IRB Guidance

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University of Pittsburgh IRB Guidance on Research Limited to Retrospective Medical Record Reviews

 http://medical-record.blogspot.com/

Research studies involving the retrospective review, collection and analysis of medical record information are descriptive studies that ordinarily seek to evaluate relationships between one or more biomedical, treatment, and/or demographic variables and one or more outcome measures in patients.  Data may include a wide range of information from the medical record (e.g., results of lab tests, nursing and physician notes, summary reports – including intake and discharge summaries and consultant reports, raw data from electrophysiological or imaging tests, etc.).  Because this is research, University IRB oversight is required, in accordance with the Federal Policy regulations (45 CFR Part 46) governing human subject protections.  Further, because the research involves medical records, compliance with the HIPAA Privacy Rule (46 CFR Part 160; Part 164 (subparts A,E) ) is required.  Regarding the latter, the University IRB also serves as the HIPAA privacy board for UPMC.



There are several different approaches to the conduct of retrospective medical record research studies that can be approved by the University IRB.



A.  Recording of Medical Information, Without Identifiers, By or Under the Oversight Of a Principal Investigator Who Would Normally Have Access to this Information by Virtue of His/Her Patient Care Responsibilities:



An investigator may personally review medical records and abstract relevant data from the medical records if ALL of the following conditions are met:



1. All medical records to be accessed for study are currently in existence at the time of the IRB submission.



2. The desired medical record data is recorded by the investigator in such a way that the respective patients cannot be identified (i.e., by the investigator or others) either directly, or indirectly via linkage codes assigned to the data.  This means that the investigator cannot record names, social security numbers, or any other patient identifiers and link this information to the data set.  As a consequence, the resulting research data set is necessarily completely anonymous.  For that reason, once the information has been extracted from the medical record, it will not be possible for the investigator to go back to the medical record and add other patient-specific information to this research dataset.



3.  The principal investigator (P.I.) of the research study has legitimate access to the desired medical information insofar as he or she is a UPMC staff member and/or has been granted UPMC privileges and provides related care (i.e., related to the information desired) to the patients, or is in the position to provide related care (including treatment, and/or diagnostic services) to the patients.  For example, any health professional providing patient care to a particular set of patients (e.g., all patients treated in the Emergency Department; all patients with aphasia; all patients undergoing CT scans), would ordinarily have access to the related medical record information of those patients  as part of his or her current or future job responsibilities, and hence would be in a position to serve as the P.I. of a research study involving a retrospective review of those medical records (regardless of whether he or she actually provided direct care to those particular patients).  For example, if the research study is directed at obtaining neurological information and the P.I. is a cardiologist, the research submission to the IRB must address the relationship of the information desired to the normal patient care responsibilities of this cardiologist-P.I.  Note that the University IRB will not approve a retrospective medical record research study if the medical record information desired is not in some way related to the patient care responsibilities of the listed P.I.  That type of study would require the use of a UPMC certified honest broker (see section B).



It is recognized that health care professional students (including medical students, residents and fellows) may be required to perform a research project and that many of these projects will involve retrospective medical record reviews.  It is further recognized that these students may have had limited or transient involvement in the care of these patients.  Thus, if the researcher is a health care professional student, the P.I. for the retrospective medical record research study must be a UPMC staff member or UPMC-privileged professional who provides related care, or is in the position to provide related care, to the particular patient population to be studied by the student.  In this example, the P.I. on the IRB submission will be the faculty member, and the student will be listed as a co-investigator (or as a Co-Principal Investigator).  Please note that in this situation the student could be the first author on any publication resulting from this retrospective research study.



It is further recognized that investigators often employ research staff members (e.g., nurse coordinators, research assistants or associates) who may be involved in accessing and recording the medical record information as part of their ordinary job responsibilities.  UPMC policies specify that these research staff members are considered members of the UPMC to the extent that they are performing services for P.I.s who are UPMC staff members or who have been granted UPMC privileges.   Thus, research coordinators or other research staff may have access to, and may record, medical record information, provided that the P.I. of the research study is a UPMC staff member or UPMC privileged professional who provides related care, or is in the position to provide related care, to the respective patient population.



Regardless of who is involved in accessing and recording the medical information, the P.I. of the research study is responsible, and will be held accountable, for ensuring the confidentiality of the patients’ medical record information.



If the protocol, study procedures, and the P.I. meet all three of these criteria, a medical record research exempt review form must be completed and submitted to the University IRB in advance of accessing medical record information for this retrospective research study.  This exempt submission is necessary so as to obtain institutional concurrence that the proposed research meets the criteria for exemption from the Federal Policy regulations as specified under 45 CFR Part 46.101.b.4.



To ensure compliance with provisions of the HIPAA Privacy Rule, a new University IRB exempt application form for retrospective medical record research studies (limited to investigators with relevant patient care responsibilities) has been developed that includes a request for a waiver of HIPAA authorization.



The HIPAA Privacy Rule (46 CFR Part 160; Part 164 (subparts A,E) requires that any request for a waiver of HIPAA authorization address three specific criteria.  Each criterion is listed below, along with examples of appropriate model justifications for each.



Criterion 1: “The use or disclosure of protected health information involves no more than a minimal risk to the privacy of individuals based on (a) an adequate plan to protect the identifiers from improper use and disclosure; (b) an adequate plan to destroy the identifiers at the earliest opportunity consistent with the conduct of the research (unless there is a health or research justification for retaining the identifiers or such retention is otherwise required by law); and (c) adequate written assurances that the protected health information will not be reused or disclosed to any other person or entity, except as required by law, for authorized oversight of the research study, or for other research for which the use or disclosure of protected health information would be permitted by this subpart.”



Justification: This criterion is readily met by investigators insofar as the medical information will be recorded without patient identifiers (e.g., names, phone numbers, addresses, etc.) or linkage codes (e.g., social security numbers, medical record numbers, etc.).  Thus, there is no collection of protected health information (i.e., identifiable medical record information) or any possibility of subsequent disclosure of protected health information.  Furthermore, and consistent with this waiver request, the investigators who will access the protected health information also provide related care, or are in the position to provide that care, to these patients, thus minimizing privacy and confidentiality concerns.



Criterion 2:  “The research could not practicably be conducted without the waiver or alteration.”



Justification:  This criterion is met by investigators insofar as the patients, whose protected health information will be accessed under this waiver request, have not previously provided informed consent for this retrospective research activity and it is impractical to obtain consent from these individuals because they are no longer in the hospital and contacting them is precluded by the researcher’s inability to use patients’ identifiable contact information without their prior consent.  Thus, obtaining the HIPAA authorization of these patients for the research use of their health information is impracticable.



Criterion 3: “The research could not practicably be conducted without access to and use of the protected health information.”


Justification: This criterion is met by the overall scientific design of the study which focuses on identifying and/or evaluating inter-relationships among various medical variables.  Consistent with the “minimum necessary standard” of the HIPAA privacy rule, investigators will access and collect only the specific health information necessary to complete this research study.



The HIPAA Privacy Rule (45 CFR 164.512.i) gives individuals the right to receive an accounting of certain disclosures of protected health information made by a covered entity.  It also allows for a simplified accounting of disclosures of protected health information for research purposes, when at least 50 patient records are reviewed as part of the research activity.  Because this simplified accounting procedure permits covered entities to provide individuals with a list of all protocols for which the patient’s protected health information may have been disclosed, the IRB will provide UPMC with a listing of each IRB protocol approved with a waiver of HIPAA authorization.  This listing will include the title of the protocol, the researcher’s name, and the researcher’s contact information.



The following IRB Application Form, available on the Exempt Page of the IRB website (www.irb.pitt.edu) should be used:  “Medical Record Review by Investigator with Patient Care Responsibilities”


B.  Use of a Certified Honest Broker System



If the P.I. of the retrospective research study does not provide related care, or is not in the position to provide related care, to the patients whose medical records are being accessed, it is recommended that the investigator utilize the services of a University IRB certified honest broker system.  The honest broker system, by definition, involves an individual or individuals (e.g., clinical clerk, nurse, IT staff) who would normally have access to the desired medical record information by virtue of her or his hospital responsibilities, and who is not involved as a listed investigator on the respective research study.  The honest broker accesses the desired medical record information on behalf of the P.I. and provides the P.I. with an appropriately de-identified data set – either a completely de-identified data set (“HIPAA Safe-Harbor”) or a data set that includes patient-specific dates and/or geographical information (“Limited Data Set”).  Use of an IRB-certified honest broker system ensures compliance with both the Federal Policy and HIPAA Privacy Rule regulations since no identifiable medical record information is being obtained or used directly by the investigators. Hence a waiver of the requirement for informed consent and/or HIPAA authorization is not necessary, and there is no need for the UPMC to track the use, on a patient-by-patient basis, of medical record information for research studies using this system.  In addition, there is no requirement that all of the desired medical record information must be in existence at the time of IRB submission.  That is, the honest broker can assign a code number to the data given to the investigator provided that the investigator does not have access to the information linking this code number to the identities of the respective patients.   Using this code number, the investigator can request, through the honest broker, additional medical information corresponding to a given patient. From an IRB perspective, this type of application (where all data are not currently available for study) would meet criteria for ‘no human subjects’ involvement (45 CFR 46.102.f) because (a) the investigators have neither interacted nor intervened with these individuals for research purposes, and (b) the use of the honest broker ensures that the investigators will not obtain private identifiable information.



The following IRB Application Form, available on the Exempt Page of the IRB website (www.irb.pitt.edu) should be used:  “Medical Record Review with Honest Broker”



C.  Request for IRB Approval of a Waiver of Informed Consent/HIPAA Authorization



It is recognized that there may be situations in which investigators conducting retrospective medical record research need to collect information that includes patient identifiers (e.g., to link patient information obtained from multiple databases; to link existing patient information with new patient information) and do not have access to, or wish to use, an IRB-certified honest broker system.  In accordance with the Federal Policy regulations and HIPAA Privacy Rule, the acquisition or use of identifiable medical record information for research requires both the written informed consent and HIPAA authorization of the involved patients, or University IRB approval of a waiver of both of these requirements.


The Federal Policy criteria (45 CFR 46.116.d) that must be addressed and justified (i.e., in the corresponding research protocol) in order for the University IRB to grant a waiver of informed consent are as follows:



(1)      The research involves no more than minimal risk to the subjects

(2)      The waiver of consent will not adversely affect the rights and welfare of the subjects

(3)      The research could not practicably be carried out without the waiver


Regarding the second of these criteria, the University IRB has minimal concerns that the privacy and confidentiality rights of the involved patients are being adversely affected if the P.I. of the research study is a UPMC staff member and/or has been granted UPMC privileges and provides related care to these patients, or is in the position to provide related care to these patients.  That is, by virtue of his or her patient care responsibilities, the P.I. would already be permitted to access the patients’ medical care information.  As outlined above, the University IRB would also permit health professional students and research coordinators to access and obtain identifiable medical record information under the oversight and responsibility of such a P.I.  The corresponding IRB application must address, and provide justifications for, each of the Federal Policy and HIPAA Privacy Rule criteria for granting a waiver of informed consent/HIPAA authorization.  The University IRB web-site (HIPAA Page) currently incorporates a “Model Request for a Waiver of the Requirements to Obtain Informed Consent/HIPAA Authorization to Access, Record, and Use Protected Health Information/Identifiable Medical Record Information for a Retrospective Research Study:  Principal Investigator Provides Care to the Respective Patients” (http://www.irb.pitt.edu/hipaa/waiver_835.pdf)  Applicable P.I.s of retrospective medical record research studies need to simply incorporate the waiver criteria and model justifications into their IRB application.  Since the University IRB has pre-approved the model justifications for the waiver criteria under this circumstance (i.e., the P.I. provides care to the respective patients), the application can be reviewed administratively (i.e., “expedited” review) and does not require consideration at a convened meeting of an IRB committee.

 If the P.I. of the retrospective medical record research study does not provide related care to the respective patients, there are obvious concerns that investigator access to, and the recording of, patients’ identifiable medical record information may adversely affect the patients’ rights to privacy and confidentiality of this information.  Thus, in this situation, the P.I. must address, in the corresponding IRB application, each of the Federal Policy and HIPAA (see above) criteria for granting a waiver of informed consent/ HIPAA authorization and must provide clear and thorough justifications regarding the applicability of these criteria to the proposed research.  Since the University IRB holds informed consent as a primary principle governing the ethical conduct of human subject research, all such requestshttp://medical-record.blogspot.com/ for a waiver of informed consent/HIPAA authorization will require review and approval by a convened IRB committee (i.e., “full board” IRB review).


This guidance was prepared under the direction of Christopher Ryan, working closely with IRB staff, and was approved by the University of Pittsburgh IRB Executive Committee on 18. February 2005.  Please note that the focus of this guidance is limited solely to retrospective medical record reviews for research purposes.

STANDARD OPERATING PROCEDURES MEDICAL RECORD AUDIT

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1.         INTRODUCTION

1.1.1.   This standard operating procedure (SOP) describes the policy and procedure in    the performance of a Medical Record Audit (MRA) for the Office of Human  Research Protection (OHRP) at the Medical College of Georgia (MCG) Health  System. A MRA may be performed on the medical record of any research subject receiving a test article.

2.         OBJECTIVE

2.1.1.   The objective of this SOP is to describe the procedures used in performing the      MRA.   

3.         SCOPE

3.1.1.   This policy and procedure applies to all MRA’s performed by the OHRP.

4.         PROCEDURES

4.1.      The CTA will contact the Investigational Pharmacist via telephone or e-mail to request a list of randomly selected research study subject names including the study subjects’ medical record numbers. The Investigational Pharmacist will either fax or email the list to the CTA.

4.2.      Once the CTA receives the list from the Investigational Pharmacist, the CTA will then access the electronic medical record (EMR) to locate the required documents. If the document(s) cannot be located in the EMR, then the CTA will contact the Health Information Management Services (HIMS) Technician and arrange a mutually convenient time for the CTA to review the hard copy medical record.  In compliance with MCGHI policies, the audit of the research subjects’ hard copy medical record will take place in the HIMS area.  

4.3.      In compliance with federal regulations and institutional policies the medical records (e.g., EMR and hard copy) are assessed using the following standards:

4.3.1.   Research Study Alert (RSA) or Study Alert located in the medical record. The RSA must be completed and submitted to HIMS for scanning into the EMR and filing in the research subject’s hard copy medical record.  A RSA is required if   more than one research related study visit is required and/or the research subject  is hospitalized.

4.3.2.   Signed and dated copy of the applicable consent document located in the research subject’s medical record as per current MCG Health System Policies and Procedures. the research informed consent documents are reviewed in  accordance with OHRP SOP Informed Consent:  Documentation of Process.

4.3.3.   Documentation of the research subject’s voluntary participation in the progress   notes prior to the initiation of any study specific procedure(s) per current OHRP SOPS.

4.3.4.   Documentation of study visits reported as such in the progress reports per current OHRP SOPS.

4.3.5.   Documentation of the research subject’s continuing informed consent at each and  every study visit per current OHRP SOPS.

4.3.6.   An electronic report is generated that addresses the standards found and standards not found. The original report is sent to the Principal Investigator (PI) via email.  The PI will be requested to provide clarification including a plan of corrective   action to eliminate the potential for this problem reoccurring in the future. The timeline given to the PI for responding is generally thirty (30) days from the date  of the findings letter. A copy of the findings letter is sent to the Study  Coordinator, Investigational Pharmacist, and a copy is provided to the IRB.

4.3.7.   Prior to sending the MRA Findings Report to the PI, the CTA will contact the PI and/or Study Coordinator by phone or e-mail to explain the process behind the MRA. This contact provides an opportunity for the site to give feedback and to  be given guidance as to how to respond to the MRA.

4.3.8.   The results of a MRA may result in a “for cause” review of the study.

5.         REFERENCES/DOCUMENTATION
  • Medical College of Georgia Policies and Procedures
  • MCG Health, Inc. Policies and Procedures
  • http://hi.mcg.edu/aboutus/PDFPolicies/16_51.pdf
  • http://hi.mcg.edu/aboutus/policies/PDFPolicies/16_51.pdf
  • Human Assurance Committee Policies and Procedures
  • International Conference on Harmonization Good Clinical Practices Guidelines
  • Food and Drug Administration Title 21 Part 50 Regulations
  • DHHS Office for Human Research Protections Regulations
  • Clinical Research Standard Operating Procedures for MCG Health System

DEPLOYED MEDICAL RECORD REQUEST INSTRUCTIONS

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DEPLOYED MEDICAL RECORD REQUEST INSTRUCTIONS
DD 2870 - Authorization for disclosure of medical or dental information, Dec. 2003
In order to facilitate the release of medical records, PASBA will follow this procedure:
Requesting a copy of the medical record
1.         PASBA will first verify if the medical record is in their possession.
2.         If the record is in PASBA's custody, the requestor must complete DD Form 2870 (Authorization for Disclosure of Medical or Dental Information) and have the Service Member sign the form authorizing release of medical information. The requestor must provide detailed information describing specifically what information is being requested and why that information is needed, (i.e. UCMJ, Medical Board Processing, Separation Processing), particularly if the Service Member refuses to sign the request.
In addition, specify exactly what episode of care the request is for.
3.      Once PASBA receives the signed authorization form, the PASBA Information Assurance (IA) Coordinator will review and verify the authenticity of the request and identity of the requestor as the patient owner of the record. After all requirements are fulfilled, the IA coordinator will approve to copy the record. PASBA will duplicate the medical record and mail the duplicate to the Service Member. A copy of DD Form 2870 will be placed in the Service Member's medical record documenting this action.
4.      The Requestor may be directed to contact NPRC in the event that the Medical Record has been retired. The Requestor may also be directed to the military treatment facility they were seen at in theater if PASBA has no record of receiving the medical record.
5.      Ft. Sam Houston SJA will review all medical records request from outside entities. Once SJA has approved this request, PASBA will duplicate the medical record and mail the duplicate to the requesting party. A copy of DD Form 2870 will be placed in the Service Member's medical record documenting this action.
Purpose
PASBA receives all Inpatient Records from deployed medical units that do not have access to the Composite Health Care System (CHCS) once that unit returns from theater. PASBA reviews, performs data quality checks, codes, enters the record information into a number of databases and then forwards them to the National Personnel Records Center (NPRC) in St. Louis, Missouri for retirement.
AR 40-66
Army Regulation 40-66, Chapter 2 explains DA policies and procedures governing the release of medical information or medical records pertaining to individual patients. DA policy mandates that the confidentiality of patient medical information and medical records be protected to the fullest extent.
Procedure
There may be instances when the patient or other agency (Staff Judge Advocate (SJA) Officer, soldier's Commander, MTF's Case Worker, etc.) requires copies of the medical records from deployments. Because the inpatient record is only at PASBA for a short time, there is a possibility the record may not be at PASBA when the request is made. PASBA will follow the above stated procedure (Requesting a copy of the medical record).
For requests, problems, or assistance contact:
Information Assurance Coordinator, (210) 221-1414 DSN: 471
E-Mail Address: Record.Request@pasba2.amedd.army.mil
Fax Num. 221-0263 DSN 471
To suggest corrective action, Deputy Director, PASBA, (210) 295-9507 DSN: 421
E-Mail Address: Record.Request@pasba2.amedd.army.mil
Fax Num. 221-0579 DSN 471

MEDICAL RECORD AND DATABASE REVIEW REQUESTS

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Policy
·         All retrospective medical record reviews and database requests that are performed for research purposes require review by the Committee on Clinical Investigation (CCI).
·         A specialized protocol application has been developed  for retrospective medical record review and database requests for research purposes.  The form requests the following information:  who will perform the review; the purpose of the review; who will have access to the information; what the information will be used for; and the steps that will be taken to protect confidentiality.  Information that is required to assure compliance with HIPAA regulations is also requested.  In addition, the form requests the information needed to determine whether activity constitutes research with human subjects, whether it may be exempt from review or whether expedited review is required.  Information is also collected to determine whether informed consent requirements may be waived under 45 CFR 46.116(d) or 45 CFR 46.117.
Purpose
To identify the medical record reviews and database requests that are subject to CCI review, and to provide guidelines for the conduct of this review.
Procedures
1.       Children’s Hospital has in place a simplified CCI review process for research that involves only the retrospective collection of data from medical records, computer databases, radiographs, and any other hospital-based records that exist for purposes other than research (e.g., quality improvement records). This form may also be used when investigator’s are obtaining records from other institutions for analysis purposes.
2.       The required CCI review applies to all research-related medical record reviews and database requests for research, regardless of whether the investigator wishes to maintain an identifier or a link to an identifier.
3.       If a protocol involves interaction with a subject, requires informed consent or requests information from physicians outside of Children's Hospital, a full CCI protocol application is required.  If the research involves only the retrospective review of information contained in a medical record, hospital record, or computer database, a specialized form may be completed.  Because X-rays and radiograph films are considered a part of the medical record, the same procedures apply.
4.       Investigator’s are asked to  submit the special application form to the Clinical Investigation Office for review and approval. 
5.       The type of information under review, where and how the data will be stored, who will have access to it, who is responsible for maintaining it, and the steps taken to maintain confidentiality will be considered.
6.       The Director of Clinical Research Compliance or Manager , reviews the form and clarifies any remaining issues with the investigator.  A determination is made as to whether the activity constitutes human subject research, whether the activity is exempt or whether expedited review is appropriate. If the activity is determined to be expeditable, the Director of Clinical Research Compliance or  Manager, as voting members of the IRB,  may approve the request.
7.       Once review is complete, the request is approved by the Director of Clinical Research Compliance or Manager, and the investigator is notified. The approval indicates whether the request was determined to be non human subject research, exempt or expedited. Non human subject research will not require any additional follow-up. Exemptions will follow the policy and procedures for “Exemptions”.
8.       For those activities that are determined to be expeditable, approval is valid for one year period. Investigators are sent notification two months prior to expiration and are asked to complete a continuing review form if the research is to continue. These forms are reviewed and approved by the Director of Clinical Research Compliance or Manager. 

ACCESS TO MEDICAL RECORDS

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1.         What is a Medical Record?

•        At common law the position is that “the person who makes the record owns the record.” Breen v Williams
•        However, the question arises as to what information makes up the medical record.
•        The AMA endorses the following guidelines on patient’s access to records concerning their medical treatment:

            “The patient has a right to be informed of all relevant factual information contained       in the medical record, but all deductive opinion therein recorded remains the      intellectual property of the doctor or doctors contributing to, or recognised            employing hospital or other organisation maintaining the record…
           
            On request , the patient should be informed of any or all content of the following             sections of the medical record:
-          History;
-          Physical examination findings;
-          Investigation results;
-          Diagnosis
-          Proposed management plan.”
•           There is a distinction between the right of the patient to access factual information regarding treatment and opinions of medical practitioners in the course of treatment: Breen v Williams per Gummow J.

2.         Policy Considerations for/against Access

•        Arguments for usually deal with the idea of patient autonomy  that is the patient has a right to know and have available at their disposal all information relating to their health so as to ensure they make informed decisions as to future treatment
•        On the other hand, medical professionals assert access may breach confidences; they may stop taking notes altogether if they knew patients could access them;

3.         General Rule on Access

The High Court of Australia in a unanimous decision held that there is no general right of access to medical records: Breen v Williams.

Breen v Williams (1996) 186 CLR 71
-          Mrs B had breast implants which were subsequently found to have leaked.
-          In order to participate in a class action against the US manufacturers, Mrs B req’d copies of her medical records.
-          She sought from Dr W (respondent) her records and he refused.
-          Later he wrote a letter saying he would be willing to provide her with a medical report of things like her history, diagnosis, investigation results, advice and treatment but not his handwritten notes. She refused this offer.
-          Mrs B went on to the Cts to seek a declaration that she had a right to examine and access her medical records.
-          High Court dismissed.
-          Mrs B argued that her right to access her medical records arose from four sources:
-                      A patient’s proprietary right/interest in the information contained in the records;
-                      An implied term of the K between doctor-patient;
-                      A fiduciary relationship between doctor-patient; and
-                      A general “right to know”
Proprietary right/interest
-                      Brennan CJ, Dawson, Toohey, Gaudron, McHugh and Gummow JJ
•                    Documents prepared by a professional person to assist the professional to perform his/her duty are not property of the lay client; they remain the property of the professional.
•                    That property right entitles the doctor to refuse other person access to the records.
Implied term in K
-           Brennan CJ
•                    In the absence of a special K between doctor-patient, doctor undertakes by the contract between them to advise and treat the patient with reasonable care and skill.
•                    No term implied that doctor act in “best interests” of patient  terms limited to subject matter of K, that is, benefiting health of patient.
•                    No term implied if K effective without it.
-           Dawson and Toohey JJ
•                    Primary obligation under K was to use reasonable skill and care in treating and advising Mrs B.
•                    Not necessary for reasonable/effective performance of that obligation to give Mrs B access to medical records.
-           Gaudron and McHugh JJ
•                    Distinction between terms implied in fact and in law.
•                    Mrs B argued an implication by law that doctor act in “best interests” of patient however although a relevant consideration, doctor’s primary duty owed is to exercise reasonable skill and care in provision of professional advice and treatment.
Fiduciary relationship
-           Brennan CJ, Dawson, Toohey, Gaudron, McHugh and Gummow JJ
•                    No definitive answer to what is a fiduciary relationship  depends on nature of relationship and facts of the case
•                    Although duties of fiduciary nature may be imposed on doctor, doesn’t cover entire relationship.
•                    No fiduciary relationship with respect to access to medical records
•                    Generally relationship not fiduciary in nature
Access to factual information
- Brennan CJ highlighted that information with respect to a patient’s history, condition or treatment etc, must be disclosed by the doctor when:
            (i)         refusal to make the disclosure requested might prejudice the general health                    of the patient;
            (ii)        the refusal for disclosure is reasonable having regard to all circumstances;                                   and
(iii)       reasonable reward for the service of disclosure is tendered or assured

•                    But the Canadian position as stated by La Forest J in McInerney v MacDonald in the Canadian Supreme Ct differs.
•                    Canadian position holds that a patient is entitled to reasonable access to examine and copy the doctors records.
•                    This was founded on the grounds of a fiduciary relationship between doctor-patient in that it was the duty of the doctor to act with “utmost good faith and loyalty.”
•                    La Forest J in McInerney v MacDonald reached the following conclusion:

            “Information about oneself revealed to a doctor in a professional capacity remains, in a fundamental sense, one’s own. The doctor’s position is one of trust and confidence. The            information conveyed is held in a fashion somewhat akin to a trust. While the doctor is the    owner of the actual record, the information is to be used by the physician for the benefit of         the patient. The confiding of the information to the physician for medical purposes fives rise    to an expectations that the patient’s interests in and control of the information will continue.”

•                    However the Australian High Ct in Breen v Williams emphatically rejected this proposition as not being the law of Australia.
•                    Dawson and Toohey JJ stated that “there is no foundation in either principle or authority in this country” as such a duty of utmost good faith and loyalty “hardly fits with the undoubted duty of a doctor in this country.”
•                    Gaudron and McHugh JJ said that in Australia “it is not possible to regard the doctor-patient relationship as one in which the doctor is under a general duty to act  with utmost good faith and loyalty.”

4.         Exceptions to General Rule

•          There are however certain exceptions to the general rule of no access.
•          The major exceptions are found under the provisions of the Freedom of Information Act 1992 (Qld) and the Privacy Act 1988 (Cth).

4.1       Freedom of Information Act 1992 (Qld)

(i)         SCOPE
•          Under the FOI scheme, a person has a legally enforceable right to be given access to documents and records of an agency that is directly/indirectly supported by Govt funds.
•          Therefore applies to:
-           govt dept’s, agencies etc
-           only in public sector (doesn’t extend to private health care facilities.)

(ii)        GENERAL

Section 21- Right of access
Subject to this Act, a person has a legally enforceable right to be given
access under this Act to—
            (a)        documents of an agency; and
(b)        official documents of a Minister

(iii)       EXEMPTIONS
•          There are certain documents to which access may be refused: s.22

Section 22 - Documents to which access may be refused
An agency or Minister may refuse access under this Act to—
            (a)        a document that is reasonably open to public access (whether or
                        not as part of a public register) under another enactment, whether
                        or not the access is subject to a fee or charge; or
            (b)        a document that is reasonably available for purchase by members of                                the community under arrangements made by an agency; or
            (c)        a document that is reasonably available for public inspection under                                   the Public Records Act 2002 or in a public library; or
            (d)        a document that—
                                    (i)         is stored for preservation or safe custody in the                                                       Queensland State Archives; and
                                    (ii)        is a copy of a document of an agency; or
            (e)        adoption records maintained under the Adoption of Children Act                            1964.

•          There are also certain categories under which there are exempt matters

Section 44 - Matter affecting personal affairs
(1)        Matter is exempt matter if its disclosure would disclose information concerning the        personal affairs of a person, whether living or dead, unless its disclosure would, on     balance, be in the public interest.
(2)        Matter is not exempt under subsection (1) merely because it relates to information         concerning the personal affairs of the person by whom, or on whose behalf, an     application for            access to a document containing the matter is being made.
(3)        If—
                        (a)        an application is made to an agency or Minister for access to a                                          document of the agency or an official document of the Minister                                         that contains information of a medical or psychiatric nature                                             concerning the person making the application; and

                        (b)        it appears to the principal officer of the agency or the Minister                                          that the disclosure of the information to the person might be                                         prejudicial to the physical or mental health or wellbeing of the                                          person;
            the principal officer or Minister may direct that access to the document is not to be        given to           the person but is to be given instead to a medical practitioner nominated by   the person and approved by the principal officer or Minister.
(4)        An agency or Minister may appoint a medical practitioner to make a decision under        subsection on behalf of the agency or Minister.

Section 46- Matter communicated in confidence
(1)        Matter is exempt if—
                        (a)        its disclosure would found an action for breach of confidence; or
                        (b)        it consists of information of a confidential nature that was                                                  communicated in        confidence, the disclosure of which could                                                     reasonably be expected to prejudice the future supply of such                                       information, unless its disclosure would, on balance, be in the public                                       interest.
(2)        Subsection (1) does not apply to matter of a kind mentioned in section 41(1)(a) unless     its disclosure would found an action for breach of confidence owed to a person or          body other than—
                        (a) a person in the capacity of—
                                    (i) a Minister; or
                                    (ii) a member of the staff of, or a consultant to, a Minister; or
                                    (iii) an officer of an agency; or
                        (b) the State or an agency.

Section 42- Matter relating to law enforcement or public safety
(1)        Matter is exempt matter if its disclosure could reasonably be expected to—
                        (a)        prejudice the investigation of a contravention or possible                                                    contravention of the law (including revenue law) in a particular case;                                            or
                        (b)        enable the existence or identity of a confidential source of                                                             information, in relation to the enforcement or administration of the                                  law, to be ascertained; or
                        (c)        endanger a person’s life or physical safety; or
                        (d)        prejudice a person’s fair trial or the impartial adjudication of a                                          case; or
                        (e)        prejudice the effectiveness of a lawful method or procedure for                                         preventing, detecting, investigating or dealing with a contravention                                               or possible contravention of the law (including
                                    revenue law); or
                        (f)        prejudice the maintenance or enforcement of a lawful method or                                      procedure for protecting public safety; or
                        (g)        endanger the security of a building, structure or vehicle; or
                        (h)        prejudice a system or procedure for the protection of persons,
                                    property or environment; or
                        (i)         facilitate a person’s escape from lawful custody; or
                        (j)         prejudice the wellbeing of a cultural or natural resource or the                                          habitat of animals or plants.
(1A)     Matter is also exempt matter if—
                        (a)        it consists of information given in the course of an investigation of a                                  contravention or possible contravention of the law (including                                             revenue law); and
                        (b)        the information was given under compulsion under an Act that                                          abrogated the privilege against self-incrimination.
(2)        Matter is not exempt under subsection (1) if—
                        (a)        it consists of—
                                                (i)         matter revealing that the scope of a law                                                                               enforcement investigation has exceeded the limits                                                              imposed by law; or
                                                (ii)        matter containing a general outline of the                                                                            structure of a program adopted by an agency for                                                                 dealing with a contravention or possible                                                                                contravention of the law; or
                                                (iii)       a report on the degree of success achieved in a                                                                   program adopted by an agency for dealing with a                                                                contravention or possible contravention of the law;                                                                         or
                                                (iv)       a report prepared in the course of a routine law                                                                  enforcement inspection or investigation by an                                                                      agency whose functions include that of enforcing                                                                 the law (other than the criminal
                                                            law or the law relating to misconduct under the                                                                   Crime and Misconduct Act 2001); or
                                                (v)        a report on a law enforcement investigation that                                                                 has already been disclosed to the person or body                                                                 the subject of the investigation; and
 (3)       A certificate signed by the Minister stating that a specified matter would, if it      existed, be exempt matter mentioned in subsection (1), but not matter mentioned in   subsection (2), establishes, subject to part 5, that, if the matter exists, it is exempt      matter under this section.
(4)        A reference in this section to a contravention or possible contravention of the law            includes a reference to misconduct or possible misconduct under the Crime and        Misconduct Act 2001.
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