New York University
School of Medicine
Institutional Review Board
Continuing Education
October 2010
Subjects with Limited Capacity
The 111 Criteria require IRBs to make sure research provides additional safeguards for subjects who are
vulnerable to coercion or undue influence, including subjects such as children, prisoners, pregnant women,
mentally disabled persons, or economically or educationally disadvantaged persons. 45CFR46 subparts B, C, and
D have special regulations for pregnant women, prisoners and children. There is no subpart, however, for
subjects with limited capacity to consent.
To redress this gap in the regulations, the NYU SoM IRB has specific policies for research involving subjects with
limited capacity. The policy requires NYU SoM IRB finds the following when reviewing r research involving
subjects with limited capacity:
 Only this population is suitable as research subjects
 The study must have one of the following risk profiles:
o No significant risks
OR
o If there is a probability of harm, there is a greater probability of direct benefit to the subject
 Appropriate procedures have been developed for obtaining consent from the subjects OR permission
from subjects’ representatives and assent from subject. If the protocol is using surrogate consent, there
must be the probability of direct benefit to the subjects from the research procedures.
NYU Capacity Guidance
NYU SoM IRB policy requires that the protocol state how capacity will be assessed. This includes who will do the
assessments and the procedures that will be used. The assessment procedures must be appropriate for the
population (including whether or not the population has fluctuating capacity) and research procedures.
NYU Consent and Assent Guidance
NYU SoM IRB’s policy requires the IRB make specific findings at the board meetings. During deliberations, the
Board must note:
1. The protocol involves the use of surrogate consent.
2. The protocol includes adequate information to ensure that an assessment will be made to verify the
authority of the individual to serve as the legally authorized representative designated to provide
surrogate consent.
3. The protocol includes a plan to conduct a competency assessment whenever there is a possibility of
either impaired mental status or decision-making capacity in prospective subjects.
4. The protocol indicates adequate provision in place to explain the proposed research to the prospective
research subject even when the surrogate gives consent.
Also when appropriate (and required by the board):
5. A consultation with a psychiatrist or licensed psychologist may be required when the determination that
the prospective research subject lacks decision-making capacity is based on a diagnosis of mental illness.
6. A plan is in place to consent subjects previously determined to lack capacity if the subjects regains
capacity during the study.