January 18, 2019

The purpose of this announcement is to provide you with the Human Research Protection Program (HRPP) plans to implement the revised regulations governing research involving human subjects, the Common Rule. We refer to the revised regulations as the Revised Common Rule or 2018 Regulations throughout this notice.

Summary

The Revised Common Rule was initially issued on January 19, 2017, with an intended implementation date of January 19, 2018. As you may know, the implementation was delayed twice in the last year. The final implementation and compliance date is now January 21, 2019.

The revisions are not applicable to FDA and DOJ (Department of Justice) regulated research. However, the FDA plans to post a notice of draft revised FDA regulations intended to harmonize with the Revised Common Rule requirements. If you are involved in the conduct of FDA-regulated research, you should be aware that these changes might be directly applicable to your research in the future. We will let you know if and when those changes occur.

What does this mean for me as a researcher?

• Protocols that were reviewed by a full board and are open to enrollment or still in an intervention phase, will see the fewest changes under the Revised Common Rule.
• These changes do not immediately affect existing studies approved or determined exempt prior to January 21, 2019.
• Pending applications for new studies will need to be reviewed under the new regulations if approval or an exempt determination has not been made prior to January 21, 2019. Researchers may need to work with HRPP staff to address any adjustments to protocol materials needed to achieve compliance with the revised regulations.
• Updated submission materials will be posted to the website. Researchers will need to check the website and ensure they are using the most currently available forms and information.

This communication addresses the following aspects of the Revised Common Rule that may be important to you:

1. Application of the Revised Common Rule to research approved by the IRB prior to the implementation date – “Grandfathered Research”
2. Minimal risk research
3. Exempt research/modified and new exemption categories
4. Informed consent requirements
5. Cooperative Research Studies
6. Coeus IRB system updates
7. Changes in IRB practices to accommodate the Revised Common Rule
8. Where you can learn more
9. Next Steps

1. Application of the Revised Common Rule to research approved prior to the implementation date – Grandfathered Research

Research projects conducted at Drexel University are held to varying standards depending upon what set of regulatory criteria applies to the research activity. As noted above, the Revised Common Rule is not applicable to FDA and DOJ (Department of Justice) regulated research.

Applicable research approved prior to January 21, 2019 will continue to be reviewed under the pre-2018 Common Rule regulations. Later this year, we will evaluate whether to transition applicable research approved prior to January 21, 2019 to the Revised Common Rule at the time of continuing review. HRPP will send out communication about the plan to the research community at that time.

Researchers may have both sets of protocols in their portfolio – protocols reviewed before the revisions took effect, and protocols under the Revised Common Rule.

2. Minimal Risk Research

The Revised Common Rule allows for most minimal risk research to be conducted without IRB continuing review.

• The Drexel IRB will NOT require continuing review for applicable minimal risk research approved after January 21, 2019.
• The Drexel IRB will NOT require continuing review for greater than minimal risk research approved after January 21, 2019 if the research is
  • Closed to enrollment and the remaining research activities are limited to data analysis, including analysis of identifiable private information or identifiable specimens,
  • Or, accessing follow-up clinical data from procedures that participants would undergo as part of clinical care.
• The Drexel IRB will require continuing review for greater than minimal risk research (unless it meets criteria described above) and any research that is under FDA or DOJ jurisdiction regardless of the phase of the study.

Regardless of the continuing review category above, you must still report modifications and reportable new information to the IRB, including, but not limited to, changes in research or study personnel, study closures, events that may constitute serious or continuing noncompliance, and potential unanticipated problems involving risks to subject or others.

The Drexel HRPP Office may check in with the investigator on an annual basis regarding the progress of the study.

3. Exempt Research

The Revised Common Rule changed the categories of research that can be deemed exempt.

• Category 1: Unchanged – includes normal educational practices in commonly accepted settings that will not adversely impact a students’ opportunity to learn
• Category 2: Revised – includes educational tests, surveys, interviews, and observations of public behavior. Now allows researchers to record identifiable data as long as the IRB conducts a limited review
• Category 3: New – includes benign behavioral interventions with adults (meaning, research has to be brief, harmless, painless, not invasive, or offensive or embarrassing). Allows researchers to record identifiable data as long as the IRB conducts a limited review
• Category 4: Revised – includes secondary research using identifiable private information or biospecimens collected as part of clinical care or an IRB-approved study. Now allows researchers to collect identifiable data if regulated under HIPAA 
• Category 5: Unchanged – includes research and demonstration projects by federal department or agency
• Category 6: Unchanged – includes taste and food quality evaluation, consumer acceptance studies
• Category 7: New – includes storage or maintenance of identifiable private information or identifiable biospecimens for secondary research with broad consent as long as the IRB conducts a limited review
• Category 8: New – includes research involving the use of identifiable private information or identifiable biospecimens for secondary research with broad consent as long as the IRB conducts a limited review

Due to lack of agency guidance related to requirements and use of broad consent, Drexel IRB will generally not grant exemption determinations utilizing these categories (7 & 8). The Drexel HRPP will re-evaluate the use of broad consent after the Department of Health and Human Services (HHS), Office for Human Research Protections (OHRP) issues relevant anticipated guidance. Due to the lack of guidance and large impact broad consent will have on institutions, the strategy to delay the use of broad consent is being taken by a clear majority of IRBs and academic institutions. 

Regardless of the exemption category, the requests for exemption determination must be submitted to the Drexel IRB via Coeus Lite. Exempt research cannot commence without a Drexel IRB exemption determination.

4. Informed Consent Requirements

Drexel IRB will apply additional Revised Common Rule consent provisions to new research approved by the IRB after January 21, 2019.  Drexel IRB will not apply the additional consent provisions of the Revised Common Rule to research that is under FDA or DOJ jurisdiction unless it is also federally funded as it is not required for this research. The current versions of the HRP-502 Consent Templates are compliant with the Revised Common Rule. Please continue to refer to the website for the current versions of the consent forms.

If your new study has been submitted and is under review by the Drexel IRB on January 21, 2019 but is not yet approved, and the consent form submitted does not comply with the new regulatory requirements, an HRPP IRB Coordinator will work with you to ensure that the new elements are added.

• Short Form: The IRB must still approve the use of a short form in research conducted at Drexel.Under the Revised Common Rule the short form written informed consent document must now also state that the study key information was presented to the participant first before other information, if any, was provided. The translated versions of the short forms that are currently posted on the HRPP website do not include the new required element. As such, the currently posted short forms can be used ONLY for studies that are not subject to the Revised Common Rule, such as research only under FDA or DOJ oversight (and without NIH, NSF, or other Common Rule entities’ funding), or research approved by the IRB prior to January 21, 2019.Revised short form templates for human research subjects to the revised rule will be available in on our website in the coming months.

5. Cooperative Research Studies

Cooperative research studies (“multi-site research”) conducted in the United States will need to be approved by a single IRB. The effective date for this provision of the Revised Common Rule is January 19, 2020. Currently, any multi-site research funded by the NIH must be compliant with the NIH Single IRB policy.

The Drexel IRB generally does not serve as the single IRB of Record for multi-site research. We are working with external IRBs that can provide this service.

If you are planning a budget for a grant application for a multi-site research study, ensure that the budget includes appropriate provisions for the external IRB review fees. A budget is only required when funding is involved. Please reach out to your pre-award administrator or DUResearch@drexel.edu for any questions or assistance with the budget process.

6. Coeus IRB System Updates

We are working with our vendor and eRA group to implement minor custom changes to the Coeus IRB module that will help track studies approved under the Revised Common Rule. These changes will be implemented over the course of the next two weeks. A separate communication will be sent out when the change is made to the system that impact you directly in submitting your application. 

7. Changes in IRB practices to accommodate the Revised Common Rule

In order to implement the Revised Common Rule, the following changes to IRB practices have been made:

Below is the explanation of the new practice for approvals of initial, modification, and continuing review submissions.

• New Research Study: The Drexel IRBs will issue the consent and protocol documents with the initial approval date.
• Modification to the consent document: The Drexel IRBs will issue the revised consent and protocol documents with approval date of the modification.
• Continuing Review: The Drexel IRBs will issue the consent and protocol documents with the approval date of the continuing review.

The principal investigator and the research study team is responsible for monitoring the expiration date of the study for continuing review purposes. To help with this responsibility, HRPP staff sends reminders to the PI 90 days, 60 days, 30 days, and 15 days prior to the expiration date of the protocol. In addition, the expiration date can be viewed in Coeus under your list of protocols.

8. Where can you learn more?

The Drexel HRPP will offer live training sessions that will focus on the changes to the regulations and how they affect research. We will also provide specialized training, as requested. A separate communication will be sent when registration for the training offerings is available.

The Office for Human Research Protections (OHRP), a division of HHS, is the lead agency who published the Revised Common Rule. This site provides a news release and commentary on the revised common rule.

The published version of the changes to the Common Rule in the Federal Register.

Public Responsibility in Medicine & Research (PRIM&R) provides many helpful resources on their website.

Collaborative Institutional Training Initiative (CITI Program) offers a wealth of resources on its website. CITI Program has created Revised Common Rule (Final Rule) Resources to help the research community understand the revisions to the Common Rule.

9. Next Steps

If your study is authorized for review by any of the external IRBs, the HRPP will work with the IRB to ensure the same implementation standard.

We value your opinions. If you have any questions or concerns regarding the implementation of the Revised Common Rule, please send them to hrpp@Drexel.edu. We expect a large volume of inquiries and will compile them into an FAQ document for the research community and address them in the subsequent communication.

Thank you for your patience during this transition period.