Does review of medical records require consent?
Review of CHOP medical records or clinic logs to try to identify potential participants is considered part of hospital operations under HIPAA and 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 consent for screening need to discuss the entire study or just the screening visit?
Providing information and answering questions about the main study is considered recruitment. The screening consent form 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; presenting information is part of recruitment. Consent is needed before conducting any study-related procedures. Obtaining information to determine if the individual is eligible for the study is a screening procedure and requires consent and HIPAA Authorization (when HIPAA applies).
If I can't ask questions without obtaining consent, can I at least explain the study requirements?
Listing the inclusion and exclusion criteria so individuals can determine if they might be eligible is permitted as part of recruitment. As long as the investigator is providing individuals with information and not the other way around, it is permissible.
I'm contacting prospective subjects by telephone, do I need to get a full consent before asking any questions?
Before you obtain information about a living individual through an interaction with them or their individually identifiable data, you need their consent or a waiver of consent or waiver of documentation of consent from the IRB. The IRB will usually permit a review of medical records to identify prospective subjects to identify potential participants. Only the individuals’ names and contact information should be recorded until consent is obtained (HIPAA limits the data retained to the minimum necessary).
When do I need to get HIPAA Authorization?
If you are using, obtaining or recording PHI as part of the screening procedures, authorization for HIPAA is required.
Does the consent and HIPAA Authorization have to be in writing?
If the research qualifies for waiver of documentation of consent and partial waiver of HIPAA (verbal authorization) then these need not be in writing.