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Archived News

On this page, you will find archived news posts from 2014-2019. Current news can be found here.

2014

12/02/2014 - New CITI training Sign-on process will be implemented Wednesday

Effective close of business 12/3/14, individuals affiliated with NU will be required to login to the CITI website via a new SSO (single sign-on) method utilizing NU netID/password.  Instructions for using this new process are below.

Click here for a PDF of instructions and screen-shots

Creating a new account:
1. Go to: https://www.citiprogram.org/index.cfm?pageID=668
2. Select “Northwestern University” from the list of options
3. An NU validation screen will come up.  Enter your NU NetID & password
4. Click on the blue banner labeled “Northwestern University Courses”
5. Click on “Add a Course or Update Learner Groups”
6. Select the appropriate course/s for the research you will be conducting

Logging In with SSO:
1. Go to www.Citiprogram.org
2. Click on the grey “Log in via SSO” button on the right hand side of the screen
3. A list of institutions will appear.  Click on “Northwestern University”
4. An NU validation screen will come up.  Enter your NU NetID & password.
5. You will now be logged into your CITI account

Affiliating your CITI account from another institution with NU
1. Log into your existing account
2. Click on the blue banner labeled “Click here to affiliate with another institution”
3. Click on the blue text “Click here to affiliate with another institution” that drops down below
4. Type “Northwestern University” into the box
6. Select Northwestern University from the drop-down menu  (*DO NOT* select “Northwestern Health Sciences University” – this is a completely unrelated institution)
7. Click “Next”
8. The next time you log in, use the instructions for Logging In with SSO above

If you are unable to log in using the instructions above, send an email to irbtraining@northwestern.edu including:
•       Your name, as listed on your CITI account
•       Your CITI username
•       Your CITI account number
•       Your NU NetID
and a member of staff will contact you

Although users may still be able to login via their previous CITI username/password, we strongly advise against doing so.  If they do there is a high probability that new training will not be tracked correctly and providing proof of completion will be the user’s responsibility.

Please communicate these changes to the various users within your departments/school and update training manuals/methods of communication appropriately.

As always, feel free to contact The IRB with any questions or concerns: irbtraining@northwestern.edu / 312-503-9338

https://dev.irb.northwestern.edu/sites/irb/files/documents/news/CITI_instructions_12-4-14.pdf

2015

03/02/2015 - Joint IRB Panel to review studies involving NU & LCH

As part of the ongoing collaboration between the Stanley Manne Children’s Research Institute and Northwestern University, we are pleased to announce the creation of an IRB panel to review studies that involve both Lurie Children’s Hospital and Northwestern University.  

Lurie Children’s Hospital Panel #2 is comprised of representatives from both institutions along with members of the community.  A schedule of the meetings can be found here: https://www.luriechildrens.org/en/research/management/research-integrity-compliance/irb/.

For specific guidance on submitting your project that may qualify for review by Panel #2, please contact your home institution IRB office:

05/28/2015 - New Data Security questions on RSS for FSM studies

Please note that the Feinberg School of Medicine now has a new policy governing Data Security. At the  time of your next Continuing Review  you will be required to indicate if the PI on this study is affiliated with the Feinberg School of  Medicine, and if so, you will be required to submit a Data Security Plan.

Some changes are in place on the supplemental portion of your submission (RSS). On page one of the RSS, you will now be required to indicate whether or not the PI is affiliated with FSM. If the answer is no, you will not be prompted to answer any further data security questions.

If the PI is affiliated with FSM, you will be required to answer a  series of questions regarding data security. A document listing these questions can be found here: RSS Data Security Questions 4/22/15 so you can familiarize yourself with the questions and prepare accordingly.

Please refer to http://www.feinberg.northwestern.edu/it/standards-policies/information-s… for more information or contact  FSMIT-policy@northwestern.edu with any questions about these requirements.

06/26/2015 - New Process for Conducting Research at VA Sites

New Studies:

New studies should be submitted to NU using the eIRB+ Submission Process, listing the VA as a study site.

Active Studies:

Studies that are currently active in eIRB+ and being conducted at the Jesse Brown VA Medical Center should submit a Modification to update the consent form and submit a Local Protocol Addendum.

Subsequent Submissions:

Subsequent submissions should be entered into eIRB+ according to the usual processes: Continuing ReviewsModifications, and/ or  RNIs.

Additional VA Requirements:

Consult Section 13: Collaborative Research in the VHA Handbook for additional VA requirements.  Please contact the VA with questions about these requirements and processes.

For access to the VA’s electronic submission system, IRBNet, you must register at www.irbnet.org.  For assistance with IRBNet registration or submissions, contact the NUCATS Center for Clinical Research (CCR).

CONTACTS:

Northwestern University:

eIRB+ Submission:

Biomedical Studies: Chicago IRB Office (312) 503-9338

Social / Behavioral Studies: Evanston IRB Office (847) 467-1723

Data Use Agreements:

Anne Grace

Sr. Contract & Grant Officer

Office of Sponsored Research

(312) 503-0884

anne@northwestern.edu

IRBNet:  (the VA’s electronic submission system):
NUCATS Center For Clinical Research
(312) 503-9999
CenterForClinicalResearch@northwestern.edu

Jesse Brown VA Medical Center:

Jennifer Ordman, IRB Administrator
jennifer.ordman@va.gov
(312) 569-7441

Sheri Lindsay, IRB Coordinator
sheri.lindsay@va.gov
(312) 569-8538

2016

01/25/2016 - Post Approval Monitoring Assessment Process

IRB Office Compliance Team NEW Post Approval Monitoring Assessments

Dear NU Investigators and Research Community,

The Northwestern University (NU) Institutional Review Board in its obligation to conduct monitoring of approved projects on a continual basis has implemented an investigator quality improvement assessment activity checklist (HRP-430). The HRP-430 can be found on the IRB website on the SOP page at: https://irb.northwestern.edu/templates-forms-sops#sops and in the eIRB+ library. The main goal of this assessment is to measure and enhance the protection of human subjects involved in research, which is accomplished by providing assistance through assessment and education to investigators and their research team.

The process involves an e-mail being sent to Principal Investigators and their primary contact indicated for a specific study in eIRB+. The studies being selected are at random from a report generated specific to studies expiring within the next 90 days.

The HRP-430 asks that the investigator and/or research team complete the attached self-assessment checklist and then return the results within 30 days. Also included in the emails will be specific instructions for completing the assessment. 

The completed checklist will be used as part of the NU IRB post approval monitoring and for quality improvement purposes for the human research protection program. If you have any questions about this, please contact the IRB Office Compliance and Education Team at irbcompliance@northwestern.edu.

Thank you in advance for your attention and participation in this post approval monitoring activity.

 

04/11/2016 - Wizard Demonstration Project

Northwestern University is pleased to announce its participation in a demonstration project, run by the Federal Demonstration Partnership (FDP) to test the validity of an electronic “wizard” that is designed to allow investigators to “self-determine” if their human research project meets the federal definitions of exempt.

Each institution participating in the demonstration will utilize the electronic “wizard” for 50-100 projects that have received an exempt determination and that received an expedited determination.  At Northwestern, Principal Investigators or their designee (this could be whoever has completed the protocol and other documents of the project, as long as that person is not an undergraduate student) will be invited by the IRB Office staff through email to complete the “wizard”, using the same information provided in the NU IRB application. We will provide you with the link to the wizard and while we recognize that it is extra work to complete another ‘application’ our hope is that  participation in this demonstration project, if successful, will reduce regulatory burden for our researchers by contributing to developing this tool. If the project is successful and the tool is validated, this will allow investigators to use an electronic smart form to make exempt determinations in most cases without further review by an IRB.

11/11/2016 - Upcoming NIH Single IRB Mandate

In preparation for the upcoming NIH Single IRB mandate scheduled to be implemented in May of 2017, we are currently undergoing a review of the external IRB process, including Institutional Authorization Agreements.    We will be paying close attention to assuring the terms we agree upon also honor our commitments to our clinical partners.  In doing this it may require updates to current agreements and also add additional time for processing of new agreements.  Please know we are committed to facilitating research at Northwestern and apologize for any inconvenience during this review period.  However, we anticipate the outcome of the analysis will significantly improve the efficiency of our program.

If you have any questions, please feel free to contact Marcella Oliver (IRB Education Specialist/m-oliver2@northwestern.edu).

 

12/14/2016 - Important Reminders & Guidance Regarding COI Process for IRB Protocols

As communicated in February 2016, Northwestern’s COI in Research Policy applies to any research involving human research participants, regardless of funding source.  Important impacts of that policy expansion include formal COI review of every PI and co-investigator named on a protocol submitted to Northwestern’s IRB.  Disclosure in the IRB application on a protocol-by-protocol basis is no longer required; the disclosures on file in Northwestern’s single disclosure system, eDisclosure, are reviewed in the context of each research study to assess whether or not any individual’s external relationships or interests could bias or compromise – or have the appearance of biasing or compromising – research objectivity, or impact research participants’ rights and welfare.  For more information on the process, please refer here

 Key points to be cognizant of noted below.

 Designation of PI, co-I, and study team member

The definition of investigator for conflict of interest purposes encompasses individuals who assume independent responsibility for the design, conduct, or reporting of research.  Anyone listed as PI or co-I on a protocol submitted to Northwestern’s IRB is considered to meet the definition of an investigator for COI purposes. 

 It is anticipated that in most cases, students (undergraduate or graduate) will not meet the definition of investigator, as they are generally working under the close supervision and direction of a faculty member PI or mentor, and although involved in the research, would not be considered independently responsible for the design, conduct, or reporting of research.  Unless assuming independent responsibility for research design, conduct, or reporting on a particular project, students should be designated with the role of “study team member” in eIRB+ rather than co-investigator.  PIs should make the determination of an individual’s role on each project based on the extent of one’s individual independent responsibility for that project. 

 Anyone listed as a PI or co-I on a protocol submitted to Northwestern’s IRB is subject to Northwestern’s COI in Research Policy, which includes requirements for COI training and disclosure. 

 External/Commercial IRBs

Protocols submitted to external IRBs must still have an a Northwestern protocol record established in eIRB+. Northwestern is responsible for performing the COI reviews for its investigators and establishing COI management plans if applicable, even when the study is reviewed by an external IRB.  Northwestern must provide information on COIs to external IRBs just as they must provide information on COIs to Northwestern’s IRB.    

 For questions on Northwestern’s COI policy and process, please contact Northwestern’s Conflict of Interest Office:

nucoi@northwestern.edu or 847.467.4515 or Julia Campbell, Director of Northwestern’s COI program: juliacampbell@northwestern.edu or 847.467.3938. 

12/22/2016 - External IRB Review Process

We wanted to provide an update regarding the internal review of the external IRB review process.  Some of the changes that have been made are that all reliance agreements are initially processed by the IRB Education Specialist and then reviewed/signed by the NU IRB Executive Director.  The IRB is taking the time to review these agreements and to also ensure that they truly outline the responsibilities for each institution listed. At this time we are still gathering information on the process and hope to have a more streamlined process in place during the upcoming year.  Some suggestions when submitting a study for external IRB review are the following: please ensure that all required NU template consent form language is included in the external IRB approved consent form(s), all documents listed on the external IRB approval letter are provided within the submission and the appropriate study sites are selected.

The process is still under review and we will provide any additional information to the research community when appropriate.

Thank you,

Northwestern University IRB Office

2017

01/18/2017 - Northwestern Earns AAHRPP Accreditation

Northwestern Earns AAHRPP Accreditation

 By Roger Anderson

January 13, 2017

Northwestern University has been awarded the Association for the Accreditation of Human Research Protection Program’s (AAHRPP) highest distinction.

The University joins more than 230 global organizations who have earned AAHRPP accreditation, an honor reserved for those institutions that have designed extensive safeguards — exceeding those required by the United States government — into their human research initiatives.

“The AAHRPP accreditation process helps strengthen Northwestern’s human research protection program (HRPP) and verifies — through policies, procedures, and practices — our commitment to scientifically and ethically sound research and to continuous improvement,” says Michelle Brown, Institutional Review Board (IRB) manager. “As the gold standard, AAHRPP accreditation offers assurances — to research participants, researchers, sponsors, government regulators, and the public — that Northwestern’s HRPP is focused first and foremost on excellence.” 

Northwestern’s IRB currently oversees more than 4,000 active protocols. Of these, about 70 percent are biomedical and 30 percent related to the social sciences. The office processes an estimated 1,200 individual submissions per month. 

“Each time a new organization becomes accredited, the global benchmark for human research protection in science is raised,” says Denise Roe, IRB executive director. “AAHRPP accreditation is not something that happens overnight; it’s a time-intensive process and the end result is a testament to the hard work and collaboration taking place at Northwestern.”

The University’s IRB’s leadership team spent several months completing a self-assessment, creating an extensive outline of the University’s research portfolio, and compiling the information into a comprehensive application. A team of AAHRPP experts then reviewed the material and scheduled a three-day site visit to evaluate the University’s performance with respect to the AAHRPP Accreditation Standards. 

AAHRPP’s Council on Accreditation reviewed the information before granting Northwestern full accreditation for three years; at which time, the University will undergo renewal to retain the distinction.

“AAHRPP’s mission is to help ensure robust research participant protections,” says Elyse I. Summers, AAHRPP president and CEO. “We applaud our newly accredited organizations and all organizations and individuals who are committed to the high standards required to attain and maintain AAHRPP accreditation.”

AAHRPP has accredited organizations in 47 US states, and in Belgium, Brazil, Canada, China, India, Mexico, Republic of Korea, Saudi Arabia, Singapore, South Africa, Taiwan, and Thailand. All major US independent institutional review boards have earned AAHRPP accreditation.

01/19/2017 - Final Rule Enhances Protections for Research Participants

FOR IMMEDIATE RELEASE
January 18, 2017

Contact: HHS Press Office
202-205-0143
ashmedia@hhs.gov

Significant changes made in response to public comments

The U.S. Department of Health and Human Services and 15 other federal agencies today issued a final rule to update regulations that safeguard individuals who participate in research. Most provisions in the new rule will go into effect in 2018.

The new rule strengthens protections for people who volunteer to participate in research, while ensuring that the oversight system does not add inappropriate administrative burdens, particularly to low-risk research. It also allows more flexibility in keeping with today’s dynamic research environment.

The current regulations, which have been in place since 1991, are often referred to as the “Common Rule.” They were developed at a time when research was conducted predominantly at universities and medical institutions, and each study generally took place at a single site. Since then, research with human participants has grown in scale and become more diverse and data has become digital.

In September 2015, HHS and the other Common Rule agencies published a Notice of Proposed Rulemaking (NPRM), which drew more than 2,100 comments. In response to concerns raised during the extensive review process, the final rule contains a number of significant changes from the proposed rule, including the removal of a provision that would have required researchers to obtain consent before using a study participant’s non-identified biospecimens. The final rule maintains the current practice with respect to oversight of these specimens.

The final rule will now generally expect consent forms to include a concise explanation – at the beginning of the document – of the key information that would be most important to individuals contemplating participation in a particular study, including the purpose of the research, the risks and benefits, and appropriate alternative treatments that might be beneficial to the prospective subject.  

“Over the years, many have argued that consent forms have become these incredibly lengthy and complex documents that are designed to protect institutions from lawsuits, rather than providing potential research subjects with the information they need in order to make an informed choice about whether to participate in a research study,” said Jerry Menikoff, MD, who directs the HHS Office for Human Research Protections, which led the government’s efforts to overhaul the regulations. “We are very hopeful that these changes and all the others that reduce unnecessary administrative burdens will be beneficial to both researchers and research participants.”

Important elements in the final rule issued today include:

  • The requirement for consent forms to provide potential research subjects with a better understanding of a project’s scope, including its risks and benefits, so they can make a more fully informed decision about whether to participate.
  • Requirements, in many cases, to use a single institutional review board (IRB) for multi-institutional research studies. The proposal from the NPRM has been modified, however, to add substantial increased flexibility in now allowing broad groups of studies (instead of just specific studies) to be removed from this requirement.
  • For studies on stored identifiable data or identifiable biospecimens, researchers will have the option of relying on broad consent obtained for future research as an alternative to seeking IRB approval to waive the consent requirement. As under the current rule, researchers will still not have to obtain consent for studies on non-identified stored data or biospecimens.
  • The establishment of new exempt categories of research based on the level of risk they pose to participants. For example, to reduce unnecessary regulatory burden and allow IRBs to focus their attention on higher risk studies, there is a new exemption for secondary research involving identifiable private information if the research is regulated by and participants protected under the HIPAA rules.
  • Removal of the requirement to conduct continuing review of ongoing research studies in certain instances where such review does little to protect subjects.
  • Requirement that consent forms for certain federally funded clinical trials be posted on a public website.

The final rule differs in important ways from the proposed rule. Some examples of proposals that, based on feedback from the public, are not being adopted, include:

  • The final rule does not adopt the proposal to require that research involving non-identified biospecimens be subject to the Common Rule, and it does not require that consent be obtained in order to conduct such research. In general, researchers can continue to use such biospecimens in the way they are currently using them.
  • To the extent that some of the NPRM proposals relied on tools or standards that had not yet been proposed, the final rule either does not adopt those proposals or includes revisions to eliminate such reliance. Examples of items that were not included in the final rule include a template to be used for broad consent forms, and a decision tool to be used for making exemption determinations.
  • The final rule does not expand the policy to cover clinical trials that are not federally funded.
  • The final rule does not adopt the NPRM’s proposed concept of “excluded” activities. Generally, activities proposed to be excluded are now described as not satisfying the definition of what constitutes research under the regulations or are classified as exempt.
  • The final rule does not include the proposed standardized privacy safeguards for identifiable private information and identifiable biospecimens. Instead, in most respects, it retains the current approach to privacy standards.
  • The final rule does not adopt the proposal for more stringent criteria for obtaining a waiver of the consent requirements for identifiable biospecimens.

Medical advances would not be possible without individuals who volunteer to participate in research. Oversight and protection of research participants is an important safeguard and essential to advancing the research enterprise. Today’s action reaffirms the federal government’s commitment to all those who participate in research studies.

To view the final rule, click here.

02/09/2017 - Guidance Added Regarding Federal Requirements for IRB Review of Grants

If you are the Principal Investigator on a primary or direct federal award to Northwestern University, where you have indicated the involvement of human subjects within the grant, then this guidance offers practical tips for assuring adherence to the requirements of the federal regulations.  Typically a federal award that indicates the inclusion of human subjects cannot be reviewed as non-human research (see more on this topic later in the guidance).

Related Link: 

Grant Guidance

04/05/2017 - Biomedical Consent Template Changes

The template for the Biomedical Informed Consent Document (HRP-592) has been updated to reflect the following changes:

  • Rehabilitation Institute of Chicago is now the Shirley Ryan AbilityLab
  • Language from the Illinois state law regarding the reporting of HIV results added to the HIPAA Authorization section
  • ClinCard language more specific
  • Loss of Confidentiality added to the list of possible risks
  • New language from National Institutes of Health (NIH) regarding the use of Certificates of Confidentiality

04/24/2017 - Reliance Agreements

Dear Research Community,

As you were previously notified, the reliance agreement process was under review for the purpose of conducting a needs assessment.  At this time we are happy to notify everyone that the process has been updated and is now ready for rollout.  We now have a dedicated webpage for Reliance Agreements, that includes information for when the NU IRB is the IRB of Record and when the NU IRB cedes review to another IRB.  The SOP (HRP-092) previously titled “Commercial IRBs” has been updated to “External IRBs” and a new SOP (HRP-093) has been created for when the NU IRB is the IRB of Record for Multi-Site Research.  There are also workflow’s available for each type of submission and FAQ’s. 

Please take time to review the webpage, including the updates SOP’s and authorization templates, and notify us of any feedback you may have regarding the process.  The NU IRB is dedicated to facilitating research and any feedback would be greatly appreciated.

Thank you,

Northwestern University IRB

08/02/2017 - Good Clinical Practice (GCP) Training

The National Institutes of Health (NIH) policy on Good Clinical Practice (GCP) training took effect January 1, 2017. This policy establishes the expectation that all NIH-funded investigators and staff who are involved in the conduct, oversight, or management of clinical trials should be trained in Good Clinical Practice (GCP). A clinical trial is defined by NIH as a research study in which one or more human subjects are prospectively assigned to one or more interventions (which may include placebo or other control) to evaluate the effects of those interventions on health-related biomedical or social behavioral outcomes. See https://grants.nih.gov/grants/guide/notice-files/NOT-OD-15-015.html.

There are also additional resources available within NU through the Northwestern University Clinical and Translational Sciences Institute (https://nucats.northwestern.edu/education-career-development/gcp-research-staff-training/required-fsm-good-clinical-practice-gcp-training).  All questions regarding GCP training can be forwarded to gcptraining@northwestern.edu.

08/22/2017 - NIH's Deputy Director for Extramural Research Clarifies Compliance Requirements for Clinical Trials

With the “final phase of implementation” looming for new mandates related to NIH-supported clinical trials, Michael Lauer, the agency’s deputy director, has explained how investigators will know whether the requirements apply to their research. In his Aug. 11 post on the “Open Mike” blog, Lauer stated that the initiatives are “aimed at improving the quality and transparency” of clinical trials. The definition of such “encompasses a wide variety of study types,” he wrote. “These range from mechanistic studies to behavioral studies, to pilot/feasibility studies, all the way to large-scale efficacy and effectiveness trials.” The requirements include the use of single institutional review boards for trials with more than one site, registration on clinicaltrials.gov and specialized training for investigators. NIH is also making available resources to aid compliance, available on a single website. The address is: https://grants.nih.gov/policy/clinical-trials.htm.

Link: http://tinyurl.com/ycy66k8q

10/02/2017 - Certificates of Confidentiality

On September 7, 2017, NIH issued its Notice of Changes to NIH Policy for Issuing Certificates of Confidentiality which is effective October 1, 2017. The agency’s policy on Certificates of Confidentiality (CoCs) was updated to comply with Section 2012 of the 21st Century Cures Act, Privacy Protection for Human Research Subjects, which amends the Public Health Service Act with respect to the certificates. Although CoCs are intended to prohibit disclosure of sensitive, identifiable information in response to legal demands, applicability has been broadened.  Please refer to our Certificates of Confidentiality webpage for more information.

11/01/2017 - NIH Single IRB Policy

Dear Research Community,

On January 25, 2018 the NIH Single IRB policy will become effective. This means that NIH-funded multi-site studies (i.e., conducted at more than one U.S. site with the same protocol) involving non-exempt human subjects research must use a single IRB of record (sIRB). This policy applies to all competing grant applications (new, renewal, revision, or resubmission) with submission dates on or after January 25, 2018 and requires a plan describing the use of a sIRB for the study.

In preparation for these upcoming requirements, the Northwestern University IRB Office is working diligently to have a process in place for our institution.  During the month of November we will be meeting with key stakeholders to conduct a needs assessment and make final decisions when the Northwestern IRB will serve as the sIRB of record or when it is appropriate to cede oversight to an external IRB. In December, we plan to send additional notifications to you via email, provide more detailed guidance via our webpage, and roll out an offering of presentations/training sessions throughout the month and into the new year. We are committed to facilitating research at Northwestern University and providing the necessary guidance and resources as we embark upon complying with the new NIH Single IRB policy.

If you have any questions or if you would like to be included in an upcoming workgroup discussion, please feel free to contact Marcella Oliver (IRB Reliance and Education Lead, irbreliance@northwestern.edu).

Thank you,

Northwestern University IRB Office

12/18/2017 - New Consent and Protocol Templates are posted!

Effective January 19, 2018 there are revised federal regulations for IRB review of research. To reflect the changes to the regulations governing the protection of participants in research, the IRB office has revised the protocol and consent templates. All new study submissions that are approved on or after January 19, 2018 must use the new protocol and consent templates. You should start using the new templates as soon as possible in case the IRB review of your study is not finalized until after the effective date. The effective date is January 19, 2018 and all new studies are required to use the new templates.

 Studies that are currently IRB approved and are still enrolling participants will be transitioned to the revised regulations at the time of Continuing Review or when there is a substantive Modification to the study and it makes sense to transition the study before the Continuing Review.

2018

01/05/2018 - Important Notice: eIRB+ System Upgrade

Dear Research Community,

Please note the eIRB+ system will undergo a software upgrade in order to incorporate functionality to comply with the revised federal regulations (effective date January 19, 2018), the NIH Single IRB policy (effective date January 25, 2018) and other system improvements.  In order to complete this upgrade, the eIRB+ system will be unavailable to all users from 7 p.m. Friday, January 12, 2018 through 8 a.m. Monday, January 15, 2018.  We apologize for any inconvenience this may present.  Thank you for your patience as we improve the eIRB+ system to better serve you.

Feel free to contact the IRB Office (irb@northwestern.edu) with any questions you may have regarding the eIRB+ upgrade.

Thank you,

Northwestern University IRB Office

01/18/2018 - Important Notice: Delayed Common Rule Effective Date

The Department of Health and Human Services along with 15 other federal departments and agencies have delayed by six months the effective date and compliance date of the revisions to the Federal Policy for the Protection of Human Subjects (also known as the Common Rule) to July 19, 2018.  Additional information on the delay can be found on the OHRP website.

Moving forward as part of best practices, initial submissions should use the recently revised consent and protocol templates that can be found on the NU IRB website.  Studies that are currently IRB approved and still enrolling participants will be transitioned to the new templates at the time of continuing review.

This delay in the revisions to the Common Rule does not affect the National Institute of Health (NIH) mandate to use a Single IRB for multi-site research studies, which is effective January 25, 2018.  More information regarding the NU IRB’s implementation of the NIH Single IRB policy will be provided next week.

Thank you,

Northwestern University IRB Office

01/24/2018 - NIH Single IRB Policy Implementation

As you were previously notified, the Northwestern University IRB Office has been diligently working to have a process in place for implementing the NIH Single IRB policy at our institution.  At this time we are pleased to notify the research community that the first phase of implementation is ready for rollout.  A dedicated Single IRB webpage has been created and we have updated the relevant SOPs [(HRP-092_External IRBs) and (HRP-093_NU IRB_IRB of Record Multi-Site Research)].  We have also created a Pre-Consultation process to provide assistance to Researchers and Study Teams when preparing the NIH proposals, to determine what IRB should be listed as the proposed IRB-of-Record.

As a part of implementation preparation, we also engaged other units within the Office for Research (e.g. OSR, ASRSP, etc.) and members of the research community.  We would like to thank all who participated in the process development.  We truly appreciate the time the various groups dedicated to providing essential input and feedback regarding the process.

Please take time to review the Single IRB webpage and updated SOPs, and notify us of any questions or comments you may have regarding the process.  The Northwestern University IRB Office is dedicated to facilitating research and any feedback would be greatly appreciated.

Thank you,

Northwestern University IRB Office

06/08/2018 - General Data Protection Regulations (GDPR)

GDPR went into effect May 25, 2018 and is a legislation of the European Union that protects “natural persons” with regards to the processing of personal data and the transfer of that data. Anyone doing research that involves collecting information or data from anyone (known as a “data subject”) who is in one of the countries of the European Economic Area has to think about what is required to be GDPR compliant.  Because this regulation affects people living or traveling in a GDPR compliant country and is unrelated to citizenship, Northwestern researchers need to consider two basic areas of their research potentially affected by these regulations: The consent process and the need for enhanced data protection.  The IRB has created some tools to assist in that process: see Guidance for General Data Protection Regulations (GDPR) compliance in the conduct of human research as well as HRP-335 Worksheet GDPR Data Protection and HRP-590 GDPR Compliance Consent template.

08/27/2018 - "No Continuing Review" Coming Your Way Soon

Due to changes in the federal regulations for the protection of humans in research, starting January 21, 2019, all new research receiving federal funding must comply with the New Rule.

Before that, starting August 31, 2018, the Northwestern University IRB is adopting one of the burden reducing provisions for research that complies with the New Rule:

  • For most new non-exempt, minimal risk, and non-FDA regulated research projects, there will no longer be an expiration date and therefore, no requirement for annual continuing review.

What this means:

  • If research project documents are in compliance with the New Common Rule and the project qualifies for expedited review and is not subject to FDA regulations, the IRB has the option to approve the project without an expiration date. (See HRP-033 3.4 for reasons the IRB might maintain the expiration date on your project.)
  • Research projects that are greater than minimal risk, FDA regulated, or which are minimal risk and require full board review will continue to have an expiration date and an annual continuing review.

Phased roll out of “No Continuing Review”:

  • Starting August 31, all new expedited, non-FDA regulated research will be considered for no continuing review.
  • If that goes well, on September 28, as standard continuing reviews are submitted for existing expedited, non-FDA regulated projects, the projects will be considered for no continuing review.
  • Starting October 26, all modification to existing expedited, non-FDA regulated research will be considered for no continuing review.

Please note:

  • Any modifications to research must still be submitted to the IRB and approved prior to implementation.
  • Reports of new information (RNIs) should still be submitted within five business days.
  • All research approved under the “no CR” requirement will receive a system generated annual reminder from eIRB+ to keep the study record up to date with modifications, RNIs and to close the study when research activities are completed.

Please contact the IRB office (irb@northwestern.edu; sbsirb@northwestern.edu) if you have any questions regarding the “no CR” requirement.

10/02/2018 - "Study Team Member" Personnel Changes

Dear Research Community,

In an effort to reduce burden on the research community and the IRB, we are changing how ‘study team member’ personnel changes are reviewed by the IRB Office.  Principal Investigators are still required to maintain the study team members list in the eIRB+ application and for ensuring that all study team members complete human subjects protection training every three years.

Beginning October 3, 2018, modifications that only add or delete an individual designated as ‘study team member’ will no longer require IRB review nor be issued an approval letter.  Upon submission, these modifications will automatically be moved to an approved state and an email notification will be sent via eIRB+.

Given the need to assess expertise and conducted conflict of interest review, modifications to add or delete Investigators (PI or Co-I) will still require IRB review and be issued an approval letter.  An Investigator is defined as: the project director or principal investigator and any other person, regardless of title or position, who is responsible for the design, conduct, or reporting of research, or proposed for such funding, which may include, for example, collaborators or consultants.  Investigators (PI or CO-I) should never be designated as ‘study team member’ in the eIRB+ application.

Thank you,

Northwestern University IRB Office

2019

01/09/2019 - Important Notice: New Guidance Documents and Templates Posted

Dear Research Community,

The IRB Office recently updated all public HRP documents in an effort remain compliant with the current regulations and to add new documents providing guidance to the research community. All updated documents can be found within the following pages:

Relevant updates have been made to the Biomedical and Social-Behavioral protocol templates, as well as consent form templates. Please utilize these versions for any new projects and at the time of any modification involving protocol or consent form updates.

Please review the updated Human Research Protection Program Plan (HRP-101) and the Investigator Manual (HRP-103). Email the IRB at irb@northwestern.edu with any questions or concerns.

The website should be your first source for all documents. It is recommended to refrain from saving frequently used documents and to always access them from the website.

The Northwestern University IRB Office

01/11/2019 - Updated SOP Document

HRP-052 – SOP Post-Review has been updated. Section 5.2 in Procedures was updated to add, “If a study is closed to enrollment, the consent form will not be stamped at the time of continuing review unless determined by the IRB Analyst that it is necessary”.

The updated document can be found within the Templates, Forms & SOPs tab.

 

01/19/2019 - Revised Memo re: New requirements for identifying funding source for IRB studies in eIRB+

Revised Memo re: New requirements for identifying funding source for IRB studies in eIRB+

What is changing?  Effective January 19, 2019, the funding page in the eIRB+ application has been updated to require the submission preparer to select the InfoEd number (e.g., SP0054321) that corresponds to the grant or contract funding sponsored IRB studies. There will be no change to non-sponsored, or internally-funded studies.

When a study is created in eIRB+, on the funding page, you will be asked to identify whether the project is sponsored or non-sponsored.  If “sponsored” is selected, you will be required to select the correct InfoEd number from a list that corresponds to the grant, contract, or other mechanism funding the study. The individuals best positioned to know exactly which grant or contract is funding any given study are the research or finance administrators in the department. 

If your project is sponsored, but did not go through Northwestern University (e.g., SRALab or Lurie Children’s is managing the grant), please select “No” to the question, “Is this funded by a sponsored project awarded to Northwestern University?” and then proceed to enter your funding information as you normally would have prior to this update.

Why make this change?  This initiative is the result of a joint effort between the IRB Office, the Office for Sponsored Research, and the Conflict of Interest (COI) Office. This will help to ensure the accuracy of Northwestern University’s research records and the associated processes that depend on associating the correct funding source with sponsored human research projects. For sponsored research, this linkage will be an attestation by the PI of the correct match and therefore evidence of regulatory compliance when the university must demonstrate a project has approval.Systematically linking the InfoEd record of the funding source to the appropriate IRB study will help our offices understand which projects are related to each other, minimize delays in the final stages of approval and/or contract signing, expedite required reporting by the COI Office, and build a foundation for streamlined billing in the future.

What are the next steps?  Review the attached FAQs and plan to attend one of the upcoming OSR monthly meetings scheduled for February 19, 2019 (Evanston Campus) and February 21, 2019 (Chicago Campus), where we will walk through the updated eIRB+ funding page and answer any questions.

Who can I contact?  If you are experiencing any technical difficulties and need troubleshooting assistance, or if you would like to submit comments/feedback on the process, please send an email to: orhelp@northwestern.edu.

Attached Document(s): 

FAQs_Updated eIRB+ Funding Page- Final2.docx

01/22/2019 - Important Notice: Common Rule Implementation and Updated Guidance Documents/Templates Posted

Dear Research Community,

As of January 21st, 2019, the revised Common Rule has taken effect. The changes to the regulations do not require immediate researcher action ––researchers should continue to follow their IRB approved protocols and the determinations made by the IRB as communicated in the determinations letters (i.e. related to submitting CRs, Mods, and RNIs), etc. 

The IRB Office has already implemented the burden-reducing provisions per the Common Rule, which includes the elimination of continuing review for non-exempt, non-FDA/DOD, minimal risk studies (please refer to the IRB Office notice), and the clarification of what activities do not meet the definition of human research. 

Northwestern University’s IRB will not implement Broad Consent at this time because it is currently optional and formal guidance has not yet been disseminated by the regulatory agencies. Any attempt to implement Broad Consent prior to receiving additional regulatory guidance and appropriately bolstering the required infrastructure, will result in heavy administrative/compliance burdens for research study teams to keep track of refusals from research participants over time.

The IRB Office has made relevant updates to the Biomedical and Social and Behavioral protocol templates, as well as consent form templates. Please utilize these new template versions for any new projects and at the time of any modification involving protocol or consent form updates. Additional documents have also been revised per the Common Rule and all key documents can be found on the IRB Office website at:

Please review the updated Human Research Protection Program Plan (HRP-101) and the Investigator Manual (HRP-103).

The IRB Office website should be your first source for all documents. It is recommended that researchers refrain from saving frequently used documents but instead to always access the documents directly from the IRB Office website.

Please email the IRB Office at irb@northwestern.edu with any questions or concerns.

Thank you,

The Northwestern University IRB Office

 

01/29/2019 - Updated Post Approval Monitoring Checklists Available

The post approval monitoring (PAM) checklists have been updated. Updates include:

  • Addition of HRP-427 – PAM Checklist – Clinical Trial
    • To be utilized for clinical trials
  • Addition of HRP-428 – PAM Checklist – Participant File
    • To be utilized for enrolled participants
  • Applicable revisions to HRP-429 (PAM Checklist – Biomedical) and HRP-430 (PAM Checklist – Social Behavioral)

The “Clinical Trial” and “Participant File” portions of HRP-429 and HRP-430 have been removed to be their own standalone documents.

The documents can be found in the Templates, Forms, & SOPs tab.

01/31/2019 - Updated Human Research Determination Form

The Human Research Determination Form (HRP-503) has been updated per the revised Common Rule.

The document can be found in the Templates, Forms, & SOPs tab.

 

03/06/2019 - Updated Biomedical Protocol and Consent Templates Available

The following templates have been updated:

  • HRP-593 Biomedical Protocol Template
  • HRP-508 Local Protocol Addendum Template
  • HRP-592 Biomedical Consent Document

Relevant updates include:

  • Addition of PI department to protocol template
  •  Instructions to indicate in the protocol which procedures are considered standard of care and which are considered research-related
  •  Guidance in consent template for studies of simple design – information presented in the “Key Information” section does not need to be repeated in the “Detailed Information” section.

Please utilize these versions for any new projects and at the time of any modification involving protocol or consent form updates.

The documents can be found in the Templates, Forms, & SOPs tab of the website.

Thank you,

The Northwestern University IRB Office

 

03/25/2019 - Updated Documents Available

Dear Research Community,

The following documents have been updated:

Per AAHRPP reaccreditation:

  • HRP-001 – SOP – Definitions
  • HRP-060 – SOP – Annual HRPP Evaluations
  • HRP-092 – SOP – External IRBs
  • HRP-101 – Human Research Protection Program Plan
  • HRP-103 – Investigator Manual
  • HRP-312 – WORKSHEET – Exemption Determination
  • HRP-318 – WORKSHEET – Additional Federal Agency Criteria
  • HRP-320 – WORKSHEET – Scientific or Scholarly Review
  • HRP-410 – CHECKLIST – Waiver or Alteration of Consent Process
  • HRP-413 – CHECKLIST – Non-Viable Neonates
  • HRP-415 – CHECKLIST – Prisoners
  • HRP-583 – TEMPLATE – Social Behavioral Protocol
  • HRP-593 – TEMPLATE – Biomedical Protocol – Revised to include research activity that is non-human subjects research and exempt
  • HRP-441 – CHECKLIST – HIPAA Waiver of Authorization – Revised to include the information about requesting a HIPAA waiver of the NU IRB as the Privacy Board
  • HRP-503 – FORM – Human Research Determination Form

Please utilize applicable versions for any new projects and at the time of any modification involving protocol updates.

The documents can be found in the Templates, Forms, & SOPs tab.

Thank you,

The Northwestern University IRB Office

06/11/2019 - Updated Data and Specimen Analysis Protocol Template

Dear Research Community,

The IRB office has significantly revised HRP-1704, the protocol template for analysis of data and/or specimens, to make the template more user-friendly and collect more of the information that the IRB needs to process these types of studies efficiently.  HRP-1704 should be used if your only research procedure is analysis of data and/or specimens, the data/specimens are identifiable or include a coding system, and you are not planning to prospectively collect biospecimens for research purposes as part of your project.  (For example, medical record review; analyzing data or biospecimens that were collected in prior research studies; analyzing data available from student education records, government datasets, etc.)  New instructions have been added to the beginning of HRP-1704 providing more detail on when this is the appropriate template to use, and additional instructions have been added about HIPAA, FERPA, and mental health records.  

Please utilize the applicable version for any new projects.

The document can be found in the Templates, Forms, & SOPs tab.

Thank you,

The Northwestern University IRB Office

07/12/2019 - Study Closure Guidance

Dear Research Community,

The IRB has new guidance on when a study may be closed (that is, no longer requires IRB oversight). Although many minimal risk studies no longer require continuing review (unless the study is FDA-regulated), all non-exempt human research studies must still be closed in the eIRB+ system when they no longer require IRB oversight. This means that, even if you do not have to submit annual continuing review for your study, you should submit a request to close the study when the circumstances are appropriate for study closure. To close a study in eIRB+, you need to submit a Continuing Review application but indicate that you are requesting study closure by checking off the first four boxes in the “Research Milestones” section of the application.

The guidance document on study closure can be found on the Policies page of the IRB website.

Thank you,

The Northwestern University IRB Office

09/16/2019 - Updated Social Behavioral Consent Templates

Dear Research Community,

The Social-Behavioral consent template (HRP-582) has been significantly revised to better fit social-behavioral research.  The revised version of HRP-582 contains instructions at the end on how to modify the final portion of the consent to fit verbal or online consent. There is now a separate Social-Behavioral consent template with HIPAA Authorization language (HRP-1721) for studies that plan to access the electronic medical record for recruitment, screening, and data analysis purposes. This will help minimize issues with HIPAA Authorization language being inadvertently included in the consent forms submitted to the IRB for studies where HIPAA does not apply. We have also created a Social-Behavioral Supplemental Consent Language Document (HRP-1722) which contains specific language to be inserted into the consent form for certain circumstances (e.g., studies using focus groups, studies with a Certificate of Confidentiality, studies using deception/incomplete disclosure).

You do NOT need to revise consent forms and scripts that have already been approved by the IRB to fit this new consent template – you can continue to use consent forms and scripts previously approved by the IRB.  For any new studies, the protocol templates and consent templates should be accessed by going to the Templates, Forms, & SOPs tab on the IRB website, rather than using protocol and consent forms from previous studies to create your documents. This will help prevent against using obsolete versions of the IRB templates.   

The IRB also has new guidance documents posted on the website on research participant payments, and research with children, parental permission, and child assent.  The guidance documents are available under the Policies tab on the IRB website.

Thank you,

Northwestern University IRB Office

09/27/2019 - Study Support Resources and Templates

Dear Research Community,

To encourage best practices, the Northwestern University Institutional Review Board (IRB) has created a variety of study support resources and templates to provide investigators with the resources needed to conduct human participant research. The tools were created to support investigators and their study teams in properly organizing paper or electronically maintained regulatory documentation and research data. Examples include delegation of authority (DOA) logs, eligibility checklists, documentation of consent process forms, etc. These tools can be modified as needed. 

Each document offers guidance on both regulatory requirements as well as best research practices.  All regulatory and participant-related information should be properly maintained and investigators are encouraged to keep a real-time accounting of all study related materials and data. Utilization of the study support tools is optional but highly recommended to assist study team in adhering to the protocol, satisfying regulatory standards, and obtaining reliable data.

The documents and a description of each form can be found within the Policies tab of the IRB website.

Thank you,

Northwestern University IRB Office

10/21/2019 - Updated/New Social Behavioral Protocol Templates

Dear Research Community,

The social behavioral protocol template for new studies (HRP-583) has been revised and the revised version is now posted on the IRB website. This revised version of the protocol for new social behavioral studies does NOT need to be used for studies that have already been reviewed by the IRB and for studies currently in the IRB review process. If you are working on IRB submission materials and have not yet submitted your study, but already completed the protocol template, you do not need to redo your protocol document. Starting November 15, any new studies submitted using HRP-583 must use the revised version – you can of course use the revised version of the protocol template for new studies submitted to the IRB before that date as well.

As part of the revisions to the protocol template, we have created two appendices that should be filled out and uploaded if they are applicable to a study – Appendix A (HRP-1723) is to be completed if the study will enroll children as research participants and Appendix B (HRP-1724) is to be completed if the study will access HIPAA Protected Health Information (PHI) for research purposes (whether for recruitment and screening purposes or for data analysis. Starting November 15, any new studies involving children and/or PHI must complete and upload the corresponding appendix.

If you have any questions about these changes to these forms, please contact the social behavioral IRB office.

Thank you,

Northwestern University IRB

10/31/2019 - eIRB+ Process Update: "Study Team Member" Only Modifications

Dear Research Community,

As a requirement of conducting human subjects research, the Northwestern University IRB requires all individuals to complete human subjects protection training and to re-certify every 3 years. In an effort to improve compliance with training requirements, we are implementing a change to “study team member” only personnel changes that receive automatic approval upon submission.

Beginning October 30, 2019, modifications that only add or remove individuals designated as “study team member” will receive an error message upon submission if any individual on the “internal” study team member list has expired or absent training. To lift the error message, individuals lacking current training must either update their training or be removed from the study team member list.

This new process is only for “study team member” modifications and will not occur during the submission of any other IRB applications. For all other IRB applications, the IRB analyst will request applicable training update during their review, per usual. As a reminder, modifications to change the Principal Investigator (PI) or add a co-investigator (Co-I) must be reviewed by an IRB Analyst and do not receive automatic approval in eIRB+. Investigators (PI or Co-I) should never be designated as “study team member” in the eIRB+ application.

Additionally, the IRB Office completed an integration of eIRB+ and CITI Training information in June, which now automates the process for updating eIRB+ user profiles with the relevant human subjects protection training courses completed through CITI under the Northwestern affiliation within the last 3 years. Please allow 24 hours for any user’s profile to be updated with the current training information from CITI, including newly registered users and training re-certification for current users. Should you have any issues with training requirements, please email irbtraining@northwestern.edu for assistance.

Thank you,

Northwestern University IRB

11/27/2019 - Update to Post Approval Monitoring Checklists

Dear Research Community,

The Compliance Unit of the Northwestern Institutional Review Board (IRB) has made significant changes to the post approval monitoring checklists. Changes include the revision of current checklists and the release of three new supplemental checklists.

The current suite of documents are:

  • HRP-427 – CHECKLIST Post Approval Monitoring: Drug or Device Clinical Trial
  • HRP-428 – CHECKLIST Post Approval Monitoring: Participant File
  • HRP-429 – CHECKLIST Post Approval Monitoring: Biomedical Research
  • HRP-430 – CHECKLIST Post Approval Monitoring: Social Behavioral Research
  • HRP-1405 – CHECKLIST Post Approval Monitoring: Registry, Data Review, and/or Specimen Collection NEW!
    • For use in studies involving data reviews, registries, and/or sample collection and retention
  • HRP-1406 – CHECKLIST Post Approval Monitoring: Studies Under IRB Review NEW!
    • For use in studies that cede review to an external IRB
  • HRP-1407 – CHECKLIST Post Approval Monitoring: Site File NEW!
    • For use in studies in which the Northwestern IRB serves as the IRB of record for 1 or more sites

Post approval monitoring can be conducted routinely or for cause by the Compliance unit, as well as self-assessments conducted by the investigator and/or study staff.

Checklists can be found in the Templates, Forms, & SOPs tab of the website.

Thank you,

Northwestern University IRB