Regulation and policy
A large, federal organization like the Centers for Disease Control and Prevention (CDC) seeks to put ethics into practice through policy and adherence to regulations. Thus, when I moved from serving as an IRB member to IRB co-chair to the human research protections manager for the entire agency, I further extended my schemas for applying irreducible judgements about ethics into standard procedures for tiered decision-making about the vast collection of research and nonresearch activities carried out by CDC or with CDC’s encouragement or support. I developed expertise in the Common Rule and other implementing regulations. I stepped into a rich history of deliberation and atonement—CDC itself had made mistakes—and helped to revamp CDC’s processes and policies for protecting personal rights and welfare. Once again, my scope expanded, this time from research and clinical investigations to a swath of scientific regulations covering privacy, confidentiality, and bureaucratic processes for managing the utility and burden of CDC’s information collections on the public.
Throughout my time in regulation and policy, I continued to bring a data analyst’s eye. I wrangled administrative data about review processes in an attempt to figure out how much collective effort those processes required, to discern where that effort might be reallocated in the cause of efficiency, and to measure whether the agency achieved measurable gains. (Spoiler: sort of.) I was thrilled to solve some tough analytic problems, but the call of research ethics pulled me back into clinical trials work.
40 works filed here — presentation 35 · publication 5. 5 prepared, 1 published on this site so far.
Within the domain: reg-admin Other administrative regulations · reg-research Regulation of research.
Selected works
- Heilig CM, Lee LM. Speeding up public health science: Reducing processing time under the Paperwork Reduction Act. Government Information Quarterly (submitted). 2012-02-24.On this site (opens in a new tab)
All 5 citable works filed here are in the works index.
In this domain
| year | form | subdomain | work |
|---|---|---|---|
| 2007 | publication | reg-admin |
pu_2007_report_omb-pra-privacy-confidentiality — Report of the OMB PRA/privacy/confidentiality assessment and strategy workgroup |
| 2010 | publication | reg-research |
pu_2010_policy_human-research-protections — Human Research Protections, CDC policy CDC-SA-2010-01 |
| 2010 | publication | reg-research |
pu_2010_policy_research-nonresearch — Distinguishing Public Health Research and Public Health Nonresearch, CDC policy CDC-SA-2010-02 |
| 2010 | publication | reg-admin |
pu_2010_report_omb-pra-time-in-process — OMB PRA Time-in-Process, October 2003–December 2009 |
| 2012 | publication | reg-admin |
pu_2012_heilig_speeding-public-health-science — Speeding up public health science: Reducing processing time under the Paperwork Reduction Act |
35 further works are filed here without a render — not cite-only, simply not yet prepared.
Crossings
Measured from the citation bridge, not asserted — presentations span, publications are pinned, and this is where that shows.
Reached from elsewhere — 1 deck(s) filed in other domains cite 1 works from this one.
| deck | filed in | cites | strength |
|---|---|---|---|
pr_20151029_dashes-dots_rug |
data-practice |
pu_2012_heilig_speeding-public-health-science — Speeding up public health science: Reducing processing time under the Paperwork Reduction Act |
high |
Cited, not served
Nothing in this domain is cite-only.
Hooks
2 of the 36 closed hooks sit on work filed here — Chad’s own first person, published as written.
pu_2010_report_omb-pra-time-in-process · tier full · ready
I wrote a report that came from an intensive workgroup effort. The report presents methods and results through several questions. The analytic core is a time-to-event model applied to administrative data on time in process.
pu_2012_heilig_speeding-public-health-science · tier full · ready
My colleague, Lisa M Lee, and I wrote the OMB-time-in-process methods and results into manuscript form so that we could share it with other scholars of administrative methodology. The version provided here was our fifth and final attempt — not accepted — to get it published. Some reviews were deemed out of scope, other reviews found it too parochial. Nonetheless, the work is in the public domain.