Emerging SACHRP Issues

K. Lynn Cates, MDAssistant Chief Research & Development OfficerDirector, PRIDEOffice of Research & DevelopmentDepartment of Veterans AffairsOctober 17, 2005

SACHRP• Secretary’s Advisory Committee on Human

Research Protection, HHS*• Purpose

• To provide expert advice & recommendations to the Secretary of HHS & the Assistant Secretary for Health on issues and topics pertaining to or associated with the protection of human research subjects.

*Authority: 42 U.S.C. 217a, section 222, PHS Act

Emerging SACHRP Issues• Federal Adverse Events Taskforce

(FAET)• IRB Workshop

Federal Adverse Event Taskforce• Charge

• Propose specific means for promoting harmonized and streamlined federal requirements for reporting, analyzing, and communicating adverse events in clinical research.

Federal Adverse Event Taskforce• Member Agencies

• AHRQ• CDC• DoD• FDA• OHRP• NIH• VA

Federal Adverse Events Taskforce• Objectives

1. Common terms & definitions2. Common AE report forms3. Common workflow patterns4. Communications

1. Common Terms & Definitions• Reduce variability in language

• e.g., “unanticipated problem” vs. “adverse event” or “unanticipated” vs. “unexpected”

• Align federal agencies’ policies & guidance

2. Common AE Report Forms• Basal Adverse Event Report (BAER)

• Develop a baseline set of core information adopted by all agencies

• Address individual agency needs by adding extra fields

3. Common Workflow Patterns• Develop a best practices blue print for

reporting, analyzing, and applying AE data

AE Reporting in Multi-Center Clinical Trials: Trans-Federal Guidance

• Clarify regulatory requirements for reporting and reviewing adverse events from multi-center trials

• Outline criteria for when AE reports should be forwarded to other sites

• Work with industry and academia

4. Communication• Effective communication

• Enhance subjects’ safety• Further scientific knowledge• Earn public trust

FAET Focus Groups• Examine current practices at the local level

• What safety information does an IRB receive and when?

• How is the safety information analyzed?• How and to whom is it communicated?

• Identify Problem Areas• Does government contribute?

• Define what needs to be done

VA Local Management of Adverse Events:Mission• Ensure that local management of

unanticipated problems in research, including adverse events, assures maximal protection for VA research participants, and complies fully with all laws, regulations, and standards.

VA Local Management of Adverse Events:Charge• Identifying/Reporting

• What should be reported?• When should it be reported?• Where should it be reported?

• Monitoring• Who monitors?• What is monitored?• What trends/patterns require further

action?

VA Local Management of Adverse Events:Charge• Research v. Patient Safety• Corrective Action

• Who takes action?• What are appropriate actions?• When does it become research

misconduct?

Alternatives to Current IRBs• IRB Workshop• VA Central IRB• “What is Research?” Panel

IRB Workshop• Steering Group

• OHRP• NIH• AAMC• ASCO• VA

• November 17-18, 2005, Washington, DC

IRB Workshop• Invitational, exploratory meeting• Diverse perspectives

• IRBs• Academic and community-based investigators• Attorneys• Patients• Ethicists• Industry officials• Senior university and medical school research

administrators

IRB Workshop Topics• Institutional responsibilities• Ways to reduce burdens

(especially for multi-site trials)• Costs and other barriers • The federal policy framework relevant

to new IRB arrangements

IRB Workshop: Follow-on Activities• Report for SACHRP on

• The suitability of alternative models of IRB review for different research contexts

• Strategies to address barriers• Public meeting

VA Central IRB• Review multi-site VA studies• Assure quality by ensuring

appropriate representation (scientific, ethical, “community”)

• Enhance efficiency

VA Central IRB:Timeline

Fall 2005• Implementation strategies Policies & procedures• Begin recruitment process for IRB Administrator• Site visits to NCI CIRB, Western & Chesapeake

Winter 2005-6• IRB Chair and field input

Summer & Fall 2006• Training – local accountability

Alternatives to Current IRB System“What is Research?” Panel

• Responsibilities• Review multi-site projects to determine

whether or not they are “research”• Develop guidance for the field on “What

is Research?” (vs. Quality)• High level representatives from ORD,

ORO, Ethics, Patient Services, Quality