St. David's Office of Research

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Research Support

St. David’s HealthCare Office of Research can help you locate and participate in a clinical trial or start your own research project at one or more of our hospitals or research institutes. Ready to get started? Explore the process by clicking on the tabs above to learn more.

 

Have a project in mind?

Perhaps you have an idea for a project but are not sure how to get started. St. David’s Office of Research can help to jump-start your project by assisting you in the preparation process. We are available to answer any questions you may have about getting started. Questions to consider when starting a project include:

  • What equipment and resources will be required?
  • Will the study involve any unanticipated costs (e.g., research-only procedures)?
  • Do research staff have the appropriate training and credentials?
  • Are there any conflicts of interest and, if so, how will they be managed to ensure the protection of subjects?
  • Are there any other legal or regulatory issues, such as contracts, Medicare approval, or intellectual property considerations?

If you are ready to begin planning your research project, feel free to give us a call. We can discuss your project with you before you get started. We can assist in identifying any potential obstacles and help you plan the most efficient approach to get your study underway.

Click on the Develop tab to get started.

Looking for a project?

Are you looking to become involved in research, but not sure of your options? If you don’t already have your own research concept in mind, there are still ways to get involved. You can become a principal investigator or sub-investigator on an existing trial. Below are some resources for finding currently ongoing research projects or collaborators for a project.

Find Clinical Trials & NIH Collaborators

Clinical Trials.gov

A registry and results database of publicly and privately supported clinical studies of human participants and conducted around the world. You can search for current research projects by condition/disease, medication, location, etc.

CenterWatch

A global source for clinical trials, drug approvals, study grants, analysis information for both patients and professionals.

NIH RePORTER

A repository of NIH-funded research projects and resulting publications and patents. Provides researchers with a detailed summary of U.S. government funded awardees, amount of award, years funded, principal investigator, institution and much more information that can be used for establishing potential collaboration. Link to list of open patient trials St. David’s.

Collaborations

Collaborations are key in addressing the global health challenges facing our society. St. David’s HealthCare Office of Research understands that and thus collaborates, through its leading researchers, with a number of major medical centers and universities both nationally and internationally. Together, we address critical healthcare issues through research. In particular, the Office of Research has established strong connections through our physicians in research collaborations to bring breakthrough research, innovation, advanced technologies, and clinically tested devices, therapeutics, and medications to improve patient care.

If you would like discuss how to further a potential collaboration please contact us at Info@stdavidsresearch.com

Once you have identified a project, there are many factors to consider, including:

Resources, Budget, and Contracts

Need to use a St. David’s hospital, clinic, or facility as a site in your project? The Office of Research can help you:

  • Ensure we have the necessary resources to support your project
  • Make sure that your grant or sponsor budget has adequate funding
  • Ensure that you have the necessary contracts with St. David’s
  • Provide clinical research training to your research staff

Staff and Investigator Training

Do you and your research staff that will be working at St. David’s HealthCare have current human subjects protection training? St. David’s maintains a robust Human Research Protections Program that includes assuring research coordinators are appropriately trained in human subjects research. Please visit our Training Page for more information.

IRB Oversight

Research activities involving human subjects are legally required to be monitored by an Institutional Review Board. St. David’s HealthCare IRB provides oversight for research at St. David’s hospitals. Before you submit your study to the IRB, you will need to have the required documentation for submission. Please visit our IRB Page for more information.

Find Funding

The process of finding funding is dependent upon the researcher and his or her project team. Office of Research resources are available to help you and your collaborators explore the wide range of funding opportunities through the U.S. federal government, foundations, foreign governments, non-profit institutions, and corporations. Finding potential academic and industry collaborators often requires navigating funding announcements, identifying best match, and then establishing potential collaborations through follow-up contacts, all which can be challenging.

While the Office of Research generally does not write or apply for grants or contracts on behalf of researchers, we can help you explore external funding opportunities to get your project going. Please visit our Resources for more information.

Once you are ready to begin your research, the Office of Research will help you to get started with obtaining required approval documentation. We work in tandem with the IRB and the Research Committee to allow a streamlined review process. Both the IRB submission and the Research Committee submission documents will be submitted through our web portal, IRBNet. This allows the IRB to share important submission and approval documents with the Research Committee in order to provide an efficient review. Full research review is a two-stage process where you will first need obtain IRB approval and then you may seek approval from the Research Committee.

IRB Review

Federal regulations require research activities involving human subjects to be monitored by an Institutional Review Board (IRB) to ensure the research does not impact the rights and welfare of human research subjects. St. David’s HealthCare Institutional Review Board (SDH IRB) is available to oversee research conducted by medical staff or employees who are affiliated with St. David’s HealthCare, even if the research takes place outside of a St. David’s location.

Before you submit your study to the IRB, you will need to complete a new study application packet that includes the required documentation. Please visit our IRB Page for more information and directions to submit your research to IRBNet.

Research Committee Review

If your research will occur at a St. David’s HealthCare hospital, then St. David’s Research Committee serves as a final review for completeness of documentation, feasibility and adequacy of resources, and IRB approval. Once you have obtained IRB approval, you will be asked to submit a Supplemental Research Committee Application Form along with any necessary documentation (executed contracts, etc.) via IRBNet. The Office of Research will then share your IRB application and approval with the Research Committee for review. You will be contacted via email if there are any outstanding questions regarding your submission, and once complete, your submission will be reviewed at the next available Research Committee meeting.

Once both the IRB and the Research Committee (if necessary) have approved your research study, you will receive corresponding in writing that you are approved to begin your research.   If your research is not occurring at a St. David’s hospital, then the IRB approval letter is generally sufficient to being your research.   Please feel free to contact the Office of Research if you have any questions.

Project Management

Once you have obtained Research Committee and IRB approval, you are approved to begin your research. However, before you start, you may want to review the following to be sure you have everything in place:

  • Obtain IRB approval for any recruitment materials or other materials to be seen or heard by potential study subjects (advertisements, screening questionnaires, etc.);
  • Be sure your staff have necessary GCP and protocol training;
  • Provide inservices for floor staff, as necessary, for them to understand your research project;
  • Clinical resource coordination – ensure you review policies and obtain necessary approvals for any hospital procedures for video, specimens, or other activities that will take place;
  • Ensure you have monitoring plans and procedures to ensure the quality of your data;
  • Ensure your research team is credentialed, as necessary.

Award Management

St. David’s HealthCare Office of Research can help you successfully manage your grant award or clinical trial.

Changes in Conflict of Interest (COI)

During the initial review of your study, the IRB will ask you to declare any COIs. It is imperative that you report any new COIs to both the IRB and the Research Committee. Please review your New Study Submission Form periodically. If you think your COIs need updating, call us with any questions you may have.

Reports to IRB

Please consult your approval letter to see what reports are required by the IRB or contact us if you have questions. Any changes to protocol, updated drug/device literature, modifications to or translations of Informed Consent Forms, changes to risks, addition of vulnerable populations (e.g., unanticipated problems, significant protocol deviations, failure to obtain consent, or termination/suspension of research) must be reported to the IRB in a timely manner.

FDA or OHRP Correspondence

If one of your research sites is inspected by the FDA or OHRP, you must report this to the IRB. If you receive a FDA Form 483, this will also need to be submitted for review along with your response and any related follow-up correspondence. If you need any documentation during an audit such as this, let us know and we will be happy to help.

Close-out

Once the study is over, you may need to finalize queries with the sponsor and ensure proper disposal of any leftover investigational drugs or devices according to your approved protocol. You will be required to submit a Final/Close-Out Site Report to the IRB at the end of your study once all study procedures have been completed with study subjects and once all data has been collected. In order to comply with federal regulations, you must keep all records of the study for a minimum of three years after the research is completed.

Explore Funding Resources

Search Comprehensive Databases for Federal Grants

Grants.gov Researchers can find and apply electronically for federal grants. Grants.gov is a central storehouse of more than 1,000 grant programs with access to approximately $450 billion in annual awards offered by all federal grant-making agencies.

Pivot a comprehensive global source of funding opportunities across all disciplines where researchers can search and sign-up for email alerts. Major academic institution collaborators usually have a subscription to track these funding opportunities and you must be affiliated with one of them to subscribe.

FedBizOpps.gov A single government point of entry for federal government procurement opportunities and amendments to existing requests for approval (RFA)

Receive Federal Agency Specific Alerts

Some of the more common government funding for medical research and innovation allows sign-ups for email alerts when a new funding opportunity becomes available. Some of the most popular sites are:

National Institutes of Health The official and largest funding source for NIH medical and behavioral research grant policies, guidelines and funding opportunities in the world. Researchers can also subscribe to the NIH Guide for updates here <https://grants.nih.gov/grants/guide/listserv_dev.htm>

National Science Foundation NSF funds research and education in the fields of science and engineering. NSF Update is a sign-up email alert service for researchers with upcoming due dates for funding opportunities, news and publications. Sign up here.

Defense Advanced Research Projects Agency (DARPA) Research and development office for the Department of Defense research proposal solicitations.

National Aeronautics and Space Administration (NASA NSPIRES) Solicits research through release of announcements in a wide range of science and technology disciplines. Examples include robotics for human performance and medical applications.

Office of Naval Research Contracts and Grants Looks for innovative scientific and technological solutions and puts out solicitations through broad agency announcements (BAAs) and funding opportunity announcements (FOAs). Research priorities include grants for advances in autonomy, human-machine teaming, command and control, training and education, human performance optimization, protective equipment, medicine, neurosciences, and bio-engineered systems.

State Department Global partnerships, education and Fulbright Scholar Program, including public-private partnership (P3) Impact Awards in areas such as health and well-being, economic growth, industry, innovation and infrastructure.

SBIR/STTR Information about SBIR/STTR grant opportunities when researchers are collaborating with small high-tech companies and future entrepreneurs to understand and make the most of the federal SBIR and STTR research funding.

Search Non-Federal Grants Databases

A majority of sponsored grant funding comes from federal sponsors. However, funding is also received from non-federal grant makers, including foundations, institutes, and societies. Here are links to the websites for a number of non-federal grant sponsors:

Alfred P. Sloan Foundation
American Cancer Society
American Heart Association
Andrew Mellon Foundation
Bill and Melinda Gates Foundation
Cancer Research Foundation
Carnegie Corporation
Ellison Medical Foundation
Ford Foundation
Helen Hay Whitney Foundation
Howard Hughes Medical Institute
Human Frontier Science Program
Juvenile Diabetes Foundation International
Kirsch Foundation
John D. & Catherine T. MacArthur Foundation
Life Sciences Research Foundation
Pew Charitable Trusts
Robert Wood Johnson Foundation
Rockefeller Foundation
Spencer Foundation
William K. Kellogg Foundation

Please note that while the above list is not exhaustive, the Foundation Center’s Grantmakers is an online site that displays links to more than 2,000 grantor websites.

Search Clearinghouses

The Foundation Center: Online source of more than 60,000 private foundations, corporate grant-makers, grant-making public charities, and community foundations in the U.S. The Foundation Center provides annotated links to grantor websites and one can search for a private foundation’s tax return.
The Grantsmanship Center (TGCI): Courses on grant training and proposals
The Chronicle of Philanthropy: Partners with grantstation to provide grant opportunities for private and international grant makers. Chronicle of Philanthropy is a subscription with an online resource center.
proposalCENTRAL: An e-grant-making site shared by multiple government, non-profit, and private grant-making organizations. It lists hundreds of funding opportunities from several non-federal sponsors.
GrantsNet: A one-stop resource to find funds for training in the sciences and undergraduate science education. This service is free.
Health Research Funding: Designed to bring researchers with peer-reviewed, worthwhile, unfunded projects together with patient advocacy organizations and other funding sources.

Stay Informed with e-Pubs / News / Library

Below is a sample of publications related to science, research, discovery, innovation and grants.

Science Online
Proceedings of the National Academy of Sciences
NSF E-Bulletin
Grants Resource Center of the AASCU
NIH Roadmap Shows a framework of the NIH priorities that it must address to optimize its entire research portfolio. It lays out a vision for a more efficient and productive system of medical research. It identifies the most compelling opportunities in three areas: new pathways to discovery, research teams of the future, and re-engineering the clinical research enterprise.
National Library of Medicine (NLM) Includes vast resources and NIH tools including PubMed as well as NIH Library and National Institute of Environmental Health Sciences Library.

Grant Writing Resources

Hints for Writing a Successful NIH grant: Links to the many NIH divisions such as the National Cancer Institute. On individual websites are materials for grant writing directly related to each division.

NIAID’s How to Write An Original Grant Proposal: https://www.niaid.nih.gov/grants-contracts/sample-applications Sample of NIH NIAID R01 Grant applications and summary statements with grant tutorials to help biomedical investigators, especially those new to the process, plan, write, and apply for the basic NIH research project grant, the R01.

Tips for Getting Started: Solid information from the University of North Carolina about the grant-writing process, including pre-writing, organization, budget planning, etc.

NSF’s Guide for Proposal Writing Advice and suggestions to improve proposals were collected from a variety of sources, including NSF Program Directors, panel reviewers, and previously successful grantees.

Industry and International Research Funding

St. David’s HealthCare Office of Research can assist you with contract negotiation, agreements, and more for your industry and international collaborations.

Research sponsored by industry is company specific and researchers need to visit the company’s website for details on current funding initiatives. The Office of Research can assist with reviews, proposals and with logistics, contract terms, research costs, export control, intellectual property matters, proprietary rights, legal issues and material transfer and nondisclosure agreements. The Office of Research works with St. David’s Partnership to make this seamless for our researchers. Our office works with researchers, including academic and industry partners, to ensure that agreements are in accord with university policies, hospital policies and procedures, as well as federal regulations and requirements.

Research projects are international when sponsored by a foreign government or by a private entity based in a foreign nation, regardless of where the work is performed. International sponsors may be foreign governments and governmental agencies, foreign universities, non-U.S. domiciled companies (defined as a company legally organized and originally incorporated under the laws of a foreign country), and non-U.S. non-governmental organizations and foreign public charities.

Export Control: International sponsored research follows the same process used for domestic sponsored research, with one noteworthy exception. Whether you are a St. David’s HealthCare employee working overseas or a foreign national working at St. David’s HealthCare, you will be required to comply with export control restrictions. The Office of Research highly advises that the Office receive proposals at least 30-60 business days before the sponsor deadline to allow for this review.

Please contact the St. David’s HealthCare Office of Research at: Info@stdavidsresearch.com