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.
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:
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.
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
Dr. Barbara Bierer is a Professor of Medicine at Harvard Medical School, co-founder and faculty director of the Multi-Regional Clinical Trials Center of Brigham and Women’s Hospital and Harvard external link (MRCT Center), program director of the Regulatory Foundations, Ethics and the Law Program of the Harvard Catalyst, Harvard Clinical and Translational Science Center, Director of Regulatory Policy for SMART IRB, and a senior physician (hematologist-oncologist) at Brigham and Women’s Hospital (BWH). Additionally, she serves on the Board of Directors for Vivli , a non-profit organization founded by the MRCT Center dedicated to global clinical trial data sharing; for Public Responsibility in Medicine and Research (PRIM&R), dedicated to promoting the ethical conduct of biomedical and behavioral research; and for Management Sciences for Health (MSH), a nonprofit international organization working in partnership and globally to strengthen health care, local capability, and access. She also chairs the Board of Trustees of the Edward P. Evans Foundation, a foundation supporting biomedical research.
Previously, she served as the Senior Vice President of Research and the institutional official for human subjects and animal research, biosafety, and research integrity at BWH, as well as the founding director of the Center for Faculty Development and Diversity at the BWH. She has served as co-chair of the Partners HealthCare Committee on conflict of interest, chair of the Board of Directors of the Association for Accreditation of Human Research Protection Programs (AAHRPP), chair of the Secretary’s Advisory Committee on Human Research Protections (SACHRP) the US Department of Health and Human Services (HHS), and as a member of the National Academies of Sciences Committee on Science, Technology and the Law. Dr. Bierer co-founded the MRCT Center, a collaborative effort to improve the ethical, logistical and regulatory aspects of international clinical trials, with a special focus on the emerging economies. She initiated the Brigham Research Institute, a resource to foster and support interdepartmental and interdisciplinary research at BWH, and the Brigham Digital Innovation Hub (iHub), a focus for entrepreneurship and digital innovation in healthcare.
Dr. Bierer has authored or co-authored over 220 publications and has served on several journal editorial boards. She received her BS in biology from Yale University and her MD from Harvard Medical School.
Partner, 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
Mr. Mark Barnes is a partner at Ropes & Gray LLP, specializing in human and animal research, digital health, data privacy, stem cell and genetic research, research grants and contracts, research misconduct, and international research. He currently serves as co-chair of the Subcommittee on Harmonization of Research Regulations under the Secretary's Advisory Committee on Human Research Protections (SACHRP) for the US Department of Health and Human Services (HHS), faculty co-director of the MRCT Center and serves as co-chair on their Executive Committee, and holds faculty positions at Yale University where he lectures at the Law School and School of Medicine. Additionally, he serves on the NIH HIV Prevention Trials Network (HPTN) Ethics Working Group, serves as the Ethics Advisor for the HPTN Trial 071 in South Africa and Zambia, and is on the Board of Directors for Vivli, a non-profit organization founded by the MRCT Center dedicated to global clinical trial data sharing.
Previously, he served as Executive Vice President and Chief Administrative Officer at St. Jude Children's Research Hospital and helped establish a vaccine study center in Zimbabwe in collaboration with Africa University. At Harvard University, he served as Senior Associate Provost for Research, Senior Research Officer, as well as the managing director of Harvard's Primate Research Center. During his tenure at Harvard, he started and directed the university’s PEPFAR-funded HIV/AIDS treatment programs in Nigeria, Tanzania and Botswana. Early in his career and as an associate professor at Columbia Law School, Mr. Barnes co- founded the AIDS Law Clinic, the first legal clinic that allowed law students to represent persons living with AIDS in anti-discrimination cases. The program was funded in part by the US Department of Education and received referrals from the New York City Commission on Human Rights and the State Division of Human Rights.
Mr. Barnes has held senior appointed positions in the New York City and State departments of health, worked on the National Health Care Reform Task Force, and has authored or co-authored over 50 publications. He received his BA from Bennington College, his JD from Yale Law School, and his Master of Laws (LLM) degree from Columbia University School of Law.
Hamilton Southworth Professor of Medicine
Professor of Epidemiology
Chief, Division of General Medicine
Columbia University Medical Center
Attending Physician, New York Presbyterian Hospital
Dr. Barr is the Hamilton Southworth Professor of Medicine, Professor of Epidemiology, and Chief of the Division of General Medicine at Columbia University Medical Center. He is a general internist and respiratory epidemiologist whose research focuses on chronic lung disease, pulmonary vasculature, and cardiopulmonary interactions using advanced imaging and molecular approaches on a population level. He is PI of the Multi-Ethnic Study of Atherosclerosis (MESA) Lung Study, a 16-year investigation of emphysema on CT in the general population, and the SPIROMICS Heart Failure Study, a 12-year investigation of heart-lung interactions.
Dr. Barr has authored over 375 peer-reviewed papers and has received numerous awards for his research. He received his BA from Duke University, his MD from McGill University, and his Doctorate in Public Health at the Harvard School of Public Health. He completed his residency at Columbia-Presbyterian Medical Center and a fellowship at Massachusetts General Hospital.
Kennedy 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
Director, Clinical Research, Simons Foundation Autism Research Initiative (SFARI)
Principal Investigator, Simons Foundation Powering Autism Research through Knowledge (SPARK)
Dr. Wendy Chung is a clinical and molecular geneticist and the Kennedy Family Professor of Pediatrics in Medicine at Columbia University where she directs the clinical genetics program, conducts human genetics research, and treats patients. Her research program investigates the genetics of human disease, the associated clinical phenotypes and penetrance, the correlation of genotype and phenotype, and the mechanism of disease. Dr. Chung specializes in rare genetic conditions associated with obesity, breast cancer, pulmonary hypertension, autism, and birth defects including congenital diaphragmatic hernia and congenital heart disease, to name a few. Through this work she has identified more than 40 new genes related to disease. Dr. Chung also serves as the director of the Precision Medicine Resource in the Irving Institute for Translational Research at Columbia, director of the Pediatric Neuromuscular Clinical Research Network (PNCR Network) Molecular Core and the New York Obesity Center Molecular Genetics Core, and director of the Diagnosis Initiative: Seeking Care and Opportunities with Vision for Exploration and Research (DISCOVER) program which integrates clinical care with cutting-edge research to make a diagnosis of rare diseases and complex conditions more quickly. In addition to her duties at Columbia, Dr. Chung is the director of clinical research at the Simons Foundation Autism Research Initiative (SFARI) and the principal investigator of Simons Foundation Powering Autism Research through Knowledge (SPARK) and the Simons Variation in Individuals Project (Simons VIP). Previously, she led the pilot newborn screening study of spinal muscular atrophy in New York that helped lead to nationwide adoption of this test in newborns and was the original plaintiff in the Supreme Court case that overturned the ability to patent genes.
Dr. Chung sits on several scientific advisory boards and was on the Institute of Medicine committee on genetic testing. She has authored over 350 peer reviewed papers and 50 reviews and chapters in medical texts and has received numerous awards for her scientific and medical contributions as well as for her renowned teaching and mentoring. She received her BA in biochemistry and economics from Cornell University, her MD from Weill Cornell Medical College, and her PhD from The Rockefeller University in genetics. She completed her residency in pediatrics and fellowships in medical and molecular genetics at New York-Presbyterian/Columbia University Medical Center.
Assistant 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
Ms. Marcela Nava is an Assistant Professor of Practice at the School of Social Work, University of Texas at Arlington (UTA) teaching graduate and undergraduate courses on social policy, health policy, research and diverse populations. Her areas of expertise and research include health equity, immigration, and policy advocacy, focusing on issues related to power and social justice to address inequities in health, and institutional forms of discrimination that affect immigrants, people of color, women, and youth. She is a Health Policy Research Scholar through the Robert Wood Johnson Foundation, a prestigious four-year national leadership development program for full-time doctoral students committed to supporting a Culture of Health in their disciplines and communities.
She previously served as a Co-Investigator on a National Institute on Minority Health and Health Disparities (NIMHD) funded Center of Excellence grant focused on community-engaged approaches to cancer disparities, obesity prevention and HIV/AIDS among youth. In addition, Ms. Nava has extensive experience collaborating with nonprofits and communities across North Texas in building capacity to implement systems change and address health disparities among women, immigrants and people of color. As a practitioner, she advanced organizational methods that contributed to health and social equity through training, presentations, and consultation on how to identify health disparities, potential causes, actions to address, and evaluation of those efforts. Ms. Nava was an NIMHD Translational Health Disparities Scholar as well as a Presidential Scholar for the AcademyHealth Institute on Advocacy and Public Policy. She received her BS in social work from the Texas Christian University, her MSSW from UTA, and her master’s in public policy (MPP) from the University of Texas at Dallas where she is currently a PhD candidate in Public Policy and Political Economy.
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
Mr. Efthimios Parasidis holds a joint academic appointment with The Ohio State University at the Moritz College of Law and the College of Public Health and is a faculty affiliate with the College of Medicine’s Center for Bioethics. Additionally, he serves as Faculty Advisor for several boards and committees at Ohio State and as a consultant on law and bioethics for the US Air Force. His areas of expertise include health law, public health law and policy, bioethics, human subjects research, regulation of medical products, intellectual property, biotechnology law, military research ethics, and informed consent. In addition to teaching, he also counsels start-up companies on corporate and intellectual property matters and is a co-inventor on a patent application related to health information technology.
Early in his career, Mr. Parasidis was selected as a Fulbright Scholar where he researched legal and ethical issues related to medical informed consent policies and practices in Greece. More recently, he was awarded a Faculty Scholar in Bioethics fellowship from the Greenwall Foundation where he examined the law and ethics of military research involving service members and biomedical enhancements. This work led to a book project with Oxford University Press (currently under contract). Prior to joining the Ohio State faculty, he was a professor at the Center for Health Law Studies at Saint Louis University and was an appointed member of the Law & Policy Workgroup of Missouri Health Connection, the entity responsible for creating Missouri’s health information exchange. Mr. Parasidis served as Assistant Attorney General for the State of New York, under Eliot Spitzer and Andrew Cuomo, as an associate with the Litigation group of Jones Day, and as a senior associate in the Intellectual Property group of Dickstein Shapiro. He also co-founded a health informatics start-up company.
Mr. Parasidis has authored over 30 publications, several book chapters, and three books that include a casebook on the ethics and regulation of research with human subjects that he co-authored; he has given over 75 professional presentations to scientific and academic communities. He received his BA in philosophy from The College of New Jersey, and his master’s in bioethics (MBE) and JD from the University of Pennsylvania.
Professor, 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
Dr. Mario Sims is a professor in the Department of Medicine at the University of Mississippi Medical Center (UMMC) and serves as the Chief Science Officer (CSO) of the Jackson Heart Study (JHS), the largest investigation of genetic and environmental factors that may contribute to causes of cardiovascular disease (CVD) in African-Americans. He is a trained Cardiovascular Epidemiologist with a background in medical sociology and social epidemiology and has specific training in population health, health disparities, and quantitative methods of secondary data in population-based research. His current research focuses on understanding the social determinants of CVD disparities, with a specific interest in examining the extent to which racism, stress and psychosocial factors may play a role. His research has addressed the extent to which socioeconomic status (SES) contributes to health disparities by race and ethnicity, how perceived racial discrimination is associated with poor health, and how psychosocial stressors are associated with poor sleep health in African Americans. As the JHS CSO, Dr. Sims prioritizes the scientific direction of the JHS, facilitates and enhances JHS collaborations with local and national institutions, and oversees the research management activities across the research coordination core, data coordination core, and JHS investigators. He serves as chair of the JHS Ancillary Studies Subcommittee where he monitors the activity of all ancillary studies and communicates with investigators and serves as co-chair of the JHS Social Determinants of Health Working Group which collaborates and supports investigators in publishing manuscripts and conducting grant research. In addition to his duties at UMMC and the JHS, Dr. Sims also serves as chair of the American Heart Association’s Social Determinants of Health Committee, Quality of Care and Outcomes Research (QCOR), Council on Epidemiology and Prevention.
He has published 135 peer-reviewed papers, given over 115 professional presentations at scientific conferences, and has received numerous awards for his contributions to research and science. He received his BA in economics and history from University of California, Los Angeles, and both his MS and PhD in medical sociology and demography from the University of Wisconsin-Madison. He completed several postdoctoral fellowships in social epidemiology, preventive medicine, and cardiovascular epidemiology and is a fellow of the American Heart Association.
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 who wish to utilize NHLBI datasets that require IRB review.
What are the requirements for institutions and investigators who want to utilize the CDS-IRB?
Institutions are required to have:
Investigators must have:
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.
Are there any criteria or requirements that need to be met before submitting an application for CDS-IRB review?
Criteria for CDS-IRB review:
Requirements for CDS-IRB review:
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?
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.
What happens after I submit my application for the CDS-IRB review?
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.
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.