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UM Policies & Procedures - HSRO/IRB
1. Preface
2. Background Topics
3. Authorities and Responsibilities
4. Conflict of Interest
5. Institutional Review Boards
6. IRB Meetings
7. General Principles for IRB Reviews
8. Definition of IRB Review Types
9. IRB Review of Initial Studies
10. IRB Review of Continuing Studies
11. Amendments
12. Closing Studies and Final Reports
13. Suspension, Termination and Administrative Closure of IRB Approved Research
14. Unanticipated Problems and Adverse Events
15. Study Violations
16. Compliance Audits
17. Data Safety Monitoring Boards
18. Ancillary Committees
19. External IRB's
20. Policies Specific to Certain Types of Research
21. Informed Consent
22. Participant Recruitment Methods, Advertising Materials and Recruitment-Relevant Payment Arrangements
23. Vulnerable Populations
24. Privacy, Security, Confidentiality and HIPAA
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Basic Folder Information

11.2 Types of Amendments and Their Review


Approval Date

Review Responsibility:

IRB Policy and Procedure Committee

Original Approval Date:

February 21, 2006

Revised: February 13, 2012; November 1, 2012

 



11.2 Types of Amendments and Their Review

The UM IRB recognizes three categories of amendments which are:

1)  Informational Amendments:
These define changes that are informational or editorial without what reasonably may be considered potential risk implications for human subjects. Examples of informational amendments include (but are not limited to):

  1. Addition or removal of a study team member
  2. Replacement of a study team member into a position for which he/she is similarly qualified
  3. Changing a study title
  4. Changing a department affiliation or telephone number
  5. Deleting items from a questionnaire without material change to the study
  6. Revision of the format of consent documents, recruitment materials or questionnaires
  7. Removal or addition of a performance site

The HSRO will pre-screen an amendment to determine whether it fits the informational category and, if it does, the HSRO will forward the amendment to an HSRO staff member who has been authorized by the IRB Chair as an administrative-designee.  This means that on occasion the examples proposed above may not qualify as informational amendments. The administrative designees may request additional information from the Principal Investigator, approve the informational amendment or, if appropriate, he/she may defer a decision and refer the amendment to the IRB Chair or to an IRB member who is a Chair-designee or to the convened IRB.  Such a deferral shall be made if, for example, the administrative-designee determines that the amendment does not meet the definition of “informational amendment.”  The administrative-designee may not disapprove the amendment but, when he/she believes disapproval may be appropriate, shall recommend that the amendment be reviewed by the IRB Chair, IRB Chair-designee or convened IRB.

2)  Minor Procedural Amendments:
These define minor changes that alter procedures but are reasonably considered to have no or minimal potential risk implications for human subjects.  Examples of minor procedural amendments include (but are not limited to):

a.   Drawing slightly different amounts of blood

b.   Changing the frequency at which blood is drawn

c.    Adding to the number of planned research participants

d.   Revising the wording (but not the message) of the consent form

e.   Decreasing the drug dosage or frequency of drug administration

f.    Changing the recruitment plan

g.   Adding a standard quality-of-life questionnaire

h.   Adding non-sensitive questions to a questionnaire

i.   Initiating videotaping of subjects

j.   Changing the Principal Investigator

k.  Changing the Co-Investigator

l.  Adding a performance site

 

Minor procedural amendments should be submitted to the HSRO where they will be pre-screened to confirm that they fit within this category. Such amendments will then be forwarded to the IRB Chair or IRB-designee for review.  The IRB Chair or IRB-designee may request additional information from the Principal Investigator, approve the amendment on an expedited basis or, if appropriate, defer a decision and refer the amendment to the convened IRB.  Keys to determining the appropriateness of an expedited review of minor procedural amendments include that the revisions must:

a.   Not alter the risk/benefit ratio

b.   Not be significant in complexity or content to decrease a subject's willingness to participate or continue to participate

c.   Be no more than minimal risk

The IRB Chair or IRB-designee shall not disapprove the modification by expedited review but, when he/she believes disapproval may be appropriate, shall recommend that the revision be reviewed by the convened IRB.

3)  Risk-relevant Procedural Amendments:
These define changes that may affect risk to human subjects in a manner that may not be considered as “minimal.”  Such amendments often reflect changes in the direction of a study that may substantially change its purpose or goals.  Examples of changes that shall be considered risk-relevant procedural amendments include (but are not limited to):

a.   Adding a new activity that may increase risk to participants

b.   Changing study drugs or medications

c.   Adding a vulnerable population

d.  Changing radiation exposure

e.  Making changes to questionnaires or interviews that raise sensitive issues not previously raised

f.   Adding or changing invasive procedures

g.  Adding a research arm to the study

Risk-relevant Procedural Amendments should be forwarded to the HSRO where they will be pre-screened to determine if they may fit this category.  Such amendments shall then be referred to the convened IRB for review and approval.  In determining the level of risk to the amended study, the IRB may shorten the approval period.  The IRB may also require a separate review, or a higher level of review of the study than was received on the original or most recent continuing review, as a result of the proposed amendment.  The IRB may also require revisions to other application materials in relation to the proposed amendment.

 



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