Version
1.2
Date Updated
Friday, May 25, 2012
Descripton

Approved by:  Human Protections Administrator, Director of OPRS, and Executive IRB Chair
AAHRPP REF#:  149
AAHRPP Elements:  II.2.D.3, II.2.E.3


POLICY


  1. UIC OPRS reviews all amendment requests to previously approved research
    applications or exempt research to determine whether the amendment affects the
    risk/benefit analysis or exempt status of the research study.
  2. Amendments for both federally and non-federally funded research must be approved by the convened IRB or, when the change meets the criteria of minor, by the Chair or designee using the expedited process before the investigator or their research team may implement the amendment.  An investigator PI may implement a change to the approved protocol prior to IRB approval only when necessary to avoid an immediate hazard to the subject.
  3. Minor changes in research previously approved by the convened IRB or expedited process is eligible for expedited review.
    1. Minor changes represent:
      1. changes not materially affecting the assessment of risk and benefit;
      2. changes not substantially changing the specific aims or design of the study;
      3. for protocols initially approved by expedited review process, the research continues to pose no more than minimal risk; and
      4. new or revised procedures are consistent with the expedited categories 1-7.
    2. Examples of minor changes include:
      1. administrative or editorial changes,
      2.  minor consent form revisions (e.g., grammar corrections, change in contact information, editorial changes that clarify but do not change the material),
      3. addition of procedures that do not increase risks, such as expanding collection of information or samples already being obtained for non-research purposes,
      4.  changes to recruitment procedures, recruitment materials or submission of new recruitment materials to be used in accordance with approved recruitment methods,
      5. non-substantive changes to study documents such as surveys, questionnaires or brochures,
      6. new study documents to be distributed to or seen by subjects that are similar in substance to those previously approved,
      7. changes in the amount or process for compensating subjects that do not significantly impact the risks or benefits,
      8.  decrease in the number and volume of sample collections as long as they do not negatively alter the risks or benefits,
      9. addition or removal of co-investigators, key personnel or performance sites (when do not adversely affect study resources),
      10. increasing subject enrollment,
      11. addition of template short form consents  and
      12. foreign language translations of materials already approved.
    3. Examples changes that are not minor include:
      1. new or expanded procedures (e.g., tissue biopsy, more frequent blood drawings) or changes in design (e.g., add or remove treatment arm, new study population) that increase risks or adversely impact the risk-benefit ratio,,
      2. changes in eligibility criteria that impact the risk-benefit ratio (e.g., lowering or raising the age limit),
      3. information concerning previously unknown risks or lack of benefit that is substantial or adversely affects the risk-benefit ratio, significant changes to materials to be given to subjects (e.g., new information about frequency or severity of adverse effects, negative outcomes from related studies), and
      4. replacement of principal investigator.
  4. Protocols previously meeting the criteria for expedited review will subsequently require review by the convened IRB when the changes proposed in the amendment increase the risk level to more than minimal or involve procedures which do not fall within one or more of the seven categories eligible for expedited review (refer to UIC HSPP Policy Expedited Review).