Conditional Approval

Major Policy Change
Effective September 6, 2011

In the past, the University allowed the release of federal grant funds for human subjects research as soon as conditional IRB approval was granted. This practice allowed researchers to begin hiring staff, though activities involving human subjects could not occur until all IRB conditions had been met.

Federal agencies have recently clarified to the UW Office of Sponsored Programs (OSP) and the Human Subjects Division (HSD) that this practice is not consistent with federal requirements (45 CFR 46.103(b)). Therefore, effective September 6, OSP will no longer be able to release federal funds for human subjects research until the researcher has obtained one of the following from the UW IRB or an appropriate IRB with which the UW has an agreement:

IRB approval, or
"Exempt" status, or
Limited Activities Determination status, or
A determination that the research does not meet the federal definition of human subjects research.

OSP will be allowed to request budget set up if the federal sponsor specifically allows in writing the initiation of the research prior to full IRB approval.

Conditional IRB approval is still sufficient for setting up budgets for non-federally funded research and for federal "flow through" dollars coming from another institution to the UW.

New and Revised Documents

You may have noticed that HSD has been releasing new or revised written policy, procedure, and guidance documents at a brisk pace during the past year. This is a major effort that will continue during the coming year, due to:

Campus requests
HSD's goal of increasing transparency and knowledge about the IRB review process
The increased frequency of federal regulatory changes.

We generally release and post all new and revised document on the last Friday of every month. We use this newsletter to alert you to those new documents. We hope you like our new format for presenting the information, and we welcome feedback and suggestions. (hsdforms@uw.edu)

Topic	Consent Form
Document(s)	REVISED consent form template
Description	Information about confidentiality has been separated out of the "Other" section into its own "Confidentiality" section. Additional guidance has been provided within the template about how to describe who will (or will not) have access to identifiable research data. Required language about a federal Certificate of Confidentiality (when one is being obtained) has been inserted from a previous Procedures document into the consent template (specifically, the new Confidentiality section).
Expected impact	For subjects: significant impact; improved information about confidentiality. For researchers: low (little or no change in procedures; little or no extra work).
Related changes	None
Link for more info	http://www.washington.edu/research/hsd/docs/555
Implementation date	August 26, 2011

Topic	Conditional Approval
Document(s)	REVISED policy and procedure (one document)
Description	This revised document expands the previous policy document to include procedures and to incorporate the November 10, 2010 federal regulatory guidance about conditional approval. The biggest change is that conditional IRB approval is no longer sufficient for allowing OSP to release federal grant funds. There are also some minor procedural changes about conditional approval of Modifications and Status Reports.
Expected impact	Significant, for research funded by new federal grants. See above.
Related changes	None
Link for more info	http://www.washington.edu/research/hsd/topics/Conditional+Approval
Implementation date	August 26, 2011

Topic	Definition of Human Subject
Document(s)	NEW policy and guidance (one document)
Description	Provides and explains the regulatory definitions of a "human subject". Includes consideration of "third party" subjects, and whether "pre-screening" medical records involves human subjects.
Expected impact	Significant. For the first time, provides researchers with written guidance about how to asses whether their research involves human subjects.
Related changes	New "Over-enrollment" guidance (see next).
Link for more info	http://www.washington.edu/research/hsd/docs/1253
Implementation date	August 12, 2011

Topic	Over-enrollment
Document(s)	NEW policy and procedure (one document)
Description	Provides operational definition of over-enrollment. Explains why it is considered non-compliance, how it is handled by HSD and the IRB, and what the possible consequences are.
Expected impact	Significant, due to long standing confusion about subject numbers.
Related changes	New "Definition of Human Subject" document (see above).
Link for more info	http://www.washington.edu/research/hsd/docs/1251
Implementation date	August 26, 2011

Topic	Using Records without Consent
Document(s)	NEW flow chart
Description	This one-page flow chart guides researchers through the regulatory requirements for using different types of records (e.g., medical records; educational records) when the researcher is not planning (or is not able) to obtain subject consent.
Expected impact	Medium. Provides "single stop", easy to grasp, assistance to researchers on this common topic.
Related changes	None
Link for more info	http://www.washington.edu/research/hsd/docs/1286
Implementation date	August 12, 2011

Topic	HIPAA
Document(s)	NEW policy, procedures and guidance (one document)
Description	Provides detailed written information about HIPAA related definitions and HIPAA requirements for human subjects research. Describes required procedures at the UW, including how to request a Waiver of HIPAA Authorization.
Expected impact	High. No changes to policy or procedure, but provides written clarification, reference, and guidance material.
Related changes	None
Link for more info	http://www.washington.edu/research/hsd/docs/1259
Implementation date	August 12, 2011

Topic	Suspension or Termination of IRB Approval
Document(s)	REVISED policy and procedure (one document)
Description	Minor revisions for clarification to an existing document that describes suspension and termination definitions and procedures. No changes in policy or procedures.
Expected impact	Low
Related changes	None
Link for more info	http://www.washington.edu/research/hsd/docs/1295
Implementation date	August 12, 2011

Topic	Certificate of Confidentiality
Document(s)	REVISED procedure, cover sheet, and consent form language (three documents)
Description	UW researchers have recently been experiencing difficulty in obtaining Certificates of Confidentiality from federal agencies. In addition, there was some duplication across the existing documents, and it was difficult for researchers to find the required consent form language. Changes include: Revised procedures so as to resolve the federal agency concerns. Clarification about the sequence of obtaining IRB approval versus applying for a federal Certificate. Two documents ("procedures" and "instructions") combined into a single, stream-lined document. Certificate consent form language moved from the Procedures document, in the standard consent form template. Revised Cover Sheet for the Certificate application, to eliminate out-of-date questions and information.
Expected impact	Medium, for research needing a federal Certificate of Confidentiality. Easier to find and use information. No longer allowable to begin recruiting subjects without a Certificate, if a Certificate is required by the IRB or the research funder.
Related changes	Additional guidance in the consent form template about describing who will have access to identifiable research data.
Link for more info	http://www.washington.edu/research/hsd/topics/Certificates+of+Confidentiality
Implementation date	August 26, 2011

Topic	Translation and Interpretation of non-English Documents
Document(s)	NEW policy and guidance(one document)
Description	Describes UW IRB policy and guidance about translation and interpretation of documents, including consent forms. Provides information about a local translation service.
Expected impact	Medium, for research requiring non-English materials.
Related changes	None
Link for more info	http://www.washington.edu/research/hsd/docs/1237
Implementation date	August 12, 2011

Topic	Signatures on IRB Forms
Document(s)	REVISED policy and procedure (one document)
Description	Section 3.1 has been revised to slightly expand the ways in which a department chair's signature can be provided on IRB applications. This is now consistent with the acceptable methods of providing the lead researcher's signature.
Expected impact	Very minor.
Related changes	None
Link for more info	http://www.washington.edu/research/hsd/docs/931
Implementation date	August 26, 2011