Protocol Review

Approval date

• NOT-OD-11-053. Guidance to Reduce Regulatory Burden for IACUC Administration Regarding Alternate Members and Approval Dates
• FAQ. What is the date of IACUC approval of an animal activity?

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?
• OLAW Online Seminar: MOUs for Collaborating Institutions: New Template from the Federal Demonstration-Partnership (FDP) - January 19, 2023
• 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?
• FAQ. May IACUCs allow designated reviewers to review and approve animal activities, thus allowing animal research to begin, before all IACUC members have had an opportunity to call for full committee review (FCR)?
• 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. What are the possible methods of IACUC approval?
• 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?
• FAQ. May IACUC members call for FCR after the deadline for a response to allow DMR has passed?
• 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
• OLAW Online Seminar: Congruence Review - January 18, 2024
• 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
• 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?

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. 2023; 52(11).(PDF - 465.7 KB) A Word From OLAW and USDA: Research Gone A-Fowl
• 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 2024; 53(02). A Word from USDA and OLAW: The Weights of Refinement and Flexibility
• 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?
• FAQ. What personnel changes qualify as significant changes to an animal activity, and which must be reported to the funding NIH Institute or Center (IC)?
• 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 2024; 53(02). A Word from USDA and OLAW: The Weights of Refinement and Flexibility
• 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: The ARRIVE 2.0 Essential 10: Guidance for NIH-sponsored Research- June 15, 2023
• 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.
• OLAW Online Seminar: Improving Experimental Design: Ethical Implications and How the Experimental Design Assistant (EDA) Can Help - September 14, 2023
• OLAW Online Seminar: Foundations for Evaluating Study Design and Statistical Approaches for the IACUC -March 9, 2023

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?
• FAQ. What personnel changes qualify as significant changes to an animal activity, and which must be reported to the funding NIH Institute or Center (IC)?
• NOT-OD-14-126: Guidance on Significant Changes to Animal Activities
• Lab Animal. 2023; 52(12). (PDF - 793.32 KB) A Word from the USDA and OLAW: The Pain and Distress of VVC.
• 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).
• OLAW Online Seminar: Congruence Review - January 18, 2024

Unapproved work

• FAQ. May the IACUC administratively extend approval of a project that has expired?
• 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?