FDA WARNING_LETTER - Salem Hospital IRB - June 25, 2012

The FDA issued a Warning Letter to Salem Hospital IRB following an inspection from June 6-25, 2012, which identified objectionable conditions regarding human subject protection. The inspection, part of FDA's Bioresearch Monitoring Program, found the IRB did not comply with 21 CFR Parts 50 and 56.

Key violations include: 1. **Inadequate Documentation (21 CFR 56.115(a)(1) and (4))**: The IRB failed to retain copies of original and revised protocols, informed consent documents, protocol amendments, progress reports, and correspondence. 2. **Lack of Written Procedures (21 CFR 56.108(a) and (b), 56.115(a)(6))**: The IRB lacked written procedures for initial/continuing review, managing changes in approved research, and reporting noncompliance or suspensions. 3. **Inaccurate IRB Member List (21 CFR 56.115(a)(5))**: The IRB failed to maintain an updated list of members with required details, leading to an inability to determine if the IRB was duly constituted. 4. **Improper Meeting Quorum (21 CFR 56.108(c))**: Research was approved at convened meetings without a majority of members present, including a nonscientific member, due to recusals. 5.