Sara Brand Associate Director Research Compliance Administration

Communicate recent changes in policies and procedures from recent AAHRPP re-accreditation Detailed Self-Assessment Accreditation Site Visit in December 2007 Report from Self-Assessment and Site Visit Necessitated Changes Accreditation Council meets in March 2008 to decide outcome NOTE: This is not a detailed explanation of how the changes will be implemented New policies and procedures and forms posted on website March 2008

Standard Operating Procedures Meeting Deadlines 5:00pm New Forms Request Forms for Vulnerable Populations Continuing Review Forms Noncompliance Reporting Form IND/IDE Checklists Human Subjects Research Engagement Examples and Requirements

Section III: Performance Sites III.B – List other facilities where research-related procedures will be performed (pharmacy, nursing, pathology, etc.) and ensure these entities are adequately informed Section IV: Subject Population Questions specific to each subject population removed and included on new request forms “Reasonable expectation of enrollment” Section VIII: Protection Procedures Clarification re: information the IRB wants to see if IUPUI is the lead site of a multi-site study Section IX: Data Safety Monitoring Plan Checkbox for repository/database protocols

Section X: Confidentiality & Safeguards Study Manager (data recording/collection method and measure for safeguarding information) Section XIV: Informed Consent Process Questions added re: who and how informed consent will be obtained (training, consent interview and consent document language) Checkboxes for describing steps to minimize possible coercion or undue influence Clarification re: waivers of informed consent and modifications to consent document Financial Conflict of Interest section removed Section XX: Investigational Drugs/Devices Clarification re: when IND or IDE is required

Pregnant Women, Human Fetuses and Neonates, Prisoners, and Children SOPs (+) Cognitively Impaired = Vulnerable Populations SOP

New Request Forms Prisoners, Children, Pregnant Women, Cognitively Impaired VA Requirements No research involving prisoners, pregnant women, or children unless waiver granted by the Chief R&D Officer Additional questions/requirements re: surrogate consent for incompetent individuals and individuals with impaired decision-making capacity Research Involving Children Assent/Waiver of Assent: some, all, or no children Parental Permission/Waiver of Parental Permission Policy when a child reaches the legal age of consent

Guidance re: when IND or IDE is required IND and IDE Checklists Guidance when investigator is the holder of the IND or IDE (i.e. sponsor) Formal face-to-face presentation Eventual on-line presentation Validation of IND or IDE Number Sponsor protocol; or Communication from FDA

Regulations Unanticipated Problems (45 CFR (b)(5) & 21 CFR (b)) Adverse Events (21 CFR & 21 CFR 812.3) Guidance OHRP (Jan ) FDA (Apr 2007) – Draft For more info… OHRP Guidance: FDA Guidance:

IUPUI/Clarian Policy for Prompt Reporting of UPs Adverse Events: Unexpected, related, greater risk of harm, revision to protocol/IC Other UPs: Major Protocol Deviations, Suspensions or Holds Report on Prompt Reporting Form Report within (5) business days (both internal and external) If IRB determines internal event represents UP, report to federal agencies (OHRP, FDA) and other entities, as applicable

IUPUI/Clarian Policy on Prompt Reporting of Noncompliance Report all noncompliance Report on Noncompliance Reporting Form Report with (5) business days If IRB determines noncompliance to be serious or continuing, report to federal agencies (OHRP, FDA) and other entities, as applicable

Continuing Review Study not reviewed by expiration date….automatically suspended List of subjects given to IRB and COS at VA to determine if research can continue on current subjects Determine Level of Risk Based on level of risk, IRB determines when patient medical records should be flagged re: participation in research Minutes will reflect this decision Enrollment of Non-Veterans Justification Regulations pertaining to veterans in research also pertain to non-veterans enrolled in VA research

Waiver of Consent for Planned Emergency Research is prohibited at the VA Waiver of Authorization/Informed Consent for Recruitment Office of Research Oversight (ORO) Guidance (10/09/2007) Accessing patient records for recruitment into research requires the IRB to approve waivers of authorization and informed consent for recruitment (even when accessing own patients’ records

Questions?