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Participants' Access to Study Records
Under federal and state law, patients generally have a right to a copy of their medical records, while participants in a research study generally do not have a right to a copy of their study records. However, there are exceptions to this general no-access rule to study records. Because the participant’s right to a copy of their study records often depends on whether the study record is also maintained as a medical record, it is important that researchers understand the rules which govern access to each type of record.
This guidance explains medical records and research records, the access rules for each and the four exceptions to the general no-access rule for study records.
General Access Rules to Medical and Study Records
Under Maryland law, in most circumstances, a health care provider must provide a copy of the medical record to the patient. A medical record is one which contains information identifying the patient and relates to the health care of the person. We interpret “health care” to mean care, treatment or procedures by a physician to address a physical or mental condition of a patient or recipient. If the study record does not relate to “health care” for the individual, the study record would not be a medical record, and the patient would not have a right to access the study record.
Under federal privacy regulations a patient has the right to a copy of their records that contain protected health information (“PHI”) if those records pertain to the provision, coordination or management of health care for that individual. If their records contain PHI but do not pertain to health care, it appears that the individual would not have a right to a copy of those records. This is so because the Office of Civil Rights, the federal agency that interprets these privacy regulations, has stated that if the study record and the medical record are kept separate, the study record would not be a record to which the individual would have a right of access under the privacy regulations.
Four Exceptions to the General No Access to Study Records Rule
1. Granting an Access Right in the Informed Consent
A research study may involve clinical procedures such as an MRI, blood tests, hearing tests, etc. even though the purpose of the study is not to treat the individual for any health condition and does not involve treatment of any kind. In these situations, the general rule of no right to access study records would be applicable. However, the researcher may decide that he/she wants participants to have an enforceable right to receive specific test information. (For pathology tests, only results from tests performed in CLIA approved labs may be disclosed unless the IRB specifically approves the disclosure of tests results for tests performed in non-CLIA approved labs.) In such cases, the researcher may include a provision in the research study informed consent advising participants that they will be given the results of these tests. The informed consent then becomes the vehicle that gives the participant a right to their test results. Language in the consent form advising the participant that they will receive test results would not entitle the participant to a copy of the entire study record unless the consent form specifically states that the participant has a right to the entire record.
2. Voluntary Disclosure of Medical Information in the Study Record:
As was the case in Exception 1 discussed above, a study may involve clinical procedures such as an MRI, blood tests, hearing tests, etc. even though the purpose of the study is not to treat the individual for any health condition and does not involve treatment of any kind. Again, in these situations, the general rule of no right to access study records would be applicable. However, the researcher may decide, even if there is nothing in the study consent form that grants such a right, that he/she wants voluntarily to provide the test results to the participants. Subject to any contractual obligations, discussed below, this voluntary disclosure may be accomplished in three ways. First, the researcher may extract these results from the study record and give them to the participant. Second, if the researcher is not the treating physician and the participant gives their consent, the researcher could extract these results from the study record and provide them to the participant’s treating physician. Third, if the researcher is also the treating physician, the researcher may extract these results from the study record and enter the medical information in the participant’s medical record.
In all these voluntary situations, so long as only the medical information is supplied to the participant, and the study analysis and other data are not provided to the participant, this disclosure of medical information should not violate any confidentiality agreements with sponsors, collaborators, etc. Of course, if the disclosure of medical information is expressly prohibited by such an agreement, the researcher could not make this voluntary disclosure.
3. Keeping a Combined Research/Medical Record:
Some studies, e.g., therapeutic trials, combine a research study with treatment (or possible treatment). In such cases the study information and the medical information may be combined in one record. If the research record and the medical record are kept as one, and are not separate, the right of a patient to access the medical record supersedes the general rule of no access by a participant to the study record. In such a case, the patient/ participant would have a right of access to the medical/study record.
Under federal privacy regulations, it is possible in research studies related to treatment to notify the participant in the study informed consent that they will not have a right of access to the study record during the course of the study. However, if a researcher is going to use this exception, two separate records, i.e., a study record and a medical record, must be kept (see the last exception below).
4. Entering Medical Information from the Study Record in the Medical Record:
In studies which combine research and treatment (or possible treatment) if there is a desire not to provide study information to the participant, then the researcher must keep two separate records. The study record would have both the medical information necessary for the trial and any study evaluation/observations/analysis, etc. The medical record would have only the complete medical information and any relevant clinical treatment entries. If this separate record keeping is done, then when patients ask for a copy of their medical records, only the medical record would need to be provided to the patient. The participant would not have a right to access to the study record.