CHECKLIST FOR ALL
IRB PROTOCOLS
Human subjects research conducted as part of your program requires approval by both the Tufts IRB as well as
the Army’s oversight committee before commencing data collection.
 Complete all required materials for submission to Tufts SBER IRB by downloading and completing the
forms, available here: http://www.tufts.edu/central/research/IRB/Forms.htm
o Protocol Cover Sheet
o Protocol Application
o Additional Investigators and Study Personnel (if necessary)
 Because your protocol will undergo a scientific review by your Program Manager prior to submission to the
Tufts IRB, you will need to make sure your protocol includes:
o At least 1 paragraph demonstrating your knowledge of background literature.
o Clearly stated hypotheses.
o Clearly stated independent, dependent, and nuisance variables.
o Clearly stated rationale for chosen method/procedures.
o Clearly stated statistical and/or mathematical procedures.
o Justification for number of subjects being used (sample size estimate and/or citing other paper(s)
using similar design and N).
 For Informed Consent and Debriefing forms, the Army requires the inclusion of specific language.
Additionally, the Army requires a more descriptive “Roles and Responsibilities” document that outlines
study personnel contributions. Use the Center’s templates to ensure all appropriate language is included.
Those templates are available here: http://www.centerforabcs.org/index.php/forms-templates
 For consistency in communication, we ask that you add Amy Wilson, the CABCS Program Coordinator, to
your protocol as a study coordinator, using the “Additional Study Personnel” form. This will ensure that we
are in the loop on any updates from the Tufts IRB that may trigger secondary review by the Army.
 Appendix: The Army also requires a separate “Relevance to Funding” document that details how the
proposed experimentation fits within the overall program goals. An example Relevance to Funding
statement is below. Note that the final sentence details how your work relates to one or more of the 4
objectives. You need to modify it; it only needs to be a single sentence.
o The U.S. Army Natick Soldier Research, Development and Engineering Center (NSRDEC) has
developed a cooperative agreement with the Tufts University School of Engineering to support
basic and applied research relevant to Soldier perceptual, cognitive, and physical performance. In
general, the research conducted under this cooperative agreement fulfills the objectives to: 1)
Understand humans and supporting systems, 2) Monitor, characterize, and optimize cognitive and
non-cognitive states, 3) Understanding the immersed ambulatory human, and 4) Pioneering
individual to team translation. The presently proposed research is aimed at [SELECT ONE] by
[DOING WHAT].
 Once all these materials are prepared, email them to your Program Manager for scientific review, making
sure to copy the CABCS Program Coordinator (centerforabcs@tufts.edu). Your Program Manager will
complete the required review and send everything back to you. The Tufts IRB must consider the scientific
review in their review, so please do not submit to the IRB without being in receipt of a scientific review
from your Program Manager.
 Submit your complete application materials (including scientific review) to the CABCS Program Coordinator
(centerforabcs@tufts.edu), who will do a final review of your materials and submit to the IRB on your
behalf.
CHECKLIST FOR ALL
IRB PROTOCOLS
 Once you obtain approvals from the Tufts IRB, confirm receipt of the following documentation by the
CABCS Program Coordinator (centerforabcs@tufts.edu) for submission to the Army oversight panel:
o Tufts IRB approval letter
o All original protocol application materials
o Current CVs and CITI Certificates of ALL personnel named on protocol