Who makes the determination that the research is exempt?
At CHOP, the IRB's SOPs place the responsibility on the IRB for making the determination. At other institutions, others may be responsible or share the responsibility with the IRB.
Is a protocol needed to submit for a determination of exemption?
No. The CHOP IRB does not require a full protocol. A description of the study should be entered into eIRB Question 3.01 (1.0). The question reads "Provide a summary of the proposed study including: 1) the age range of subjects; 2) projected enrollment at CHOP and total enrollment study-wide; and 3) description of study procedures. If the study will enroll children, provide the justification for involving children in this research."The information provided should include enough details so that the IRB can determine that the research qualifies as exempt.
For studies which require a limited IRB review, additional information regarding the privacy of subjects and confidentiality of the data must be included. The eIRB application will ask the investigator to provide information regarding how the data is stored, how confidentiality of the data will be ensured, etc.
Does Category 2 apply to research involving children?
Surveys and observations of behavior require IRB approval, usually through expedited review. The lone exceptions are observations of public behavior or educational tests where the investigator does not participate in the activities being observed, for example, watching children play on a playground.
When research is not federally funded, the CHOP IRB's SOPs permit an expansion of Category 2 to include adolescents for whom the IRB would otherwise waive the requirement for parental permission.
When would a record review study not qualify for exemption under category (4)(iii)?
Exempt category 4(iii) includes the secondary use of data (not including specimens) if all of the abstracted data is regulated by HIPAA (meaning that subjects’ personal health information is being used or disclosed). The data can be recorded in an individually identifiable manner (e.g. a master list can be maintained, etc.), and both prospective and retrospective data can be used. For this exempt category to apply, HIPAA must apply to ALL individuals whose individually identifiable or coded data is recorded.
If, for example, an investigator reviews medical records to obtain individually identifiable patient data on complications of tracheostomy for research purposes, HIPAA would apply to the use of patient data (personal health information about the patient is being collected). If the investigator also records which clinician performed the procedure to determine how years of experience impact complication rates, HIPAA would NOT apply to the use of clinician data (no personal health information is being collected about the clinician). The study would therefore NOT qualify under category 4(iii).
In order for the study to qualify for exemption, the data about the clinicians would need to be recorded without identifiers and without a way to re-identify these individuals (i.e. no master list). The study would then qualify for exemption under category 4(ii) for the clinician data and 4(iii) for the patient data.
Do I need to obtain HIPAA authorization for exempt research?
It depends. If the exempt research involves the use or disclosure of PHI, HIPAA applies. Investigators would either have to obtain HIPAA authorization or justify why the criteria for a waiver or alteration of HIPAA are met. If HIPAA authorization will be obtained, a copy of the HIPAA authorization form for this study does not need to be submitted to the IRB.
When do I need to submit an amendment for exempt research?
In general, amendments are only required for exempt studies if the changes made to the research could affect the determination of exemption.
Please note that staff changes are never required for exempt studies.
Examples of the need for such amendments include:
- For studies determined to be exempt under category 7, additional changes to the research must be reported to the IRB through an amendment. An amendment should be submitted whenever changes include moving information or specimens from the original location where they are maintained, storing information or specimens for longer than they otherwise would have been, granting other investigators (e.g. external to CHOP) access to the information or specimens, and any other change that introduces or alters risks to the privacy or security of the information or the specimens. As noted above, staff changes are not required for exempt studies.
- An investigator conducting a chart review now wants to include mental health records (as defined by CHOP policy (IM-2-04). Written consent will now have to be obtained. As the study now requires consent, it no longer meets the exemption criteria under category 4 (iii).
- A study includes surveys with adults and was determined to be exempt under category 2(i). If the investigator now wishes to survey children, the study may no longer meet the criteria for exemption.
- An investigator obtains new NIH funding. If the study was previously determined to be exempt under the expanded exempt criteria (which only apply to non-federally funded, non-FDA regulated studies; see IRB SOP 302; https://irb.research.chop.edu/sites/default/files/documents/IRBSOP302.pdf), in light of the newly obtained federal funding, the expanded exempt categories may no longer apply.