Clinical Data Science Institutional Review Board (CDS-IRB)

Description

The NHLBI established the Clinical Data Science IRB (CDS-IRB) to provide a useful resource for the research community by offering—at no cost—central review of secondary research proposals utilizing NHLBI datasets for which IRB approval is required.

As a central IRB for research protocols that propose secondary analyses of existing clinical data, the CDS-IRB will address the growing complexity of research and non-traditional uses of biomedical data. Broad utilization of the CDS-IRB will also provide an opportunity for the NHLBI to systematically understand the evolution and range of requests to conduct secondary analyses, recognize emerging trends, and explore ways to enhance data stewardship with the research community.

The NHLBI endorses and promotes the broad and responsible sharing of clinical research data from NHLBI-supported clinical studies as well as the use of these data for subsequent research (i.e., secondary analyses). The NHLBI makes available to the research community hundreds of de-identified datasets from clinical trials and observational studies as well as from the Trans-Omics for Precision Medicine (TOPMed) program, which is providing deep whole-genome sequencing and other omics data to pre-existing clinical studies. These data are available through a cloud-based platform, BioData Catalyst, that allows investigators to readily find, access, share, store, cross-link, and compute on large-scale NHLBI (and other) datasets. A significant number of the NHLBI datasets, including nearly half of the TOPMed datasets, have an associated data use limitation of “IRB Approval Required” before they can be used for secondary research purposes.
There is little extant guidance for IRB review of secondary analysis research of existing de-identified human datasets. The potential risks associated with secondary analyses are not necessarily the same as the risks associated with research that involves people (for example, direct physical harm to subjects). Ethical review of secondary analyses needs to consider possible risks such as re-identification, breach of privacy, and non-physical harm to the research participants and their families/descendants and communities. This includes the potential for stigmatization or discriminatory impact. In addition, the rapid pace of scientific and technological advances is making possible new research applications that could not have been anticipated even a few years ago and thus were not included in the original informed consent. In recognition of these challenges, NHLBI established the CDS-IRB to address ethical issues that may arise during secondary analyses.
The CDS-IRB members are diverse by profession, expertise, ethnicity, gender, and geography. Collectively, CDS-IRB members are well versed in the federal regulations governing protection of research participants; biomedical and behavioral research; research ethics; institutional policies and practices; and issues that may be of concern to participants of cohort studies, including, for example, re-identification, third-party harms, data misuse, privacy, and stigmatization. This ensures that the CDS-IRB is well-poised to review proposals for secondary research. If necessary, however, the CDS-IRB members will consult with outside subject matter experts on an ad hoc basis. The CDS-IRB has also developed an ethics framework and principles to ensure consistent, comprehensive reviews of proposals for secondary analyses.
Point of contact:
Lisa Viviano, R.N., B.S.N.
Office Email: cds-irb_helpdesk@emmes.com
Office Number: (844) 200 - 8952

How can I request CDS-IRB review of secondary research proposals?

To request CDS-IRB review, your home institution must have a reliance agreement in place with the CDS-IRB. There are two ways in which this can be accomplished:

  1. By using the SMART IRB (the Streamlined, Multisite, Accelerated Resources for Trials IRB) Reliance platform (with more than 800 participating institutions), or
  2. By signing the CDS-IRB’s Reliance Agreement

 

Once the Reliance Agreement is in place, you can apply for review by establishing an IRBManager account.

There is no cost for using CDS-IRB services.

If you have any questions about how to request CDS-IRB review, please email CDS-IRB_Helpdesk@emmes.com. For more information about establishing a reliance agreement and other general information pertinent to requesting CDS-IRB review, see the FAQ section below.

Current CDS-IRB Members

Barbara E. Bierer, M.D. (IRB Chair)

Barbara E. Bierer, M.D. Faculty Director, the Multi-Regional Clinical Trials Center of Brigham and Women’s Hospital and Harvard
Program Director, Regulatory Foundations, Ethics and the Law Program, Harvard Catalyst, Harvard Clinical and Translational Science Center
Director of Regulatory Policy, SMART IRB
Professor of Medicine, Harvard Medical School
Senior Physician, Brigham and Women’s Hospital

Mark Barnes, J.D., L.L.M.

mark barnesPartner, Ropes & Gray LLP
Co-chair, Subcommittee on Harmonization of Research Regulations, Secretary's Advisory Committee on Human Research Protections (SACHRP), US Department of Health and Human Services (HHS)
Faculty Co-director and Executive Committee Co-chair, Multi-Regional Clinical Trials Center of Brigham and Women’s Hospital and Harvard (MRCT Center)
Faculty, Yale University

R. Graham Barr, M.D., Dr.P.H

graham barrHamilton Southworth Professor of Medicine
Professor of Epidemiology 
Chief, Division of General Medicine
Columbia University Medical Center
Attending Physician, New York Presbyterian Hospital 

Wendy Chung, M.D., Ph.D.

Wendy ChungKennedy Family Professor of Pediatrics in Medicine
Director, Precision Medicine Resource, Irving Institute for Translational Research
Director, Clinical Cancer Genetics
Co-director, Medical Genetics Training Fellowship
Attending Physician, Division of Molecular Genetics, Department of Pediatrics and Medicine
Columbia University
Director, Clinical Research, Simons Foundation Autism Research Initiative (SFARI)
Principal Investigator, Simons Foundation Powering Autism Research through Knowledge (SPARK)

Marcela Nava, M.S.S.W., M.P.P.

marcela navaAssistant Professor in Practice, School of Social Work
Associate Professor in Practice, School of Social Work
Faculty Research Associate, Center for Mexican-American Studies
The University of Texas at Arlington
Health Policy Research Scholar, Robert Wood Johnson Foundation
Ph.D. Candidate, University of Texas at Dallas

Efthimios Parasidis, J.D., M.BE.

Efthimios Parasidis Professor of Law, Moritz College of Law
Professor of Public Health, College of Public Health
Faculty Affiliate, College of Medicine, Center for Bioethics
The Ohio State University

Peipei Ping, FAHA, FISHR, Ph.D.

Peipei PingProfessor, Physiology, Medicine/Cardiology, and Bioinformatics
Director, Data Science in Cardiovascular Medicine
Director, NIH BD2K CoE and Coordination Center
Associate Director of Scalable Analytics Institute
Principal Investigator, Center for Excellence (CoE) for Big Data Computing
Faculty, Cardiovascular Research Laboratory, University of California, Los Angeles (UCLA), David Geffen School of Medicine and School of Engineering
President, North American Section, International Society of Heart Research
Founder and Executive Operation Officer, International Forum of Proteomics

Charmaine Royal, Ph.D.

Charmaine Royal Associate Professor, African and African-American Studies
Associate Professor, Biology
Associate Professor, Family Medicine and Community Health
Associate Research Professor, Global Health
Director, Center on Genomics, Race, Identity, Difference
Director, Center for Truth, Racial Healing & Transformation
Senior Fellow, Kenan Institute for Ethics
Duke University

Mario Sims, Ph.D., M.S., FAHA

mario simsProfessor, Department of Medicine
Chief Science Officer, Jackson Heart Study (JHS)
Associate Director, Research Training, JHS Field Center
Graduate Faculty, School of Graduate Studies in the Health Sciences
Co-Investigator, JHS, Coordinating and Field Centers
University of Mississippi Medical Center
Graduate Learning Community Advisor, JHS Graduate Training and Education Center (GTEC)
Jackson State University

More Information

General Questions
- Clinical Data Science Institutional Review Board (CDS-IRB)

What is the Clinical Data Science Institutional Review Board (CDS-IRB) and why was it established?

The NHLBI established the CDS-IRB as a useful resource for the research community to address the ethical issues that may arise during secondary analyses of existing de-identified human genomic datasets.  For proposals that utilize NHLBI datasets for which IRB approval is required, the CDS-IRB considers the potential risks associated with this type of research, such as re-identification of the original research participants, risks to family members, data misuse, breaches of confidentiality, harms to communities or groups, or the stigmatization of a population.  The services of the CDS-IRB are offered free of charge. 

My local IRB categorizes secondary analysis of de-identified data as “Not Human Subjects Research.”  Why do I need IRB review if the data is de-identified?

The NIH categorizes human genomic data as either unrestricted access (i.e., publicly available) or controlled access.¹,²  The informed consent under which the data were collected is the basis for determining this level of access.  When the dataset is submitted to an NIH data repository the submitting institution stipulates how the data may be used, one of which may require IRB approval. The charter of the CDS-IRB is located here.

Do I have to use the CDS-IRB or can my local IRB review my research protocol?

Utilization of the CDS-IRB is not required and review by your local IRB is acceptable for access.³ The NHLBI CDS-IRB has been provided as a free service for researchers utilizing many of the NIH cloud-based data platforms, such as the NHLBI BioData Catalyst platform where access to certain datasets requires IRB review.       

What are the requirements for institutions and investigators who want to utilize the CDS-IRB? 

Institutions are required to have:

  • A current Federalwide Assurance (FWA) issued by the Department of Health and Human Services (HHS), Office for Human Research Protections (OHRP).  Get detailed information on the FWA and the process of filing for an FWA. One of the requirements of filing for an FWA is to identify an IRB of Record.  If you do not have an IRB to list on the FWA, contact the CDS-IRB Office for guidance.
  • A reliance agreement in place, either directly between the institution and NHLBI, or through the SMART IRB process; and
  • An institutional NIH eRA Commons account.  Learn more about eRA Commons and how to obtain an account.

Investigators must have:

  • Human subjects protection training in accordance to their local institutional policies;
  • A current curriculum vitae;
  • Meeting the minimum qualifications of the NIH Data Access Committee located here; and
  • An investigator NIH eRA Commons account.  Learn more about eRA Commons and how to obtain an account.

Reliance Agreement Questions
- Clinical Data Science Institutional Review Board (CDS-IRB)

What is a reliance agreement, why do I need one, and who needs to sign it? 

A reliance agreement (also called an IRB Authorization Agreement) is a document that permits one or more institutions to rely on another IRB.  Institutional officials or signatories of the involved institutions must sign the reliance agreement.

Only researchers and institutions who want to cede IRB review to the CDS-IRB will need to enter into a reliance agreement.  Those using their local IRB would not need to obtain a reliance agreement. 

How does my institution enter into a reliance agreement to utilize the CDS-IRB? 

There are two options for entering into a reliance agreement for ceding review by the CDS-IRB.  The first option is through the signing of the NHLBI Reliance Agreement document which can be found on this website and the second option is through the SMART IRB platform where the NHLBI is a participating institution.

For relying through the NHLBI Reliance Agreement, relevant institutional officials must review and sign the document and then submit the signed copy to the CDS-IRB Office at CDS-IRB_Helpdesk@emmes.com. CDS-IRB Office personnel will route the signed agreement to the NHLBI institutional official for review and final signature thus completing the reliance process. 

For relying through the SMART IRB, your institution must be a participating institution of the SMART IRB platform.  Participating institutions are required by SMART IRB to designate a Point of Contact (POC) responsible to facilitate the SMART IRB reliance process. You can either talk to your institutional official from your local IRB office or check here to see if your institution participates with the SMART IRB Agreement. Here is an overview of the steps involved in relying on CDS-IRB through the SMART IRB system.  For the specific steps involved and information required in initiating a request through the SMART IRB Online Reliance System, review the following SMART IRB checklist:  https://smartirb.org/assets/files/Reliance-Checklist.pdf. A sample SMART IRB Reliance Request Form can be accessed at https://smartirb.org/assets/files/SampleRelianceRequestForm.pdf.

My institution participates in the SMART IRB system. In that system, reliance on another IRB is generally on a case-by-case basis.  But for review of secondary research involving NHLBI datasets, the reliance would need to be for a category of research, not case-by-case.  Is this possible through the SMART IRB system?

Yes.  Instead of using the SMART IRB Online Reliance System, the NHLBI CDS-IRB has developed a Letter of Acknowledgement (LoA) that can be signed by your local IRB, thereby establishing an “umbrella” arrangement.  The LoA describes the type of research permitted under this arrangement and maintains adherence to the SMART IRB Master Common Reciprocal IRB Authorization Agreement.  Once the LoA is signed, an investigator can bypass the step of obtaining local IRB permission and submit the agreed-upon research projects directly to the CDS-IRB. Contact your institution’s SMART IRB Point of Contact (POC) to facilitate this process. The LoA for the CDS-IRB can be found on this website.       

Who do I contact for questions or assistance on obtaining a reliance agreement or with the documentation process?

Contact the CDS-IRB Office by phone (844) 200-8952 or email: CDS-IRB_Helpdesk@emmes.com. Investigators should also contact their local IRB and/or their institutional SMART IRB POC who will work with the CDS-IRB Office to help facilitate the reliance agreement process.

Application Submission Questions
- Clinical Data Science Institutional Review Board (CDS-IRB)

Are there any criteria or requirements that need to be met before submitting an application for CDS-IRB review?

Yes.   

Criteria for CDS-IRB review:    

  • The proposed research involves the secondary use of controlled access data from an NIH cloud-based data repository (e.g., NHLBI BioData Catalyst, NIH Data Commons, etc);  
  • IRB approval is required as a condition of the data use limitations associated with the selected dataset(s); and
  • You and your institution want to cede IRB review to the CDS-IRB. 

Requirements for CDS-IRB review:

  • Lead PI meets the minimum qualifications as set by the NIH Data Access Committee.  Those qualifications can be found here;
  • PI holds an NIH eRA Commons account.  For more information about eRA Commons and how to obtain an account, visit the following website:  https://public.era.nih.gov/commons.
  • A reliance agreement is in place through either the NHLBI Reliance Agreement or the SMART IRB process;
  • Institution’s Federalwide Assurance (FWA) number.  For more detailed information on the FWA and the process of filing for an FWA visit the following website:  https://www.hhs.gov/ohrp/register-irbs-and-obtain-fwas/fwas/index.html.
  • PI must obtain an IRBManager username and password through the CDS-IRB Office to submit through the application electronic process.

How should I prepare for submitting my application for review to the CDS-IRB?

The following steps and recommendations will assist with a more efficient submission process.

What is the process for submitting a secondary research project to the CDS-IRB for review?

  • Review the Application Sample Form for the information that will be requested.
  • Click on the IRBManager link on this website and register for a username and password.
  • Login to IRBManager and click on Start xForm on the upper left side of the page.
  • Fill out the application questions.  

Where can I ask for help if I can't upload documents into the CDS-IRB Application Website?

Contact the CDS-IRB Office by phone (844) 200-8952 or email: CDS-IRB_Helpdesk@emmes.com 

Review Process Questions
- Clinical Data Science Institutional Review Board (CDS-IRB)

What happens after I submit my application for the CDS-IRB review? 

  • As soon as you hit the submit button in IRBManager™ two emails are generated:
  • An acknowledgement email is sent to the submitter and PI, and
  • An alert email to the CDS-IRB Office that a submission has come in.
  • The CDS-IRB Office conducts a preliminary administrative review to assess if all the required information has been provided and obtain any needed clarifications.  Once the CDS-IRB Office has all the necessary information in hand you will receive an update email indicating the project has been forwarded for IRB review.
  • The project is assigned to designated board members for the ethical review of the project. 
  • If needed, CDS-IRB Office personnel will contact you with board member requests for more information, clarifications, and/or additional documentation.
  • The assigned board members present the project at the monthly IRB meeting where a determination is made.
  • You will be sent an email indicating the CDS-IRB determination.
  • An overview of the CDS-IRB review process is located here.

How often does the CDS-IRB meet to review protocols?

Currently, the NHLBI CDS-IRB meets monthly.

Who do I contact if I have questions about the review process?

Contact the CDS-IRB Office by phone (844) 200-8952 or email: CDS-IRB_Helpdesk@emmes.com.

Forms and Documents
- Clinical Data Science Institutional Review Board (CDS-IRB)

References
- Clinical Data Science Institutional Review Board (CDS-IRB)

1. Refer to the NIH Genomic Data Sharing Policy for more information.

2. Refer to the Points to Consider for Institutions and IRBs in Submission and Secondary Use of Human Genomic Data under the NIH GDS Policy for information on the process of categorizing data for public or controlled access.

3. Review any requirements for data use for a specific dataset as noted in the Data Use Certificate, such as whether IRB review is required.

4. A copy of the SMART IRB Agreement can be found at:  https://smartirb.org/agreement/.

5. For the steps involved and information required in initiating a request through the SMART IRB Online Reliance System, review the following SMART IRB checklist:  https://smartirb.org/assets/files/Reliance-Checklist.pdf.

6. For a sample SMART IRB Reliance Request Form - https://smartirb.org/assets/files/SampleRelianceRequestForm.pdf.

7. For a description of these categories, refer to the Project Information section of the Sample Application Form located on the CDS-IRB website.

8. IRBManager™ is the electronic system for IRB application submission and management of IRB-related records used by the CDS-IRB.