances where it may be eliminated are noted below:

  1. If it is determined that your study meets the “Expedited” review level; or
  2. If your study was reviewed by the Full Board committee, but is now in the data-analysis stage only.

The IRB does still have the option to require Continuing Review on a case-by-case basis for studies that meet one of those criteria, but it must be well-documented and justified, and communicated to the researcher in the outcome letter. For studies that no longer require Continuing Review, you will instead be required to submit a very brief Administrative Check-In Form on a yearly basis. This form will be one-page in length and will capture only current status and protocol deviation information for the study. The name of the form is also likely to change in the future as we work on its creation.  

As a result of the changes, your study will fall into one of the following categories:

  1. Your study was reviewed by the Full Board committee and is still engaged in active data collection or follow-up interventions/monitoring: You will still be required to submit the annual Continuing Review form.
  2. Your study was reviewed by the Full Board committee, but is closed to enrollment with researchers only analyzing existing study data: Unless otherwise determined by the reviewer, you will be required to submit an annual Administrative Check-In Form.
  3. Your study was determined to be at the “Expedited” review level, but the IRB reviewer noted that Continuing Review is still required for a documented reason: You will still be required to submit the annual Continuing Review form.
  4. Your study was determined to be at the “Expedited” review level, and the IRB reviewer noted that Continuing Review is no longer required: You will be required to submit the annual Administrative Check-In Form.
  5. Your study was determined to be at the “Exempt” review level: You will not need to submit any annual forms regarding the status of the study.

For each of the situations noted above, you will still need to submit Modification and Protocol Deviation forms when necessary. When it’s time to close out your Expedited or Full Board study, you will also still need to submit the Continuing Review/Final Report form for now. To close out an Exempt study, you will need to submit the Exempt Study Closure Report.

As a reminder, if your Expedited or Full Board study was approved prior to January 21, 2019, you will still need to submit a Continuing Review form before your noted expiration date. Your study will be transitioned to the new regulations at that time.

Consent Requirements

          

Pre-RCR research: Follow previous policies. Post-RCR research: Follow new policies.

 

Which regulations apply to my study?

All studies submitted or pending after January 21, 2019, will be reviewed and approved according to the new regulations. Any studies still pending approval after this date will be transitioned once they submit stipulation revisions back to the IRB office.

All studies approved before January 21, 2019, will be transitioned to the new regulations at the time of their next Continuing Review. Any Modifications or Protocol Deviations submitted before the next Continuing Review will be processed under the previous regulations.

During the processing of the Continuing Review submission, the IRB reviewer assigned to your study will determine the following:

  1. Whether the review level of the study should be reduced to “Exempt” based on the new exemption categories; or
  2. Whether the review level of the study should be kept at the "Expedited" review level, in which case,
    1. You could be required to continue submitting annual Continuing Review submissions, OR
    2. The reviewer could replace the Continuing Review requirement with an Administrative Check-In requirement.

If the study is determined to be “Exempt,” you will be notified in your Continuing Review outcome letter. You will not need to submit yearly check-in reports, but will still need to submit Modification and Protocol Deviation forms when appropriate. When it’s time to close out the study, you must submit an Exempt Study Closure Report form.

If the study is determined to be “Expedited” and still requires Continuing Review submissions, we will note the determination and reasoning behind the determination in your Continuing Review outcome letter. You will need to continue submitting Continuing Review submissions like you did before the regulations changed.

If the study is determined to be “Expedited” and does NOT require further Continuing Review submissions, we will note the determination in your Continuing Review outcome letter. You will instead be required to submit an Administrative Check-in Form annually. Notifications for this form will be very similar to the current Continuing Review form. You will receive a notice from iRIS 60 and 30 days before the check-in submission is due. The Administrative Check-In form is very brief (one page), and captures only study status and protocol deviation data. Please note: The name “Administrative Check-In Form” is temporary. It will likely change before any studies are due to complete it. We will send out announcements with detailed instructions as that time approaches.

Regardless of continuing review determinations, you will need to continue submitting the Continuing Review/Final Report form to close out an Expedited study. Instructions for that process can be found HERE.

 

What do I need to know about transitioning my consent form(s)?

The consent form templates have been updated with a new section required for all studies that collect identifiable information.

All studies submitted or pending after January 21, 2019, must include the new consent form requirements. Any consent form(s) for studies still pending approval before this date will be updated once the stipulation revisions are submitted back to the IRB office.

All studies approved before January 21, 2019, will have their consent form(s) updated during either 1) their next Continuing Review, or 2) their next Modification that includes consent form changes.

For existing studies, we encourage you to update your consent form(s) to match the new templates when submitting Modification (if the modification includes a consent form revision already) or Continuing Review forms. If a revised form is attached to a submission, the IRB Administrator and reviewer will process the form using our standard review procedures.

If a revised form is not attached, the IRB Administrator will send a stipulation through iRIS requesting that you select from two statement options that she will provide. Once a selection has been received, she will update the consent form(s) to note that language. If you have consent forms that have been translated into another language, these will need to be updated by the research team.

 

What training opportunities are being offered?

Training sessions for Norman Campus researchers have been scheduled at the Bizzell Library during the end of January and beginning of February (schedule HERE). To attend one of these sessions, please email shelly.smith@ou.edu with the date and time that you would like to attend. If there is enough interest, we will continue offering scheduled training sessions throughout February. If you are unable to attend during this time-frame, please contact us and we can provide one-on-one trainings by request. We can also conduct classroom and/or departmental trainings if that would be more convenient.

For those of you who are not able to attend an in-person session, here is a link to the slides: Revised Common Rule Researcher Training

If you are an OU-Tulsa, Cameron, or Rogers State University researcher, we will visit your campus during the months of January and February for training. These sessions will be advertised prior to our arrival to give everyone plenty of time to make plans to attend. We will also update this page to note the dates and times for those sessions.

OU-Tulsa:
January 28, 2019 - Schusterman Library Conference Room (115)
10 AM - 11 AM: Training Session
11 AM - 1 PM: Q&A Office Hours (come and go as needed)
1 PM - 2 PM: Training Session
2:30 PM - 3:30 PM: Training Session
 
Rogers State University:
February 1, 2019 - Dr. Carolyn Taylor Center, Conference Room A
10 AM - 11 AM: Training Session
11 AM - 1 PM: Q&A Office Hours (come and go as needed)
1 PM - 2 PM: Training Session (also accessible via Zoom)
 
Cameron University:
January 24, 2019
11 AM - 12:15 PM: Presentation to Psychology Research Class
1:30 PM - 2 PM: Q&A Office Hours (come and go as needed) - Nance Boyer Room 1039
2 PM - 3 PM: Training Session
 

In addition to in-person training sessions, we are also offering an optional CITI course to any user with an OU CITI account. This optional course covers all of the major changes with the Revised Common Rule (including some that we will not be implementing), and can be taken from the comfort of your home or office. Although there are quizzes at the end of each module within the course, you do not need to worry about passing them. This is not something that we are requiring, so you do not need to obtain a certain score to gain credit.

 

Will I need to re-take my existing CITI training?

Unless your training is currently expired, you will not need to re-take the required CITI modules. Once your CITI training expires and you are due for either the Refresher Course or Basic Course, your assigned modules will be automatically updated with content from the new regulations. The training requirements for timing or coursework will not change as a result of the regulation changes. You will still be active for three years, and you will still be able to complete two Refresher courses before being required to re-complete the Basic Course. The only difference will be the content in some of the modules.

 

If you have questions regarding the transition plan or regulation changes, or if you would like to schedule a training session with a member of our staff, please contact us at either 405-325-8110 or irb@ou.edu