Starting a New Study

Starting a New Study


 IRB fees:  Fees as of January 1, 2010

The Swedish Institutional Review Board (IRB) has a fee schedule for IRB review. The fee schedule only applies to research approved after January 1, 2010. 

For assistance determining how the fee schedule applies to your individual research project, contact the IRB Office at 206-215-2536 or via email at review.board@swedish.org

Non-Swedish Researchers:

If you are interested in conducting research at Swedish and are not affiliated with Swedish or you do not have hospital privileges, your project may require the participation of an internal Swedish researcher or contact. Please contact the IRB Office for more information at 206-215-2536. Swedish is committed to protecting patient privacy in the conduct of research.

12 Steps to Start a New Study:

Significant delays in IRB review may occur if each step is not followed.

  1. Qualifications for Review
  2. Steering Committee Review
  3. Project Initiation Form (PIF) & Budget Process
  4. Determine Research Key Study Personnel (KSP)
  5. Education Requirements
  6. Conflict of Interest Disclosure Statement 
  7. Confidentiality Pledge (for non-SMC employees only)
  8. Department Approval
  9. LabCorp Research Specimen Request Form
  10. Informed Consent Form (ICF) Requirements
  11. IRB Review
  12. Complete a New Study Application


1.  Qualifications for Review

A Federal Wide Assurance (FWA) lists entities for which Swedish may provide IRB oversight. The FWA number for Swedish is FWA00000544.

Look up the most current Swedish covered entities at:
http://ohrp.cit.nih.gov/search/fwasearch.aspx?styp=bsc

If the entity where you will conduct research is not listed under Swedish’s FWA, the research may not qualify for Swedish IRB review or oversight.
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2.  Steering Committee Review

Each Swedish Service Line, Institute, or Specialty Area may develop a steering committee for purposes of reviewing research protocols prior to IRB review. Documentation of committee approval will be maintained by the committee and must be submitted with the new IRB application.

Contact the Research Center Manager in the department where your research project will take place to determine if Steering Committee Review is required for your study. The Manager must be informed of any contracts and/or agreements related to the research.  Please note: Steering Committee Review is required for research projects conducted by researchers not affiliated with Swedish.

Nursing Research Steering Committee:

Valda Upenieks, PhD, RN
Research Scientist
Clinical Education and Practice
206-320-2566
valda.upenieks@swedish.org


Research Managers:  

Tracie Granger
Heart & Vascular and Neuroscience
206-215-2466
tracie.granger@swedish.org

Heather Algren
Clinical Trials and Perinatal Studies
206-386-2820
heather.algren@swedish.org   

Patra Grevstad
Oncology
206-386-2442
patra.grevstad@swedish.org

Terri Spinelli
Organ Care
206-215-3063
terri.spinelli@swedish.org

Research Center
Other
206-215-3100
research.center@swedish.org

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3.  Project Initiation Form (PIF) & Budget process 

Download PDF file:      Project Initiation Form (PIF)
Download DOCX file:  Project Initiation Form (PIF)

A PIF notifies the Research Center of the new study and is used to start a study file for the research project's budget and contract information. 

Email PIF to research.center@swedish.org   Call the Research Center at 206-215-3100 with any questions related to the PIF.

Visitors who have access to our intranet pages may wish to view this page to learn about the research study budget process.

 

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4. Determine Research Key Study Personnel (KSP)

KSP are individuals who contribute in a substantive manner to the design or conduct of a research study such as: 

  • Obtaining informed consent of or otherwise enrolling research subjects

  • Administering primary study interventions being tested under the research protocol

  • Conducting interviews, surveys, or other data collection activities with research subjects

KSP are usually Research Investigators, Coordinators, Associates, and Assistants.

When starting a new study in iRIS, the application includes a section to list all KSP involved in the research project. KSP must have an iRIS user account in order to add them to the study. This is why it is important to determine who the KSP are early on so iRIS user accounts can be created for KSP involved.

Contact the IRB Office at (206) 215-2536 to set up an iRIS account with User ID and Password (requires identification of: KSP role in the research project, their email address, phone number, department and mailing address).

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5. Education Requirements

All KSP involved in a research project must complete Human Subject Protection (HSP) Training in the ethical conduct of human subjects in research.
Please Note: HSP Training is required of all KSP whether Swedish employee or otherwise.

HSP Training courses accepted by the Swedish Research Center include:

Before the IRB reviews a new study, certificate of completion from one of the above sources is required for all KSP involved in the study.

For questions about education requirements contact the IRB Office at (206) 215-2536.
 

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6.  Conflict of Interest Disclosure Statement

Download: Conflict of Interest Disclosure Statement

All KSP must complete a Swedish COI Statement. Sponsor specific Conflict of Interest/Financial Disclosure Statements are not accepted by the Swedish IRB.  If you are unable to scan and attach the completed, signed statements to the new study in iRIS, please fax them to the IRB Office at (206) 215-2413.

Federal regulations require new disclosures regarding institutional related conflicts of interest. This is in addition to IRB related disclosures. Please follow this link for important information regarding this policy.
 

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7.  Confidentiality Pledge (for non-SMC employees only)

Download: Confidentiality Pledge

The term "confidential information" includes any and all patient or research subject information in any form (oral, written or electronic), including health care information protected by Washington state and Federal law. Every investigator or study staff member who is exposed to, receives, or has access to confidential information is required to maintain the confidentiality of that information.

Non-Swedish employees or researchers not affiliated with Swedish or without Swedish hospital privileges must sign the Swedish Confidentiality Pledge. Swedish employees sign a confidentiality pledge annually per employment with Swedish; therefore, signing another pledge for the specific research is unnecessary.

If you are unable to scan and attach the signed pledge to the new study in iRIS, please fax it to the IRB Office at (206) 215-2413.
 

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8.  Department Approval

Download: Department Approval Form

Department Approval is required for all research studies requesting services from Swedish or Swedish off-campus clinics. Researchers must contact the Swedish department/service area directly for the name of the appropriate Manager to provide signature for the Department Approval.

  • One Department Approval Form must be completed for each Swedish department/service area where the research will take place.

  • If the research includes ionizing radiation a Department Approval Form must be approved and signed by an authorized representative of the Radiation Safety Committee.

  • The Department Approval Form is not required for pharmacy or laboratory services.


If you are unable to scan and attach the completed, signed Department Approval Forms to the new study in iRIS, please fax them to the IRB Office at (206) 215-2413.
 

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9.  LabCorp Research Specimen Request Form

Download: Research Specimen Request Form

The Research Specimen Request Form is required for all research studies requesting laboratory support from Dynacare.

  • Allow 7 calendar days for Dynacare to review and process the Research Specimen Request Form.

If you are unable to scan and attach the completed, signed Research Specimen Request Form to the new study in iRIS, please fax it to the IRB Office at (206) 215-2413.
 

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10.  Informed Consent Form (ICF) Requirements

Download SMC ICF Templates:  

If patients from Swedish or Swedish off-campus clinics will participate in research, a Swedish ICF must be used. The Swedish ICF must follow the applicable ICF template guidelines. Templates may be downloaded from the links listed above. If the research calls for a waiver of consent and/or waiver of authorization, contact the IRB Office at 206-215-2536 to discuss applicable waivers.

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11.  IRB Review

Swedish IRB generally reviews studies that are Federally funded, investigator initiated, or studies with limited funding resources. Swedish IRB reviews research studies through an Expedited review process or through the Full review process.

Expedited Review applies only to studies that present minimal risk to subjects per the Expedited Categories defined by 45 CFR 46.110 and as determined appropriate by the Swedish IRB Chair.
Minimal risk means that the probability and magnitude of harm or discomfort anticipated in the research are not greater in and of themselves than those ordinarily encountered in daily life, or during the performance of routine physical or psychological examinations or tests.
Studies that qualify for expedited review may be submitted to the Swedish IRB at anytime; there are no IRB required deadlines for these submissions.

Full Review applies to studies that present more than minimal risk to subjects. These studies are reviewed by the full Board at a scheduled IRB meeting. The study’s Principal Investigator or a Sub-Investigator must attend the IRB meeting to discuss the study with the Board and answer questions. IRB meetings take place once a month and deadlines for these meetings do apply.

2014 Swedish IRB Agenda Deadlines & Meeting Date Schedule
2015 Swedish IRB Agenda Deadlines & Meeting Date Schedule

Please note: Meeting Dates are subject to availability. Agenda Deadlines do not guarantee review at the corresponding Meeting Date listed on the schedule.

WIRB Review applies to studies that are commercially sponsored, involve an investigational device, or other studies if determined appropriate by the Swedish Director of Research.
Studies that qualify for WIRB Review may be submitted to the Swedish IRB at anytime; there are no IRB required deadlines for these submissions.

IMPORTANT: WIRB Review studies must be submitted to the Swedish IRB and not submitted directly to WIRB because WIRB must first receive authorization from the Swedish IRB before they will review the research. Studies sent directly to WIRB without Swedish IRB authorization experience significant delays in review.

Cooperative Review applies to studies that have already had prior review and approval by an IRB with which Swedish has a documented cooperative arrangement. These studies are reviewed by the Swedish IRB through an expedited review process or through the Full review process as determined by the Swedish IRB Chair.

For questions about the appropriate review process for your research project contact the IRB Office at (206) 215-2536.
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12.  Complete a New Study Application

The Swedish IRB uses iRIS (Integrated Research Information System) to electronically review, track and process all research submissions. All applications must be submitted through iRIS.

Access iRIS at: https://swedish.imedris.net

To access iRIS you must have a user account. In addition, all KSP involved in the study must also have an iRIS account in order to be added to the study.

Contact the IRB Office at (206) 215-2536 to set up an iRIS account with User ID and Password (requires identification of: your role in the research project, your email address, phone number, department and mailing address). At the same time, have the IRB Office verify each department involved in the research is included in iRIS.

Email notifications from the Swedish IRB are identified as coming from swedish@imedris.com.
Contact the IRB Office at (206) 215-2536 Monday - Friday between 7:30 AM and 4:30 PM for iRIS assistance.
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Institutional Review Board
206-215-2536
review.board@swedish.org