Modification Form {Ver 5.50}

7/30/2019 Modification Form {Ver 5.50}

http://slidepdf.com/reader/full/modification-form-ver-550 1/6

Modification FormVersion 5.5

Human Subjects Division, Box 359470Seattle, WA 98195-9470

Phone: 206-543-0098Fax: 206-543-9218

Quick submit instructions for Modification; More Instructions are available on the HSD Forms Page • Complete this form then DELETE sections that do not apply.• COPY and PASTE tables you need (i.e., tables describing recruitment materials and/or consent forms) before you complete this form.

• When preparing double-sided copies, please make sure that each item (e.g., Modification Form, consent forms, study instruments, etc.)

begins on the front of a new piece of paper.

• NUMBER OF COPIES: Three (3) copies. (Two copies for minimal risk.)

Research Study Information

IRB Application # 42337 IRB Committee A

IRB Application TitleClonal analysis of B cell repertoires following Gardasil vaccination or

HPV infection.Lead Researcher Name

Anna Wald, MD, MPH Contact Name Kirsten Hauge, MPH

Position and/or academic appointment Professor

Position and/or academic appointment Research Manager

Department/Division Medicine/Allergy & ID Department/Division Medicine/Allergy & IDPhone # 520-4340 Phone # 520-4341Fax # 520-4371 Fax # 520-4371Box # 359928 Box # 359928Street address, if applicable Street address, if applicable Email [email protected] Email [email protected] for users of the UW Clinical Research Center (CRC) in the UW Medical Center on 7 South: modifications that impact resource utilization onthe CRC MUST also be submitted to the ITHS Administrative Director for review and approval prior to implementation. Email [email protected]

[ ] Person completing this form is the same as the Lead Researcher [ ] Person completing this form is the same as the Contact

Name of Person Completing this Form:(if not Lead Researcher or Contact) Email: Phone:

REASON SUBMITTED:

[ ] Reason #1: Supplemental Form: Offsite Adverse Event Log[Report of Other Problems is now a separate form. Please click on link for new form.]

[ ] Reason #2: Researcher or Sponsor Initiated Modification: Check all of the types of modifications you are requesting:

[ ] A. Purpose[ ] H. Confidentiality of Research Data, HIPAA Authorization or Waiver of

HIPAA Authorization, UW Confidentiality Agreement

[X ] B. Procedures [ ] I. Researchers and research staff

[ ] C. Populations [ ] J. Sites or locations

[X] D. Recruitment [ ] K. Investigator Brochure and/or Protocol Amendment

[ ] E. Consent/assent [ ] L. Funding

[ ] F. Waiver documentation of consent [ ] M. Conflict of Interest

[ ] G. Waiver of consent[ ] N. Other compliance approval letters/reports (Radiation Safety

Approval, Data Safety Monitoring Reports)Page 1 of 6 9/28/12 K-325

For HSD Office Use Only Date Received:

[ ] Master Copy [ ] Approved

[ ] IRB Working Copy [ ] Conditional Approval

[ ] Researcher Copy [ ] Noted

[ ] Full IRB Review Required [ ] Denied

[ ] Expedited Review [ ] Withdrawn DORA MOD #

Date of IRB Action: Printed Name:

IRB Chair or Designee Signature:

Notes:

https://www.washington.edu/research/hsd/topics/Modification+-+Changing+Your+Research

mailto:[email protected]


http://www.washington.edu/research/link.php?id=11











Modification Form After completing the form, delete sections that do not apply.Version 5.5 More Instructions are available on the HSD Forms Page.

Section B – PROCEDURES:

PURPOSE OF THIS SECTION: Complete this section if you intend to change any research procedures. Procedures include (but are not limited to) developing research study instruments, changing your recruitment process, changing your consent process, requesting review of medical or other records for pre-screening or requesting records review as part of your research, changing the amount of compensation offered to subjects, adding additional surveys, questionnaires or interventions.

NOTE: You may also need to complete other sections of the Modification Form if you are changing recruitment materials, consent materials,and/or are requesting to review health care records.

1. Summarize the proposed changes or new procedures.

We would like add a new recruitment method and a few additional recruitment materials to

the communication and recruitment plan for this study. Please see section D below fordetails.

2. Explain why the changes are being made.

We are adding new recruitment methods and materials in order to increase publicawareness about the HPV study and also recruit participants for this study.

3. Do the changes affect any of the following processes and/or document(s)? Yes No

a. Recruitment process and documents, including advertisements. If yes, complete Section D.[X]

[ ]

b. Consent process and documents. If yes, complete Section E.[ ]

[X]

c. Records and/or research data. If yes, complete Section H.[ ]

[X]

d. Radiation exposure. If yes, contact Radiation Safety.[ ]

[X]

e. Administrative/Other: [ ] [X]

4. Are there changes in the risks and/or benefits to the subjects? [ ] [X]

If yes, describe:

If no, explain why not:

There is no change to the risks/benefits to subjects. Therecruitment materials/method will provide study specific

information like purpose of the study, key eligibilitycriteria and compensation. We will utilize the participant’s

preferred methods of communication and inform them inthe case of email that we cannot guarantee absolute

confidentiality.

5. Check all of the boxes below that apply to your research:

Drug administration

[ ] Administration of a drug (either FDA-approved or investigational) for research purposes to a subject-patientduring general or regional anesthesia.

[ ] Administration of a drug (either FDA-approved or investigational) for research purposes to a subject-patientduring the 1.5 hours preceding general or regional anesthesia.

Blood lines

[ ]Inserting an intravenous (central or peripheral) or intra-arterial line for research purposes in a subject-patientduring general or regional anesthesia.

Sample collection

[ ]Obtaining samples of blood, urine, or cerebrospinal fluid for research purposes while a subject-patient is under general or regional anesthesia.

[ ]Obtaining a research sample from tissue or organs that would not otherwise be removed during surgery, while thesubject-patient is under general or regional anesthesia.

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Radio-isotopes

[ ] Administration of a radio-isotope for research purposes during the 3 hours prior to anesthesia or while a subject-patient is under general or regional anesthesia.

If you checked this box, you are responsible for informing in advance all appropriate clinical personnel (e.g.,nurses, technicians, anesthesiologists, surgeons) about the administration and use of the radio-isotope, to ensurethat any personal safety issues (e.g., pregnancy) can be appropriately addressed. This is a condition of IRB

approval.

Experimental devices

[ ] Implantation of an experimental device while a subject-patient is under general or regional anesthesia.

Other experimental manipulations or procedures

[ ]Other manipulations or procedures performed solely for research purposes while a subject-patient is under general or regional anesthesia (e.g. experimental liver dialysis, experimental brain stimulation).

None of the above

[X] None of the above apply to my research.

6. If you checked any box in question 5 except “None of the above”, answer the following questions:

a. Provide the name and institutional affiliation of the physician anesthesiologist who is a member of your research

team or who will serve as a safety consultant about the interactions between your research procedures and thegeneral or regional anesthesia of the subject-patients. If your procedures will be performed at a UW Medicinefacility or affiliate, the anesthesiologist must be a UW faculty member.

b. If you have not yet consulted with an appropriately qualified person about this issue, describe in detail your plans

to do so. The IRB will not approve your modification without this consultation. If UW Department of Anesthesiology approval has been obtained, please provide the Department’s letter of support.

Section D – RECRUITMENT:

1. Provide a general overview and context for the changes you are making to recruitment:

We are adding a new recruitment method and materials in order to increase awareness of this study among University of Washington staff and students. As a new recruitment

method, we would like to contact individual students and staff (including faculty) throughtheir *uw.edu* email addresses. We will obtain a list of student/staff email ids after

approval from the UW Office of Registrar and Human Resources. We will only contact thosestaff/students who have provided prior consent for the release of their UW directory

information. We would like to send separate emails to students in the 18-26 years and 27-

45 years age groups in accordance with the study protocol.

We would like to add a new flyer and a postcard targeting the 27-45 year age group (Group3 in study protocol). We have approval to post flyers and print ads at public STD clinics and

the University of Washington campus.

We have prior approval to send emails to various UW listservs. We are adding new

recruitment emails to improve outreach among University of Washington staff and students.We plan on sending emails to various UW listservs including (but not limited to):

Department of Psychology, School of Social Work, Department of Epidemiology,Department of Biostatistics, Department of Health Services, School of Pharmacy,

Department of Global Health, Department of Environmental and Occupational Health,Department of Pathobiology, School of Law, College of Education, Department of

Communications, School of Nursing, Evans School of Public Affairs and Department of Women Studies. We will request permission from the administrator of each email listserv.

When emailing the School of Medicine listservs, the email text will be specific to medical

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students.

Email communications will always contain the phrase, “We cannot guarantee theconfidentiality of any information sent by email”.

2. Describe the proposed changes to your recruitment process:

• If there are multiple recruitment strategies, describe each one individually.

• If there are multiple subject groups and your recruitment differs for each, describe the recruitment for each group.

No change

3. Explain who will approach subjects and how this will be done to protect subjects’ privacy:

No change.

4. Describe how you will minimize potential coercion or undue influence during recruitment:

No change.

5. Describe any changes to subject gifts, payments, services without charge, or extra course credit, and include thevalue/dollar amount, if applicable:

No change.

6. Complete the table below for each new or revised recruitment document.• If you are submitting multiple new or revised recruitment documents with this Modification Form, copy and paste the

table as many times as needed.

• Identify the documents that are being revised and the documents that are new.

• Attach all of the materials in the same order that you listed the documents.

• Submit 3 clean copies and 3 copies with the revisions in tracked changes. (2 copies for Minimal Risk.)

EXAMPLES for Row #1 -- “Type of recruitment materials” can be: EXAMPLES for Row #2 -- “Reason submitted” can be:

• Advertisement

• Email

• Flyer

• Letter to subjects

• Letter to colleagues

• Magazine ad or article

• Newspaper ad or article

• Oral script

• Poster

• Radio ad

• Television ad

• Website text and layout

• Adding new recruitment flyer

• Deleting old recruitment letter to subjects, no longer in

use

• Revising existing oral script

• Replacing existing oral script with new one

Back to Page 1

Row 1Types of recruitmentdocument or material

Email: subject – “HPV study at the UW Virology Research Clinic”

(for UW School of medicine listservs)

Row 2 Reason submitted Adding new

Row 3

IF APPLICABLEIRB Approval Date(most recent approval date of recruiting material being revised or replaced)



(for all other UW listservs and staff/faculty)


Row 3



Email: subject – “HPV study at the UW Virology Research Clinic” (for UW students in the 18-26 year age group)

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Row 3




(for UW students in the 27-45 year age group)


Row 3



Flyer – “HPV Research” “Never had the HPV Vaccine?”


Row 3



Print ad (Postcard) – “HPV Research”

“Never had the HPV Vaccine?”


Row 3


I N D E X O F A T T A C H M E N T S

• Check to make sure that all of the required attachments are included with this submission.

• Collate all of your attachments.

• Use clips, not staples, with at least one packet, so that HSD staff may easily distribute your materials to additional IRB reviewers as needed.

• If you are attaching consent forms and materials and/or recruitment materials, provide a total of 3 clean copies of each document

and total of 3 copies of each document with the revisions in tracked changes.

• Unless otherwise instructed below, include 3 copies of each document.

•

You should have a total of 3 complete submission “packets” with attachments included.

[ ] Explanation of Attachments, if necessary:

[ ] Assent form(s)[ ] Confidentiality Agreement (1 copy ONLY)[ ] Consent form(s)[ ] Consent materials translated into a language other than English[ ] Consent materials: addendum consent, information sheets, oral consent scripts[ ] CVs and/or training certification for researchers[ ] Data collection instruments/forms[ ] Data safety and monitoring charter and/or report(s)

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[ ] Data Safety Monitoring Plan[ ] Data Use Agreement(s)[ ] Embryonic Stem Cell Research Oversight Committee (ESCRO) approvals/letters/report[ ] Environmental Health and Safety (EHS) approvals/letters/report[ ] Federal Certificate of Confidentiality[ ] Financial Management Plan Letter

[ ] GIM10 Review Letter/Conflict of Interest Resolution Letter

[ ] Grant application and title page of grant application (1 copy ONLY)[ ] HIPAA authorization Form[ ] Implant and Investigational Device Committee (IIDC) approvals/letters/report[ ] Individual Investigator Agreements[ ] Institutional Biosafety Committee (IBC) approvals/letters/report[ ] Investigator brochure (1 copy ONLY)[ ] IRB Authorization Agreements[ ] Letters of cooperation[ ] Literature or abstracts supporting the purpose of your research[ ] Material Transfer Agreement(s) (MTA)[ ] Oral scripts[ ] Other funding documentation, only if you have funding that is not a grant application/proposal[ ] Non-UW IRB approval letters/notifications

[ ] Non-UW IRB approved applications[ ] Protocol (1 copy ONLY)[ ] Radiation Safety Applications or Radiation Safety Approval Letters (RS)[ ] Radioactive Drug Research Committee (RDRC) approvals/letters/report[ ] Recruitment – electronic materials: scripts for emails, and/or copies of web pages[ ] Recruitment – oral materials: scripts, radio ads[ ] Recruitment – written materials: flyers, brochures, newspaper ads, and/or letters[ ] Study instruments: surveys, questionnaires, assessment tools, tracking forms, web surveys[ ] Supplemental Form for Offsite Adverse Event Log[ ] Supplemental Form for Protected/Vulnerable Populations[ ] Training in the Protection of Human Research Subjects refresher/renewal documentation of frequency

[X] Other, specify: Email text, flyer and print ad for recruitment and disseminating informationabout the HPV study

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Documents

Modification Form {Ver 5.50}