PII: Personally Identifiable Information: any information that can be used to distinguish or trace an individual’s identity and does not include protected health information under HIPAA, including:Īny other information that is linked to an individual, such as medical, educational, financial, and employment information Vehicle identifiers and serial numbers, including license plate numbers īiometric identifiers, including finger and voice prints įull face photographic images and any comparable images andĪny other unique identifying number, characteristic, or code (note this does not mean the unique code assigned by the investigator to code the data)įor more information regarding HIPAA and protected health information, see the HIPAA FAQs or HHS website: SOP - Definitions of 13Īll elements of dates (except year) for dates directly related to an individual, including birth date, admission date, discharge date, date of death and all ages over 89 and all elements of dates (including year) indicative of such age, except that such ages and elements may be aggregated into a single category of age 90 or older The following identifiers are considered PHI:Īll geographical subdivisions smaller than a State, including street address, city, county, precinct, zip code, and their equivalent geocodes, except for the initial three digits of a zip code, if according to the current publicly available data from the Bureau of the Census: (1) The geographic unit formed by combining all zip codes with the same three initial digits contains more than 20,000 people and (2) The initial three digits of a zip code for all such geographic units containing 20,000 or fewer people is changed to 000. PHI: Protected health information means individually identifiable health information protected under HIPAA law. The IRB staff would notify you if you submitted exempt, but the study needs to be bumped to expedited or full board review. See our “Example Consent Text for Study-Specific Items” in the templates section of our Researcher Resources page. Typically, this is added to the “Will information about me be kept private?” section of the consent. Researchers must inform participants in the consent document of the protections and limitations of certificates of confidentiality. Researchers not funded by HHS can continue to apply to NIH or the FDA as appropriate to request a CoC for HHS-mission relevant research. Other Department of Health and Human Services (HHS) agencies issue CoCs to researchers they fund. NIH funded researchers are automatically issued a CoC through their award. They allow the investigator and others who have access to research records to refuse to disclose identifying information on research participants in any civil, criminal, administrative, legislative, or other proceeding, whether at the federal, state, or local level. CoCs are issued to protect identifiable research information from forced disclosure. If your project involves the collection of sensitive data that could put subjects at risk of criminal or civil liability, you may be asked to obtain a Certificate of Confidentiality (CoC) from NIH. Obtaining a Certificate of Confidentiality Providing subjects with a copy of the questions in advance.Ĭollecting data anonymously OR using pseudonyms so that identifiers are not stored with their data. Also, providing a list of resources subjects can utilize should the need further help dealing with their distress. Common procedures include:Īllowing subjects to skip questions that make them feel uncomfortable.ĭisclosing in the consent form the type of questions that may induce emotional distress, etc. You will be asked to describe the steps you are taking to limit risk to subjects on the application. It will depend on whether the disclosure of the information would put subjects at more than minimal risk and if the privacy and confidentiality protections you have in place limit this risk. If your project involves the collection of sensitive data, it might not qualify for exempt review. This includes information related to alcohol or drug use, traumatic experiences, child/elder abuse, or illegal behavior, or where disclosure outside of the research study has the potential to place participants at risk of criminal or civil liability or be damaging to their financial standing, employability, educational advancement, or reputation. Data is considered sensitive when disclosure of identifying information could have adverse consequences for subjects or damage their financial standing, employability, insurability, or reputation.
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