Guidance for Human Subject Research The documents below provide guidance about the conduct of human subjects research at Kessler Foundation. If you have questions, please contact the IRB Office at [email protected]. IRB Policies and Guidance 5004 Initial Review of Research 5005 Continuing Review of IRB-Approved Research Projects 5006 Review of Amendments in Previously Approved Projects 5007 Suspension or Termination of IRB Approval 5008 Investigations of Unauthorized or Noncompliant Research 5009 IRB Record Keeping 5010 Submission of Reports Adverse Events 5010a Adverse Events Log 5010b Serious Adverse Events Report 5010c Unexpected Adverse Events Report 5011 Research Involving Minors as Participants 5012 Research Involving Pregnant Woman as Participants 5013 Subject Recruitment Advertisement and Incentives 5014 Cooperative Research 5015 IRB Confidentiality Policy and Procedures 5017 IRB Review of Research to be Preformed Off Site 5026 Research Misconduct 5034 Substituted-Surrogate Consent 5035 Obtaining Informed Consent from Human Subjects 5036 Registering for Clinical Trials 5037 Who May Serve as Principal Investigator and Mentor 5039 Multi-Site Collaborative Research Single IRB of Record Policy 5040 Calculation of Approval and Expiration Dates
