HSD Compliance Updates
Inquiries and Complaints
New guidance has been posted to help researchers and their staff members understand their role in resolving "research inquiries." "Research Inquiries" include complaints and concerns about the research, the researcher or others voiced to the researcher by a subject, subject's family, or any other source.
The new guidance describes which inquiries:
HSD can provide advice and help with inquiries. Contact Stefan Shipman, HSD Compliance Administrator (shipmans@uw.edu) with questions. The new guidance is found at this URL: http://www.washington.edu/research/hsd/docs/92
Out-of-Window study visits: Reporting to the IRB is no longer required
Our policy about reporting these events has been revised. "Out-of-window" study visits do not necessarily require reporting to the IRB even though these events may meet the definition of non-compliance with approved study procedures. They should be reported only when:
- The IRB has required the reporting of all non-compliance for a particular study due to the risks the study poses to subjects, or
- The out-of-window visit results in harm to subjects, or
- The sponsor requires a report to the IRB.
The decision to discourage routine reporting of out-of-window visits was based on a review of our 2011 compliance data showing that reporting these events did not result in changes to the research or research procedures nor did they present risk to subjects. In addition, most out-of-window study visits were out of the researcher's control so these events seldom met the required reporting criteria. The revised guidance is in Section 4.1.2 of this document: http://www.washington.edu/research/hsd/docs/1218
WIRB Fee Schedule Change: Effective 6/1/2012
Western Institutional Review Board (WIRB) is changing its fee schedules effective June 1, 2012. The revised fees are posted to the HSD Web site at: http://www.washington.edu/research/hsd/docs/1354
All services provided on or after June 1, 2012, will be billed at the new rates.
Contact WIRB's Client Services Department at 360-252-2500 or 1-800-562-4789 if you have any questions.
Presidential Commission for the Study of Bioethical Issues
Request for public comment
The Presidential Commission for the Study of Bioethical Issues is requesting public comment on the ethical issues raised by the ready availability of large-scale human genome sequence data, with regard to privacy and data access and the balancing of individual and societal interests.
The deadline for comments is May 25, 2012. See the Bioethics Commission Web site and Federal Register Notice at: http://bioethics.gov/cms/node/676 for more information on how to comment, and on which specific issues.
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 documents 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 |
Research Inquiries |
| Document(s) |
NEW Research Inquiries Guidance for Researchers |
| Description |
Describes the roles of researchers and their staff in helping to resolve inquires from study subjects |
| Expected impact |
Medium - will clarify what constitutes a reportable inquiry, and the timeframe for reporting
|
| Related changes |
HSD internal procedures
|
| Link for more information |
http://www.washington.edu/research/hsd/docs/92
Article within this eNews
|
| Implementation date |
March 30, 2012 |
| Topic |
Research Non-Compliance |
| Document(s) |
REVISED Research Non-Compliance: Researcher Overview |
| Description |
A revision to Section 4.1.3 informs researchers that "out-of-window" study visits do not require reporting to the IRB |
| Expected impact |
Medium - will lessen burden on both researchers and the HSD Compliance Team in reporting these events
|
| Related changes |
None
|
| Link for more info |
http://www.washington.edu/research/hsd/docs/1218
Article within this eNews
|
| Implementation date |
March 30, 2012 |
| Topic |
Limited Activities Determination |
| Document(s) |
REVISED Limited Activities Determination for Funding |
| Description |
Added clarification that PIs should submit a LAD closure request and indicate the LAD number where appropriate
|
| Expected impact |
Minor
|
| Related changes |
None
|
| Link for more info |
http://www.washington.edu/research/hsd/docs/776
|
| Implementation date |
March 30, 2012 |
| Topic |
Documentation of Funding |
| Document(s) |
REVISED Human subjects Review Application: UW 13-11 |
| Description |
Added language to the funding section that states: "This should include grants that support faculty time for data analysis and manuscript preparation." |
| Expected impact |
Minor
|
| Related changes |
None
|
| Link for more info |
http://www.washington.edu/research/hsd/docs/3
|
| Implementation date |
March 30, 2012 |
| Topic |
Engagement |
| Document(s) |
REVISED Modification Form |
| Description |
In order to determine more accurately engagement of researchers and sites, questions in Section I and Section J were updated |
| Expected impact |
Minor
|
| Related changes |
None
|
| Link for more info |
http://www.washington.edu/research/hsd/docs/325
|
| Implementation date |
March 30, 2012 |
 Quick Tips from HSD
Welcome to Quick Tips, a new eNews feature that reveals the true meaning of some of those confusing IRB terms!
Exempt?
Exempt is another one of those terms that has a different meaning in connection with human subjects research than you might expect. (Recall how "expedited" doesn't mean quicker in the IRB world.)
It is often thought that "exempt" means that the research activity does not involve human subjects. This is not the case. Exempt, in regulatory speak, means that the activity involves human subjects, however, because it is no more than minimal risk and fits into one or more of the six specific categories of research defined by the federal Office of Human Research Protections or OHRP (affectionately pronounced "O-Harp") it is "exempt from the regulations." An exempt determination is a specific determination that is made only by the Human Subjects Division (HSD). Take a look at either the regulations themselves, or HSD's well written and easy to read Exempt Status Request Guidance document to learn more about the six categories.
While you're reading that guidance, Quick Tips is going to consult the Exempt Magic Eight Ball to clear up some misconceptions about Exempt Research:
 Can I use deception in Exempt research, as long as the risk is minimal and I debrief the participants afterwards?
"My reply is no." Deception studies that intentionally provide misleading or false information are not eligible for Exempt status. One example: Participants complete a quiz and are falsely told that they did poorly, regardless of performance.
Does a determination of "Exempt" mean that I have IRB approval?
"Outlook not so good." Exemption is a determination by the staff of HSD that the research is exempt from review by the IRB. However, keep in mind that researchers still have a responsibility to protect the rights and welfare of their subjects, and are expected to conduct their research in accordance with ethical principles, as well as state and local institutional policy.
Exempt means it's not Human Subjects Research, right?
"My sources say no." If a research project involves humans (see the definition of a human subject on the HSD website) it is still human subjects research, even if it is minimal risk, and falls under one of the six categories of exemption.
I've heard that I can determine whether my research is exempt.
"Don't count on it." The staff of the Human Subjects Division are the only individuals authorized at the UW to determine whether the research activity is exempt from federal regulations. The UW applies the federal regulations and guidance about exemption to all human subjects research, regardless of funding, or funding source.
So, if my research is "exempt," I don't have to do anything?
"Very doubtful." You must complete the form "Initial Application: Exempt Status Request" either in Word or PDF. Then, send it to the HSD office to request a determination of "Exempt." Think of "Exempt" as a status that is determined by HSD, according to the specific federal regulations governing human subjects protections. The everyday usage of the word exempt does not really apply.
Hmm, the Exempt Magic Eight Ball is on a negative streak today. Let's refrain from asking it about the lottery.
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