# Presentation: 381176

## Public Health Research...or is it practice?

- Kathleen M. MacQueen, PhD, MPH
- Emerging Issues in Research with Human Subjects
- NIEHS, Research Triangle Park, NC
- September 23, 2005

## Overview

- What is public health?
- Practice v. research considerations
- 2 case studies

## “Public health is what we, as a society, do collectively to assure the conditions in which people can be healthy.”

Institute of Medicine.  
The Future of Public Health.  
Washington, DC.  National Academy Press, 1988, p. 1

- Institute of Medicine.
*The Future of Public Health.*
- Washington, DC.  National Academy Press, 1988, p. 1

- Hygeia, Greek goddess of health.
- CDC, Atlanta, GA.

## Public Health

- 6 Purposes:
- Prevents epidemics and the spread of disease
- Protects against environmental hazards
- Prevents injuries
- Promotes and encourages healthy behaviors
- Responds to disasters and assists communities in recovery
- Assures the quality and accessibility of health services

**10 Essential Services:**
**The Practice of Public Health**

## Public Health Practice vs. ResearchA Report for Public Health PractitionersIncluding Cases and Guidance for Making Distinctions

- James G. Hodge, Jr., J.D., LL.M.
- Lawrence O. Gostin, J.D., LL.D. (Hon)
- With the CSTE Advisory Committee

- Council of State and Territorial Epidemiologists
- May 24, 2004
- http://www.cste.org/pdffiles/newpdffiles/CSTEPHResRptHodgeFinal.5.24.04.pdf

## Public health research

- Generates knowledge that benefits those beyond the participating community who bear the risks of participation
- Explore hypotheses
- Advance current knowledge
- Contribute to the welfare of persons beyond the study itself
- IRBs are legally & ethically responsible for protections

## Public health practice

- Collection & analysis of identifiable health data by a public health authority
- For purpose of protecting the health of a particular community
- Benefits & risks primarily designed to accrue to the participating community

## “The responsibility to protect human participants in public health practice is addressed through federal, state, and local administrative and regulatory oversight and protections.”

- CSTE Report on
*Public Health Practice & Research*

## “No set of principles or checklist may completely distinguish between public health research and practice.”

- CSTE Report on
*Public Health Practice & Research*

## Criteria that don’t work

- “Primary intent”
- Who is performing the activity
- Intent to publish
- Urgency
- Funding source
- Data collection methods

- CSTE Report on
*Public Health Practice & Research*

## Public health practiceCharacteristics

- Legal authorization for activity at federal, state, or local levels
- Governmental duty to perform activity
- Performance or oversight by governmental public health authority with public accountability
- Legitimate authority for non-voluntary participation
- Supported by principles of public health ethics that focus on populations while respecting the dignity and rights of individuals

- CSTE Report on
*Public Health Practice & Research*

## Consent vs. coercion

- Does a coercive intervention truly reduce aggregate health risks?
- What, if any, less intrusive interventions might reduce those risks as well or better?

- Gostin, Lawrence O.  *Public Health Law: Power, Duty, Restraint.*  Berkeley, University of California Press, 2000

## Imposing vs. expressing

- Imposing community involves mandating or compelling action through coercive measures.
- Expressing community involves taking steps to express solidarity with individuals, to protect their interests, and to gain their trust.

- Childress JF et al.  Public health ethics: mapping the terrain. *Journal of Law, Medicine & Ethics* 2002;30:170-178.

## Case Studies

- Tuberculosis in a prison
- Evaluation of a program for improving HIV prevention services
- Originally presented & discussed at a CDC workshop in January 2002
- From: MacQueen KM, Buehler JW.  Ethics, practice, and research in public health.  *AJPH* 2004;94(6):928-931.

## TB in a prison: Setting

- HIV dormitory in a state prison
- 300 HIV+ inmates exposed to infectious inmate
- 30 developed active TB
- “Large number” had documented conversion of TB skin tests
- Anergy possible in others
- Potential for rapid progression from TB infection to active disease in HIV+’s
- CDC officially requested to assist in handling the outbreak

## TB in a prison: Treatment options for latent TB

- 9-month isoniazid or 2-month pyrazinamide + rifamycin-class drug (usually rifampin)
- Approx 10 inmates released per month
- Potential loss to follow-up
- 2-month course therefore optimal
- Rifampin contraindicated with some HIV medications
- Substituted with rifabutin
- Interactions with rifabutin occur but dose adjustment recommendations not known for all antiretrovirals in use at prison
- Serum rifabutin levels monitored during outbreak response to maintain safe & effective levels

## TB in a prison: Uses of data

- Intervention constituted best practice
- Objective of monitoring was to provide optimal medical care for inmates
- Systematic safety & effectiveness data of nonstandard treatment regimes generated
- Assisted in providing optimal care to inmates
- Led to revisions of recommendations on dose adjustments for rifamycins used combination with ARTs
- MMWR, Vol 49, No 09;185, 03/10/2000

## TB in a prison:Public health research?

- Generates knowledge that benefits those beyond the participating community who bear the risks of participation
- Explore hypotheses
- Advance current knowledge
- Contribute to the welfare of persons beyond the study itself

## TB in a prison:Public health practice?

- Collection & analysis of identifiable health data by a public health authority
- For purpose of protecting the health of a particular community
- Benefits & risks primarily designed to accrue to the participating community

## HIV program evaluation: Background

- CDC funded 5 health departments to develop HIV prevention & referral services for HIV+’s
- Health departments contracted with CBOs for provision of most services
- Grantees encouraged to tailor interventions to local circumstances
- Funding supported local evaluations of effectiveness of interventions
- Technical assistance provided via project-wide contract with an evaluation center
- Anticipated that evaluations could also generate lessons learned useful elsewhere

## HIV program evaluation: Research/practice determinations

- CDC/NCHSTP determined evaluation component to be practice
- Some health departments determined evaluation was research
- IRB review delayed implementation
- at one site by a year
- Formative pilot data lost at one site when IRB determined appropriate approvals were not in place

## HIV program evaluation:Public health research?

- Generates knowledge that benefits those beyond the participating community who bear the risks of participation
- Explore hypotheses
- Advance current knowledge
- Contribute to the welfare of persons beyond the study itself

## HIV program evaluation:Public health practice?

- Collection & analysis of identifiable health data by a public health authority
- For purpose of protecting the health of a particular community
- Benefits & risks primarily designed to accrue to the participating community

## Summary

- Public health practice shares many characteristics with research
- E.g., systematic, data-driven, empirically-based
- Public health practice is authorized and governed by local, state, and federal laws
- Oversight and accountability mechanisms in place
- Public health ethics includes an emphasis on communal good that is generally lacking in research ethics
- Public health research is still research
- Human subjects protections may apply