Additional information:

Category 1:

• Research must be conducted in normal educational settings, involving normal educational practices, such as implementing a new curriculum.
• Investigators must seek approval from specific school or school district before applying to the IRB. If the district does not have their own IRB or research evaluation committee, then the investigator should seek permission from a principal or superintendent. Documentation of approval or permission must be submitted with your University IRB application.
• If your study involves research subjects under 18, parental consent and student assent are both required. The IRB may waive the need for a signature on the parental consent form, if this is requested and approved by the school, but active assent is always required.
• Be sure to submit your Appendix M.

Category 2 & 3:

• Minors cannot be included under this category unless observation only. No interaction or contact with the child is allowed.
• If at all possible, make surveys anonymous
• Sensitive or personal topics can not be exempt
• If you are using a private list for recruitment you must have permissible access to make initial contact yourself. If you do not have permissible access to the list you must ask the custodian of the record to make initial contact for you. Potential subjects then must contact you if they are interested.
• Consent form signatures are not required, but consent is. Consent can be obtained verbally or by participation as completion of the survey implies consent. This detail must be clarified in the form.

Category 4:

• Pathological or diagnostic specimens must be considered waste tissue or must be previously stored by the Tissue Procurement Facility. Waste tissue used cannot have any patient identifiers attached.
• If you do not normally have access to data, the data must be stripped of all identifiers including:
  • Name
  • All geographic subdivisions smaller than a state (street address, city, county, precinct)  Note:  zip code or equivalents must be removed, but can retain first 3 digits if the geographic unit to which the zip code applies if the zip code area contains more than 20,000 people
  • For dates directly related to the individual, all elements of dates, except year. (date of birth, admission date, discharge date, date of death)
  • All ages over 89 or dates indicating such an age
  • Telephone number
  • Fax number
  • Email address
  • Social Security Number
  • Medical Record Number
  • Health Plan Number
  • Account Numbers
  • Certificate or license numbers
  • Vehicle identification/serial numbers including license place numbers
  • Device identification/serial numbers
  • Universal Resource Locators (URL’s)
  • Internet Protocol addresses (IP’s)
  • Biometric Identifiers
  • Full face photographs and comparable images
  • Any other unique identifying number, characteristic or code
   
• If you have legitimate access to the data, through an internship, job, medical resident, then you may access private information, but you may not record any identifiers or maintain a link to identifiers.
• If you will access PHI (medical records, databases), then you must complete Appendix H to fulfill HIPAA obligations.
• Public use data includes sets posted on the internet that include a responsible use statement or other confidentiality agreement for authors to protect human subjects. This includes de-identified data sets prepared by other investigators with intent to make publicly available to other researchers such as the SEER database: http://seer.cancer.gov/data
• Many data suppliers may have both publicly available and restricted public use data. Examples: National Center for Health Statistics, National Center for Education Statistics, U.S. Bureau of the Census, CDC