• An individual (or entity, where permitted) who both initiates and conducts, alone or with others, a clinical study, and under whose immediate direction the drug product is administered to, dispensed to, or used to treat a patient.
• In the case of a non-interventional/observational, human biological sample, or non-clinical study, an individual (or entity where permitted) who initiates designs and implements, alone or with others, a research effort, and under whose immediate direction the scientific systematic investigation is conducted.

• Designing and conducting the scientific investigation
• Complying with institutional requirements where the study will be conducted and all relevant laws, regulations and guidelines for research.
• Reporting safety data to regulatory authorities and Johnson & Johnson Innovative Medicine, as required.
• Registering the clinical study on a public website such as www.clinicaltrials.gov, as required.
• Exercising best efforts to publish results in peer-reviewed journals and/or presentation at a scientific congress.

• A completed Research Application
• Investigator Curriculum Vitae
• Budget (when funding is requested)

• Download an example template of the Clinical Research Worksheet
• Download an example template of the Non-Clinical Research Worksheet  

NOTE: All submissions must be via the website. Email submissions are not accepted.

• Click here to make a submission
• Create an account
• Create your user profile
• Complete the online Research Application

NOTE: The Johnson & Johnson Innovative Medicine IIS Review Committee requires all application submittals to be made in English.

Each request will go through Johnson & Johnson Innovative Medicine internal review which consists of a cross-functional team composed of personnel from Regulatory, Clinical and Medical Affairs, Statistics, and Health Care Compliance. A decision is based on criteria in the areas of, but not limited to, scientific merit, strategic fit with the evidence generation plan of Johnson & Johnson Innovative Medicine, investigator research experience, and adherence to Good Clinical Practice / Good Laboratory Practice.

You will be notified via e-mail of the decision. If your Research Application is approved you will be asked to submit study documents for final review. These documents include:

• Full protocol
• Informed consent form, if applicable
• Itemized budget (when funding is requested)

Once these documents have been approved and a research agreement has been fully executed, agreed-upon funding and/or product will be released according to the terms in the research agreement.