May state agencies disclose identifiable personal records and/or protected health information if subjects will not be recruited for research?
You should assume that the written authorization of subjects will be required, unless you document that the general criteria in state law and federal regulations for waiver of authorization are satisfied, and the WSIRB approves the waiver. If waiver of authorization is approved, identifiable personal records held by DSHS and DOH may be disclosed under the state research records law (RCW 42.48). The ability to disclose identifiable personal records without authorization also is governed by specific statutes and regulations that protect the confidentiality of information regarding children receiving child welfare services and persons receiving mental health services, alcohol/drug abuse treatment, and/or treatment for sexually transmitted diseases. Information needed for the IRB to approve a waiver of authorization is requested in the WSIRB Research Application, Appendix I, Section 4.
Related Questions
- May state agencies disclose identifiable personal records and/or protected health information if subjects will not be recruited for research?
- When is authorization to disclose protected health information (PHI) not required for research?
- Do research subjects have to authorize the use or their protected health information?
