There are additional circumstances that may prevent the Company from sharing the requested data.
- The Company may not have the legal authority because the product was co-developed with a partner or obtained from an external partner under a contract that does not permit the disclosure.
- It may be difficult to ensure protection of the privacy and confidentiality of research participants. For example, small trials (e.g., with less than 50 participants) or studies of rare diseases may have too few participants to prevent re-identification of individuals.
- The informed consent may not allow for data sharing.
- There may be substantial practical constraints to providing access to the data (for example, size and complexity of databases or resources required to retrieve data from repositories and redact personally identifiable information from relevant documents).