These pages discuss the special ethical considerations for research studies
that involve the use of private and sensitive information. Also see Category: Ethics in research.
2008
[[There is no material yet from my new site.]]
Outside resources:
- Gabrielle B. Goldstein, Jill H. Gordon. Don't Ask, Don't Tell? Transfer
and Sale of De-Identified Patient Data. Journal of Clinical Research Best
Practices. 2008;4(4). Excerpt: "Advances in bioinformatics and automated
laboratory equipment have made it possible to �mine� very large medical
databases and repositories of biological samples for information that will
ultimately produce novel therapies. Some physicians and hospitals have noted
the commercial implications of this research and have begun to charge
pharmaceutical companies and biomedical researchers fees for medical data and
biological specimens obtained during patient care. Commercialization of this
emerging area of research has made it more important to address issues that
relate to the original source of the information and samples: patients and
clinical research subjects (in this article, collectively referred to as
�patients�)." [Accessed December 5, 2009]. Available at:
http://firstclinical.com/journal/2008/0804_HIPAA.pdf.
- Office for Human Research Protections. Guidance on Research Involving
Coded Private Information or Biological Specimens. 2008. Excerpt: "This
document applies to research involving coded private information or human
biological specimens (hereafter referred to as �specimens�) that is conducted
or supported by HHS. This document does the following: (1) Provides guidance
as to when research involving coded private information or specimens is or is
not research involving human subjects, as defined under HHS regulations for
the protection of human research subjects (45 CFR part 46). (2) Reaffirms OHRP
policy (see OHRP guidance on repository activities http://www.hhs.gov/ohrp/humansubjects/guidance/reposit.htm
and research on human embryonic stem cells http://www.hhs.gov/ohrp/humansubjects/guidance/stemcell.pdf)
that, under certain limited conditions, research involving only coded private
information or specimens is not human subjects research. (3) Clarifies the
distinction between (a) research involving coded private information or
specimens that does not involve human subjects and (b) human subjects research
that is exempt from the requirements of the HHS regulations. (4) References
pertinent requirements of the HIPAA Privacy Rule that may be applicable to
research involving coded private information or specimens." [Accessed
December 5, 2009]. Available at:
http://www.hhs.gov/ohrp/humansubjects/guidance/cdebiol.htm.
- PSCA International. Privacy needed for patients' data. Excerpt:
"Approximately one half of patients and the general public believe that
identifiable patient data should never be used for research without consent.
Whilst only 11 per cent of researchers believed this should never happen, 53
per cent of the general public and 46 per cent of patients thought it was
unacceptable without prior consent. But more than half of researchers thought
patient identifiable data should be used without patient consent if it had
first been reviewed by the Patient Information Advisory Group (PIAG). Only 30
per cent of both patients and the general public agreed." [Accessed
December 5, 2009]. Available at:
http://www.publicservice.co.uk/news_story.asp?id=11486.
All of the material above this paragraph is licensed under a
Creative Commons Attribution 3.0 United States License. This page was written by
Steve Simon and was last modified on
2017-06-15. The material
below this paragraph links to my
old website, StATS. Although I wrote all of the material
listed below, my ex-employer, Children's Mercy Hospital, has claimed copyright
ownership of this material. The brief excerpts shown here are included under
the fair use provisions of U.S. Copyright laws.
2006
6. Stats: A clumsy attempt at
anonymization (August 15, 2006). Statisticians frequently deal with
confidentiality issues when deciding what type of data and what amount of
detail should be withheld to protect sensitive information about individual
patients or institutions. It's not an easy task and there are some subtle
traps. And sometimes there are not so subtle traps.
5. Stats: Withholding Personal
Health Information from a patient (June 20, 2006). An interesting
discussion on the IRBForum related to a statement in an informed consent
document that informed the patient that PHI (Personal Health Information)
would be withheld from the patient during the course of the research study.
2005
4. Stats: HIPAA and research
(September 22, 2005). I am collaborating with researchers at another
institution, and they are requiring me to take their training modules on
research protection, even though I have already taken similar training here
at Children's Mercy Hospital. I could gripe and grumble, but it is an
opportunity for me to review some very important material. I'm going to quote
some of the training material and add some comments of my own.
2004
3. Stats: Retrospective chart
reviews and IRB approval (July 21, 2004). Someone stopped by today with a
question about getting IRB approval for a retrospective chart review. The
first question you might ask is why is IRB approval needed.
2. Stats: Secondary Uses of Data
(August 2, 2004). Mark Barnes gave a seminar on August 2, 2004 on
Secondary Uses of Biologic Materials and Medical Data by Researchers and
Commercial Research Sponsors. Here are my notes taken at that seminar.
2002
1. Stats: Privacy
concerns in research (July 12, 2002). Dear Professor Mean, I
want to do some research using tissue samples, but the Institutional Review
Board has said that I have to get consent first, because the data are not
anonymized. The also told me that I might be able to get a waiver from
consent if I deidentify the data. What's up with all these privacy concerns
in research. -- Doubting Denise
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