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UM Policies & Procedures - HSRO/IRB
1. Preface
2. Background Topics
3. Authorities and Responsibilities
4. Conflict of Interest
5. Institutional Review Boards
6. IRB Meetings
7. General Principles for IRB Reviews
8. Definition of IRB Review Types
9. IRB Review of Initial Studies
10. IRB Review of Continuing Studies
11. Amendments
12. Closing Studies and Final Reports
13. Suspension, Termination and Administrative Closure of IRB Approved Research
14. Unanticipated Problems and Adverse Events
15. Study Violations
16. Compliance Audits
17. Data Safety Monitoring Boards
18. Ancillary Committees
19. External IRB's
20. Policies Specific to Certain Types of Research
21. Informed Consent
22. Participant Recruitment Methods, Advertising Materials and Recruitment-Relevant Payment Arrangements
23. Vulnerable Populations
24. Privacy, Security, Confidentiality and HIPAA
25. Subcontracts/Agreements for UM-Initiated Studies that Engage or Involve non-UM Institutions or Investigators
26. International Research
27. Emergency Use
28. Record Retention
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Basic Folder Information

20.2 Retrospective Chart Reviews


Approval Date

Review Responsibility:

IRB Policy and Procedure Committee

Current Approval Date:

June 5, 2007



20.2(a) General Principles

20.2(a) General Principles

"Retrospective Chart Reviews" of existing medical records that are intended as a systematic investigation designed to contribute to generalizable knowledge require prior IRB approval. 

For this definition, "medical records" consist of information collected and generated for the purpose of providing health care for the personal benefit of the patient.  It is usual that the information within medical records will have clinical validity and utility and that the collector of the information is a health care provider. 

Medical records are distinguished from "research records" since the latter are collected and generated for the purpose of providing information about a research question.  The intent in collecting research records is to conduct research and the collector of the information is a researcher.  

Retrospective chart reviews of existing medical records do not require prospective IRB approval if any of the following intentions apply:

1)  The intent is a non-generalizable investigative review such as for quality assurance or a review of a physician's competency

2)  The intent is for quality management issues such as to ascertain the need for health care delivery 

3)  The intent is for compliance issues such as those of third party billing or investigator non-compliance

4)  The intent is to obtain clinical information for teaching purposes.

If the intent of a retrospective review of medical charts does not fit those defined above, the retrospective chart review should be considered research and must receive prospective IRB approval.



20.2(b) Approval Categories for Retrospective Chart Reviews

20.2(b) Approval Categories for Retrospective Chart Reviews

No matter the review category, waivers of informed consent and HIPAA regulations may be requested.  Such requests must be appropriately justified in writing.

1)  EXEMPT REVIEW: 
A retrospective chart review may receive IRB approval under the exempt process if the research fits both of the exempt criteria of 45 CFR 46.101(b)(4).   These exempt criteria are:

a.   The research involves the collection or study of existing data, documents, records, pathological specimens or diagnostic specimens; AND

b.   The data sources are publicly available or the data is recorded by the investigator in an anonymous manner such that subjects cannot be identified directly or through identifiers linked to the subject

 

2)  EXPEDITED REVIEW: 
Retrospective chart reviews may qualify for expedited review according to 45 CFR 46.110 category 5 if:

a.   The research involves no more than minimal risk or minor changes in approved research; AND 

b.   The research involves materials (data, documents, records, or specimens) that have been collected, or will be collected solely for non-research purposes (such as for medical treatment or diagnosis).

The expedited review procedure may not be used for studies in which identification of the subjects and/or their responses would reasonably place them at risk of criminal or civil liability or be damaging to the subjects’ financial standing, employability, insurability, reputation, or be stigmatizing, unless reasonable and appropriate protections will be implemented so that risks related to invasion of privacy and breach of confidentiality are no greater than minimal.

Unlike exempt review, expedited review of retrospective charts does not require that the data be de-identified or anonymous.  Expedited reviews can be given to studies in which the data already exists, but data may be prospectively collected.  No matter whether the data exists or will be prospectively collected, the HIPAA "minimum necessary" rule applies. 

3)  FULL BOARD REVIEW: 
Retrospective medical cart review studies that do not meet the criteria outlined in categories 1 and 2 must be approved by a convened meeting of the full IRB panel.  Examples of such studies might be those in which the information contained in the medical records is of a sufficiently sensitive nature that additional safeguards are necessary to protect subjects' rights.  In this case, the full IRB panel will make a determination of risk and the need for informed consent.



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