Many research efforts supported by the NIH do not include human subjects. Final research data from studies that generally do not contain disregard for humans should not be limited by restrictions deemed necessary and appropriate for humans. FDP data models can be used. Where research involves human subjects and data needs to be shared, the application should examine how participants` rights and confidentiality are protected. In the “Human Topics” section of the notification, the applicant should consider the potential risks to research participants associated with data exchange and the steps taken to address them. An agreement on the use of data (or the transfer of material) is required when researchers at the university or associated companies are considering conducting research involving data/sample sharing with an external entity (whether a supplier or recipient), when the data/samples contain protected personal data (protected personal data) or protected health information. Health information protection rules (the HIPAA data protection rule) allow for limited data sets for the use and disclosure of protected health information for research, health or health operations. Lead investigators who wish to exchange data or samples with protected personal data or a protected TH should stick to the following questions: problems related to proprietary data may also arise if co-financing by the private sector (e.g. B the pharmaceutical or biotechnology industry) is conducted with appropriate disclosure restrictions.
NIH recognizes the need to protect patentable data and other proprietary data. Any restrictions on the exchange of data resulting from co-financing agreements should be reviewed in the “Data Exchange Plan” section of an application and reviewed by program staff. While NIH understands that an institution`s desire to exercise its intellectual property rights may justify the need to delay the disclosure of research results, a 30 to 60-day delay is generally considered a reasonable period of time for such activity.