Recruiting participants is a crucial component of research studies involving human subjects. Research teams must get the word out about their studies to interested and qualified volunteers who are motivated and able to participate. In addition, while identifying a sufficient number of eligible participants, the research team must ensure that their recruitment methods and materials comply with all required regulatory standards. The following resources include information about several available tools and services to support recruitment efforts.
For additional information about resources available to assist with the recruitment of human subjects, you can reach us by creating a login (one-time process) and submitting a request to the ORS Help Center.
Regulatory Requirements for Advertising Recruitment for Clinical Research
All forms of advertising or dissemination of information for the purposes of recruitment of subjects into research studies must be approved by the Program for the Protection of Human Subjects (PPHS) Institutional Review Board (IRB) prior to the distribution or publication of the material.
Epic for Research Participant Recruitment
The EpicCare EHR (Electronic Health Record) by the Mount Sinai Health System makes it possible for clinicians and clinical researchers to work together to offer the best options for patients, while helping alleviate the problem of recruitment shortfalls for clinical research studies. Piloted by the Epic research team in the Clinical Trials Office of Tisch Cancer Institute, Epic Clinical Trial Alerts (CTAs) can help make a meaningful match between clinical researchers and clinicians who have recently seen potentially eligible candidates for their studies.
Epic CTAs appear in the Epic Electronic Health Record (EHR), visible to care providers at the point of care, indicating patients matching screening criteria for a clinical trial. The provider can then discuss the clinical trial opportunity with the patient. If the patient agrees, the provider indicates within the EHR that the patient is interested. That message is sent in Epic to the designated research personnel. The researcher will contact the patient to discuss the trial further and obtain consent.
Any research team that would like to request a CTA for their study should open a ticket to request access via the Mount Sinai support desk (x4HELP). An informaticist and the Epic team will assess these CTA requests for feasibly, specificity, as well as for any possibility of alert fatigue for providers. Upon implementation of the CTA in Epic, CTAs will be evaluated for development time required. An estimate will be provided to the researcher for charge back to the study. To help outline the CTA design, interested researchers should complete and submit the Epic Translational Research Committee Feasibility Form to the Mount Sinai support desk when the request is opened. Upon submission, the Epic and informatics teams will review and contact the researcher for next steps.
For further details or with questions about the functionality being offered via the EMR, Mount Sinai Health System researchers can also contact Joseph Kannry, MD, lead technical informaticist, EMR Clinical Transformation Group.
Epic CTA Use Approval
As with all recruitment methods, the use of Epic Clinical Trial Alerts must be submitted to the Program for the Protection of Human Subjects (PPHS) and approved by the IRB. Below is template language for Epic CTA submissions. Contact the PPHS with any questions about their forms, procedures, and processes.
CTA Submission Template Language
This study will use Epic Clinical Trial Alerts (CTAs) to accrue patients for clinical trials. Alerts will be presented to providers at the point of care in the EpicCare EHR (Electronic Health Record) for patients matching screening criteria for a clinical trial. Before accepting requests for CTAs, all trials are assessed for feasibility as well as the potential for alert fatigue. At the point of care the provider will see an alert informing him/her that this patient might be a candidate for <title of study>. The provider can then discuss with the patient and choose, "yes, interested" in which case an inbox message is sent in Epic to the designated research personnel. The patient will then be contacted to discuss the trial further and obtain consent. If the patient says "no," a message via Epic inbox will also be sent to the designated research personnel.
Our trial will reconcile all messages received as a result of CTAs with other means of accruement such as reports and phone calls. This will ensure that no patient is asked twice. We will supply the Epic team with an end date for our study.
Please feel free to contact the Office of Research Services, if you have any questions or need more information.
ResearchMatch is a national web-based recruitment registry that will help match researchers with willing volunteers all over the country who may wish to participate in research studies. This recruitment tool was developed through the collaborative spirit of the Clinical and Translations Science Award (CTSA) Consortium and is now available to all researchers at the Mount Sinai Health System.
Mount Sinai researchers are signing up and actively using this tool upon receiving PPHS IRB approval. If you are a researcher who may be interested in using this free resource, select ResearchMatch.org assistance in the ORS Help Center.
Adding a Project to the MSHS Clinical Research Pages
The Office of Research Services (ORS) maintains the clinical trials webpages for the Icahn School of Medicine at Mount Sinai. To list, update, or close a clinical research project, please complete this online form. View and search for current clinical trials.
The following Local Census Statistics for East Harlem and the Upper East Side can provide researchers with the basis for feasibility studies and for describing the populations you plan to enroll for your grant proposals:
QuickFacts provides the data from the US Census Bureau, the New York City Department of Health and Mental Hygiene 2006, 2009, and by City-Data.
The Mount Sinai Health System Statistics
The Mount Sinai Data Warehouse (MSDW) facilitates access to de-identified data for researchers planning new studies or grant applications. MSDW collects data from many Mount Sinai sources into one database, linked together and easily searchable. MSDW provides access to clinical and financial data derived from patient care processes of The Mount Sinai Hospital and Faculty Practice Associates since 2003, encompassing over 3 million patients (inpatient, outpatient, and emergency visits), approaching one billion facts.
The Mount Sinai Health System Patient Population Statistics 2016 provides researchers the basis for feasibility studies and for describing populations researchers plan to enroll for their grant proposals including:
- MSMC patient visits and demographics by location of care
- MSMC patient populations stratified by race, ethnicity, and language
- For the time period January 1, 2016 to December 31, 2016
The MSDW enables searches of electronic information that would previously have been prohibitively time-consuming. MSDW facilitates identification of cohorts meeting specified criteria, exports of specific data, development of automated reports, and much more. It contains data suited for both retrospective and prospective research.
MSDW is compliant with HIPAA, New York State privacy and security regulation, and Mount Sinai IRB policy regarding protection of human subjects and participation in research. With appropriate approvals, the data accessed may contain personal health information (PHI). The MSSM Data Warehouse Team provides the data.