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January 21st, 2019

New Common Rule Implemented! Finally.

The new federal regulations for human subjects research are here. Please review our New Common Rule Page for the details.

Several forms have been updated to reflect these new regulations. When beginning a new form, whether it is a new application or modification, always be sure to return to our website and download a new form. That ensures you are always working with the latest version.

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October 2nd, 2018

New Procedures Implemented This Fall

This year has been a time of change for the WWU compliance office. We have appreciated your patience and feedback during this time of growth. In this academic year, we look forward to demonstrating our vision of making Western’s Compliance Office better and improving our support of the research community.

There is yet another delay in the implementation of the New Common Rule, but we are moving forward with several burden-reducing provisions allowed by federal regulations. We are also introducing new flexibility for non-federally funded research.

Included below is a description of the new procedures and our implementation plan.

Revised Definition of Research

Summary: There is revised definition of “research” that specifies that scholarly and journalistic activities are not considered research. More specifically, this includes scholarly and journalistic activities (e.g. oral history, journalism, biography, literary criticism, legal research, and historical scholarship), including the collection and use of information, that focus directly on the specific individuals about whom the information is collected. You no longer need to submit IRB applications for these activities.

Context: Federal regulations are allowing universities to implement certain burden reducing procedures prior to the implementation of the New Common Rule. The WWU IRB has decided to adopt these provisions, which include this new definition.

Previous Definition: “Research means a systematic investigation, including research development, testing and evaluation, designed to develop or contribute to generalizable knowledge. Activities which meet this definition constitute research for purposes of this policy, whether or not they are conducted or supported under a program which is considered research for other purposes. For example, some demonstration and service programs may include research activities.”

New Definition: “Research means a systematic investigation, including research development, testing, and evaluation, designed to develop or contribute to generalizable knowledge. Activities that meet this definition constitute research for purposes of this policy, whether or not they are conducted or supported under a program that is considered research for other purposes. For example, some demonstration and service programs may include research activities. For purposes of this part, the following activities are deemed not to be research:

(1) Scholarly and journalistic activities (e.g., oral history, journalism, biography, literary criticism, legal research, and historical scholarship), including the collection and use of information, that focus directly on the specific individuals about whom the information is collected.

(2) Public health surveillance activities, including the collection and testing of information or biospecimens, conducted, supported, requested, ordered, required, or authorized by a public health authority. Such activities are limited to those necessary to allow a public health authority to identify, monitor, assess, or investigate potential public health signals, onsets of disease outbreaks, or conditions of public health importance (including trends, signals, risk factors, patterns in diseases, or increases in injuries from using consumer products). Such activities include those associated with providing timely situational awareness and priority setting during the course of an event or crisis that threatens public health (including natural or man-made disasters).

(3) Collection and analysis of information, biospecimens, or records by or for a criminal justice agency for activities authorized by law or court order solely for criminal justice or criminal investigative purposes.

(4) Authorized operational activities (as determined by each agency) in support of intelligence, homeland security, defense, or other national security missions.”

Implementation: We plan to implement this new definition immediately.

No Continuing Review for Expedited Research

Summary: Only full-board studies will require continuing review on a yearly basis. Expedited studies no longer need to submit status reports for renewal.

Context: Federal regulations are allowing universities to implement certain burden reducing procedures prior to the implementation of the New Common Rule. The WWU IRB has decided to adopt these provisions, which include the removal of continuing review for expedited research.

Previously, both expedited and full board studies were given expiration dates on their approval. Researchers needed to renew these applications, typically each year, by submitting a “continuing review report” (also known as a status report) before the end of the expiration. Now, only full board applications will have expirations dates and will need to be renewed.

We will continue to ask that Principal Investigators (PIs) close expedited applications and full board applications when there is no longer interaction or intervention with humans or identifiable data. For example, if you are only conducting data analysis and identifiers have been destroyed, you should close your application.

If you are running a full board study and are looking for a way to manage your renewals, our office recommends putting an appointment on your calendar that reminds you when to submit a status report. Our office does not currently have a system for sending automatic renewal reminders, so it is up to the PI to keep track of their full board application expirations.

Implementation: We plan to implement this change immediately. If you have an open expedited application, you will receive an email with additional information and instructions.

No More Submission of Human Subjects Research Training Certificates

Summary: The IRB is now handing over responsibility for tracking training certifications to Principal Investigators (PIs).

Context: Training in human subjects research protections is required of the PI and any other research personnel who interact or intervene with human subjects or have access to their identifiable data. If the PI is a student, their Faculty Advisor must also complete the training.

There are two acceptable training certifications. One is the CITI Social &s; Behavioral Research training course. This is an online training, paid for by Western. The other is certifications from the NIH training program. While the NIH training has been retired, certifications are valid until expiration, which is 5 years after the completion date. Other training certification programs must be approved by our office.

Previously, these certificates were submitted with new application submissions or any time new personnel was added. Requests for missing certifications would often delay research approvals and researchers frequently submitting modifications just to add research personnel. For these reasons, with support from faculty feedback, we have determined that these certifications are better tracked by the PI.

Under this new plan, PIs must retain records of training for all past and present research personnel, according to the university’s retention requirements. Currently, that means keeping research records for 6 years after the closure of the study. PIs should also ensure that trainings do not expire.

The easiest way to do this is to have all research personnel complete the CITI Social &s; Behavioral Research training course. CITI stores documentation of training online and sends email reminders when trainings are about to expire. In this scenario, the PI will only need to maintain a list of the names of past and present research personnel.

When records are paper-based, like with NIH certificates, the PI will need to store these certificates and track their expiration dates to ensure that personnel have up to date training.

Studies that have approved field training programs, which differ from the standard online course, will only need to document that training occurred.

If you are looking for advice on how to start getting these records in order, we recommend that you gather your application and any modification approval packets. The certifications will be in those packets. To track your personnel you could create a spreadsheet of personnel with their certification type and the certification expiration date. To track when NIH certifications expire, you could create appointments on your calendar for the expiration dates. To store the NIH certifications, you could put them in a physical or electronic study folder. While it might be tempting to ask our office to distribute your NIH certifications, we unfortunately don’t have the resources to do this for every investigator, so we are asking for your assistance. If you find that you don’t have your approval packets already stored, then this is a great time to go in search of them. You need to have your approval packets as part of your study records.

This is a new system, so the IRB will conduct random post-approval monitoring check-ins of these certifications to make sure it is working smoothly. A check-in will consist of our office sending the PI, or PI Proxy, a records request email. We will ask the PI to respond within a reasonable time period with the names and email addresses of all past and present research personnel, including an indication of which type of certification they hold (NIH or CITI). For those personnel with NIH certifications, PDFs of their certifications should be attached to the response. For personnel trained through CITI, the IRB will be able to look up documentation of their training online. These check-ins will only occur for currently open applications.

Implementation: Starting immediately, our office will no longer request certifications with new applications or modifications. The post-approval monitoring check-ins of certifications will not begin until mid-fall quarter, to allow researchers time to get their records in order.

Western Washington University Students as Mature Minors

Summary: For non-federally funded research that does not involve FERPA, the WWU IRB will consider WWU university students who are minors as capable of consenting to participate in research as adults, without parental permission. This means that when conducting classroom research at Western you no longer need to screen participants for age.

Context: Researchers often request to recruit adults with university students as their subject population, forgetting that not all university students are 18 years old or older. Anyone under the age of 18 is considered a minor and requires special protections in research, such as parental permission for participation. While easy to fix – we would request that the research include some mechanism of screening, like a screening question or a statement in the consent form that participants must be 18 years old or older – these frequent clarifications would increase screening times and delay research.

One of the WWU IRB's goals is to tailor our compliance process to the needs of Western. Historically, the WWU IRB has applied the same federal rules to all research regardless of the funding source. This has been beneficial in ways, but often puts unnecessary restrictions on some of the most common research types at Western. The WWU IRB has determined that our community would benefit from a customized framework for research, rather than one set of rules. For federally funded research, the procedures set by the New Common Rule will remain the same. For non-federally funded research, the WWU IRB has created a modified set of procedures to better facilitate research. We want to assure you that this customized framework is open for feedback and further improvement. We also want to emphasize that our office will continue use the federal regulations and the Belmont Report as a foundation for compliance decisions. These new procedures maintain the integrity of research compliance while making everyone's lives a little easier.

When research is not federal funded, and does not involve FERPA (such as accessing education records for any reason), our office will consider WWU enrolled university students who are minors as capable of consenting to participate in research as adults. If you indicate in your application that your population is WWU students, then we will not ask you to screen for age.

This does not prevent researchers from continuing any current screening processes in place. This will only apply to new applications. Unfortunately, if you want to incorporate this new flexibility, and your current approved application specifies that you are only recruiting participants 18 years old and older, you will need to submit a modification to change your subject population.

Implementation: This flexibility is available immediately for new applications and currently approved studies looking to modify their procedures.


New Exempt Categories

Summary: For non-federally funded minimal risk research, the WWU IRB has created new categories for exemption. These include benign behavioral interventions and benign survey research with minors.

Context: There are 6 categories of research that are determined eligible for exemption under the federal regulations. An exemption means that the research does not need to meet federal regulations. One of the WWU IRB's goals is to tailor our compliance process to the needs of Western. Historically, the WWU IRB has applied the same federal rules to all research regardless of the funding source. This has been beneficial in ways, but often puts unnecessary restrictions on some of the most common research types at Western. The WWU IRB has determined that our community would benefit from a customized framework for research, rather than one set of rules. For federally funded research, the procedures set by the New Common Rule will remain the same. For non-federally funded research, the WWU IRB has created a modified set of procedures to better facilitate research. We want to assure you that this customized framework is open for feedback and further improvement. We also want to emphasize that our office will continue use the federal regulations and the Belmont Report as a foundation for compliance decisions. These new procedures maintain the integrity of research compliance while making everyone's lives a little easier. Two new exemption categories were created to address common types of non-federally funded research at Western.

Non-Federally Funded Exempt Category 7: Tasks & Benign Behavioral Interventions


This category includes research with adults involving:

  • Non-invasive tasks or activities that supplement or inform the procedures in Exempt Category 2, such as such as participation in a game (real or virtual), watching and responding to visual or auditory stimulation (videos, music, pictures, etc.), and usability or software testing.

  • Benign behavioral interventions in conjunction with the collection of information from an adult subject through verbal or written responses (including data entry) or audiovisual recording if the subject prospectively agrees to the intervention and information collection unless:

    (1) information obtained is recorded in such a manner that human subjects can be identified, directly or through identifiers linked to the subjects; AND

    (2) any disclosure of human subjects’ responses outside the research could reasonably place the subjects at risk of criminal or civil liability or be damaging to the subjects’ financial standing, employability, or reputation.

A benign behavioral intervention is brief in duration, harmless, painless, not physically invasive, not likely to have a significant adverse lasting impact on subjects, and the investigator has no reason to think the subjects will find the interventions offensive or embarrassing.

The research procedures cannot involve collection of biological specimens, exercise procedures, or the physical assessment of subject’s physical characteristics, except for standard anthropometrics and vital signs.

Non-Federally Funded Exempt Category 8: Benign Survey Research With Minors


Non-federally funded research with minors, which would otherwise be eligible under Exempt Category 2 with an adult population, involving survey or interview procedures on benign topics. In order to be considered for this category, the following should be true:

  • Parental permission and child assent must be obtained. An exception is made for students under 18 years old enrolled at Western Washington University unless FERPA or PPRA applies to the research.
  • Survey topics cannot include: political affiliations or beliefs of the minor, mental or psychological problems, sex behavior or attitudes, sexual orientation, illegal, antisocial, self-incriminating, or demeaning behavior.

Implementation: These new exemption categories are available for newly submitted research applications. If your application was approved as expedited, and now could be considered exempt under one of these categories, you can contact our office. We may re-review your application and issue a new determination, if applicable.

A New Way of Reviewing Exempt Research

Summary: For exempt eligible applications our office will no longer review recruitment documents or consent forms.

Context: : Previously, the same procedures were applied to all types of research. Recruitment documents and consent forms were required to be submitted with every application.

Continuing with our goal of reducing burden for researchers and streamlining processes, the WWU IRB will begin reviewing exempt research in a manner more closely aligned with the intent of the category. While only the IRB has the authority to provide exempt determinations and is required to ensure basic protections are in place, exempt studies should otherwise be exempt from IRB review. For this reason, we will no longer be requiring the submission of consent forms and recruitment documents for exempt applications. If your application is eligible, you will only need to describe your recruitment process and consent process.

To help you determine whether your research is eligible for exemption, our office has created an online research category determination and an application guidance tool:

Implementation: We plan to implement this method for all new applications.

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March 20th, 2018

Why We Updated Our Human Subjects Procedures

In an effort to better support our researchers while improving our compliance with human subject regulations, we have been working hard to bring you this new website as well as new forms, guidance documents, and procedures.

What's New?

• New Forms

— One application form is replacing the two forms that existed previously. This new form has supplements that can be completed if applicable to your research.

Why the change? Having one form eliminates confusion over which application to complete. A majority of the new or expanded questions address common problems and misunderstandings in submitted applications. Some questions were added to improve our compliance with human subject research protections.

Burden increased: The new form will be longer to complete than the old form. For certain types of research, such as studies with minors, a short supplement to the application will need to be completed.

Burden reduced: There should be a significant reduction in screening back and forth between the IRB and researchers. The new application will walk researchers through all of the information that we normally needed to clarify or modify via email after submission. Separating some questions into supplements that are attached to the application if needed will keep the application focused on relevant questions. We will accept scanned signatures, rather than requiring all ink signatures. Researchers will no longer be required to submit curriculum vitae or resumes with their application. Researchers only need to submit certificates of training in human subjects protections for individuals interacting or intervening with human subjects or identifiable data.

When to start using it? By April 1st 2018 all new applications should be submitted using the new form, unless otherwise cleared by the IRB.

— Consent templates and examples with updated suggested and new required language are available.

Why the change? New consent form template options will be helpful for researchers. New suggested and required language will increase transparency for research subjects.

Is there a change in burden?

Burden increased: Researchers submitting new applications for non-exempt research will have new consent form language to incorporate.

Burden reduced: There should be significant reduction in screening back and forth between the IRB and researchers. Consent forms are often the area that need the most discussion. The numerous new example consents will make it easier to create a complete consent form that is more flexible for the study design.

When to start using it? By April 1st 2018, all new applications should follow these guidelines for their consent form.

— A new modification form is available.

Why the change? To improve the speed by which modifications are reviewed and improve the documentation of changes.

Is there a change in burden?

Burden increased: None anticipated.

Burden reduced: There should be a reduction in screening back and forth between the IRB and researchers. The IRB will no longer require modifications for certain minor changes made to exempt applications.

When to start using it? All new modifications submitted on or after April 1st 2018 must use the new form.

— A status report form is now available for extending non-exempt research (see below for the new status report process).

Why the change? To give necessary oversight during extensions and closure of non-exempt research protocols.

Is there a change in burden?

Burden increased: Researchers will need to track the study expiration date of non-exempt applications and complete a continuing review form in order to extend their research on time.

Burden reduced: Once the new Common Rule changes are implemented, status reports will only be required for full board studies.

When to start using it? Effective immediately researchers will be required to submit this form to request an extension of research applications.

• New Processes

— Application Submissions

We encourage all new applications to be submitted through email to compliance@wwu.edu. If you need to submit your application on paper this is still acceptable, but not preferred.

Why the change? To create an electronic record of your submission.

Is there a change in burden?

Burden increased: None anticipated.

Burden reduced: Researchers no longer need to hand deliver or mail applications. Signatures will no longer need to be originals.

When to start using it? Effective immediately.

— Status Reports

We are instituting a new system for study extensions to improve our compliance and oversight of open applications. Researchers will need to submit a status report form 4-6 weeks prior to the expiration of their non-exempt research. This lead time is to prevent any interruption in the study. While the IRB will attempt to send reminders to renew studies, it is ultimately the researcher’s responsibility to renew (or close) a research protocol. Modification forms will no longer be able to serve as approval to extend a study, as the forms and processes serve different purposes for review. You can, however, submit a modification form and a status report form at the same time.

Why the change? To give necessary oversight during extensions of research.

Is there a change in burden?

Burden increased: Researchers will need to track their study expiration date and complete a status report form in order to extend their research. If a researcher wants to modify their study while submitting a status report, they will need to complete both forms.

Burden reduced: Once the new Common Rule changes are implemented, status reports will only be required for full board studies.

When to start using it? Effective immediately, researchers of non-exempt studies will be required to submit this form in order to extend their research past the expiration.

— Closing Your Application

For expedited and full board applications, we will send study expiration notifications.

Closing an application will involve completing a final Status Report form and selecting the option for study closure.

Why the change? To know which applications are ongoing or closed in order to improve our oversight of research compliance.

Is there a change in burden?

Burden increased: Researchers will need to submit a Status Report form to close applications when the study is complete.

Burden reduced: None anticipated.

When to start using it? Effective immediately.

What You Can Do

  • Explore our new compliance website.
  • ORSP is holding several workshops and talks on these new changes and forms. Visit our Workshops page to learn more.

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December 4th, 2017

New Common Rule Changes: The Biggest Overhaul in Decades

Researchers or would be researchers be aware, there are changes on the horizon. We think you'll like these changes.

We've created a New Common Rule Page just for you, as we navigate these new rules together.

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