Phase 1 Preliminary Results – Survey of Publicly Available Research Ethics Resources at State and Territorial Departments of Health Michelle Conklin, B.S.

Phase 1 Preliminary Results – Survey of Publicly Available Research Ethics Resources

at State and Territorial Departments of Health

Michelle Conklin, B.S.1

Jenna Mullet1

David Perlman, Ph.D.1,2

1University of Pennsylvania2University of the Sciences, Philadelphia

What is Project Phobos?

• Phobos is one of the moons of Mars.

• But it also stands for:– Public health (the Ph)– Behavioral (the B)– Social (the S)

• Project Phobos will concentrate on research on these three areas of science and health.

Phases of Project PhobosPhase Description Type of Project

1 A preliminary analysis of publicly available information about the research ethics infrastructure and processes at State Departments of Health (DOHs).

Research

2 A survey of DOHs regarding their knowledge, use, and dissemination of guidance documents and processes for distinguishing public health practice from research.

Research

3 Educational and decision tools to be produced by Dr. Perlman's small business, E4 - Eclipse Ethics Education Enterprises, LLC and hopefully funded by small business grants and contracts from appropriate federal agencies.

Research and Development

4 A national, independent Institutional Review Board (IRB) for public health research and a human research protection program (HRPP) that will assist agencies and DOHs in properly distinguishing public health research and practice.

Research and Development

Introduction

• Parsing public health activities into human subjects research (which requires Institutional Review Board (IRB) oversight) and practice (which does not) can be vexing (Perlman, 2008).

Guidance Can Help

• The Center for Disease Control (CDC) and the Council of State and Territorial Epidemiologists (CSTE) have guidance to help.

Much Is Unknown

• Much is unknown about how states and territories distinguish research from practice, including: 1. who makes the determination; 2. the extent of awareness and use of CDC and CSTE

guidance; and 3. what infrastructure, policies, and procedures

exist.

Methods

• Using public information, we determined how many states and territories operate an IRB and have federalwide assurances (FWAs).

• We also searched state and territory Departments of Health websites for mention of research versus practice information.

FindingsState Territories

IRBs 39 1

Active FWA 44 3

Inactive FWA 5 0

Website mentions CSTE Report

4 0

Website mentions CDC Guidance

1 0

Website mentions both CSTE and CDC

4 0

Website mentions other information

13 0

Conclusions

• This data might indicate lack of awareness of this public health issue.

• This preliminary analysis helps to answer some of our research questions; however, conducting quantitative and qualitative surveys will help confirm these preliminary results and provide more detail.

Data Available OnlineOur results and data are publicly available at http://sites.google.com/site/projphobos.

Questions and Contact Information

David Perlman, Ph.D.Visiting Professor, University of

the Sciences, PhiladelphiaSenior Lecturer, Penn NursingAssociate, Penn Center for

[email protected]

• Interested in collaborations and ideas on funding Phase 2 of this project