Category: Privacy in research. These pages discuss the special ethical considerations for research studies that involve the use of private and sensitive information. Articles are arranged by date with the most recent entries at the top. You can find the theme and closely related categories and other resources at the bottom of this page.
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.
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.
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.
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.
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.
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
Theme and closely related categories:
- Don’t Ask, Don’t Tell? Transfer and Sale of De-Identified Patient Data. Description: This article reviews the privacy regulations associated with research and offers an explanation of de-identifed data. The authors raise some provocative issues about individual property rights to medical data, even data that has been de-identified.
- Guidance on Research Involving Coded Private Information or Biological Specimens. 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 and research on human embryonic stem cells) 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. This website was last verified on 2007-06-06. URL: www.hhs.gov/ohrp/humansubjects/guidance/cdebiol.htm
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This webpage was written by Steve Simon on 2007-08-08, edited by Steve Simon, and was last modified on 2008-07-14. Send feedback to ssimon at cmh dot edu or click on the email link at the top of the page.