Rush eResearch Portal Login

Basic Folder Information


REDCap Upgraded to Version 10.0.0

Click here for a complete new features, changes and bug fixes for this update

If you have any questions please contact REDCap Support

Subject Enrollment Standard Work Announcement:

As you are aware, the Rush Subject Enrollment Policy OP-661 indicates that, for those studies requiring a full coverage analysis, each individual subject must be registered in the CTMS (OnCore) within 24 hours of consent and have their informed consent form uploaded to REDCap within 24 hours of consent.

A group of Research Administrators, Clinical Research Coordinators, and other subject matter experts recently participated in an improvement event designed to standardize and improve the subject enrollment process. Over the course of the past month, this group has developed and experimented with a series of tools and job aids that we have packaged for your use and access. This Subject Enrollment Standard Work Package consists of the following:

• Research Administrator Subject Enrollment Standard Work 
• Clinical Research Coordinator Subject Enrollment Standard Work
• Research Administrators – Key Reports in OnCore
• Clinical Research Coordinators – Key Reports in OnCore
• How to View Informed Consent Forms in REDCap - Research Administrators
• Virtual Daily Huddle / MS Teams
• Subject Enrollment - Key Resources
• Subject Management Trainings - Pre-Requisites

The purpose of this Subject Enrollment Standard Work Package is to highlight the best and most waste-free way of enrolling research subjects that we currently know and to encourage a more standard approach to subject enrollment activities. We hope that these resources will allow you and your teams to employ creative solutions developed and validated by a group of your own colleagues. We recommend that each department follow the standard work outlined above and use the tools developed to help promote adherence to the Subject Enrollment Policy.

Please reach out to Crista Brawley ( with additional questions about this policy.


Committee Service Opportunity

The Institutional Biosafety Committee (IBC) of Rush University Medical Center is seeking new physician and scientist members.  The IBC is required for compliance with the NIH Guidelines for Research Involving Recombinant or Synthetic Nucleic Acid Molecules (rev. 2019; and has federal oversight.  Its scope includes safety review and risk assessment for bench experiments using recombinant DNA techniques including CRISPR/Cas9 to knock in/out genes in cultured cells and use of viral vectors to express or suppress genes in experimental animals.  Clinical studies include gene replacement/augmentation in humans to address inherited genetic diseases, and immunomodulation for cancer treatment and vaccine development.  Each submitted application is evaluated by two or three principal reviewers, one of whom must be a physician for clinical projects.  Reviews are performed through a branch of the Rush Research Portal and discussed at a convened monthly meeting.  Regular attendance is expected of all members.  Physician members should expect to review one clinical project per month; basic scientists may review an average of one or two projects.  Committee-specific training is provided, and service is financially compensated.  Qualified persons should contact Amarjit Virdi, Ph.D., (IBC Chair)



REDCap is a secure web application for building and managing online surveys and databases. While REDCap can be used to collect virtually any type of data in any environment (including compliance with 21 CFR Part 11, FISMA, HIPAA, and GDPR), it is specifically geared to support online and offline electronic data capture for research studies and operations.

Rush REDCap by default will allow any Rush employee with a valid Rush user name and password to login into REDCap here.

If you don’t currently have a Rush account or you are not a Rush employee then you will not be able to login to Rush REDCap. Please perform the following steps to request an external/collaborator REDCap account:

  • Fill out the account request form using the following link: REDCap Account Request.
  • Once a user completes the form above, the PI/Sponsor will receive an email notification requesting the PI/sponsor to authorize the user for a new REDCap account.
  • Rush IS will create a new REDCap account and send the account information to the user.

Note: The PI/Sponsor is responsible for sharing the external/collaborator REDCap account request above to the external/collaborator.

Please visit REDCap at Rush University for REDCap Office Hours, FAQs, and more information.


IRB Policies Update and New Spanish Consent Template

To: Rush Principal Investigators, Research Administrators and Staff

From: John Cobb, BA, CIP, IRB Director, Research Regulatory Operations

Re: IRB Policies Update and Spanish Consent Template availability

The research community should be aware of updated IRB policies. All IRB policies were reviewed and updates were made to those policies that were outdated. Also, the current Rush Revised Consent Template with Combined HIPAA is now available in Spanish.

Adding a Clinical Trial to the Website

  1. Complete and submit this form for each clinical trial you want to add to the website.
  2. The submission is reviewed to ensure it has Institutional Review Board approval.
  3. Marketing’s web team adds the clinical trial to the website and notifies you when it’s live.
  4. When your trial has completed enrollment, please contact Michael Gallagher ( so it can be removed from the website.

If you have any questions about this process, please contact:

Michael Gallagher

Web Editor and Project Manager

(847) 903-0216

Starting 7/12/20, the Rush Research Portal (RRP) is switching to use Rush Single Sign On (SSO) to authenticate users attempting to login the RRP. Upon entering the login page, please click the top button “Rush SSO Login” and enter the user login ID in the following format in the resulting SSO login page: rush\userID

FY21 New Rates (IRB and CTMS Fees)

As FY21 began on July 1, Rush has adopted new rates for IRB fees and new CTMS fee, implemented by the Research Revenue Cycle. Please find these new rates on the Rush Research Portal.

Link for FY21 Fees


Please note this policy is effective immediately, please distribute widely to your research faculty and staff.

Effective immediately for studies requiring a full coverage analysis, each individual study subject must be registered in OnCore, the  Clinical Trial Management System (CTMS), and have the corresponding Informed Consent Form (ICF) uploaded into REDCap within one (1) business day after informed consent is obtained; or prior to the initiation of treatment.  REDCap storage of ICF documents is a temporary measure being employed while the Office of Research Affairs works on a solution to facilitate storage within the CTMS. 

This mandate is outlined in the newly created policy OP-661 Mandatory Subject Enrollment in CTMS which aligns best practices for research subject identification. 

For instructions on how to enroll subjects in OnCore, please refer to the video tutorial. You can also signup for subject enrollment training courses via LEAPOnline.

For assistance on how to upload ICFs into REDCap, refer to the job aid titled How to Submit Informed Consent Forms in REDCap.

For any OnCore training or access related inquiries, please reach out to or contact Crista Brawley directly at 312.942.7276.

Please be aware that Compliance will be auditing all study teams for adherence to this policy. These audits will begin in May and any non-compliance will be reported to Department leadership.


Monitoring Visit Letter 3/10/2020

Rush University Medical Center is striving to limit the spread of COVID-19 and has issued restrictions on faculty and staff travel and non-essential faculty and staff meetings. The leadership of Rush recognizes the critical importance of clinical trials to our mission and will continue to foster these activities. Until further notice while COVID-19 containment efforts are underway, we are strongly encouraging that site initiation visits (SIVs) be conducted virtually. We would also prefer that routine monitoring visits be rescheduled until after April 15, 2020. If a sponsor/CRO would prefer to engage in remote monitoring, there is a fee for administrative costs to prepare for such a visit. If a monitor does choose to come onsite for a visit, please be aware that access to the clinic and pharmacy is prohibited at this time. There will also be additional screening conducted prior to the scheduled visit and additional onsite screening required prior to entering a monitoring room. A visitor pass must be obtained while onsite, which requires picture identification.

Letter attached here.


Suggested REDCap Language for Publications

REDCap requests that the following language be used in publications that used REDCap for data collection and management:


Study data were collected and managed using REDCap electronic data capture tools hosted at Rush University Medical Center.1,2 REDCap (Research Electronic Data Capture) is a secure, web-based software platform designed to support data capture for research studies, providing 1) an intuitive interface for validated data capture; 2) audit trails for tracking data manipulation and export procedures; 3) automated export procedures for seamless data downloads to common statistical packages; and 4) procedures for data integration and interoperability with external sources.


1PA Harris, R Taylor, R Thielke, J Payne, N Gonzalez, JG. Conde, Research electronic data capture (REDCap) – A metadata-driven methodology and workflow process for providing translational research informatics support, J Biomed Inform. 2009 Apr;42(2):377-81.


2PA Harris, R Taylor, BL Minor, V Elliott, M Fernandez, L O’Neal, L McLeod, G Delacqua, F Delacqua, J Kirby, SN Duda, REDCap Consortium, The REDCap consortium: Building an international community of software partners, J Biomed Inform. 2019 May 9 [doi: 10.1016/j.jbi.2019.103208]


For questions, please contact:

Crista Brawley, PhD, CCRP

AVP, Res Reg Ops


Mandatory Annual Conflict of Interest Survey

Subject: Rush’s annual Conflicts of Interest (COI) survey launches the week of July 14th

July Dissemination

Rush University Medical Center, including Rush University, is an institution of public trust.  In recognition of that status, all Rush employees, faculty and staff are expected to conduct their affairs in ways that exemplify the Rush mission and ICARE values.  Annual reporting on outside professional activities through the COI survey process helps safeguard the work and reputations of Rush employees, faculty and staff.

Rush COI policies are designed to ensure that individuals disclose these relationships, and RUSH appropriately manages or eliminates situations in which personal or familial interests might otherwise compromise or appear to compromise individuals’ objectivity as caregivers, teachers, researchers or administrators.

Rush’s annual COI survey launches the week of July 14th.  Based on your role at Rush, you may receive an email with survey instructions from the Rush Portal.  Those not receiving the survey by email are still required to report any relationships or activities described in the policy and/or vendor guidelines to their supervisor and the COI Office if such a relationship exists.  You have two weeks to complete your survey.  Below outlines key dates you should be aware of.

Week of July 14th – COI Survey Launch                                          July 31st – COI Survey Completion Deadline & Reminder

August 5th – Resident COI Survey Launch                                     August 21st – Resident Survey Completion Deadline

August 31st – Referral to Supervisors for non-completion           September 7th – Sanctions imposed

For answers to Frequently Asked Questions on the COI policy and vendor guidelines, click here.

For questions that are general COI related please call 312-942-5303.

For technical COI survey questions and help, please call Rose Garcia at 312-942-0287.


New Policy Research Data: Access, Ownership and Retention (CC-RC-0011)

To:   Rush Principal Investigators, Research Administrators and Staff

From:   Stephanie Guzik, MBA, BSN, RN, CHRC, Office of Research Compliance

Re:  RE: New Policy Research Data: Access, Ownership and Retention (CC-RC-0011)

The research community should be aware of a new policy titled Research Data: Access, Ownership and Retention (CC-RC-0011) addressing accountability, responsibility and ownership of research data.

This umbrella policy aims to contribute to the framework for Responsible Conduct of Research (RCR), standardize criteria that is consistent across disciplines, level set expectations for data management and safe housing for access and use, outline responsible parties and align Rush with National Best Practice.

The policy was designed for all types of research and does not conflict with other policies, rather it provides a consistent approach to this important matter.

The full policy can be accessed here and on the Rush Intranet Policies and Procedures homepage.

Stephanie C. Guzik
Associate Vice President, Research Compliance and Conflict of Interest

Corporate Compliance
Rush University Medical Center


NIH Releases Protocol Template for Behavioral and Social Sciences Research Involving Humans

Today, the National Institutes of Health (NIH) launched a new protocol template to help behavioral and social science researchers prepare research protocols for human studies measuring social or behavioral outcomes.

The protocol template is an effective resource for communicating the science, methods, and operations of a clinical trial, to allow for efficient review by peers and oversight bodies, to facilitate reporting of information into, and to guide replication of studies.  Use of the template will also help ensure adherence to the International Conference on Harmonisation (ICH) E6 Good Clinical Practice guidelines.  The template will be especially helpful for investigators less familiar with the information and level of detail expected in a clinical protocol.  While use of the template is encouraged, it is not required.

This template was based upon the NIH-FDA Phase 2 and 3 IND/IDE Clinical Trial Protocol Template but is tailored specifically for clinical trials with a behavioral or social intervention or manipulation.  As with the Phase 2 and 3 template, the behavioral and social template has been fully integrated in the NIH Clinical E-Protocol Writing Tool.  The Clinical E-Protocol tool allows multiple collaborators to author protocol documents and then submit them to or the NIH IC(s) funding the study. 

To learn more about the importance of this new resource please see the latest “Under the Poliscope” blog authored by Dr. Carrie D. Wolinetz, Acting NIH Chief of Staff and Associate Director for Science Policy and Dr. William Riley, Associate Director for Behavioral and Social Sciences Research.

The Protocol Template for Behavioral and Social Sciences Research Involving Humans: A New Community Resource!

Questions may be sent to the NIH Office of Science Policy at


New Monitoring Informed Consent, HIPAA & Consent Documentation SOP

Effective February 1, 2019, The Office of Research Compliance (ORC) and the Institutional Review Board (IRB) are introducing a new Standard Operating Procedure (SOP) titled:  Monitoring Informed Consent, HIPAA & Consent Documentation.  

The SOP outlines the process to monitor and assess investigator compliance with regulations and Rush policies relating to Informed Consent (IC).

Criteria for review includes the following:

  • Human Subject Research Studies where informed consent is required
  • The study is newly approved by the IRB
  • A COI Management Plan was issued and requires the ICF to be amended and, if necessary, the re-consenting of currently enrolled subjects
  • Individuals obtaining consent are new to Rush or new to obtaining research consent

** The first three consents will be reviewed.  If unsatisfactory results are obtained, monitoring will occur until demonstrated successful passing of all elements of proper ICF execution is obtained.

An ORC staff member will contact the research team to notify them of the submission process and that the ICF review is required for that study.  The review is performed remotely.  Materials to be submitted for review include:

  • Copy of the executed Informed Consent Form (ICF)
  • Copy of the executed Assent Form (when applicable)
  • Copy of the executed Short Form (when applicable)
  • Copy of the executed HIPAA Authorization (when applicable)
  • Copy of the documentation of the Informed Consent Process (signed and dated by the individual obtaining consent)
  • Copy of the Subject’s Demographics Page from the medical record

Questions about the new process can be directed to:

Poorna K. Nagarajan, MD, CCRC
Clinical Research Auditor, Research Compliance
Tel: 312-942-8613


Informed Consent Education Sessions

January 21, 2019: the effective date for the Revised Common Rule (45cfr46)
– All new studies approved after 1/21/19, must comply with the Revised Common Rule

– Any study approved prior to 1/21/19 should remain under the old Common Rule.

               • If there is a reason to transition the study, please contact the Crista Brawley ( or Jonathan Young ( for a plan forward. Any study that would transition needs to adhere to all the new requirements of the Revised Common Rule.

Please note: All FDA-regulated studies are unaffected by the revisions to the Common Rule, and renewals must continue to be submitted annually or more frequently if required by the IRB.

What Do I Need To Know: (Please click here  for a more detailed presentation on the changes.)

               • Use the new ICF template: the required statements are required by regulation; no separate HIPAA document if you include the HIPAA language from the template (except NCI CIRB studies)
                  **The template is available here.

               • Document the ICF process, including stating you presented the key information section to the subject first

               • New regulations do call out having changes to federally funded research approved prior to implementation (even staff changes)

               • Short form process: must have a witness to the oral presentation (translator can be the witness), the subject and witness signs the short form, the witness and the person obtaining consent sign the
                 summary document

               • Discuss a plan at SIV/study start and document it to post ICF to or

Crista Brawley  
AVP, Res Reg Ops

Informed Consent Education Sessions

What: Brown Bag Lunch sessions to discuss the informed consent

When: 2nd Thursday of every month

Time: 12 noon to 1 p.m.

Where: Jelke 602A (Large Conference Room)

  • 2/14, 5/9, 8/8, 11/14– Regulatory Implications of ICF
  • 3/14, 6/13, 9/12, 12/12– Informed Consent and Process Note
  • 4/11, 7/11, 10/10, 1/09– Assents and Short Forms


New Informed Consent Template Available

NEW INFORMED CONSENT TEMPLATE is available! It contains all the new requirements. Please use for all new studies! It is available here.

-          If you use the new ICF template, the appropriate HIPAA language is within the document. You do NOT need a separate HIPAA document.

-          You may choose to implement the new ICF template at any time for an approved study. We recommend at continuing renewal. But if you choose to use it sooner, please submit an amendment.


Update regarding New Revised Common Rule - June 19, 2018

Dear Rush Research Community,

*The effective date of the Revised Common Rule is now January 21, 2019.

**Based on this Final Rule, the requirement to use the new Rush Consent Template will now be January 2019.

How this affects me?

·         No changes are required on your end.

·         The submission process through the Rush Research Portal will not change.

·         The use of the new ICF template is optional until January 2019. We will continue to review comments from our research community on ways to improve the new template.

On June 19, 2018, OHRP and 16 other federal departments and agencies published a Final Rule in the federal register. The rule implements a six month delay of the general compliance date of revisions while allowing the use of three burden-reducing provisions during the delay period. The effective date of the Revised Common Rule is now January 21, 2019.

At this time, Rush leadership is evaluating a plan of action in regards to the optional provisions. The optional three burden-reducing provisions are defined as:

1.    The revised definition of “research”, which deems certain activities not to be research covered by the Common Rule;

2.    Allowing for no annual continuing review with respect to certain categories of research;

3.    The elimination of the requirement that institutional review boards (IRBs) review grant applications or other funding proposals related to the research.

Of note, if institutions choose to implement these 3 optional provisions for particular studies during this delay period, such studies will be required to adhere to all New Common Rule requirements beginning on January 21, 2019.

Based on this Final Rule, the requirement to use the new Rush Consent Template will now be January 2019. In the interim, we will continue to review comments from our research community on ways to improve the new template. We will continue to update you as information becomes available.

This Final Rule has been put on public display by the Office of the Federal Register and can be accessed at:

Please feel free to reach out to me with any questions at 312-942-7276.

Crista Brawley, Ph.D., CCRP

Associate Vice President, Research Regulatory Operations


Updated Rush Informed Consent Template –  April 5, 2018

Changes in NIH policy as well as imminent changes to the Revised Common Rule provide us with an opportunity to update our Rush informed consent template so that we remain compliant with current regulatory standards and are prepared for changes to come. Although the update to the Common Rule was temporarily postponed until July 19, 2018, we have updated our consent template to meet the proposed standard, as well as making other improvements.There is also a new assent template for minors between the ages 7 – 12.

The new consent template employs the “reasonable persons” standard as required by the Revised Common Rule. This standard means that the consent must provide all of the information that a reasonable person would need in order to make an informed decision about whether to participate in a study up front. The consent is divided into two sections (‘Important Information’ pages 2-4, and then ‘General Information’). The latter pages provide the more detailed information. It is important to note that although a topic may be briefly discussed, for example, on page 2, it is still required to include more detailed information later in the document. Other dynamic changes include:

  • removal of the PI signature line
  • more detailed instructions, explanations, and examples; this version features “plug-in” language options in order to help researchers construct their consent whether expert or novice. The feature was included in two of the most problematic sections of the consent document -  Costs and Research-related injury
  • inclusion of additional elements of informed consent
  • statements about research that involves the collection of identifiable private information or identifiable biospecimens
  • standardized language for Certificates of Confidentiality and other topics
  • inclusion of a separate Rush assent template and guidance document

The consent template will be updated annually to address changes in the research landscape or to make simple improvements.

Future changes being considered:

  • employing a separate socio-behavioral consent template
  • incorporating HIPAA Authorization into the consent document

Implementation of the new consent template:

The new consent and assent templates have been posted and are now available. The previous consent template will still temporarily be available. Use of the new templates is voluntary until June 30, 2018. Investigators submitting a new study can voluntarily use the new templates. Investigators submitting an amendment to an already approved study can voluntarily choose to convert to the new templates or continue to use the previous version.


-     July 1, 2018:  New studies submitted on or after July 1, 2018 will be required to use the new consent/assent templates. The previous template will be removed.

Studies IRB- approved prior to July 1, 2018 using the previous templates are not required to be amended to update to the new consent/assent templates. Converting to the new consent/assent templates for already IRB-approved consents/assents is and will remain voluntary.

Amendments for Sync Changes

Occasionally, during the synchronization process, changes to the Costs and Research- Related Injury sections of the consent document are required in order to ensure that the study’s contract is in agreement with the information provided in the consent document. These changes are facilitated via Amendment for review and approval by the IRB. We ask that you now include a copy of the correspondence (the document that specifies the changes that need to be made) that you receive from the Sync Specialist in your Amendment. The inclusion of this document is a quality assurance measure that ensures that the IRB has the necessary documents to complete their review.

We will continue to use our normal channels of communication (Research Administrator’s Forum, Rush Research Portal Home Page, and Rush research list- servs) to educate our research community on these topics. We will also plan for other opportunities to discuss as needed.

Please feel free to reach out with any questions at 312.942.6855 or


Information regarding the New Final Common Rule - January 22, 2018 

Dear Rush Research Community,

  • This rule delays the effective and general compliance dates of the rule changes by six months, to July 19, 2018. The cited reason for the delay is due to the complexity of 2018 Requirements, the lack of prepared guidances and tools, and the need to revamp institutional policies and electronic research systems.

  • Due to the fact that no 2018 Requirements could be implemented prior to 01/19/2018, the RRO chose a more conservative approach. We did not alter the Rush Research Portal (RRP) and did not publish new policies. The new IFR also does not allow any implementations prior to the new date of 7/19/2018. We will follow the same conservative approach for this date as well; as we expect that few, if any, substantial changes will immediately affect your own research workflow

  • Additionally, the above departments and agencies are also developing a new notice of proposed rulemaking (NPRM) that will seek public comment on a proposal for a further delay of implementation of the 2018 requirements, for an unspecified timeframe.

  • Please note that the FDA was not an agency that signed on to the 2018 requirements, thus all of the old pre-2018 policies and processes would have to be followed for studies that fall under FDA oversight.

  • Please contact me or any RRO staff with questions or concerns.

Mary Jane Welch, DNP, APRN, BC, CIP
Office of Research Affairs
Associate Vice President, Research Regulatory Operations
Associate Professor, College of Nursing
Rush University Medical Center
1653 W. Congress Parkway, Jelke 601F
Chicago, Illinois 60612
Telephone: 312-942-7276

Material Transfer & Data Use Agreements 

Dear Rush Research Community,


During this busy Holiday period (today through December), we remain committed to all your Research Administration needs and our service levels to you.  We are anticipating some staff vacations and PTO during this period and as a result there may be slight delays, especially in processing MTAs/DUAs.  Please let us know if you need specific or heightened attention on any MTA or DUA during this period – our goal as always is to ensure your research remains uninterrupted. 


If necessary, please notify Heather Kartsounes at so your agreements can be expedited on a need basis.

FY 2018 Key Rates

To:         Industry Sponsored Researchers

Re:         Updates to the Fringe and Overhead Rates

Date:     September 20, 2017

An updated version of the Industry Sponsored Studies Overhead and Key Rates document has been posted in the Clinical Research Finance section of the Rush Research Portal.  It reflects the status quo for the industry sponsored overhead rate (applies to all costs) and the fringe rate for this fiscal year.

You are aware that the Federal indirect rate has changed to 57%, and only applies to the modified total direct costs (MDTC).  It has been updated in the document. 

There is ongoing analysis of the activity costs (study start-up, IRB fees, and personnel rates).  As a result, the minimums are included, but are subject to change.


Please visit us online: RushU Clinical Research Administration


Mandatory Annual Conflict of Interest Survey

The mission of Rush University Medical Center is to provide the very best care for its patients. As one of the nation’s leading academic medical centers, Rush University Medical Center is committed to ensuring its health care professionals carry out the mission in an objective and responsible manner.

To exemplify this commitment, Rush’s Board of Trustees, corporate officers, employees, faculty, students and members of the medical, nursing, professional and technical staffs must use their best efforts and judgment to avoid any influences which could compromise patient care, research, business transactions with integrity.  Compliance with completing the Conflict of Interest Annual Survey ensures Rush University Medical Center maintains transparency in its daily operations.
The Conflict of Interest Survey for FY2017 will be launched the week of
July 10th and must be completed by July 31, 2017.  Research personnel are required to complete the survey and will be notified by an e-mail from which will provide additional information about how to login to the Rush Conflict of Interest survey portal at Rush's Research Internet Site.  The current disclosure survey covers the time period of July 1, 2016 through June 30, 2017.
If you have any questions concerning the policy or completing the attached disclosure form, please contact the Conflicts of Interest survey team at: or 312-942-5303.


The Final Rule changes to the Common Rule


Dear Rush research Communities;

OHRP along with 15 other federal agencies have finally published a new Final Rule for conducting human subject research.  The published Final Rule truly paid attention to the many comments, from various people and agencies, based on the previous Notice of Proposed Rule Making ( NPRM).

The 16 agencies that have signed on to the new “Common Rule” did not include the FDA.  Thus, for now,  they will continue to have their own regulations.

I am working my way through the final rule, but included below is a press release summary of the important changes.  It looks as if the more egregious items were dropped & included some items that were quite favorable, for example bulletpoint #5 (highlighted) .  This may allow long term studies that are only monitoring survival data, to no longer submit for annual continuing reviews.  

The link to the newly published (today) Final Rule is included below; as well as the excerpt from the press release published yesterday.

As I review the document, I will update you.  Stay tuned.

Mary Jane Welch

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.


Funding Opportunities

To:          Research Colleagues and Rush University Faculty and students

From:    Thomas J. Champagne, Jr., Chief Research Administrator and Associate Vice President

Re:         Funding Opportunities

Date:     Jan. 5, 2017


The National Academies of Sciences, Engineering and Medicine have announced three funding opportunities as part of the Gulf Research Program.  

Science Policy Fellowships contribute to leadership development and capacity building for masters and PhD students or recent graduates with an educational experience at the science-policy interface.  Fellows will spend one year on the staff of a state environmental, natural resources, oil and gas, or public health agency; or regional offices of relevant federal agencies in the Gulf region. Fellows will participate in and contribute to the state or federal policy-making process. Applications are due by 5 p.m. ET on Feb. 22. Click here for more information. 

Early Career Research Fellowships provide flexible support and mentorship to tenure-track faculty at colleges, universities and research institutions. The awards recognize exceptional leadership, past performance and the potential for future contributions to the applicant’s field. Fellowships are open to early career researchers in the social and behavioral sciences, health and medicine, engineering, earth and life sciences or relevant interdisciplinary fields. Applications are due by 5 p.m. ET on Feb. 22. Click here for more information. 

Research and Development Grants will support the work that advances fundamental science or provides the scientific basis for the development of new technologies, processes or procedures to reduce or better understand the systemic risk leading to uncontrolled hydrocarbon release in the offshore oil and gas environment. Proposed research should address scientific and/or technological research gaps identified in literature, by industry or by regulatory agencies – gaps that, if filled, could result in a reduction of systemic risk in the offshore oil and gas environment. A Letter of Intent is required for this funding opportunity, and must be submitted by 5 p.m. ET on Feb. 1. Expected review period is from mid-April to June. Click here for more information.

If you know someone who might be interested in applying for any of these funding opportunities, please help us spread the word.

Please feel free to reach out with any questions at 312.927.8703 or


New Process for Non-Human Subjects Research Determinations

The Division of Research Regulatory Operations in the Office of Research Affairs keeps track of research activities which use de-identified human data or specimens but do not meet the definition of Human Subjects Research.  Research Regulatory Operations determines whether the research activity involves human subjects or not.  If the research activity involves human subjects, it will require IRB review.

One of the goals of Research Regulatory Operations is to improve our response time to your submissions and the quality of documentation. In an effort to improve the process of making these determinations, Research Regulatory Operations has created a new, electronic submission form (Form 118) that can be submitted via REDCap directly to Research Regulatory Operations. Previously, Form 118 had to be submitted to Research Regulatory Operations in paper format via hand delivery or e-mail.

Some examples of studies that may fit the definition of “not human subjects research”(NHSR) under federal regulations can include studies only using publicly available data, case reports, or studies intended solely for quality or program improvement at Rush.

For any questions regarding what may qualify as NHSR or how to fill out the new Form 118, please feel free to contact Research Regulatory Operations at 312-942-3606 or email

To get started on your Form 118 submission now, you may go to (please save this as a favorite in your browser for easier access).

Thank you.


Quick Reference Guide for Clinical Trial Agreements

 Hello Research Community!

 The following can now be found under the “Grants and Contracts” Section to the left, as well as two available CDA forms. To help you through the Clinical Trials contracting process, here is the content.

Institution’s Legal Name:             Rush University Medical Center (“RUMC”) (includes the University, RUMG, ROPH, and all subsidiaries)

Institution’s Address:                   1653 West Congress Parkway, Chicago, IL 60612

Parties to the Agreement:            RUMC and Sponsor

The Principal Investigator is not a party to the Agreement, but will sign the agreement to document that they have read and acknowledged the agreement.




Vice Provost for Research

Rush University Medical Center

Office of Research Affairs

1653 West Congress Parkway

Chicago, IL 60612

Fax: (312) 942-2874


With a copy to:

General Counsel

Rush University Medical Center

Office of Legal Affairs

1700 West Van Buren Street, Suite 301

Chicago, IL 60612

Fax: (312) 942-4233


Payments from Industry Sponsors:

Federal Employer ID (TIN) Number:        36-2174823

Payable to:     Rush University Medical Center

                         75 Remittance Drive, Suite 6807

                         Chicago, IL 60675

Checks must include the following: 1) Invoice Number; 2) Principal Investigator’s Name; and 3) Sponsor’s Protocol Number.

Invoicing Procedure:

RUMC will generate and send monthly invoices to industry sponsors for services performed in the prior month in accordance with the final negotiated budget.  Invoices will be calculated from visit data that has been entered into the paper or electronic Case Report Forms (“CRFs”) for each subject.  Sponsors shall reimburse RUMC within 45 days of receipt.

Named Person for Institutional Signature after March 1, 2016:

                Name: Crista Brawley

                Title: AVP, Clinical Research Admin; AVP, Research Regulatory Operations


Consent Form Information and Tips

Consent forms are complicated! You must get the appropriate approval from the patient or a legally authorized representative, and the researcher. But on the research side, who exactly should sign-off? Is the Principal Investigator’s (PI) signature needed?

The answer is both yes and no.

Federal regulations (21 CFR 50.27) require that the written consent form approved by the IRB be signed and dated by the subject or the subject's legally authorized representative at the time of consent. A copy should be given to the person signing the form. It is the Rush IRB's expectation that the person obtaining consent (sometimes the PI, sometimes a trained delegate), also will sign and date the form, attesting to the informed consent conversation.

  • While a number of qualified research personnel can, and should, be involved in the process of consent, it should be remembered that the Principal Investigator (PI) is ultimately responsible for all aspects of the research including informed consent.
  • It is incumbent upon the PI to be involved in both the process and documentation of informed consent, particularly in studies involving investigational drugs or devices under an IDE.
  • If the PI is unavailable, a sub-investigator with appropriate expertise can serve as the PI’s surrogate. To document the PI’s awareness however, he/she must sign the consent form.
  • The PI should sign the form in a “timely” manner, but in instances where this may not happen (e.g., travel) the PI should sign as soon as possible and a note to file describing the circumstance around the untimely signature should be created and filed in the record, in real time.

The RUMC policy related to this topic can be found here. Click here for a printable tip sheet on this topic. And, for more information on patient consents and legally authorized representatives (LAR), click here.

Want more information about Research Compliance issues? Visit their intranet page. For questions, or to learn about training and education opportunities offered by the Office of Research Compliance, Mary Keller at 2-4485.




Project type Description - Changes for Sunday, August 23, 2015
Master project summary work space Update Master Project summary workspace information: short title, multiple PI listing, principal investigator employee ID number, Link financial report recipients, department, national clinical trial identifier number (NCT), award type, user selection of human subjects, clinical trial, animal subjecs, deceased subjects, drugs, devices, biologic products, combination products, radiation.
Master project smart form New fields added for short title, Link financial report recipients,
IRB smart form New external IRB question in IRB smart form.
Grant workspace Update Grant workspace summary information: short title, multiple PI, principal investigator employee ID number, Link financial report recipients, department, national clinical trial identifier number (NCT), award type, user selection of human subjects, clinical trials, deceased subjects.
SF424 form Fix copy map in SF424 to reflect default email to, change % indirect rate from 53% to 55%, map SF424 department to reflect user selection of department approval, organization name change to Office of Research Affairs.
Contract workspace Update Contract workspace summary information: short title, link financial report recipients, department, funding type, direct sponsor, primary sponsor, CRO, user selection of clinical trial, humans, animal, deceased subjects, potential clinical trial revenue.
Contract smart form Update project information page with selections for human subjects, animal use, and deceased subjects.
Contract/Grant workflow Add new activity "Finalize Contract Information" for contract specialist to move contract in "Fund Accounting Review" stage to "Awarded" state. This workflow does not consider if the current contract has subcontract or not.
Contract / Grant workflow Add new activity "Finalize Contract Information" for contract specialist to move contract in "Fund Accounting Review" stage to "Awarded" state. This workflow does not consider if the current contract has subcontract or not. Automatic email notification to fund accouting regarding contract funding information is ready for review.


New Research Onboarding Program

The Office of Research Compliance and the Office of Human Subjects’ Protection (IRB) are pleased to announce a new Research Onboarding Program will begin in early February of 2015.
In addition to the Rush Research Portal (RRP) training, all new research staff will now receive training on research compliance matters.  The new training is being offered to provide staff with an awareness of research compliance principals and the basic information needed for success in their roles as related to Rush University Medical Center (RUMC) internal policies and procedures, good clinical practice and federal regulations.  These sessions as well as CITI training are mandatory prior to obtaining access to the RRP.

The Research Onboarding Program will be held every Friday at 10:00 AM,  just prior to the Rush Research Portal Training in the Jelke ORA conference room, 1653 West Congress Parkway.

To schedule training, please contact Antonio DeMarco at 2-5097 or to arrange.  Additional group training can be accommodated for those that cannot attend on Friday.
These sessions are one component of an ongoing process improvement initiative as we continue to facilitate sound research at Rush University Medical Center.

Annual Conflict of Interest Survey

The mission of Rush University Medical Center is to provide the very best care for its patients. As one of the nation’s leading academic medical centers, Rush University Medical Center is committed to ensuring its health care professionals carry out the mission in an objective and responsible manner.

To exemplify this commitment, Rush’s Board of Trustees, corporate officers, employees, faculty, students and members of the medical, nursing, professional and technical staffs must use their best efforts and judgment to avoid any influences which could compromise patient care, research, business transactions with integrity.  Compliance with completing the Conflict of Interest Annual Survey ensures Rush University Medical Center maintains transparency in its daily operations.
The Conflict of Interest Survey for FY2014 will be launched on July 7.  Research personnel are required to complete the survey, and will be notified by an e-mail from which will provide additional information about how to login to the Rush Conflict of Interest survey portal at Rush's Research Internet Site.  The current disclosure survey covers the time period of July 1, 2013 through June 30, 2014.
If you have any questions concerning the policy or completing the attached disclosure form, please contact the Conflicts of Interest survey team at: or 312-942-5303.

Research Compliance Awareness: Mandatory Reporting of an 8-Digit Clinical Trial Number on Medicare Claims

Dear Researcher-

Effective January 1, 2014, CMS will require providers and suppliers to report an 8-digit clinical trial number on claims for items or services furnished pursuant to clinical trials that qualify for coverage as set forth in the Medicare National Coverage Determination Manual. The reporting of this number is voluntary thru December 31, 2013.

The clinical trial number that CMS is making mandatory is the number assigned by the National Library of Medicine (NLM) website. CMS uses this number to identify all items/services provided to beneficiaries during their participation in a clinical trial, clinical study, or registry that may result from a study covered under coverage with evidence development (CED), the Medicare Clinical Trial Policy, or a CMS-approved investigational device exemption (IDE) study.  This number is listed prominently on each specific study’s page and is always preceded by the letters “NCT.”

CMS anticipates that the mandatory reporting will improve its tracking of Medicare payments, ensure that the information gained from the research is used to inform coverage decisions, and make certain that the research focuses on issues of importance to the Medicare population.

Providers and suppliers are required to implement the mandatory reporting by January 6, 2014. The CMS transmittal discussing the mandatory reporting requirement is available here.

Please work with Revenue Cycle Operations for Rush University Medical Group when requests are made to assist in achieving compliance with this mandatory requirement.  Should you have questions please email Dawn Preston or Carrie Gill.

Electronic Record (Epic) Access by Research Study Monitors - Rush Privacy Position

External access by study monitors are used to assure progress and accuracy in clinical trials by reviewing source documentation.  A large percentage of source verification is by reviewing a subject’s medical record.  Direct access to the legal medical record (LMR) through Epic presents a privacy risk to Rush patients as Epic (in its current version) does not have the capacity to restrict access to a discrete list of subjects and/or subject visits.

To address this issue with study sponsors, the Compliance Office has created a position statement letter that should be shared with monitors to communicate Rush’s position on the matter.  You can find this letter in the Rush Research Portal here.

If you have additional questions regarding study monitor and record access, please contact the Rush Privacy Office at 312-942-4416.

Annual Conflict of Interest Survey

The mission of Rush University Medical Center is to provide the very best care for its patients. As one of the nation’s leading academic medical centers, Rush University Medical Center is committed to ensuring its health care professionals carry out the mission in an objective and responsible manner.

To exemplify this commitment, Rush’s Board of Trustees, corporate officers, employees, faculty, students and members of the medical, nursing, professional and technical staffs must use their best efforts and judgment to avoid any influences which could compromise patient care, research, business transactions with integrity.  Compliance with completing the Conflict of Interest Annual Survey ensures Rush University Medical Center maintains transparency in its daily operations.
The Conflict of Interest Survey for FY2013 will be launched on July 8.  Research personnel are required to complete the survey, and will be notified by an e-mail from which will provide additional information about how to login to the Rush Conflict of Interest survey portal.  The current disclosure survey covers the time period of July 1, 2012 through June 30, 2013.
If you have any questions concerning the policy or completing the attached disclosure form, please contact the Conflicts of Interest survey team at: or 312-942-5303.

Office of Research Affairs

The Office of Research Affairs is located in the 6th floor of the Jelke building, 1653 West Congress Parkway. The following units are housed in the RCTA:  grant submissions, research contracts, budget personnel, coverage analysis, IRB, research administrative core, Rush Research Portal support and intellectual property.

Office of Research Affairs Consultation Service:

Each division in the Research and Clinical Trials Administration will meet with researchers and/or their staff to provide an individual consultation.  We encourage the use of this service during protocol design to help maximize the support available to you.   Fridays are encouraged for the appointments, however if this is not possible we will accommodate your schedule whenever possible.

To arrange a consultation please call a representative from the division from which you wish to receive assistance.  Or, if you are new to research at Rush, please contact Elanda Shannon at  or (312) 563-2721 to set up consultations with all divisions.

Office of Research Affairs Hotline:

The RCTA provides a hotline (312-942-7777) for all researchers and staff within RUSH.  This hotline is available for you to contact the RCTA if you have a problem reaching someone specifically in the RCTA, you have a complaint, a suggestion, or any other feedback or question you need assistance with.  This hotline is monitored daily and you will receive a return call by the next business day.


As of early August, 2011, the Conflict of Interest (COI) module was implemented within this system.  At this time, only key personnel and select individuals have been required to complete a disclosure survey.  Only if you are required to complete a COI survey, you will see a link for Conflict of Interest Disclosure along the left hand side within your My Home section.  The Conflict of Interest Disclosure section will work similar to other inboxes you may have.  Pending Submission will be your 'inbox' for any disclosures that you have not completed.  Submitted Disclosures will be the disclosure for the current year, and Archived Disclosure will contain previous years.

This section will continue to grow as we begin to develop protocol specific disclosures.  This will allow a centralized location to electronically manage all COI disclosures and protocol specific disclosures.  Should you have any questions, please contact Research Compliance at 312-942-1296.

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