Revised Common Rule 45 CFR 46 Effective on January 21, 2019
As you know, the revised Common Rule 45 CFR 46 will take effect on January 21, 2019. Your studies will be affected in the following ways:
- Any new studies, including exempt studies, submitted in iRIS (final PI signature in place) on or after 01/21/2019 must be consistent with the revised Common Rule. This means that consent forms must begin with a Concise Summary and contain the new required Elements of consent. For examples of Concise Summaries, please click here.
- Please do not use an old approved consent form as your starting point if you are creating a consent form for a new study. Use the Sample Consent Template on the IRB website, because it contains the new required Elements for compliance with the new regulations.
- Likewise, the waiver of Consent/HIPAA authorization has been modified to contain new required language and has been embedded in the iRIS application since iRIS Go-Live.
- New minimal risk studies that receive an expedited review (upon initial review) will be assigned a 2 year approval period upon completion of the IRB’s initial review.
Please note: All FDA-regulated studies are unaffected by the revisions to the Common Rule, and renewals must continue to be submitted annually, or more frequently if required by the IRB, using the current progress report template.
- Throughout 2019 until 01/21/2020, all existing studies must submit a renewal (continuing review) to DUHS IRB according to the current schedule (45 days prior to the current expiration date).
- For renewals of existing studies submitted on or after 01/21/2019, a study team may opt to conduct the study under the old Common Rule or transition to the revised Common Rule for the remaining life of the study.
- A choice will be offered in the annual progress report in iRIS to indicate the study team’s preference.
- If your study is not FDA-regulated and meets any of the following criteria, it would qualify to transition to the revised Common Rule:
- initial review was completed via the expedited process and that status has never changed (minimal risk studies);
- greater-than-minimal risk studies which are now in a data analysis phase only--these studies are closed to enrollment and all participants have completed all study activities;
- greater-than-minimal risk studies where enrollment is closed, and the sole remaining study activity is collection of clinical data that would normally be part of standard care.
- If choosing to transition to the revised Common Rule, the study team will have to ensure that a Concise Summary and the new required Elements are added to the consent form via an amendment. Every two years thereafter, the study team will have to complete an abbreviated progress report (two-year check-in). This abbreviated progress report will reside in iRIS after 01/21/2019. Approval notices sent out by the iRIS system will reflect the new change to two-year check-ins for studies transitioning to the revised Common Rule.
- A study team that opts to continue the study under the current Common Rule will continue to complete annual Continuing Reviews and will not have to revise the consent form.
- Submission timelines for amendments are not affected by the revised Common Rule; all changes to previously approved research are required to be reported via amendment to the IRB for review and approval, per current practice.
- The IRB may require addition of the Concise Summary and the new required Elements to the consent form of an existing study to be conducted under the revised Common Rule if other changes are also being made to that document.
Submission timelines for safety events are unaffected by the revised Common Rule and should proceed per current practice.
If a study team opts to conduct an existing study under the revised Common Rule, the current IRB-approved waiver will need to be replaced by the revised waiver. The revised waiver can be accessed via an amendment to the application.
For a more detailed summary of the revisions to the Common Rule, including more information on biorepositories and databases, please follow this link: https://irb.duhs.duke.edu/about-us/irb-news/key-points-new-common-rule-communication-research-community. Please keep this summary for your reference, and contact the IRB Board Specialist for your department/CRU if you have additional questions.
REMINDER FROM DOCR:
For each clinical trial supported by a federal department or agency, one IRB-approved consent form must be uploaded to a publicly available federal website after enrollment has closed. To facilitate compliance with this requirement, any federally-supported clinical trial with initial IRB approval on or after January 21, 2019 will need to be registered on ClinicalTrials.gov before receiving full institutional approval in OnCore. After enrollment has closed, one IRB-approved consent form will need to be posted in the ClinicalTrials.gov record. This consent form can be posted by the study team in ClinicalTrials.gov at the same time they are making status updates and editing completion dates. DOCR will provide support. Please contact DOCRemail@example.com for questions or assistance.
Appropriate Study Personnel to Conduct the Consent Process
The DUHS IRB recently revised the policy Appropriate Study Personnel to Conduct the Consent Process. The following statement has been added to the policy:
“For greater than minimal risk studies, the IRB requires that Key Personnel of level CRC (Clinical Research Coordinator) or above conduct the consent process.”
Please visit the IRB web site to view the revised policy.
Duke Office of Scientific Integrity
Duke University has implemented multiple programs/initiatives to support a culture of rigor, reproducibility, and responsible conduct of research. These programs are intended to support a culture of research integrity at all levels. The newly formed Duke Office of Scientific Integrity (DOSI) is a key element in advancing a culture of scientific integrity. DOSI is composed of five main areas of focus:
- Conflict of Interest (COI): DOSI-COI collaborates with faculty, staff, internal Duke offices and external organizations to ensure quality review, management and reporting of financial conflicts of interest.
- Misconduct in Research: The Misconduct Review Officer (MRO), Dr. Donna Kessler, oversees the review of allegations of misconduct. Duke faculty and staff are able to report possible misconduct concerns directly to Dr. Kessler, their department chair or division chief, dean or other appropriate institutional official.
- Advancing Scientific Integrity Services and Training (ASIST): ASIST develops programming in support of Duke’s collective commitment to maintaining and improving a culture of scientific integrity. This includes Responsible Conduct of Research training for faculty and staff, as well as rolling out an electronic research notebook in 2019, LabArchives.
- Clinical Quality Management Plan (CQMP): The CQMP was established to develop and implement a comprehensive, standardized, prospective clinical research monitoring program including quality assurance and quality control measures. The program focuses on helping departmental clinical research units develop CQM Plans for all consenting and prospective studies that are not externally or independently monitored and that do not have ongoing approved monitoring plans.
- Institutional Research Incident Response Committee: This committee works to resolve issues that could hinder research progress or that could create an institutional risk, but that do not generally require a formal institutional response.
In addition to these initiatives, DOSI supports the Research Town Hall Series, which is a recurring, engaging series developed to reinforce a strong research culture at Duke University. To learn more about DOSI, visit our website: https://medschool.duke.edu/DOSI.
Resources: Multimedia Project Studio
The Duke Office of Information Technology has a Multimedia Project Studio available to Duke Faculty, Staff, and Students for production of multimedia and graphic content.
The lab features high-end, integrated hardware and software that encourages imaginative creation and editing of graphics, web pages, audio, video and 3D. Production tools include the latest Apple iMacs, industry standard software such as Apple's Final Cut Pro, Motion, Compressor and the full Adobe Creative Cloud Suite as wells as a compliment of popular 3D modeling titles such as Rhino, Fusion 360, Blender and AutoCAD.
The lab is also equipped with specialized peripherals, such as drawing tablets, video network data storage, scanners and a VR development Oculus Rift system.
For additional information regarding the Multimedia Project Studio including hours, location, and reservation instructions, visit the Duke Office of Information Technology website.
Spear Phishing Attacks
The IT Security Office is currently experiencing an uptick in the number of Spear Phishing Attacks targeting Duke Employees.
Spear Phishing Attacks are a type of E-mail Impersonation Fraud where attackers are attempting to impersonate Duke staff.
These attacks usually attempt to impersonate staff members in management positions and follow the same general format:
- The attacker registers an email address with an external email provider (ex: Gmail) that appears as if it may be a personal email account for the person they're impersonating.
- Utilizing publicly available information to determine targets, the attacker then sends a message to users they suspect may work with the person they're impersonating. These messages are usually simple in nature and ask a question such as "Are you available?" or "May I ask a favor of you?".
- If the user responds to the message, the attacker will respond to begin the fraud. Typically this will lead to them asking for money to be transferred or for gift cards to be purchased.
Any email message from a Duke employee not originating from a duke.edu email address should be treated with suspicion. As always, any suspicious message can be reported to firstname.lastname@example.org for evaluation.
This information is also available on the IT Security Website: https://security.duke.edu/secure/phish-20180719
Data Privacy Day: January 28, 2019
Data Privacy Day is recognized each year on January 28th with the goal of raising awareness and promoting privacy and data protection best practices. So why does this matter? At Duke, data privacy, and privacy in general, is a shared responsibility. We are all responsible for ensuring that best practices and methods are used when collecting, using and storing the information needed to perform our jobs. Safeguarding the data we collect allows us to enable the trust of those we serve. See oarc.duke.edu/privacy for all things Duke Privacy.
Inappropriate or Unauthorized Use/Disclosure of PHI: Change Reporting
Effective January 1, 2019, the Duke University Health system (DUHS) Compliance Office will be responsible for receiving and investigating all privacy incident reports involving PHI for the School of Medicine and the School of Nursing. Please contact the DUHS Compliance Office via email at email@example.com or via phone at 919-668-2573 for investigation and resolution.
Requesting Access in OnCore
The OnCore Service Team has noticed that there continues to be confusion regarding requesting OnCore Access. To assist the Research Community in requesting OnCore Access, the correct process for requesting access has been outlined below along with notes where requestors often make mistakes in the access request process.
OnCore Access request process - CORRECT
- Go to Service Now - https://duke.service-now.com/sp
- Click Get It
- Click Accounts and Access
- Click the Account Access order Guide
- Complete the top part of the form and under the Enterprise Services section check OnCore-CRMS
- Select Next at the bottom of the screen
- A new screen will appear. Select Options
- Fill in the CRU and Role(s) requested and if a PI, add your NPI, then finish the order and checkout.
OnCore Access request process – INCORRECT
If you happen to go to the Research Section Service Now
Then click OnCore
DO NOT fill out that form and choose OTHER. This form does not get manager approval which is required for OnCore access. Instead of filling out the form – click on the blue hyperlink word form instead
It will take you to the correct order form that gets sent to an approving manager.
Funding Opportunities from CTSI
CTSI Population Health Improvement Co-Development Awards: LOI Deadline January 24, 2019
Encourages and facilitates new investigative community-academic partnerships designed to improve community health and may also include health research that advances the science of stakeholder and community-engaged research.
- Up to $25,000
- Mandatory Letter of Intent Deadline: January 24, 2019
- View the RFA
CTSI Population Health Improvement Advanced Partnership Awards: LOI Deadline January 24, 2019
Seeks to support joint research proposals from community organizations/groups and Duke researchers who have already developed innovations to address health problems and are ready to advance pilot testing these solutions through broader community-engaged implementation research studies.
- Up to $25,000
- Mandatory Letter of Intent Deadline: January 24, 2019
- View the RFA
Population Health Improvement Collaboration Seed Awards: Applications accepted on a rolling basis
Small planning awards of $1,500 to community organizations and Duke investigators interested in working with the CTSI’s Community Engaged Research Initiatve (CeRi) for guidance on developing impactful community-research partnerships and planning collaborative population health improvement research proposals that impact community and population health.
RFP for Duke Collaboratory Funds
The Duke Collaboratories RFP for this year has now been released. This is the second year for the Collaboratories, which is one of several faculty RFPs being offered through Together Duke. Last year, six faculty groups were awarded multi-year Collaboratory grants.
Collaboratory grants provide support for groups of faculty working on more established projects that seek to provide tangible solutions to targeted problems in 3 areas: 1) Energy & Water Resources; 2) Race, Religion & Citizenship; and 3) Population Health.
Duke has the intellectual resources and organizational nimbleness to convene technical, legal, scientific, ethical, cultural and historical explorations of these issues. By drawing on disciplinary depth, interdisciplinary strengths, and commitment to engagement, we have the capacity to make crucial research contributions in these vital areas and to serve as an important node for convening stakeholders.
Project funding ranges from $20,000 to $200,000 annually.
The deadline to submit proposals is February 15, 2019.
Questions may be directed to Carolyn Mackman at firstname.lastname@example.org.
Translating Duke Health Pilot Grants in Immunology
Duke Health invites proposals for innovative approaches to supporting immune health. This RFP is designed to invest in transformative areas of research and technology where Duke Health can have the greatest impact on human health.
Translating Duke Health is one of the signature programs animating Advancing Health Together, our Duke Health Strategic Planning Framework. Translating Duke Health is a multiyear, multidisciplinary program to capitalize on our collective strengths in research, clinical care and population health to address major health challenges. Additional information about Translating Duke Health is available at www.translatingdukehealth.org.
For this call, we are focusing on new approaches that could bear on our understanding of transplantation tolerance, tumors, autoimmunity, and protective immunity. To be responsive to this RFP, projects should include an aspect of human immunology. Applicants are also encouraged to take advantage of available biobank samples and Duke Core Facilities.
The steering committee is looking for projects that build new collaborations and/or new teams and might lead to extended productive (and NIH-funded) collaborations.
Deadline: Proposals must be received by 5 PM EST, March 1, 2019
Questions and completed applications should be submitted as a combined pdf file to: email@example.com.
DOCR To Offer Study Monitoring Services
Starting in January, the DOCR Outreach Team will offer study monitoring services on a percent effort basis. DOCR will assist study teams and CRUs with development of the Clinical Quality Management Plan (CQMP), will conduct required CQMP case reviews, and will complete the corrective action and follow-up process. Additional in-depth monitoring services also are available for studies without an external monitor. Please contact firstname.lastname@example.org with questions.
Maestro Care Research Concierge (MCRC) Services
Maestro Care Research Concierge (MCRC) services have transitioned to the DOCR Maestro Care Research Analyst and DOCR Training and Communications Team. Reni Jackson has transitioned to a new role as Business Analyst for the iRIS application. Please direct all of your Maestro Care for research needs to the DOCR analyst team via Service Now. This includes recruitment assistance using alerts, custom schedule columns, Reporting Workbench reports and MyChart as well as workflow enhancements, and Maestro Care-related questions/issues. Congratulations to Reni on her new position.
Revised iRIS Training Now Available!
We are happy to report the New Enhanced iRIS training module –Introduction to Submitting an IRB Application in iRIS 2.0 –DOCR—is now available!
The major enhancements to the online module include:
- Updated and clarified information and content, including updated animations to relay this information
- Integrated videos of the iRIS system to provide more engaging and relatable content regarding the iRIS System
- iRIS System simulations within the module including “Try Me” simulations
- 10 Question Assessment to mark training complete in the LMS
It is recommended that learners launch the iRIS LMS Module in Firefox browser.
While this training module is not required for all learners, it will provide the learners with a solid foundation for use of the iRIS System along with background information about how the iRIS System interfaces with the OnCore System. This module is strongly recommended. It also provides trouble shooting information for common questions that arise when submitting a new protocol application.
To access the on-line module in the Duke Learning Management System, click here.
iRIS Office Hours Available
The Duke Office of Clinical Research will host Office Hours twice per month beginning in December. Instructors will be available to assist end users with general questions regarding using the iRIS system to submit protocols to the DUHS IRB. Please bring a laptop if possible along with your protocol specific questions to the sessions.
Dates and locations for January and February are:
- January 14, 11 AM – Noon, DMP 2W91
- February 4, 11 AM – Noon, DMP 2W91
- February 18, 11 AM – Noon, DMP 2W91
REDCap: You can require a reason when making changes to existing records
This option can be enabled by checking the option for Require a 'reason' when making changes to existing records? Which can be found under Project Setup à Additional customizations.
Require users to enter a reason (200 character max) in a text box when making any data changes to an already existing record on a data collection instrument. The prompt is triggered when clicking the Save button on the page. Any 'reasons' entered can then be viewed anytime afterward on the Logging page.
Note: If the instrument does not yet have any data collected for it, then a reason will not be required (this includes importing data via the Data Import Tool). This feature is only triggered when adding, editing, or deleting data for an instrument that contains previously-collected data for one or more fields on the instrument.
Please contact us at email@example.com with any questions.
Upcoming DOCR Training Offerings
DOCR training offerings are available in the Duke LMS. There are 2 easy ways to find all DOCR classes: Enter “DOCR” in the search field and click Search, or click the Category link, and then click the DOCR link. The results display all the offerings currently available from DOCR. Hint: If you want to bookmark the Duke LMS in your browser, edit the bookmark to this address: https://lms.duhs.duke.edu/Saba/Web/Cloud
Detailed information about each offering and direct links to the offering are also available on the DOCR Course Listing.
The Surgery office of Clinical Research (SoCR) welcomes Nikia Person-Pittman to the finance team as a Financial Management Analyst II.
The Heart Center CRU Lumberton Cluster welcomes Jessica Garris who joined us as a CRNC on December 4th. Jessica worked as a nurse in the Emergency Department at Southeastern Regional Medical Center. Welcome Jessica!
The Heart Center CRU PAC Cluster welcomes Alyssa Bilewski as a Clinical Research Coordinator.
DUHS Compliance Office Newsletter
Catch up on news from the DUHS Compliance Quarterly Newsletter.
Subscribe to the Clinical and Translational Science Institute (CTSI) Bi-Weekly Newsletter
Stay up to date on news, funding, and education opportunities in translational science at Duke by subscribing to CTSI UPDATES. Read past newsletters and subscribe at https://www.ctsi.duke.edu/news/newsletters.
To be added or removed from the distribution list for the DOCR Clinical Research Update newsletter, please contact the DOCR at firstname.lastname@example.org.