Research Care Plan Note
Guidelines and Procedures for Application of UW Medicine Policy Requiring Information in Medical Record of Participants in Studies Reviewed by FHCRC and Consortium Institutional Review Boards (IRBs)
Revised January 22, 2009
Background
The FHCRC Research Care Plan Note (RCPN) requirement was developed in response to the UW Medicine policy requiring that the UW Medicine/SCCA medical records for research participants contain a "research care plan" note to facilitate research billing compliance and enhance patient safety. The RCPN requirement will mandate that certain information about research studies conducted at UW Medicine or SCCA facilities or by UW Physician members be entered into the UW and SCCA medical record for each research participant enrolled in those studies. The specific information to be entered in the medical record will be discussed below but it will include the title of the study and contact information for study staff.
Will my research study be covered by the RCPN requirement?
You may be affected by the RCPN requirement if your research study involves both #1 and #2:
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Study involves active consent by research participant and
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Study involves any clinical services, items, or tests provided at
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UW Medicine hospitals or clinics (includes UW Medical Center, Harborview Medical Center, Eastside Specialty Center, Hall Health Primary "Care Center, and Sports Medicine Clinic); or
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Other locations where UW Physicians (UWP) will perform the study procedures; or
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Seattle Cancer Care Alliance (SCCA).
Please complete the determination flowchart to determine if your study may be covered by the RCPN requirement.
I am currently preparing to submit a NEW application to the IRB. What do I need to do?
The FHCRC model consent form has been updated with new template language to address the research care plan note requirements. See Page 9. The IRB RCPN Guidelines have been revised as follows:
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TYPE OF STUDY |
ACTION TO BE TAKEN |
| For Therapeutic Studies that have study procedures at SCCA or UW |
Consent revisions consistent with the template language are RECOMMENDED BUT NOT REQUIRED. |
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For Non-Therapeutic Studies that have study procedures at SCCA or UW |
Consent revisions consistent with the template language are REQUIRED. |
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For Non-Therapeutic Studies that do not have study procedures at SCCA or UW |
Consent revisions consistent with the template language are NOT REQUIRED. |
Non-Therapeutic study: The primary objective of the study does not include treatment of a disease or other health condition (including consents for creation of data or tissue repositories).
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Healthy volunteers who sign a consent document that currently does not explicitly inform research participants that information about their participation will become part of their medical record.
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A Certificate of Confidentiality approved by the National Institutes of Health.
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Studies involving sensitive information in the study title (e.g., HIV/AIDS, sexually transmitted diseases, mental health conditions, alcohol or substance abuse treatment).
Examples include studies involving individuals who agree to provide data and/or specimens for cancer research but who medical record contains no indication that the research subject has been diagnosed as having cancer or a heightened cancer risk. Other examples include studies involving health volunteers who agree to participate in a HIV-AIDS research study but who do not have HIV-AIDS. Including a study title with the terms HIV or AIDS in an individual's medical record could negatively impact on the individual.
If you enroll research participants at other sites, you may choose to submit a consent supplement or addendum to attach to only those consents to be presented to research participants who will receive services, tests or procedures at UW Medicine or SCCA.
The IRB will determine whether the re-consenting of enrolled study participants is required.
What if my study has already been submitted to the IRB for review?
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STATUS OF MY STUDY |
ACTION TO BE TAKEN |
| NEW Study that has already been submitted to the IRB and is currently in review | The Research Care Plan Note requirement will be included in the IRB result letter if appropriate. There is no immediate action needed from you. |
| EXISTING study (CRR or modifying a consent form) that has already been submitted to the IRB | The Research Care Plan Note requirement will be included in the result letter email/letter, if appropriate. |
| Determination Form submitted last summer | There is no immediate action needed from you. |
What if I did not submit a Determination Form last summer or I have not yet submitted the CRR for my existing study?
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Determination forms will be distributed to research staff for their current (existing) studies at the upcoming SCCA/Consortium Clinical Trials Policy Training sessions.
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Research staff will receive notice about this training soon.
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There is no immediate action needed from you for existing studies. Wait for the training.
What if my study is supported by funding administered by the University of Washington?
Should you have questions about this update, please contact Associate General Counsel Gerianne Sands at (206) 667-1224 or gjsands@fhcrc.org.
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©2009 Fred Hutchinson Cancer Research Center 1100 Fairview Ave. N., P.O. Box 19024 Seattle, WA 98109 |
