Protocol Review

Approval date

• NOT-OD-11-053. Guidance to Reduce Regulatory Burden for IACUC Administration Regarding Alternate Members and Approval Dates

Approval of extensions

• FAQ. May the IACUC administratively extend approval of a project that has expired?
• Lab Animal. 2012; 41(8). (PDF - 96 KB) Management of a holding protocol.
• Lab Animal. 2010; 39(11). (PDF - 178 KB) Refusal to renew an expiring protocol.
• Lab Animal. 2007; 36(7). (PDF - 60 KB) Getting around late protocol renewals.
• Lab Animal. 2003; 32(9):33-36, question #8.

Approval methods

• FAQ. What are the possible methods of IACUC approval?
• Lab Animal. 2022; 51(08). (PDF - 730.56 KB) When Assigned but Now Unavailable
• Lab Animal. 2017; 46(11). (PDF - 544 KB) How should the IACUC balance an efficient approval process with minimizing risk?
• Lab Animal. 2011; 40(10). (PDF - 171 KB) Managing a pending IBC approval.
• Lab Animal. 2010; 39(6). (PDF - 180 KB) Revisiting approved protocols.
• Lab Animal. 2003; 32(9):33-36, question #4.
• Lab Animal. 2002; 31(9). Correct Conduct of Full-Committee and Designated Member Protocol Reviews.
• Contemporary Topics. 2001; 40(6). Suggestions to Bring Electronic Protocol System into Compliance.
• Lab Animal. 2001; 30(6). Is Ad Hoc Approval Enough?
• Lab Animal. 2001; 30(3). Innovative, But Not Compliant.
• Lab Animal. 1998; 27(8). So Much Work, So Little Time.
• ILAR News. 1993; 35(3-4):47-49, question #3.

Collaborating institutions

• FAQ. When institutions collaborate or when the performance site is not the grantee institution, which IACUC is responsible for review of the research activity?
• Lab Animal. 2021; 50(1). (PDF - 736 KB) A COVID clash: How to proceed when IACUCs and IBCs disagree?
• Lab Animal. 2019; 48(1). (PDF - 733 KB) Misunderstanding of an MOU?
• Lab Animal. 2013; 42(4). (PDF - 159 KB) Communication between collaborating IACUCs.
• Lab Animal. 2009; 38(6). (PDF - 188 KB) Clinical study or research activity?

Conditional approvals

• FAQ. May the IACUC grant conditional or provisional approval?
• Lab Animal. 2022; 51(09). (PDF - 649.24 KB) A Word from OLAW: You've Been Approved to Wait
• Lab Animal. 2017; 46(11). (PDF - 544 KB)  How should the IACUC balance an efficient approval process with minimizing risk?
• Lab Animal. 2011; 40(10). (PDF - 171 KB) Managing a pending IBC approval.
• Lab Animal. 2008; 37(2). (PDF - 95 KB) Collaborative studies and animal reuse.
• Lab Animal. 2003; 32(9):33-36, question #2.
• OPRR Reports. 90-01, 5/21/1990. Use of Expedited Protocol Review Procedures by IACUCs.

Conflict of interest

• Lab Animal. 2019; 48(9). (PDF - 798 KB) A late notice & personal conflict - was a suspension warranted?
• Lab Animal. 2013; 42(3). (PDF - 246 KB) Should 'duplicative research' still be reviewed?
• Lab Animal. 2010; 39(6). (PDF - 180 KB) Revisiting approved protocols.

DMR & FCR

• FAQ. May an IACUC use designated member review (DMR) to review an animal study protocol subsequent to full committee review (FCR) when modifications are needed to secure approval?
• Lab Animal. 2022; 51(08). (PDF - 730.56 KB) When Assigned but Now Unavailable
• Lab Animal. 2021;50(10). (PDF - 689 KB) The Full Committee Review Plunder.
• Lab Animal. 2017; 46(4). (PDF - 533 KB) Who should request a full committee review?
• Lab Animal. 2015; 44(9). (PDF - 569 KB) Expediting assignment of protocol reviewers.
• Lab Animal. 2012; 41(11). (PDF - 144 KB) Amendment submitted; protocol reviewed?
• Lab Animal. 2009; 38(7). (PDF - 182 KB) Required modifications and designated member reviews.
• NOT-OD-09-035. Guidance to IACUCs Regarding Use of Designated Member Review (DMR) for Animal Study Proposal Review Subsequent to Full Committee Review (FCR).
• Lab Animal. 2002; 31(9). Correct Conduct of Full-Committee and Designated Member Protocol Reviews.

Foreign-derived samples

• FAQ. Is IACUC approval required for the collection of samples in foreign countries from captive wild animals or research colonies?

Foreign institutions

• FAQ. If an animal activity will be performed outside of the US (either by a non-US grantee or by a foreign institution as a subproject for a domestic grantee), is the grantee's IACUC required to review and approve that activity?
• NOT-OD-12-081. Change in Criteria for Renewal of Animal Welfare Assurances for Foreign Institutions
• Contemporary Topics. 1997; 36(2):47-50, question #2.

Frequency of review

• FAQ. How frequently should the IACUC review research protocols?
• Lab Animal. 2012; 41(11). (PDF - 144 KB) Amendment submitted; protocol reviewed?
• Lab Animal. 2000; 29(3). Problem Children.
• ILAR News. 1993; 35(3-4):47-49, question #7.

Grant review

• FAQ. Is the IACUC required to review the grant application?
• NOT-OD-22-006. Notice of Clarification of Offeror Responsibilities Regarding Contract to Protocol Congruence Review
• NOT-OD-22-005. Notice of Clarification of Institutional Responsibilities Regarding NIH Grant to Protocol Congruence
• Lab Animal. 2020; 49(2). (PDF - 657 KB) Is reproducibility an IACUC’s concern?
• Lab Animal. 2015; 44(4). (PDF - 650 KB) Congruence between grants and protocols.
• Lab Animal. 2006; 35(2). Grants proposals and animal use protocols: Is the IACUC playing by the rules?
• Lab Animal. 2003; 32(9):33-36, question #1.
• Lab Animal. 1999; 28(7). Who's to Blame?
• OLAW Online Seminar: The 2016 Vertebrate Animals Section, Grants Policy, and Congruence - March 10, 2016
• OLAW Online Seminar: Grants Policy and Congruence - June 7, 2012

Humane endpoints

• Lab Animal. 2022; 51(04). (PDF - 881.87 KB) Delaying the Inevitable: a Justified Means to an End?
• OLAW Online Seminar: Monitoring for Humane Endpoints: Developing an Appropriate Strategy - September 20, 2018

Nonresearch activities

• FAQ. Is IACUC approval required for the use of animals in breeding programs, as blood donors, as sentinels in disease surveillance programs, or for other non-research purposes?
• OLAW Online Seminar: IACUC responsibilities regarding service animals - June 10, 2021
• Lab Animal. 2013; 42(9). (PDF - 136 KB) Using research animals as sentinels.
• Lab Animal. 2003; 32(10). (PDF - 96 KB) Dog as Sculpture Models: Is IACUC Review Needed?

Nontraditional species

• FAQ. What guidelines should IACUCs follow for fishes, amphibians, reptiles, birds, and other nontraditional species used in research?
• Lab Animal. 2022. 51(7). (PDF - 1013.21 KB) The IACUC's Wild Classification
• Contemporary Topics. 1997; 36(2):47-50, question #6.
• OLAW Online Seminar: Wildlife Research Permits: What IACUCs Need to Know - March 30, 2017
• OLAW Online Seminar: Zebrafish 101 for IACUCs - March 12, 2015
• OLAW Online Seminar: Oversight of Research Involving Wildlife - March 20, 2014

Pilot studies

• FAQ. May the IACUC approve pilot studies?
• Lab Animal 2022; 51(3). (PDF - 846.59 KB) A Word from OLAW: Renewed Responsibility
• Lab Animal. 2020; 49(2). (PDF - 657 KB) Is reproducibility an IACUC’s concern?
• Lab Animal. 2016; 45(2). (PDF - 591 KB) Should refinement ‘mess with success’?
• Lab Animal. 2001; 30(3):21. A Pain in the Rat.

PIs

• FAQ. Is it acceptable to have different individuals named as PI on the grant application and the IACUC protocol?
• Lab Animal. 2018; 47(7). (PDF - 694 KB) Who gets to be a PI?
• Lab Animal. 2007; 36(1). (PDF - 73 KB) The importance of being ‘in charge'.

3 R's

• FAQ. Should the IACUC consider the three “Rs” of alternatives when reviewing protocols?
• OLAW Online Seminar: Best Practices for Conducting a Search for Alternatives and Finding Animal Model/Model Organism Information - December 9, 2021
• Lab Animal 2022; 51(03). (PDF - 846.59 KB) A Word from OLAW: Renewed Responsibility
• Lab Animal. 2020; 49(1). (PDF - 788 KB) If a researcher disagrees with a veterinarian's recommendations, whose say goes?
• Lab Animal. 2016; 45(2). (PDF - 591 KB) Should refinement ‘mess with success’?
• Lab Animal. 2016; 45(1). (PDF - 510 KB) When reducing numbers might increase pain.
• Lab Animal. 2010; 39(2). (PDF - 149 KB) Breeding without research.
• Lab Animal. 2009; 38(11). (PDF - 187 KB) Categorizing insufficient pain alleviation.
• Lab Animal. 2008; 37(7). (PDF - 95 KB) Deciding which animals to use.
• PI eAlert. 2010; Jul (PDF - 415 KB) Was McGill's “Mouse Pain” Study Compliant With Lab Animal Welfare?
• OLAW Online Seminar: Resources for the 3Rs - September 24, 2015
• OLAW Online Seminar: Meeting Requirements for Alternatives Searches - June 26, 2014

Review criteria

• FAQ. What criteria should the IACUC consider when reviewing protocols?
• Lab Animal. 2020; 49(1). (PDF - 788 KB) If a researcher disagrees with a veterinarian's recommendations, whose say goes?
• Lab Animal. 2014; 43(3). (PDF - 192 KB) Rationale for new model development.
• Lab Animal. 2013; 42(6). (PDF - 192 KB) Scientific justification for exemptions.
• Lab Animal. 2009; 38(7). (PDF - 182 KB) Required modifications and designated member reviews.

Scientific merit

• FAQ. Is the IACUC responsible for judging the scientific merit of proposals?
• Lab Animal. 2020; 49(2). (PDF - 657 KB) Is reproducibility an IACUC’s concern?
• Lab Animal. 2016; 45(1). (PDF - 510 KB) When reducing numbers might increase pain.
• ILAR News. 1991; 33(4):68-70, question #7.

Significant changes

• FAQ. What is considered a significant change to a project that would require IACUC review?
• FAQ. Does OLAW expect the IACUC to notify NIH when there is a change in an animal activity supported by PHS funds?
• NOT-OD-14-126: Guidance on Significant Changes to Animal Activities
• Lab Animal. 2022; 51(04). (PDF - 881.87 KB) Delaying the Inevitable: a Justified Means to an End?
• Lab Animal. 2019; 48(1). (PDF - 733 KB) Misunderstanding of an MOU?
• Lab Animal. 2019; 48(1). (PDF - 742 KB) Reply to "Clarification on a contradiction"
• Lab Animal. 2018; 47(6). (PDF - 728 KB) What's the appropriate adjustment when an approved drug is in short supply?
• Lab Animal. 2018; 47(4). (PDF - 773 KB) Is ‘saving money’ a valid justification?
• Lab Animal. 2018; 47(1). (PDF - 521 KB) How should the IACUC handle a questionable VVC change to a protocol? 
• Lab Animal. 2017; 46(3). (PDF - 467 KB) Making changes: when is VVC appropriate?
• Lab Animal. 2016; 45(8). (PDF - 568 KB) Referencing an approved protocol in an amendment.
• Lab Animal. 2015; 44(3). (PDF - 620 KB) Interpreting guidance on significant changes.
• Lab Animal. 2012; 41(4). (PDF - 155 KB) Amending a protocol to import and breed knockout mice.
• OLAW Online Seminar: Implementing Guidance on Significant Changes: One Institution's Experience - September 8, 2016
• OLAW Online Seminar: Guidance on Significant Changes to Animal Activities - August 21, 2014

SOPs

• FAQ. May standard operating procedures (SOPs) or blanket protocols that cover a number of procedures be utilized in lieu of repeating descriptions of identical procedures in multiple protocols?
• Lab Animal. 2018; 47(5). (PDF - 802 KB) Protocols for pets: what authority does an IACUC have?
• Lab Animal. 2012; 41(8). (PDF - 96 KB) Management of a holding protocol.

Time of grant award

• FAQ. Does the IACUC have to review proposed animal research activities at the time of grant award if the animal research activities will not be conducted until year 4 or 5 of a grant?
• “Just-In-Time”. Federal Register, 8/7/2002, 67 FR 51289 (PDF).

Unapproved work

• FAQ. May the investigator begin animal work before receiving IACUC approval?
• Lab Animal. 2015; 44(4). (PDF - 650 KB) Congruence between grants and protocols.
• Lab Animal eAlert. 2010; No. 6 (PDF - 334 KB) What is Protocol for Reporting an Animal-Research Project Exceeding Its Expiration Date?