New Policies and Procedures
On Friday, November 1st, a new group of Standard Operating Procedures (SOPs) and related tools were implemented and posted to the HSD website. The specific documents are listed below.
They focus on:
- FDA-Regulated research
- Research involving specific federal agencies such as the Department of Justice and the Environmental Protection Agency.
- Research involving prisoners, unviable neonates, or neonates of uncertain viability
In addition to the SOPs, a CHECKLIST has been created for each topic and agency. These can be used by researchers to identify the relevant requirements when preparing an IRB application. This should reduce the amount of "back and forth" during review.
The policies regarding prisoners and neonates have been revised to take advantage of regulatory flexibility. Specifically, this means that the federal requirements about these vulnerable populations are applied only to federally-funded research and to non-federally-funded research with the types of risks and methodology that the federal regulations were designed to address.
HSD Forms: A New Naming System
HSD has implemented a new naming system for our forms, to make the names more consistent, and the forms easier to find on our website.
The naming scheme will generally follow this formula: ACTION: Event, Audience. For example, the "Initial Application Use of Identifiable Biological Specimens/Data" has become: "APPLICATION: Specimen or Data Use, Identifiable". The Human Subjects Review Application: UW 13-11 is now: "APPLICATION: Human Subjects Review (13-11), Full Board or Subcommittee.
The main keywords will remain in the title of the form, and the alphabetical forms list on our website is now much easier to scan and navigate.
Send your questions or comments to Sherry Edwards, Information Manager at email@example.com or 206-221-0994.
A New HSD Service for WIRB Reviewed Studies
HSD examines the consent forms for industry-sponsored clinical trials before giving permission for the trials to be reviewed by Western IRB (WIRB). This often involves negotiation with the industry sponsor or Contract Research Organization (CRO) about specific wording in the consent form and the HIPAA authorization form. The negotiation has always been conducted through the study research staff, who act as "go betweens".
HSD is now offering to negotiate directly with the sponsor or CRO. This optional service is selected by the principal investigator of the study staff when completing the REQUEST AUTHORIZATION: UW/WIRB form.
This will reduce the workload of study staff. It is likely to also reduce the time required for any negotiation, and therefore, the time required for this part of the study start-up process.
Contact Brecken Cardinal (HSD Clinical Trials Administrator) with any questions, at firstname.lastname@example.org, or 206-543-0639.
Executive Order 24
Executive (presidential) Order 24 is the University's highest level statement about its commitment to the ethical and compliant conduct of research with human participants. A significant revision was implemented on October 11, 2013, after broad feedback from faculty groups, other compliance offices, and IRB members.
EO 24 provides a brief summary of principles, responsibilities, administration, and oversight.
Read the executive order here.
HSD on YouTube
HSD now has its own YouTube channel. We are producing short (3-7 minutes), focused video presentations about the IRB review of human subjects research. The video are available from the left hand navigation on the HSD website. Click on "Training" then "HSD Training Videos".
These videos are an alternate way for researchers to obtain "on-demand" education and information. The first video focuses on the set of policy changes implemented this summer by HSD. More videos will follow focusing on the remaining policy changes implemented this year. During the coming months, we will post many additional short videos about specific topics, such as Translation & Interpretation, and Certificates of Confidentiality.
We hope you enjoy this exciting new feature. Please send any questions or comments to Katy Sharrock, Training and Education Specialist, email@example.com.
Reminder IMPORTANT ANNOUNCEMENT
Applicability of FDA Regulations
Effective October 25, 2013
A revised UW policy, will cause the basic Food and Drug Administration (FDA) regulations to be applied to significantly more studies than in the past. These basic FDA regulations are 21 CFR 50 (informed consent requirements) and 21 CFR 56 (IRB review requirements). This will be in addition to the basic "Common Rule" federal regulation of 45 CFR 46, and any other applicable regulations.
Why is this change occurring?
The UW IRB is adopting a slightly different interpretation of the FDA's definition of "human subjects research", to bring the UW IRB into alignment with most other IRBs and with federal agency discussions. The primary change is for studies involving drugs. The FDA considers "any use of a drug outside of medical practice" that involves one or more human subjects to be FDA-regulated human subjects research. The following issues are irrelevant in determining the applicability of the FDA regulations:
- Whether or not the drug is investigational or already approved by the FDA;
- Whether or not the study is assessing the safety or efficacy of the drug;
- Whether or not the study data will be submitted to the FDA;
- Whether or not the purpose of the study is to support commercial development of the drug.
Does this mean that more studies will need an IND or IDE?
IND and IDE are the initials that refer to obtaining permission from the FDA to do research with an investigational drug or device. Being subject to FDA regulations does not necessarily mean that a study needs an IND or IDE. HSD has released worksheets that guide researchers through the process of determining whether they need to apply to the FDA for an IND or IDE.
What impact will this have?
The basic FDA regulations are very similar to the basic federal human subjects regulations that are already applied by the UW IRB. This means that being governed by the basic FDA regulations does not have much impact on the study or how it is reviewed by the IRB. The most important differences are listed here. They are also described in a new procedure document called SOP FDA-Regulated Research.
- A waiver of consent cannot be granted except for certain types of emergency medicine research. Note that the FDA does not consider it to be human subjects research when medical records are screened in order to identify potential study participants, so a waiver of consent can still be granted for this activity, under the other federal human subjects regulations.
- The FDA requires a few additional elements in the consent form. These were already incorporated into HSD's standard consent form template within the past few years.
- Serious non-compliance, unanticipated problems, and suspensions of IRB approval must be reported by the IRB to the FDA as well as to other agencies and the study sponsor.
Is there a way to determine whether the FDA regulations apply to a study?
HSD posted the WORKSHEET Human Subjects Research to its website at the end of June. Researchers, HSD staff, and the IRB can use this worksheet to determine whether the study meets the FDA's definition of human subjects research. If it does, then the basic FDA regulations apply. If the study is FDA-regulated, the researcher can then use the Worksheets about INDs and IDEs to determine whether an IND or IDE is needed.
Will any other FDA related changes occur at the same time?
Yes, HSD has now implemented:
These new documents will provide the IRB with more initial information, thereby reducing the need for some back-and-forth correspondence.
Contact HSD through firstname.lastname@example.org if you have any questions or concerns.
New and Revised Documents
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 welcome feedback and suggestions. (email@example.com)
||NEW: SOP Neonates; NEW: CHECKLIST: Neonates; NEW: SOP Prisoners; NEW: CHECKLIST: Prisoners; UPDATED: SUPPLEMENT: Protected and/or Vulnerable Populations
||New tools and checklists to document and track the regulatory requirements involved in using protected and/or vulnerable populations in human subjects research. Revised policies take advantage of regulatory flexibility for non-federally-funded research involving these populations.
|Link for more information
||See the eNews article above, and the SOPs and tools linked above.
November 1, 2013
||Main Application for Human Subjects Review
||UPDATED: APPLICATION: Human Subjects Review (13-11), Full Board or Subcommittee
||The main application no longer contains sections on drugs and devices. It now refers researchers to the SUPPLEMENTS: Drugs, Biologics, Botanicals and Devices. Also added are references to the new supplements or checklists for other federal agencies, such as the Department of Justice, the Department of Energy and the Environmental Protection Agency.
|Link for more information
||See the eNews article above, and the application linked above.
November 1, 2013
Quick Tips from HSD
The research scientist stood in front of the Health Sciences BB elevators, waiting for what seemed like an eternity, when her colleague appeared at her elbow. He leaned over her shoulder.
"What are you reading?" He asked, as his coffee cup started dripping over the pages.
She sighed, shaking the paper, trying to rid it of the coffee before it soaked in too much. "I'm just going over my UW IRB application." She thumbed through the sheets of paper. "I want to make sure that I've got all the right attachments."
The elevator finally arrived. The researcher and her colleague stepped in. The elevator was full of people and a large hospital food trolley. "I'm very excited about starting this new oncology study..." she continued. "I've just joined the Cancer Consortium, and they offer some great support services." She waived her application back and forth to dry off the spilled coffee.
"Oh no!" piped a voice from somewhere at the back of the elevator. After some shuffling, the voice continued from behind the food trolley. "Don't apply to the UW IRB!"
"What the heck..." the research scientist scanned the crowded elevator, looking for the source of the voice. "This is happening far too often..." she mumbled under her breath.
The elevator lurched to a stop on the 3rd floor, and more people pushed on.
"Read the application cover page. Most UW cancer-related studies go to the Fred Hutch Cancer Consortium IRB instead of the UW IRB."
The researcher twisted around, trying to pinpoint the location of the voice. "You're not seriously hiding behind a food trolley, are you?"
"Give me a break," the voice squeaked back. "It's hard to be mysterious and deliver timely advice in an elevator."
"That mysterious voice is right you know, it says right here: 'Do not complete this form if you are member of the Cancer Consortium.'" The colleague tapped the cover sheet a few times. "Right here..."
The elevator stopped on the 4th floor. The researcher sighed again as more people pushed on and only two exited. "Well, the link is right here, I guess I can transfer all this information over."
"That's the spirit!" The voice from behind the trolley yelled. The elevator lurched to yet another floor and the person pushing the trolley started to move out. "After all, tomorrow is another day!" The voice moved along behind the trolley, out of the elevator.
"Someday, you're going to have to thank that mysterious voice." The colleague took a giant slurp of coffee.
"Uh, yeah." The research scientist scratched her head. "I just wish that voice would pop up before I filled anything out."
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