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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 FY2018 will be launched the
week of July 9th and must be completed by July 27, 2018.  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, 2017 through June 30, 2018.
 
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.

 

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: https://urldefense.proofpoint.com/v2/url?u=https-3A__www.federalregister.gov_documents_2018_06_19_2018-2D13187_protection-2Dof-2Dhuman-2Dsubjects-2Ddelay-2Dof-2Dgeneral-2Dcompliance-2Ddate&d=DwIFaQ&c=7gilq_oJKU2hnacFUWFTuYqjMQ111TRstgx6WoATdXo&r=eCofxLGGXxtcSj8y_rTFW_0ynGZfiyIYrS_XMrosxZM&m=O44MFJJqtC7bb8I2N7nVmgLzL0P4Y5q72IWpnIw21G8&s=6bUG2-IPzoGSzDxwlF8JeW3lpSFPaYuYxX6Nb4dxNu0&e=.

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 John_T_Cobb@rush.edu

 

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

Dear Rush Research Community,

 https://www.federalregister.gov/documents/2018/01/22/2018-00997/federal-policy-for-the-protection-of-human-subjects-delay-of-the-revisions-to-the-federal-policy-for

  • 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 Jay Vijayan at shrijay_vijayan@rush.edu, or call 312-563-2736 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
7/11/17

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 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, 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:
Rush_Conflict_Of_Interest_Survey@rush.edu 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.

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.

 

Department Approval List in the Rush Research Portal

Please note that we have loaded in a 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 LINK system. Please see the list of departments below.

Department First Name Last Name Approver's Email
Academic Affairs - All Colleges Susanna Chubinskaya Susanna_Chubinskaya@rush.edu
Anesthesiology Ken Tuman ken_tuman@rush.edu
Behavioral Sciences Mark

Christopher
Pollack

Grote
mark_pollack@rush.edu

Christopher_Grote@rush.edu
Breast Cancer Task Force David

Anne Marie
Ansell

Murphy
David_Ansell@rush.edu

AnneMarie_Murphy@rush.edu
Cardiovascular Thoracic Surgery Michael Liptay michael_liptay@rush.edu
Cell & Molecular Medicine Rita

Dale
Eaddy

Sumner
rita_eaddy@rush.edu

rick_sumner@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 Sarah

Christy
Peterson

Tangney
sarah_j_peterson@rush.edu

Christy_Tangney@rush.edu
CHS - Communication Disorders Emily

Christy
Wang

Tangney
emily_wang@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 Susan

Mona
Breitenstein

Shattell
susan_m_breitenstein@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 Vijaya Reddy Vijaya_Reddy@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

Natalia

Jochen

Vineet
Freed

Glubisz

Reiser

Gupta
cherie_freed@rush.edu

natalia_a_glubisz@rush.edu

Jochen_Reiser@rush.edu

vineet_gupta@rush.edu
IM - Allergy Natalia

Jochen

Vineet

Mary
Glubisz

Reiser

Gupta

Tobin
natalia_a_glubisz@rush.edu

Jochen_Reiser@rush.edu

vineet_gupta@rush.edu

mary_tobin@rush.edu
IM - Cardiology Natalia

Jochen

Kim

Vineet
Glubisz

Reiser

Williams

Gupta
natalia_a_glubisz@rush.edu

Jochen_Reiser@rush.edu

kim_a_williams@rush.edu

vineet_gupta@rush.edu
IM - Digestive Diseases Natalia

Nancy

Ali

Jochen

Vineet
Glubisz

Reau

Keshavarzian

Reiser

Gupta
natalia_a_glubisz@rush.edu

nancy_reau@rush.edu

ali_keshavarzian@rush.edu

Jochen_Reiser@rush.edu

vineet_gupta@rush.edu
IM - Endocrinology Brian

Natalia

Jochen

Vineet
Kim

Glubisz

Reiser

Gupta
brian_w_kim@rush.edu

natalia_a_glubisz@rush.edu

Jochen_Reiser@rush.edu

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

Natalia

Jochen

Vineet
Dunham

Glubisz

Reiser

Gupta
Daniel_dunham@rush.edu

natalia_a_glubisz@rush.edu

Jochen_Reiser@rush.edu

vineet_gupta@rush.edu
IM - Geriatrics Sean

Natalia

Jochen

Vineet

Martha
O'Mahony

Glubisz

Reiser

Gupta

Morris
sean_omahony@rush.edu

natalia_a_glubisz@rush.edu

Jochen_Reiser@rush.edu

vineet_gupta@rush.edu

martha_c_morris@rush.edu
IM - Hematology, Oncology, and Cell Therapy Natalia

Jochen

Crista

Vineet

Timothy
Glubisz

Reiser

Brawley

Gupta

Kuzel
natalia_a_glubisz@rush.edu

Jochen_Reiser@rush.edu

crista_brawley@rush.edu

vineet_gupta@rush.edu

Timothy_Kuzel@rush.edu
IM - Infectious Diseases Natalia

Alan

Jochen

Vineet
Glubisz

Harris

Reiser

Gupta
natalia_a_glubisz@rush.edu

Alan_A_Harris@rush.edu

Jochen_Reiser@rush.edu

vineet_gupta@rush.edu
IM - Nephrology Natalia

Jochen

Vineet
Glubisz

Reiser

Gupta
natalia_a_glubisz@rush.edu

Jochen_Reiser@rush.edu

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

Natalia

Jochen

Vineet
Balk

Glubisz

Reiser

Gupta
robert_balk@rush.edu

natalia_a_glubisz@rush.edu

Jochen_Reiser@rush.edu

vineet_gupta@rush.edu
IM - Rheumatology Meenakshi

Natalia

Joel

Jochen

Vineet
Jolly

Glubisz

Block

Reiser

Gupta
Meenakshi_Jolly@rush.edu

natalia_a_glubisz@rush.edu

Joel_Block@rush.edu

Jochen_Reiser@rush.edu

vineet_gupta@rush.edu
Microbial Pathogens and Immunity Lena Al-Harthi Lena_Al-Harthi@rush.edu 
Neurological Sciences Lee

Igor
Esker

Koralnik
lee_esker@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

Pete

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
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 & Biophysics 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 Angelique

Patricia
Richard

Nedved
Angelique_L_Richard@rush.edu

patricia_nedved@rush.edu
Psychiatry Mark Pollack mark_pollack@rush.edu
Radiation Oncology Aidnag

Dian
Diaz

Wang
aidnag_diaz@rush.edu

dian_wang@rush.edu
RMC - Acad. Affairs Elizabeth Baker elizabeth_a_baker@rush.edu
ROPH - Professional Nursing Practice Mary

Karen
Heitschmidt

Mayer
Mary_G_Heitschmidt@rush.edu

karen_mayer@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 Alfonso Torquati Alfonso_Torquati@rush.edu
 

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

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: 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, 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 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.

 

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 antonio_s_demarco@rush.edu 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 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.
 


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 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.

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