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No. The individual who has patient care responsibilities and has UPMC-approved access to medical records must be the Principal Investigator and must take full responsibility for your retrospective medical record review. The student must be listed as a Co-Investigator. This does not, however, preclude the student from being first author on a publication based on the study. The only time a medical student could be listed as PI is when a certified honest broker system is used.
2.
I understand that I cannot record identifiers along with the medical information
I abstract from the medical records. Exactly what is meant by 'identifiers'?
Researchers cannot record the patient's name, address, phone number, e-mail address, medical record number, social security number, or any other piece of information that will readily identify the person. Note that this list of identifiers is less restrictive than the HIPAA list of 18 identifiers. For example, dates and health care providers names may be recorded - so long as they are absolutely required for this research project.
3. I have received IRB approval to conduct my retrospective medical record review and have already record information from 10 medical records (without identifiers), but now realize that there are several additional medical variables that I would like to collect from all the records. How do I go back and get this information from the records I have already reviewed?
Because you have recorded medical information without identifiers, there is no easy way for you to go back to those initial records and abstract and record this additional information. It is critically important that a retrospective medical record study be carefully planned before submitting it to the IRB.
4. I am not able to complete my retrospective medical record review in the Medical Records Department. May I make a copy of the medical records I need and take the copy home so I can abstract the relevant information, and then return the copy to the Medical Records Department when I am finished?
No. You are not permitted to remove identifiable medical record information from the 'covered entity' - i.e., from UPMC - and hence cannot make copies of medical records with identifiers.
5. I am planning to conduct a retrospective medical record review of patients who have had heart attacks, and although my medical school professor provides care to patients, she is a dermatologist. Can she serve as the PI on my project?
No. The PI must provide care and have UPMC-approved access to the types of medical records that you are going to be studying. In this instance, the PI must be someone who is in Cardiology, or Emergency Medicine, or a similar discipline that would ordinarily provide direct care to the group of patients whose records you are planning to review.
6. I am a post-doctoral fellow in the Psychology department and am interested in the relationship between ethnicity and health outcomes in hypertensive adults. My mentor has an appointment at the medical school but does not see patients. How can I review the medical records of hypertensive patients?
If neither you nor your faculty mentor have UPMC-approved access to medical records, you cannot personally review medical records. A UPMC-approved certified honest broker must be used to provide you with a de-identified data set.
7. I have completed the Research Practice Fundamentals module on Human Subjects Protections (Module 2); are there any other RPF modules I must complete before conducting retrospective medical record research?
Yes, you must complete Module 6: HIPAA Researchers Privacy Requirements.
8. I want to review a number of medical records, but how can I keep track of which records I've reviewed, and which I haven't reviewed, unless I write down or otherwise record the medical record numbers.
You can record a list of medical record numbers, and tick off each number as you complete review of the record. What you cannot do, however, is link or record the medical record number to the information that you abstract from the medical record and insert into your research database.
9. I would like to conduct a medical record review to identify people with a very specific medical condition. I then want to record their names and contact information and send them a letter, inviting them to participate in a clinical trial I am planning to conduct. I do provide care to these types of patients as part of my regular Medical School responsibilities and I am part of UPP (University of Pittsburgh Physicians). Can I use the exempt application form to conduct the medical record review?
Back to TopNo. The federal research regulations (45 CFR 46.101.b) are very clear: identifiable information cannot be recorded by investigators. The only way you can review medical records to identify patients who might be eligible for a subsequent study, and contact them would be to request a waiver of informed consent, according the guidance provided by the IRB at http://www.irb.pitt.edu/hipaa/waiver_8311.doc . Please note that this waiver (which can be reviewed administratively by the IRB, using an expedited mechanism), requires that the researcher making this request is one who provides medical care to these patients. If this request is approved by the IRB, the researcher and his or her clinic staff would be permitted to review the medical records to identify eligible subjects. Also note that any letters of invitation to participate in a study must come from a physician or health care professional who is known to the patient.
