OFFICE OF RESEARCH AND DEVELOPMENT (ORD)

Office of Research and Development

Office of Research and Development
The Queen’s Medical Center
1301 Punchbowl Street, UHT 508
Honolulu, HI 96813

Policies and SOP

Home » RIRC/Regulatory » RRO Policies and SOP

Policies

Policies	Format
Case Report Policy	PDF
Coverage Analysis Need Policy	PDF
Visit QHS’ Policy website for all other updated policies	Website

SOP

SOP 100 Administrative	Format
SOP 101 Policies and Procedures Management	Word
SOP 102 Training and Education	Word
SOP 103 Management of RRO Personnel	Word
SOP 104 IRB Authority and Signatory Authority	Word
SOP 105 Non-Federal Research	Word
SOP 106 Final Rule Implementation	Word

SOP 200 Institutional Review Board	Format
SOP 201 IRB Management and Composition	Word
SOP 202 Duties of RIRC Member	Word

SOP 300 IRB Process	Format
SOP 301 Research Submission Requirements	Word
SOP 302 Admin Review and Distribution of Materials	Word
SOP 303 Review of Submissions	Word
SOP 304 Convened IRB Meeting	Word
SOP 305 Documentation of IRB Discussion, Decisions, Findings	Word
SOP 306 Ad Hoc Reviews	Word

SOP 400 Review Categories and Submission Types	Format
SOP 401a Non-Human-Subject Research NHSR	Word
SOP 401b Exempt Review	Word
SOP 402 Expedited Review	Word
SOP 403 Criteria for IRB Approval	Word
SOP 404 Continuing Review	Word
SOP 405 Amendments	Word
SOP 406 Final Projects Reports	Word
SOP 407 RIRC Actions to Approve Or Disapprove	Word
SOP 408 Medical Case Reports	Word
SOP 409 Alternative IRB Arrangements	Word
SOP 410 Appeal of IRB Decisions	Word

SOP 500 Special Circumstances	Format
SOP 501 Vulnerable Populations	Word
SOP 502 Clinical Research	Word
SOP 503 Genetic Research	Word
SOP 504 Emergency Use	Word
SOP 505 Expanded Access	Word

SOP 600 Research Participant	Format
SOP 601 Participant Enrollment	Word
SOP 602 Payment for Participation	Word

SOP 700 Informed Consents	Format
SOP 701 Informed Consent	Word
SOP 702 Documentation of Consent	Word
SOP 703 Waiver of Consent	Word
SOP 704 Assent	Word

SOP 800 Protection of Rights	Format
SOP 801 Conflict of Interest	Word
SOP 802 Privacy and Confidentiality	Word

SOP 900 Reporting and Monitoring	Format
SOP 901 Unanticipated Problems	Word
SOP 902 Deviations	Word
SOP 903 Non-Compliance	Word
SOP 904 Administrative Hold	Word
SOP 905 Reporting	Word
SOP 906 Participant Protections	Word
SOP 907 Complaints	Word
SOP 908 Routine and For Cause Audits	Word