P.Mean >> Category >> Privacy in research (created 2007-08-08).

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.


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Outside resources:

  1. 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.
  2. 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.
  3. 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.

Creative Commons License 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 2010-04-11. 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.


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.


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.


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.


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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