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wHMHpFmavgm8mYxcvxqLpnWyJdRHEwdXHCke2NIsRWkSH5opJgIXHQZVRLezz2SoRHfHyXBb

OBGYN IRB Intake Form

Returning?

A A A

PLEASE READ BEFORE SUBMITTING

This intake form is used to obtain departmental approval for IRB submissions.

This form is NOT for Data Service Requests; those can be submitted at: https://is.gd/washuobgynrequest.

For assistance with study planning or grant submissions, please contact obgynresearch@email.wustl.edu

Other questions can be directed to: obgynresearch@email.wustl.edu

NOTE: Completion of this form will be more time-consuming for studies without a written protocol, grant submission, or "one-pager"/summary.

You may wish to complete the form after drafting a summary that can be attached to reduce manual input. Please see the attached file below for information on what will be required in this form.

Attachment:DCR IRB Intake Guide.docx

Name of person completing this intake form:

* must provide value

Today's Date:

* must provide value

M-D-Y

PI Name (Last, First)

* must provide value

PI Division:

* must provide value

The study PI listed above is: (Choose One)

* must provide value

Faculty Mentor Name (Last, First)

* must provide value

Do you have a myIRB application drafted?

* must provide value

Yes No

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REMINDER! Please be sure that Kristen Powers and Cassara Cook are listed as delegates for you in the myIRB system. They will not be able to review your protocol until they are added.

Please see instructions here: myIRB FAQs | Human Research Protection Office | Washington University in St. Louis (wustl.edu)

Please attach the myIRB application draft (only necessary if Kristen Powers/Cassara Cook are not listed as delegates)

Upload file

Study Title:

* must provide value

Study Nickname:

Will this be a multi-site study?

* must provide value

Yes

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Will WashU be the coordinating site?

* must provide value

Yes

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What other sites will be participating?

* must provide value

Expand

Provide the coordinating site's information:

NOTE: Please include the name and contact information for a representative or coordinator that can be contacted with questions.

* must provide value

Expand

What type of study is this?

If the study has multiple arms, select all that apply.

* must provide value

Biobank Specimen Acquisition

Secondary Analysis (of existing dataset)

Chart Review (Retrospective, Including Case Studies/Series)

Device Trial

Drug Trial

Observational

Prospective Data/Specimen Collection (Including Survey Studies)

Other Interventional (Non-Drug or Device)

Who holds the IND?

* must provide value

WashU PI

Industry Sponsor

Investigator at non-WashU Site

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Provide the IND number:

* must provide value

Who holds the IDE?

* must provide value

WashU PI

Industry Sponsor

Investigator at non-WashU Site

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Provide the IDE number:

* must provide value

List the people who should be included on the research team for this study:

NOTE: If someone is NOT part of the WashU OB/GYN department, please provide the department with which they are affiliated.

* must provide value

Expand

What type of funding will be used for this study?

* must provide value

Unfunded

Division Funding

Grant

Individual Faculty Fund

Industry

Other

Who is the study sponsor?

* must provide value

Expand

Other Funding Type:

* must provide value

Grant Type:

* must provide value

WashU Grant (i.e., L.A.B. Award)

External Foundation (i.e., Barnes-Jewish Hospital Foundation, Robert Wood Johnson Foundation)

Federal Grant

Other

Other Grant Type:

* must provide value

Federal Agency Awarding the Grant:

* must provide value

Do you have access to a copy of the grant submission?

* must provide value

Yes

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Please provide a copy of the grant submission.

*Remove budget file with salary information prior to uploading*

* must provide value

Upload file

Is there a written protocol for this study?

* must provide value

Yes

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Please attach the study protocol.

* must provide value

Upload file

Do you have a short, drafted summary or "one-pager" of the study?

* must provide value

Yes

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Please upload the summary.

* must provide value

Upload file

What populations will be enrolled (or reviewed) for this study?

* must provide value

Adults

Emancipated Minors

Minors

How many adult participants will the study have?

* must provide value

How many emancipated minors will participate?

* must provide value

How many minors will participate?

* must provide value

What are the inclusion and exclusion criteria?

For chart/retrospective reviews, describe how charts will be identified for this study.

* must provide value

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How do you plan to recruit for this study?

* must provide value

Existing Registry/Database

Flyers/Posters

MyChart

Phone Recruitment

Referral

Screening via Appointment Schedules/Admissions

Social Media

Through Other Research Study

Volunteer for Health

Other

Other Recruitment Method:

* must provide value

What research study do you plan to utilize for recruitment?

NOTE: If the study utilized for recruitment is a non-OB/GYN study, provide the PI's name and department as well as the study's IRB protocol number.

* must provide value

What email list(s) will be used?

For example: WashU class email lists, faculty/physician/nurse staff lists, or sent through an outside organization.

* must provide value

What social media platforms will be utilized?

* must provide value

Instagram

Facebook

Twitter

Other

Other social media platform:

* must provide value

Will this study use surveys or questionnaires?

* must provide value

Yes

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Do you have a finalized copy of the survey(s)/questionnaire(s)?

i.e., Do you plan to use standardized and/or validated questionnaires, or (if you are creating the survey) have you already drafted the questionnaires?

* must provide value

Yes

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How many surveys/questionnaires do you plan to use?

Include only the individual surveys- do not count repeat uses of the same survey.

* must provide value

Please upload the first survey:

* must provide value

Upload file

Please upload the second survey:

* must provide value

Upload file

Please upload the third survey:

* must provide value

Upload file

Please upload the fourth survey:

* must provide value

Upload file

Please upload the fifth survey:

* must provide value

Upload file

Please upload the sixth survey:

* must provide value

Upload file

Please upload the seventh survey:

* must provide value

Upload file

Please upload the eighth survey:

* must provide value

Upload file

Please upload the ninth survey:

* must provide value

Upload file

Please upload the tenth survey:

* must provide value

Upload file

Please upload the eleventh survey:

* must provide value

Upload file

Please upload the twelfth survey:

* must provide value

Upload file

Please upload the thirteenth survey:

* must provide value

Upload file

Please upload the fourteenth survey:

* must provide value

Upload file

Please upload the fifteenth survey:

* must provide value

Upload file

Provide a brief summary or abstract of the study:

* must provide value

Expand

Please provide the background information and significance for this study, including preliminary studies if applicable:

* must provide value

Expand

Provide references cited in the background/significance section:

* must provide value

Expand

Provide a list of all data points and specimens (if applicable) that will be reviewed and/or collected for screening, CRF completion, or other study activities.

* must provide value

Expand

Provide a brief description of the study procedures.

* must provide value

Expand

Do you have any other items you wish to attach (i.e., Investigator's Brochure, additional funding information, etc.)?

* must provide value

Yes

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Please attach the additional documents.

* must provide value

Upload file

Who is the best person to contact with questions about the study?

* must provide value

Is there any additional information the regulatory team should be aware of?

* must provide value

Yes

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Additional information for the regulatory team:

Expand

Complete initial review now?
(This should ONLY be completed by DCR management or regulatory staff)

Yes

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Reviewed by:

* must provide value

IRB Status:

* must provide value

IRB Review Notes:

Expand

Mark field as:

[Clear value]

No information (NI)

Not asked (NASK)

Not Required (Study Predates This Field) (NR)

Unsure (UN)

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