What is an Investigator-Initiated Study?
An Investigator-Initiated Study (IIS) is a research effort in which the investigator designs and implements the study and the investigator or the institution acts as the study sponsor, not Johnson & Johnson Vision Care, Inc. (JJVCI). As the sponsor, the Investigator assumes all responsibilities for complying with applicable regulatory requirements. IIS may be supported by VISTAKON® in the form of product, funding, and/or technical input.
What are the responsibilities of the Investigator?
- Designing and conducting the scientific investigation
- Complying with institutional requirements where the study will be conducted and all relevant laws, regulations and guidelines for clinical and pre-clinical research
- Reporting safety data to regulatory authorities and JJVCI as required
- Registering the clinical study on a public website such as www.clinicaltrials.gov, as required
- Providing JJVCI with interim and final research summary reports, a proposed publication plan and a draft manuscript, as applicable.
What is needed for an application?
- A completed IIS Application Form
- A study protocol or proposal that includes at a minimum the study objectives, background and rationale, clinical population description and size, study plan, projected study timeline, and amount of product/funding requested
- Investigator Curriculum Vitae
- Itemized budget (when funding is requested)
How do I submit an application?
Please contact the Clinical Research Review Committee (CRRC) Administrator at RA-VISUS-IISRequests@its.jnj.com or call (904) 443-1525 for an Application Form and additional instructions. Once the Application Form has been completed, it should be emailed to the CRRC Administrator, along with documents referenced in the submittal package.
NOTE: The Clinical Research Review Committee of Johnson and Johnson Vision Care, Inc. is located in the United States of America, and therefore requires all application submittals to be made in English.
What is the review process?
Each request will go through an internal review by the CRRC, which is a cross-functional team composed of personnel from several departments, including the Regulatory, Clinical & Medical Affairs, and Health Care Compliance (HCC) departments. A decision is based on criteria in the areas of strategic fit with the business plan of JJVCI, investigator research experience, scientific merit, adherence to Good Clinical Practice, etc. You will then be notified of the committee's decision regarding your study proposal.
What happens after my Study Proposal is approved?
You will be notified via e-mail and asked to submit study documents for final review. These documents include:
- IIS Research Funding Agreement
- IRB Approval Letter
- IRB-approved Informed Consent
- IRB-approved Full Protocol
Once these documents have been approved, agreed-upon funding, product, and/or technical input will be released according to the terms in the funding agreement. The study cannot commence until final approval is provided by the CRRC.