IRB Request for Modification/Amendment
INSTRUCTIONS and USE OF FORM
A research protocol must be carried out in accordance with the protocol as approved by the IRB. Any changes to the research, including but not limited to changes in subject population, drug dosage, informed consent process, recruitment activities, advertisement material, study procedures, study instruments, or study sites must be approved by theIRBprior to implementation.
In general, minor administrative changes and changes that do not pertain to information about risk or that pose no increased risk to subjects can be approved through expedited review. Also, recruitment material that can be compared against the informed consent form can generally be approved through expedited review. The IRB Chair reserves the right to require full-board review at his/her discretion.
Substantivechanges to study design or changes regarding information on risk or that impose increased risk to subjects require full-board review. Examples include revisions to broaden eligibility criteria, additions or deletions of research groups, changes in treatment dose or frequency.
This form may be used to submit multiple documents for the same study.
Formatting Requirements
Documents must contain a version number and/or date. If you are amending a protocol, consent form(s), parental permission form and/or study information sheet(s). Please update the version number/date in the header/footer section(s) on all affected documents.
To facilitate the review process, usethe “track-changes” feature in Microsoft Word when revising previously approved documents; this will track each insertion, deletion, or formatting change that you make to the document.
Submitting the Form
An e-mailed version of this form along with the amended documents may be sent to (a signed hard copy is not required). A Research Coordinator, Associate, or Assistant may complete and submit this form.
Include/attach the sponsor’s amendment summary, if available, as well as any other supporting information that may prompt this amendment request (i.e. DSMB report, sponsor letter, unanticipated adverse event, etc).
The Principal Investigator must be CC:’d on the e-mail submission.
Principal Investigator: / Project # orAccount #:Title of Research Project(s):
1) Amendment requested by:
Principal Investigator
Sponsor (Must include a copy of correspondence from Sponsor)
2) Indicate the type of modification:
Minor modification
Major modification (including Substantive changes)
Note: A minor modification is one which makes no substantial alteration in: (i) the level of risks to subjects; (ii) the research design or methodology; (iii) the number of subjects enrolled in the research (no greater than 10% of the total requested). Minor modifications may be eligible for expedited review. Adding procedures that are not eligible for expedited review would generally not be considered a minor change. (Examples of minor modifications include minor wording changes in the consent form(s), recruiting materials, or measures; minor changes in compensation, time of participation, or subject recruitment).
3) Please check from the following list all documents that were revised (or added) as a result of this
Amendment(version date refers to the newly revised version date being submitted):
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IRB Request for Modification/Amendment
Protocol
[ Version #/Date: ]
Investigator’s Brochure (drug)
[ Version #/Date: ]
Instructions for Use (device)
[ Version #/Date: ]
HIPAA Authorization
[ Version #/Date: ]
HIPAA Authorization
[ Version #/Date: ]
Informed Consent Form (Main Study)
[ Version #/Date: ]
Informed Consent Form (Genetic)
[ Version #/Date: ]
Informed consent Form (Substudy)
[ Version #/Date: ]
Minor Assent Form
[ Version #/Date: ]
Parental Permission Form
[ Version #/Date: ]
Information Sheet
[ Version #/Date: ]
Addendum to Informed consent
Consent process (i.e., written and/or oral
process)
Partial waiver of authorization for recruitment
Purposes
Certificate of Confidentiality
Surveys/Questionnaires/Rating Scales
List Surveys/Scales here:
Phone Screening Tools
Data Collection Instruments
Patient Educational Material (pamphlet/brochure)
Other:
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IRB Request for Modification/Amendment
We understand that a study may have multiple consent forms for different groups of subjects (healthy controls, family member, etc.) If the above list does not accommodate your submission, please use this space to describe or list the additional consents.
Advertisement, flyer or other recruitment activity [ Revised New ]
Advertising Medium (check all that apply and attach materials):
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IRB Request for Modification/Amendment
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IRB Request for Modification/Amendment
(a) Direct Advertising:
Poster/billboard
Flyer
Brochure
Other:
(b) Media Advertisements:
Newspaper/Magazine
Radio
TV/Video
Internet website
(c) Other Recruitment Materials
Letter/postcard
Newsletter
Other:
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IRB Request for Modification/Amendment
Where will the materials be used? List locations.
Notes about Advertisements:
- For advertisements to be placed in newspapers/ magazines, etc., please consult with the Planning and Marketing Department to ensure proper use of the applicable Hartford HealthCare partner logo.
- Simple text postings to internet websites like Cragslist.com do not need Planning & Marketing approval.
- Registration/Postings on ClinicalTrials.gov does not require IRB review.
4)In the space provided below, provide a detailed summary of and rationale/justification for requesting these changes. What is prompting this amendment? Why are the changes needed? (“See Attached” is NOT an acceptable response.)
5) As a result of this amendment, the risks of study participation have:
Increased (see 5A-C below) Decreased (skip to #6) Remained unchanged (skip to #6)
5A) Describe any implications for increased risks to study subjects due to the proposed changes.
5B) Could the increase in risk potentially impact the decision of subjects already enrolled to continue
their participation?
Yes
No
N/A
5C) As a result of this amendment, will subjects be re-consented?
Yes
No. If no, please explain:
N/A
6) Status of Study and Recruitment:
Open to enrollment. [# Subjects enrolled to date:]
Closed to enrollment, but subjects are still receiving a required research intervention (drug, device, or biologic). [# Subjects actively receiving study treatment/procedures:]
Closed to enrollment, no subjects are currently receiving the research intervention (drug, device, or biologic),but subjects are still undergoing follow-up
Closed to enrollment and no subjects receiving the research intervention (drug, device, or biologic) or follow-up; in data analysis phase only.
N/A – There is no subject enrollment for this project (i.e. a waiver of consent/authorization was granted by the IRB)
Principal Investigator’s Assurance:By signing below, I declare that I have reviewed the submitted materials, which provide a complete and accurate description of the proposed amendment. Based on the information provided, I believe approval of this request for addendum/modification to this study is justified.
Signature of Principal Investigator
(or typed name if submitting electronically) / Date
For HRPP Office Use Only:
Check all that apply.
Pre-review of Modification Form completed. The form accurately reflects new or revised item(s) submitted (version numbers and dates).
Pre-review of Modification Form completed. Either the form contains errors that must be corrected or materials are missing in order to be reviewed further by the IRB. Requested changes sent to PI/Study Coordinator on ______,
Revised form/ additional materials received on: ______(see new form).
This request includes changes that are of minimal risk to subjects and is therefore being forwarded to the IRB Chair or designee for expedited review on: ______.
This request includes changes that appear to be greater than minimal riskor substantially alter the study. It will be referred on and presented at the next convened IRB meeting on ______.
Processing IRB Administrator:
CLG PMJ SAB SMH LAC CLBASB
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