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34th annual Rush University Forum for Research and Clinical Investigation
2/15/17

 

To:       Faculty, Staff and Students

From:   Research Forum Committee

Re:      Forum for Research and Clinical Investigation

We are excited to invite you to the 34th annual Rush University Forum for Research and Clinical Investigation from March 1-2.

The event provides faculty and students an opportunity to showcase their research activities, and it fosters awareness of research at Rush and its affiliated institutions. Investigators engaged in basic, clinical and applied research in various disciplines will have an opportunity to share their work, get to know one another and explore new collaborative possibilities.

A full event program is available online.

The following is a schedule of some of the Research Forum’s main events:

  • Poster Competition Session: Wednesday, March 1, from 3 - 5 p.m.
  • Distinguished Keynote Lecture: Thursday, March 2, from 8:40 - 9:20 a.m.
  • Award Ceremony: Thursday, March 2, at 3:30 p.m.

For additional information, contact Norma Sandoval or visit the Research Forum Web page.

The Research Forum is sponsored by Rush University Medical Center, Rush University, the Rush University Chapter of Sigma Xi, the John H. Stroger, Jr. Hospital of Cook County and the affiliated hospitals of the Rush System for Health.

 

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.

Regards,
Mary Jane Welch

https://www.gpo.gov/fdsys/pkg/FR-2017-01-19/pdf/2017-01058.pdf
 

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 Tom_Champagne@Rush.edu.

 

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 Reva_T_Wymbs@rush.edu.

To get started on your Form 118 submission now, you may go to https://redcap.rush.edu/redcap/surveys/?s=LWREMPAE4X (please save this as a favorite in your browser for easier access).

Thank you.

 

New Department Approval List Added to the Rush Research Portal

Please note that we have loaded in a new list of departments that will be used to identify departments for their required approval on grant, contract and IRB submissions. This is in an effort to standardize the RRP list we use with the list used in the new LINK system. Please see the new list of departments below.

Department First Name Last Name Approver's Email
Academic Affairs - All Colleges Susanna Chubinskaya Susanna_Chubinskaya@rush.edu
Anatomy and Cell Biology Rita

Dale
Eaddy

Sumner
rita_eaddy@rush.edu

rick_sumner@rush.edu
Anesthesiology Ken Tuman ken_tuman@rush.edu
Behavioral Sciences Christopher

Stevan
Grote

Hobfoll
cgrote@rush.edu

Stevan_Hobfoll@rush.edu
Biochemistry Di

Wendy
Chen

Tedesco
di_chen@rush.edu

wendy_a_tedesco@rush.edu
Breast Cancer Task Force David

Anne Marie
Ansell

Murphy
David_Ansell@rush.edu

anne_m_murphy@rush.edu
Cardiovascular Thoracic Surgery Michael Liptay michael_liptay@rush.edu
Center for Community Health Equity Raj

David
Shah

Ansell
raj_c_shah@rush.edu

David_Ansell@rush.edu
CHS - BS in Health Sciences Christy Tangney Christy_Tangney@rush.edu
CHS - Clinical Nutrition Kathryn

Christy
Keim

Tangney
Kathy_Keim@rush.edu

Christy_Tangney@rush.edu
CHS - Communication Disorders Gail

Christy
Kempster

Tangney
Gail_B_Kempster@rush.edu

Christy_Tangney@rush.edu
CHS - Dean's Office Charlotte

Christy
Royeen

Tangney
charlotte_l_royeen@rush.edu

Christy_Tangney@rush.edu
CHS - Health Systems Management Tricia

Christy
Johnson

Tangney
Tricia_J_Johnson@rush.edu

Christy_Tangney@rush.edu
CHS - Imaging Science James

Christy
Chu

Tangney
james_c_h_chu@rush.edu

Christy_Tangney@rush.edu
CHS - Medical Laboratory Sciences Maribeth

Christy
Flaws

Tangney
maribeth_l_flaws@rush.edu

Christy_Tangney@rush.edu
CHS - Medical Physics James

Christy
Chu

Tangney
james_c_h_chu@rush.edu

Christy_Tangney@rush.edu
CHS - Occupational Therapy Linda

Christy
Olson

Tangney
linda_m_olson@rush.edu

Christy_Tangney@rush.edu
CHS - Perfusion Technology David

Christy
Vines

Tangney
david_vines@rush.edu

Christy_Tangney@rush.edu
CHS - PhD in Health Science Douglas

Christy
Kuperman

Tangney
douglas_kuperman@rush.edu

Christy_Tangney@rush.edu
CHS - Physician Assistant Regina

Christy
Chen

Tangney
Regina_Chen@Rush.Edu

Christy_Tangney@rush.edu
CHS - Rel. Hlth & Human Values Clayton

Christy
Thomason

Tangney
clayton_thomason@rush.edu

Christy_Tangney@rush.edu
CHS - Research Admin Bill

Christy
Hendey

Tangney
Bill_Hendey@rush.edu

Christy_Tangney@rush.edu
CHS - Respiratory Care David

Christy
Vines

Tangney
david_vines@rush.edu

Christy_Tangney@rush.edu
CHS - Vascular Ultrasound James

Christy
Chu

Tangney
james_c_h_chu@rush.edu

Christy_Tangney@rush.edu
CON - Adult Health Nursing Elizabeth

Barbara

Susan
Carlson

Swanson

Buchholz
elizabeth_carlson@rush.edu

barbara_a_swanson@rush.edu

susan_buchholz@rush.edu
CON - Comm, Systems, Mn Hlt Nurs Mary

Mona
Johnson

Shattell
mary_e_johnson@rush.edu

mona_shattell@rush.edu
CON - Dean's Office Marquis Foreman Marquis_D_Foreman@rush.edu
CON - Women's & Children's Hlth Nurs Lynn

Janet

Wrenetha
Mohr

Engstrom

Julion
lynn_mohr@rush.edu

janet_l_engstrom@rush.edu

wrenetha_a_julion@rush.edu
Dermatology Michael Tharp michael_d_tharp@rush.edu
Diagnostic Radiology Miral

Mark

Sharon
Jhaveri

Supanich

Byrd
miral_d_jhaveri@rush.edu

mark_supanich@rush.edu

sharon_e_byrd@rush.edu
Emergency Medicine Dino

Yanina
Rumoro

Purim-Shem-Tov
dino_rumoro@rush.edu

yanina_purim-shem-tov@rush.edu
Family Medicine Steven Rothschild steven_rothschild@rush.edu
General Surgery Steven

Alfonso
Bines

Torquati
Steven_D_Bines@rush.edu

Alfonso_Torquati@rush.edu
General Surgery Transplant Alfonso Torquati Alfonso_Torquati@rush.edu
Hospital Affairs Omar

David
Lateef

Ansell
omar_b_lateef@rush.edu

David_Ansell@rush.edu
IM - Administration Cherie

Jochen

Vineet
Freed

Reiser

Gupta
cherie_freed@rush.edu

Jochen_Reiser@rush.edu

vineet_gupta@rush.edu
IM - Cardiology Jochen

Kim

Vineet
Reiser

Williams

Gupta
Jochen_Reiser@rush.edu

kim_a_williams@rush.edu

vineet_gupta@rush.edu
IM - Digestive Diseases Nancy

Ali

Jochen

Vineet
Reau

Keshavarzian

Reiser

Gupta
nancy_reau@rush.edu

ali_keshavarzian@rush.edu

Jochen_Reiser@rush.edu

vineet_gupta@rush.edu
IM - Endocrinology Brian

Jochen

Vineet
Kim

Reiser

Gupta
brian_w_kim@rush.edu

Jochen_Reiser@rush.edu

vineet_gupta@rush.edu
IM - General Interal Medicine (GIM) Daniel

Jochen

Vineet
Dunham

Reiser

Gupta
Daniel_dunham@rush.edu

Jochen_Reiser@rush.edu

vineet_gupta@rush.edu
IM - Geriatrics Sean

Denis

Jochen

Anthony

Vineet
O'Mahony

Evans

Reiser

Perry

Gupta
sean_omahony@rush.edu

denis_evans@rush.edu

Jochen_Reiser@rush.edu

Anthony_J_Perry@rush.edu

vineet_gupta@rush.edu
IM - Hem-Onc Jochen

Crista

Vineet

Timothy
Reiser

Brawley

Gupta

Kuzel
Jochen_Reiser@rush.edu

crista_brawley@rush.edu

vineet_gupta@rush.edu

Timothy_Kuzel@rush.edu
IM - Infectious Diseases Gordon

Jochen

Vineet
Trenholme

Reiser

Gupta
Gordon_m_trenholme@rush.edu

Jochen_Reiser@rush.edu

vineet_gupta@rush.edu
IM - Nephrology Jochen

Vineet
Reiser

Gupta
Jochen_Reiser@rush.edu

vineet_gupta@rush.edu
IM - Pulmonary/Critical Care Robert

Jochen

Vineet
Balk

Reiser

Gupta
robert_balk@rush.edu

Jochen_Reiser@rush.edu

vineet_gupta@rush.edu
IM - Rheumatology Meenakshi

Joel

Jochen

Vineet
Jolly

Block

Reiser

Gupta
Meenakshi_Jolly@rush.edu

Joel_Block@rush.edu

Jochen_Reiser@rush.edu

vineet_gupta@rush.edu
Immunology/Microbiology Alan

Lena

Mary
Landay

Al-Harthi

Tobin
alanday@rush.edu

Lena_Al-Harthi@rush.edu

mary_tobin@rush.edu
Neurological Sciences Steven

Igor
Lewis

Koralnik
slewis@rush.edu

Igor_Koralnik@rush.edu
Neurological Surgery Richard Byrne richard_w_byrne@rush.edu
Obstetrics/Gynecology Howard Strassner howard_t_strassner@rush.edu
Ophthalmology Kirk

Mathew
Packo

MacCumber
kirk_packo@rush.edu

macretina@gmail.com
Orthopedics Elisa

Joshua
Ortiz

Jacobs
elisa_ortiz@rush.edu

joshua.jacobs@rushortho.com
Otolaryngology Bobby

Sukhpreet

Gem
Tajudeen

Batra

Begolli
bobby_tajudeen@rush.edu

pete_batra@rush.edu

gem_p_begolli@rush.edu
Pathology Vijaya Reddy Vijaya_Reddy@rush.edu
Pediatrics Andjelka

Anna
Tomov

Spagnoli
andjelka_tomov@rush.edu

anna_spagnoli@rush.edu
Pharmacology Wendy Tedesco wendy_a_tedesco@rush.edu
Pharmacy In-Patient Ishaq

Nora
Lat

Flint
ishaq_lat@rush.edu

Nora_Flint@rush.edu
Physical Medicine and Rehabilitation - Research James Young James_Young@rush.edu
Physiology Michael Fill mfill@rush.edu
Plastic & Reconstructive Surg Alfonso Torquati Alfonso_Torquati@rush.edu
Preventive Medicine Don

Lynda
Boydston

Powell
don_a_boydston@rush.edu

lpowell@rush.edu
Professional Nursing Practice Patricia Nedved patricia_nedved@rush.edu
Psychiatry Mark Pollack mark_pollack@rush.edu
Radiation Oncology Ross

Katherine
Abrams

Griem
ross_a_abrams@rush.edu

katherine_l_griem@rush.edu
RMC - Acad. Affairs Elizabeth

Keith
Baker

Boyd
elizabeth_a_baker@rush.edu

Keith_Boyd@rush.edu
Rush Alzheimer's Disease Center David Bennett dbennett@rush.edu
Rush Alzheimer's Disease Ctr - Alternate Lisa Barnes lisa_l_barnes@rush.edu
Rush University Cancer Center Nicklas

Parameswaran

Crista

Timothy
Pfanzelter

Venugopal

Brawley

Kuzel
Nicklas_Pfanzelter@rush.edu

parameswaran_venugopal@rush.edu

crista_brawley@rush.edu

Timothy_Kuzel@rush.edu
Urology Charles Bush-Joseph cbj@rushortho.com
 

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.

Notice:

 

 

Chief Research Administrator

Rush University Medical Center

Office of Research Affairs

707 South Wood Street, Annex LL

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: Allecia A. Harley, MPH

                Title: AVP, Clinical Research Admin

 

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, contact Rita Tharpe at ext. 2-4485 or Renee Reber at ext. 2-8314.

 

 

 

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 ora_grants@rush.edu, 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.

 


The Office of Research Affairs has welcomed the Sponsor Invoicing Team (formerly known as Research Revenue Cycle/ Vyridian) into the Clinical Research Administration Team

The Sponsor Invoicing Team is co-located with us in the Annex, Lower Level and report to Peggy McAndrew. Their phone numbers and email addresses haven’t changed, but as a reminder, you can reach them at:

Victoria (Jorden) Mallard, MBA

Phone: (312) 563.2107

Email:  Victoria_Mallard@rush.edu

Peggy McAndrew

Phone:  (312) 942.9934

Email:  Peggy_McAndrew@rush.edu

General questions can be directed to:  Sponsor_Invoicing@rush.edu

 

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 Annex conference room, lower level (707 S. Wood).

To schedule training, please contact Antonio DeMarco at 2-5097 or antonio_s_demarco@rush.edu to arrange.  Additional group training can be accommodated for those that cannot attend on Friday.

For additional information or questions regarding the Research Compliance Onboarding Program, please contact the Research Compliance RN auditors, Rita Tharpe at 2-4485 (rita_tharpe@rush.edu) or Renee Reber at 2-8314 (renee_reber@rush.edu). 
 
These sessions are one component of an ongoing process improvement initiative as we continue to facilitate sound research at Rush University Medical Center.

Archiving Consent Documents in the Rush Research Portal
 
As of December 1, 2014, a process will begin that will list only currently IRB approved documents under the “Document” tab of the IRB module in the RRP. A new tab labeled “Archive” will hold previously approved, but currently retired documents. This change is administrative and is a response to multiple audit results and researcher feedback in order to prevent the wrong documents to be used. This archiving of documents is a process and will not be immediate.  When a study has a transaction with the IRB, the IRB staff will use that opportunity to update the document section and archive when appropriate.  At the very least this will occur during the continuing review of the study.  IRB staff may also archive documents at any time if the have availability. The principal investigator and research team will have access to the archived documents, but should only use the documents in the “Documents” tab and should only access documents from the RRP.
 

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 Rush_Conflict_Of_Interest_Survey@rush.edu 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: Rush_Conflict_Of_Interest_Survey@rush.edu 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) ClinicalTrials.gov 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 Rush_Conflict_Of_Interest_Survey@rsh.net 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:  Rush_Conflict_Of_Interest_Survey@rsh.net or 312-942-5303.


Important Changes to the Policy on Reporting Unanticipated Problems Involving Risk to Subjects or Others

The policy on reporting unanticipated problems involving risk to subjects or others, including serious adverse events, has been revised to make it easier for investigators to determine which events must be reported to the Rush IRB.  Under the revised policy, internal and external events should be screened identically for determination of whether to report to the Rush IRB.  That is, only those events that meet the criteria as an unanticipated problem, as defined by the policy, must be reported to the Rush IRB regardless of where the event occurred.

The revised policy effective date is December 11, 2012.  

Please review the policy with your research staff so that all members of the research team will be familiar with the change.

A few reminders about reporting unanticipated problems:

1)  An Unanticipated Problem (UP) includes any incident, experience, or outcome that meets all of the following criteria:

a) unanticipated or unexpected (in terms of nature, severity, or frequency) given (a) the research procedures that are described in the protocol-related documents, such as the IRB-approved research protocol and informed consent document; and (b) the characteristics of the subject population being studied;

b) related, probably related or possibly related to participation in the research; and

c) suggests that the research places participants or others at a greater risk of harm (including physical, psychological, economic, or social harm) than was previously known or recognized.
Any event that meets the criteria as an unanticipated problem (including serious adverse events and/or unanticipated adverse device effects) must be reported to the Rush IRB within 10 working days of notification of the event.

2) An internal problem or event is defined as an event or occurrence with a study subject recruited at Rush University Medical Center, Rush Oak Park, or by an investigator working on behalf of Rush University Medical Center or Rush Oak Park at another location.  It also includes subjects recruited for studies of which the Rush IRB is the IRB of Record

An external problem or event is defined as an event or occurrence that does not meet the criteria as an internal problem or event.

3) If an external Sponsor still forwards event reports that do not meet the reporting criteria above, the Principal Investigator must document that the event reports were reviewed but not reported because they did not meet the reporting criteria set out in this policy (RA-IRB-209).  Documentation can be in the form of a letter, spreadsheet, or physical signature on copies of each event report.  Depending on the terms of the study contract, the study team may still seek reimbursement from the Sponsor for the review of reports, as this activity constitutes review of events even if the events were not reportable under this policy.

4) Please only forward reports to the Rush IRB that meet the criteria set forth in the policy.  Submitting every received report without determining whether the event meets reporting criteria creates a large amount of backlog that could potentially prevent more serious reports from being reviewed promptly.  However, if an event has been screened as not reportable and the Investigator  wishes to report the event as part of the reportable event application, these events will be reviewed. The Investigator should document the concerns the IRB should consider.


CHANGES TO IRB APPLICATION
 

The Research and Clinical Trials Administration Office (RCTA) has received accreditation of our human research protection program with the Association for the Accreditation of Human Research Protection Programs (AAHRPP).  AAHRPP is a non-profit organization that works with organizations that conduct human research to raise the level of protection for research participants and therefore increase the public trust in research. AAHRPP accredits organizations that can demonstrate they provide participant safeguards that surpass the threshold of state and federal requirements.

 As part of the accreditation process, as well as changes in federal guidance, the Rush IRB is required to meet specific federal and accreditation-specific standards regarding how IRB review is conducted.  For this reason, revisions to the IRB Application and the Continuing Review Application have been implemented in order to collect information necessary for IRB review.

On both applications, you will see additional questions in certain sections of the Portal. For the IRB application, you will see an updated drop-down menu but this change requires nothing additional from the user.

Please contact the IRB Administrative staff with any questions about the revisions.


Office of Research Affairs
 

The Office of Research Affairs is located in the lower level, Annex Building, 707 S. Wood. 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 elanda_t_shannon@rush.edu  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.



CONFLICT OF INTEREST
 

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.


 


NEW FEATURES ADDED TO THE RUSH RESEARCH PORTAL

  • Budget Billing Grid (BBG) Performance Enhancement – We have implemented changes to the system to help enhance the performance of the BBG smartform page.
  • Clinical Trial Participant Tracking (CTPT) Role – There is now a new role added that can be accessed from a user’s personal workspace. The new role provides a better way for users to manage CTPT studies.
  • Sponsor Billing Address – A new page has been added within the Budget smartform.  This page will now capture the sponsor billing address so that invoicing can be automated.
  • CTPT Visit Logging – The states that represent the subjects visit have been expanded.  We can now help you identify which visits are certified as complete and if the CRF is complete.  This is visible in tabs located in the new Clinical Trial Participant Tracking (CTPT) Role. Visits that are complete and have completed a CRF (if applicable) will ultimately generate an invoice through the system.
  • Mark One-Time and Per-Occurrence Items for Invoicing – Two activities have been added to the budget summary workspace.  These activities, when performed, identify which items are ready for invoicing.
  • Master Project Change to Study Staff – The page that captures the PI, Co-I, study coordinator, etc., has been changed to mimic the look of the IRB.  Ultimately, our vision is that this will allow us to update the Master Project staff, title, etc. when an IRB amendment is approved.
  • Creating Projects Off the Master Project – The automatic creation of the Grant / Contract and Coverage Analysis has been removed from the Master Project.  Users will add only the projects that need to be added to the master project. Once the Master Project is created, the staff will click on the create buttons for the project types they would need to create for that specific project.
  • Master Project Related Projects List – The Master Project summary workspace has been changed to allow a quick view of all related projects within that Master Project.  This quick view will also allow users to access their related projects and/or their smartform pages quicker.
  • Key Personnel Listed in the Master Project – The Master Project now helps to identify key personnel in anticipation of incorporating protocol specific financial disclosures into the system.
  • New Questions in the Master Project – The Master Project will now collect information regarding drug, device, biologic and combination products.  This is important information necessary to ensure that any financial relationships are disclosed and managed, if needed.
 
UPDATED HIPAA PRIVACY PROCEDURES FOR RESEARCH
 
The Human Subjects’ Protection Division of the Research and Clinical Trials Administration Office has been working closely with the HIPAA Privacy and Security Office in the Corporate Compliance department to provide the research community with clear, concise policies and procedures regarding HIPAA rules for the use of PHI in research.
 
Therefore, we are pleased to announce that improved “HIPAA Privacy Procedures for Research” are now posted on the Rush Research Portal and the Research at Rush webpage.
In response to requests by members of the research community, we are also releasing several new HIPAA forms that we hope will facilitate research at Rush:
 
• The current HIPAA Authorization form has been revised and is now available as two separate forms; one for studies involving blinded treatments and another for studies that do not involve blinded treatment.   Additionally, at the request of researchers who do not do biomedical research, a HIPAA Authorization form for SocioBehavioral research is now available. 
 
• The form previously known as “HIPAA Waiver to Access Names and Contact Them” has been revised and re-titled “Preparatory to Research and Recruitment Form”.  As before, this form should be used when reviewing information on or recruiting from populations to which you do not have a pre-existing relationship (“natural access”).  Please see the revised policy and procedures for more information.
 
These forms are available on the Rush Research Portal.
 
Study teams should delete any saved templates and begin using the revised forms (Version IV April 2011) with submission of any new protocols from this date forward.
 
If you have any questions about HIPAA and Research, please contact the Research and Clinical Trials Administration Office at 312-942-5498. Comments or concerns may also be provided by calling the Rush Privacy Hotline at (312) 942-4416.

 

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