Does review of medical records to identify eligible individuals require consent?
Review of CHOP medical records or clinic logs to try to identify potential participants is generally permitted as part of an IRB protocol without prospective consent or HIPAA authorization. The IRB will require that the investigator have a either a reasonable justification for access to the medical records (e.g., the child is their patient) or have the permission of the physician of record.
Does the screening consent form need to discuss the entire study or just the screening visit?
The screening consent form (if one is required - see Recruitment vs Screening) should focus entirely on the procedures for the screening visit and not on the main study. The purpose of screening is to determine if the prospective subject, who has an interest in participating in the main study, is eligible or not. The information about the main study will be in the consent form for the main study.
Can I retain lists of potential subjects identified as part of Work Preparatory to Research?
HIPAA permits investigators to retain lists of prospective subjects obtained during Work Preparatory to Research provided that the data does not leave the covered entity, the data sought is the minimum necessary for the proposed purpose and the data is needed for the proposed purpose. No contacts with study subjects identified as part of Work Preparatory to Research may take place prior to IRB approval of the research.
Do I need to get consent before telling someone about the study?
Consent is not needed to present information about a study. Providing information (e.g. listing the inclusion and exclusion criteria so individuals can determine if they might be eligible) and answering questions about the main study is considered recruitment.
I'm contacting prospective subjects by telephone, do I need to get consent before asking any questions?
The IRB may approve certain screening procedures without requiring prior informed consent of the prospective subject. If the requested information is obtained through only oral or written communication with the prospective subject and is limited to the minimum necessary for screening/determining eligibility for the main study, consent does not need to be obtained (for additional information, see Recruitment vs Screening).
Note: Even if consent does not need to be obtained for screening procedures, HIPAA Authorization may still need to be obtained if HIPAA applies (the IRB's responsibilities related to HIPAA are described in more detail in the IRB's Role in HIPAA).
When do I need to get HIPAA Authorization?
If you are using or accessing PHI as part of the screening procedures, either HIPAA Authorization must be obtained from the participant or the IRB must issue a waiver of HIPAA authorization.
Does the consent and HIPAA Authorization have to be in writing?
If the research qualifies for a waiver of documentation of consent and partial waiver of HIPAA (verbal authorization), then these do not need to be in writing.