Indiana University

 

Procedures for Protocol and Amendment Review

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 General Information

  1. Application forms can be downloaded from:

http://research.iu.edu/rschcomp/BIACUC/Forms/forms.html

  1. Always download a new application before you submit any kind of proposal to make sure you are using the most current version of the application

  2. Submit all applications to the IACUC Administrator (IACUC-A) via email attachment to: biacuc@indiana.edu.

  3. Applications available for download include:

      • Animal Use Protocol

      • Observation-only study

      • Animal Colony Protocol

      • Purchase of Custom Antibody

      • Minor Amendment

  1. The following applications are renewals of previously approved protocols.  Reminders with instructions will be sent to the PI prior to expiration.

      • Annual Review

      • Three-year Renewal

  1. Protocols for which Full Committee Review is required should be submitted by the 20th of the month PRIOR to the month you with them reviewed.
  2. Regardless of the type of application, you may not start the work described in the protocol until you receive notice of approval from the IACUC-A

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What kind of submission do you have?

Full committee review vs. designated review.

A full committee review is required to review the following:

  • Most new study submissions (see designated review below for exceptions)
  • 3-year renewals
  • Major amendments to previously approved protocols

These submissions must go through the pre-review and full committee review process (see item #4 “What is the Full Committee Review process?” below).  Submissions for full committee review are due on the 1st of each month.

  • New Study Submissions – These require a Animal Use Protocol Application. If you are beginning a new study, using a different animal than you have in the past, or are new to the campus, then you should probably submit a new protocol application. If you making changes to an already approved research project that involves significant changes to the research objectives, procedures involving pain or distress when none was present, or lead personnel, a new protocol is required.
    • Example of changes requiring new protocols:
      • New PI
      • New species that require housing, handling, or procedures that significantly differ from those included in the original protocol.
      • Change in research objectives
      • Addition of survival surgery or other painful or distressful procedures when no such procedures are part of the original protocol
    • Upon submission your protocol will be assigned a protocol number.  You may not start the work described in the protocol, however, until you receive notice of approval from the IACUC-A.
  • 3-year renewals – These require aAnimal Use Protocol Application. Each protocol is approved for no more than 3 years.  After 3 years it expires and must be re-submitted as a new protocol following the procedure described above.  You will receive a new protocol number at this time. The IACUC-A will email you a renewal reminder a couple of months before your protocol expires.
  • Major amendments – See “what qualifies as a major amendment?” If you determine that the amendment you wish to make to your protocol is a major one, you must incorporate the change(s) you wish to make directly into the body of your original approved protocol.  The preferred method for doing this is to use the tracking tool in MS WORD.  Any deletions to the protocol should be struck out, not removed, and any additions should be added in a different color than the main text.  Once an amendment is approved, you should change the text color to match the rest of the text.

A designated review may approve the following applications:

  • Minor amendments to previously approved protocols
  • Annual reviews
  • New protocols for observation-only studies or classes
  • Applications for the purchase of custom antibodies

Applications for designated review are generally reviewed on Friday mornings. It is recommended that you submit your application no later than Wednesday afternoon of the week you wish it to be reviewed.

  • Minor amendment – This requires a Minor Amendment Application.  See “What is a minor amendment?” After a minor amendment is approved, incorporate the changes into the body of your full protocol.
  • Annual reviews – Animal Welfare Regulations require that all protocols be reviewed annually.  An annual review form will be sent to you each year.  Please complete and return this form promptly to avoid any lapse in approval.
  • Observation-only protocols – If you plan to do a field study in which there will be no interaction of any kind with the animals, including no collection of animal parts or by-products (feathers, eggs, feces, etc), then you may use the Application for Observation-Only Study.
  • Purchase of custom antibodies – If you do not use animals in your research at all, but you do wish to order custom antibodies from a commercial vendor, then you must file an Application for Purchase of Custom Antibodies to ensure that the vendor you are using is approved to use animals under U.S. regulations. 

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Full Committee Review Process

Submissions requiring  Full Committee Review (new studies, 3-year renewals, major amendments) are due on the 20th of the month PRIOR to the month you wish it reviewed.  The IACUC-A reviews submissions for completeness (i.e., correct boxes checked, regulatory exams completed by personnel, and correctly classified as new protocols major amendments or minor amendments) and notifies the investigator to re-submit if need be. 

  • The IACUC-A distributes the protocols to the LAR director/veterinarian and the IACUC Chair.  The Chair and the IACUC-A identify at least one member of the IACUC and one member of the veterinary staff to pre-review the application. Whenever possible, pre-reviewers will include an IACUC member who is familiar with the kind of research under consideration.  This person can help to convey the significance of the work, while also pointing out issues that might not be obvious to reviewers less familiar with the area. 
  • Pre-reviewers identify aspects of protocol that are likely to require change before it can be approved and generate a document that asks the investigator for specific revisions to the protocol or amendment.
  • The pre-review documents are sent to the investigators by the 5th of the month by the IACUC-A.
  • Investigators have roughly 10 days to revise and resubmit protocols and amendments. The revised versions are due on the 15th of the month.
  • The revised documents are distributed to the IACUC by the 20th of the month.
  • IACUC members have one week to prepare for the monthly meeting, and that meeting typically occurs during the last week of the month.
  • The pre-reviewers present the protocols to the committee at the monthly meeting.
  • At the meeting the IACUC discusses each of the distributed protocols and, if necessary, raises issues and identifies aspects of the protocol that need to be altered further. The committee votes to approve, require modifications (to secure approval), withhold approval, or table the request.  In all cases the IACUC must state reasons for its decision and these will be relayed to the investigator.  In the case of required modifications, the IACUC will decide whether it anticipates that approval can be achieved by designated review or whether it anticipates that the protocol should receive full committee review at the next monthly meeting.  Although the IACUC may anticipate that designated review of the modified protocol will be sufficient, any member of the committee has the option to call for full committee review.
  • All voting members vote (i.e., the Chair votes with the members, not just in the case of a tie). The IACUC-A keeps notes during the meeting. The decision of the committee and the reasons articulated are conveyed by the IACUC-A to the investigator by e-mail.  Possible decisions of the full committee may be:
    • Approve: requires no further action by the investigator.
    • Require modifications to secure approval: these modifications are described in an e-mail, and the investigator will respond by submitting a revised protocol or amendment by a certain deadline.
    • Withhold approval: e-mail from IACUC-A will indicate issues that prevented approval.  Investigator will decide whether to initiate the process again by submitting a new protocol.
    • Table: requires e-mail to investigator indicating that there are issues about which the IACUC is still gathering information.

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Designated Review Process

  • The IACUC-A in collaboration with a veterinarian confirms new protocol that can be expedited by designated review (these are generally observation-only studies). An e-mail or other electronic communication is sent to the IACUC indicating submissions have been identified as ones to be handled by designated reviewers, IACUC members have 48 hours (2 business days) to review the submission and to call for full committee review if deemed necessary.
  • If no IACUC member calls for full review, the IACUC-A distributes the submission to the designated member reviewers. 
  • Examples of protocols that can be approved by designated review
    • Request to have an antibody generated by a commercial vendor or non-Indiana-University core facility
    • Request to observe wild or domestic animals as part of a class
    • Request to obtain animals tissues from commercial sources or other research labs
    • Request to observe wild or domestic animals as part of a research project
  • Other designated review applications (minor amendments, annual reviews, etc.), will go directly to a designated review committee. The designated members have authority to approve, require modifications in (to secure approval), or request full committee review.  Designated reviews will be performed by two IACUC members and both of their signatures will be required to approve the protocol or amendment.
  • The decision of the committee and the reasons articulated are conveyed by the IACUC-A to the investigator by e-mail.  Possible decision by designated review may be:
    • Approve: requires no further action by the investigator.
    • Require modifications (to secure approval): these modifications are described in an e-mail, and the investigator will respond by submitting a revised protocol or amendment by a certain deadline.
    • Call for full committee review: a decision by the designated members that there are issues with the protocol that merit review by the full committee.

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What is a Major Amendment?

Modifications of animal protocols fall into two general catagories, major and minor.  Major amendments involve the addition of new surgeries or procedures to the protocol that may cause pain and distress to animals and thus require greater scrutiny by the IACUC.  Note that all major amendments require a new search of the literature for alternatives to the procedure being added. To file a major amendment the investigator must incorporate the proposed changes into the latest version of the approved protocol to produce a modified document that includes the proposed amendment.  This is done by using the track changes function in WORD to introduce high-lighted text.  Note:  the proposed changes may also require the removal of text that describes procedures that will no longer be used, and this should be indicated by using the strike-through function.

When the changes are complete the investigator should submit the amended protocol as an attachment to the IACUC-A (biacuc@indiana.edu) along with an email that concisely summarizes the changes that have been incorporated. The purpose of the e-mail is to aid the reviewer in interpreting the intentions of the investigators.  Major amendments of this type require full committee review similar to that applied to the original protocol.  Once approved by the BIACUC, the Administrator will accept the changes in the document, change the file name to reflect the current date, and return the document to the investigator to file and post as his/her current protocol.

  • Examples of major amendments:
    • New surgery
    • Any new procedure
    • The use of a new chemical, environmental condition or biological agent that induces disease or other substantial change in animal health (includes new classes of test therapeutics, toxic chemicals, disease agents, hormones or radiation.)
    • Change in degree of invasiveness of a procedure or discomfort to an animal
    • Addition of a strain or transgenic-line that has a severe disease or disability
    • An increase in the total number of animal subjects >20% of the original approved number

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What is a minor amendment?

Minor amendments include changes or additions to existing protocols that do not explicitly involve new procedures. With the exception of strictly administrative issues (i.e., change in granting agency or removal of personnel), minor amendments must include a complete description of the proposed change, and a scientific rationale section justifying the proposed change.  The form should be submitted to the IACUC Administrator who will determine whether the submission is truly a minor amendment and then forward it to the designated member reviewers.  The Chair or designate and the veterinarian will serve as designated reviewers for most minor amendments. If the amendment is approved by designated member review, the IACUC-A will append the form to the original protocol.  The information contained in minor amendments should be integrated into the original protocol by the PI.

  • Examples of minor amendments:
  • Request to add personnel
  • New source for purchasing animals
  • Request to add a new strain of a specific species or to use of a closely related species, defined as those animals that require similar housing and care.  NOTE: This does not extend to any USDA covered species. 
    • Examples of closely related species (for the purpose of minor amendments):
      • Rats and mice
      • Different species of songbirds
      • Different species of nonpoisonous snakes
      • Different species of nonpoisonous lizards
      • Different species of frogs
      • Different species of salamanders
  • Change in euthanasia
  • Small changes in approved surgical procedure
  • Change in anesthesia in approved procedure
  • Change in analgesia in approved procedure
  • Request to increase animal numbers < 20% of the original approved total or if the original animal total was less than 10, then up to 3 additional could be added.
  • Changes in duration or frequency of an approved procedure
  • Change in sex or age of animals
  • Change in titles of grants covered by protocol
  • Change in funding agencies
  • Request for new antibody generated specifically for the investigator by a commercial vendor
  • Change in location for housing or animal use
  • Request to administer a new compound closely related to other compounds already approved

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Electronic File Nomenclature

  • When sent to the IACUC-A a submitted file should be named using the following rules:
    • Protocol number (for amendments and annual reviews ONLY)
    • A label indicating the type of application
      • protocol (for new submission)
      • revised protocol (for revisions)
      • ma (for minor amendment)
      • MajAmend (for major amendment)
      • CAb (for custom antibody)
    • Last name of the PI (in the case of graduate students and post-docs without PI status the faculty mentor)
    • the date 
  • Examples:
    • 07-444.ma.foley.9.13.07 [for a minor amendment]
    • 08-555.revisedprotocol.foley.9.28.07 [for a revised protocol]
    • protocol.foley.9.1.07 [for a new protocol]
  • For new protocol submissions and 3-year renewals, IACUC-A will append a new protocol number to the beginning of the file name.
  • In response to reviews each new version should have a revised date

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