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 DOCRfirstname.lastname@example.org for questions or assistance.
Recruitment and Engagement Policy Update
The Duke University Health System (DUHS) has revised language in the Notice of Privacy Practices (NPP) Brochure. The go-live date for the updated brochure has been postponed to March 1st. The updated Research section of the NPP notifies patients that Duke “may contact you to invite you to participate in certain research activities. If you do not wish to be contacted for research purposes, please contact Duke’s Research Navigators at (919) 660-9172 or email@example.com. We will use reasonable efforts to prevent this research-related outreach. This will not apply to the use of your health information for research purposes as described above and will not prevent your providers from discussing research with you.”
To align with the revised NPP, the Recruitment and Engagement Policy is scheduled to be posted March 1st. The policy will be rolled out in phases to CRUs during the months of March and April. This policy will allow study teams to engage patients through contacts including, but not limited to portal messages, mobile health devices, telephone, electronic surveys at clinic visits or hospital admissions, or directly via one or more clinicians. Any of these methods may be used to engage patients in research related to their health, if approved by the DUHS Institutional Review Board (IRB). The DUHS IRB will, in its review, consider the appropriateness of the recruitment methods in regard to the target population and the research objectives.
Training on the new policy is required prior to the IRB approving updated recruitment plans utilizing these expanded recruitment options.
The Duke Office of Clinical Research will work with CRU Leadership during the phased roll-out to provide training to interested study teams.
Research Data Storage Plan (RDSP): Do Not Use the COPY Function
The Information Security Office would like to advise the Research Community not to use the COPY record function in RDSP located in eGRC as it will also copy in the prior approval. If you have done this before, contact ISO and they can delete the record so that you can begin a fresh record.
E-Consents and Email
HIPAA requires that a study participant receive a signed copy of his or her consent/authorization form. If you are sending the signed consent/authorization to the study participant by email, please remember to use the 'send secure' feature of Outlook or add "(secure)" to the beginning of the title. Otherwise, the Data Loss Prevention software will intercept it, secure it, and send a report to the Compliance Office.
New Vendor for Campus Relocation, Surplus Property, and Duke Storage Management
Duke University and Duke University Health System, Inc. (Duke) have established a contract with a new vendor for campus relocation, surplus property management, and coordination of Duke storage.
Storr Office Environments was selected to provide these services for Duke following a comprehensive request for proposal and a thorough review based on price, responsiveness, support, customer service, communication, technology, and quality.
For more information, including answers to frequently asked questions, visit the Procurement and Supply Chain Management website.
Note that Iron Mountain and Access will continue as vended solutions for secured document storage. Contact information for both of these vendors is available on the Duke Financial Services Procurement website.
Updated Standard Language for MRI Now Available
The Radiation Safety Committee has updated the standard language for risks from MRI. The updated standard language is available on both the DUHS IRB website as well as the Radiation Safety website.
Protected Analytics Computing Environment (PACE) Resources Available
We are pleased to announce that as we continue to roll out the implementation of the Protected Analytics Computing Environment (PACE) for Duke Research, the DOCR training team has released a series of informative tip sheets and short training videos! These documents and videos have been uploaded to the PACE website under the “Get Started” tab. Some of the topics explored include: how to request PACE, finding software in PACE, collaborating within PACE, importing and exporting data, and requesting Honest Broker services. These will serve as great resources in addition to the new and improved PACE training in LMS (coming soon)!
Announcing: Searching Clinical Notes with DEDUCE
Have you had difficulty search for notes from Maestro Care? Does a large part of your chart review process involve reading clinical notes?
DEDUCE can help. The following note types from Maestro Care are available in DEDUCE:
- H & P (history and progress)
- OP notes (surgeon)
- ED Provider notes
- And coming in March: Progress Notes (inpatient and outpatient)
Learn more about searching text notes:
Basic DEDUCE Text Report Search (3 min video)
Using Settings for DEDUCE Text Report Search (3 min video)
Clinical Quality Management Program (CQMP)
The Clinical Quality Management Program (CQMP) was established to develop and implement a comprehensive, standardized clinical research monitoring program to replace the Quality Assurance Monitoring Review Standards for Clinical Research Policy. The Clinical Quality Management Program pilot CRUs received training in July 2018 and we are rolling out the program to additional CRUs via bi-monthly training sessions. The program focuses on helping CRUs develop Clinical Quality Management Plans for all consenting and prospective studies that are not externally or independently monitored and that do not have ongoing approved monitoring plans. These plans focus on identifying key quality indicators, like the informed consent process, participant eligibility, and safety reporting that may affect study conduct. A designated trained Quality Management (QM) reviewer will conduct regulatory file and participant chart reviews at predetermined time points. For questions regarding the CQMP, please e-mail CQMP@duke.edu.
FDA Oversight of Tobacco Product Investigations—ITP or IND?
The Duke Office of Regulatory Affairs and Quality (ORAQ) will host a seminar on FDA oversight of tobacco products and their use in clinical investigations. This will be a one hour, interactive session that will aid investigators and study teams in determining when an investigational tobacco product will require FDA oversight through an ITP or an IND. In addition, this presentation will include details on submitting applications to FDA, and describe how ORAQ can assist Duke Investigators with any questions or regulatory needs.
- Speaker: Stephanie Pierce, PhD, RAC
- March 12, 2019
- 1:00 PM – 2:00 PM
- Hock Auditorium
- Ground Floor, Hock Plaza
RFP for Duke Collaboratory Funds
The Duke Collaboratories RFP for this year has 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.
NCBiotech Announces the New Translational Research Grant (TRG) Program
DEADLINE: Wednesday, March 13th (Noon)
The TRG program funds projects that explore potential commercial applications or initiate the early commercial development of university-held life science inventions. The technology must have the potential to solve a real world problem as a commercial product in the life science sector.
The goals of the TRG program are:
- Transform basic research discoveries into product-focused translational research development
- Generate data that addresses important product development milestones, addresses the concerns of potential licensees or investors, or otherwise de-risks the technology for a specific commercial application
- Enable strategic “go/no-go” decision-making regarding further technology development and/or pursuit of intellectual property protection
- Enable technology licensing efforts by the university
- Establish goal-oriented partnerships between university scientists, product development professionals, and key stakeholders
Proposals will be evaluated on the composition of the project team, including a project manager, and the setting of relevant, realistic, and achievable milestones during the product development tasks. See the guidelines for details.
Up to $100,000 may be requested for the technical and business development activities; an additional $10,000 supplement is available to support a project manager if one is not available through the applicant institution.
Applicants must be researchers employed by North Carolina-based universities or nonprofit research institutes. Technical projects may be conducted at awardee institutions or outsourced to contract research organizations.
Details on program requirements and application instructions are provided in the program guidelines available at www.ncbiotech.org/trg.
Clinical Research Training Program Accepting Applications
The Clinical Research Training Program (CRTP) of the Duke University School of Medicine / Biostatistics and Bioinformatics Department provides academic training in the quantitative and methodological principles of clinical research. CRTP is designed primarily for faculty, fellows, and other health professionals. The program offers formal courses in research design, research management, medical genetics, comparative effectiveness, translational methodologies, and statistical analysis.
A degree option in the program leads to a Master of Health Sciences in Clinical Research, a professional degree awarded by the School of Medicine. An advanced degree in a clinical health science (or two years of medical school) from an accredited institution is a prerequisite for admission either as a degree candidate or as a non-degree participant. In addition, CRTP offers non-degree and certificate options for individuals interested in taking one or more courses.
The program is now accepting applications for the academic year 2019-2020. For a detailed description of the program, the course offerings, and a link to the online application, please visit the CRTP website at http://crtp.mc.duke.edu. The application deadline for priority review is May 15, 2019. Applications will be accepted through August 1, 2019. On-line registration for fall term courses begin on July 8, and classes begin on August 26.
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:
- February 18, 11 AM – Noon, DMP 2W91
March 4, 11 AM – Noon, DMP 2W91
March 11, 11 AM – Noon, DMP 2W91
You Can Organize your Projects into Folders in REDCap?
To create a project folder, navigate to the “My Projects” tab and click the newly added “Organize” button. The following popup will allow you to define your project folders with a name and custom colors. You can then assign projects—both active and archived ones—to a category.
Organizing projects is unique for each REDCap user, meaning one user’s approach to organization will not change someone else’s if both have access to the same project. Project organization will also not impact the data contained in a project in any way.
Each folder is collapsible, which allows for uncluttered navigation as seen in the following image. In addition, the order of projects can be changed by dragging and dropping the folders in the “Organize Projects” popup.
Coming soon… You will be able to organize Reports with folder as well.
Email us at firstname.lastname@example.org 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.
Medicine CRU welcomes the following new employees:
- Donna Hobson joined the Muir team in GI as a CRC
- Lisa Conze joined ID as a CRC
- Janze Taylor joined ID as a CRNC
- Dana Thompson joined CAGPM as a CRC
- Tyffany Coleman joined CAGMP as a CRC
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 email@example.com.