CUMC IRB Investigator Meeting November 9, 2004 Research Use of Stored Data and Tissues.
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CUMC IRB Investigator Meeting November 9, 2004 Research Use of Stored Data and Tissues
Presentation Overview This presentation will provide information on: Setting up Data and Tissue Repositories Accessing Clinical Data and Specimens for Research Developing Protocols to Allow for Future Use of Data and Tissues
Definition of Research A systematic investigation, including research development, testing and evaluation, designed to contribute to generalizable knowledge
Definition of Human Subject A Living Individual about who an investigator (whether professional or student) conducting research obtains: 1.Data through intervention or interaction with the individual, or 2. Identifiable private information
Research Database/Tissue Repository – Definitions Data, tissue, specimens will be collected for use in future research projects Multiple individuals potentially have access to the data Information may be collected from clinical as well as research sources __ __ __ __ __ Types of databases (see handout)
Consent and Databases Where participants information will be entered into a database or repository, these individuals should be consented (in writing). Further, genetics studies will require appropriate genetics language in the consent form.
Waiver of Consent/Authorization For future studies, waiver of consent and/or authorization is possible for a database or tissue repository as long as the study meets the requirements for both the waiver of consent and the authorization.
HHS Guidance – Research Involving Coded Private Information or Biological Specimens: August 10, 2004 guidance from OHRP: “This guidance applies to existing private information and specimens, as well as to private information and specimens to be collected in the future for purposes other than the currently proposed research.” Coded means: Identifying information (such as name or social security number) that would enable the investigator to readily ascertain the identity of the individual to whom the private information or specimens pertain has been replaced with a number, letter, symbol, or combination thereof (i.e. the code); and A key to decipher the code exists, enabling linkage of the identifying information to the private information or specimens. (Keep in mind that the Privacy rule has separate definitions that will need to be complied with – for more information consult the Privacy Office).
Points to Consider IRB Review Recruitment issues Data confidentiality plans Re-obtaining consent from individuals when necessary Designing an informed consent form that may apply to future research Ethics of subjects agreeing to participate in future projects which they may have little information about Data – whose is it (institution or researcher)
CUMC IRB Investigator Meeting November 9, 2004 Research Use of Stored Data and Tissues Accessing Clinical Data and Specimens for Research
HHS regulations and Accessing Data §46.111 Criteria for IRB approval of research. (a)In order to approve research covered by this policy the IRB shall determine that all of the following requirements are satisfied: (6) When appropriate, the research plan makes adequate provision for monitoring the data collected to ensure the safety of subjects. (7) When appropriate, there are adequate provisions to protect the privacy of subjects and to maintain the confidentiality of data.
WebCIS and Accessing Data Who can use WebCIS? What about access from home? WebCIS is currently available to clinical system users who take care of patients at the Columbia- Presbyterian Medical Center of the New York- Presbyterian Hospital. http://webcis.cpmc.columbia.edu http://webcis.cpmc.columbia.edu
WebCIS and Preparatory to Research Activities According to HHS guidance on the Privacy rule, researchers should be aware that that “research activities” which are essentially preparatory to research, involve “human subjects research” as defined by the HHS Protection of Human Subjects Regulations and are not exempt are required to be approved by the IRB AND approved by an IRB and must satisfy the informed consent requirements of HHS regulations. (Protecting Personal Health Information in Research: Understanding the HIPAA Privacy Rule).
Accessing Identifiable Information Example, the research team has access to medical records, which has identifiable information. HOWEVER, the research team records the information from the medical records in such a way that individuals cannot be identified. This research would be exempt from IRB review.
Accessing De-identified Information Where data is stripped of all identifiable information before the research team receives the information AND there is no link between the data and the individuals in the study, the IRB may determine that this is not human subject research.
Certificates of Confidentiality Certificates of Confidentiality are essential in preventing identifiable data from being disclosed via a court order. (These include civil, criminal and administrative proceedings). Research does not have to be federally funded in order to benefit from a Certificate of Confidentiality. ihttp://grants1.nih.gov/grants/policy/coc/background.htm
Certificates of Confidentiality - Sensitive Information Data or Tissue repositories that involve sensitive information may need to obtain a Certificate of Confidentiality. A Certificate of Confidentiality is required if a substantial portion of the research involves the following activities: HIV Testing to determine eligibility or to screen subjects before enrolling Illegal drug testing to determine eligibility or for screening purposes Asking potential participants to self-report illegal drug use of HIV status Other indications
Summary - Final points to consider Individuals accessing information from a database or repository must have IRB approval. Participants whose data/tissue/specimens will be entered into the database or repository should provide consent using a written consent document (there are instances, however, where waiver of consent may be appropriate). For genetic studies, genetic language must be included in the consent document.