Starting a New Study
For assistance determining how the fee schedule applies to your individual research project, contact the IRB Office at 425-525-3307 or via email at sharedservices@providence.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 425-525-3307. 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.
- Qualifications for Review
- Steering Committee Review
- Project Initiation Form (PIF) & Budget Process
- Determine Research Key Study Personnel (KSP)
- Education Requirements
- Conflict of Interest Disclosure Statement
- Confidentiality Pledge (for non-SMC employees only)
- Department Approval
- LabCorp Research Specimen Request Form
- Informed Consent Form (ICF) Requirements
- IRB Review
- 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.
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
Lari Johnson MN, RN, Nurse Research Scientist
lari.johnson@swedish.org
Swedish Medical Center - Clinical Education and Practice
420 James Tower
500 17th Avenue
Seattle, WA 98122
Research Directors:
Doniell O'Connor
Neuroscience, Heart & Vascular Research
206-215-2466
donielle.o'connor@swedish.org
Heather Algren
Clinical Trials
206-386-2820
heather.algren@swedish.org
Jodie Davila
Organ Care Research
206-215-2971
jodie.davila@swedish.org
Evonne Lackey
Oncology Research
206-386-2443
evonne.lackey@swedish.org
Caryl Tongco
Manager, Neuroscience Research
206-215-3565
caryl.tongco@swedish.org
Research Center
Other
206-215-3100
research.center@swedish.org
3. Project Initiation Form (PIF) & Budget process
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.
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 Click, the application includes a section to list all KSP involved in the research project. KSP must have a Click 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 Click user accounts can be created for KSP involved.
To request an account for our eIRB system, Click:
- Go to https://eirb.providence.org
- Under External Users, click on the button for 'Request an Account'. In the request window, be sure to describe why you are requesting a Click account and provide your contact information for any questions.
Once you receive a Click account:
- Click eIRB training documents and manuals are available within Click (choose the Library link)
- Click users will receive important announcements and reminders from no-reply@eirb.providence.org and should add this email address to their spam whitelists so that they do not miss important notifications.
- Technical Questions: Contact the Application Analysts at ORPOPeResearchSupport@providence.org.
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:
- University of Miami CITI Course. Directions to sign up and complete this course are found here.
- NIH Training Course: http://phrp.nihtraining.com/users/login.php
- Internal training course offered through the Fred Hutchinson Cancer Research Center is also acceptable.
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 425-525-3307.
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.
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.
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.
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.
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.
10. Informed Consent Form (ICF) Requirements
Download SMC ICF Templates:
- Clinical ICF Template
- Non-Clinical ICF Template
- Biological Specimen Collection ICF Template
- Future Unspecified Research ICF Template
- Injury Language
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 425-525-3307 to discuss applicable waivers.
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.
2019 Swedish IRB Agenda Deadlines & Meeting Date Schedule
2020 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 425-525-3307.
12. Complete a New Study Application
The Swedish IRB uses Click eIRB to electronically review, track and process all research submissions. All applications must be submitted through Click.
Access Click at https://eirb.providence.org
To access Click you must have a user account. In addition, all KSP involved in the study must also have an Click account in order to be added to the study.
Click eIRB accounts can be requested by clicking the “Request Account” link at https://eirb.providence.org. When you request access, please include in the free text section the reason for access, your role, and a contact number. This will help expedite your request..
Email notifications from the Swedish IRB are identified as coming from no-reply@eirb.providence.org. Click users should add this email address to their spam whitelists so that they do not miss important notifications.
Contact the IRB Office at 425-525-3307 Monday - Friday between 7:30 AM and 4:30 PM for Click assistance.