New York University Langone Medical Center/School of Medicine
Institutional Review Board
Continuing Education
IRB Member Refresher
July 2009
The results of our 2008NYU SoM IRB member survey indicated several topics were clearly of interest to all of you. The
goal of our 2009 Refresher was to address your request for more information in the following areas: International
Research, Genetic Research, Federal Regulations requirements and hot topics in human research subject protection. In
May 2009, all NYU SoM IRB members were invited to attend a ‘refresher’ session. Below is a summary of the topics
presented and the key points you will want to remember.
(1) International Research.
 Review as rigorously as if the project was being completed at NYU SoM/ Langone Medical Center and its
affiliates;
 US rules prevail over research being conducted abroad;
 Recruitment methods should not violate the cultural norms of confidentiality for the participants;
 Look for a description of how data is to be collected make sure it is respectful to the norms and customs of the
region;
 Make sure if the research plan uses sensitive and identifiable information additional protections are in place and
uses are justified;
 Focus on any risks to the subject beyond physical such as government or community repercussions to the
subject if identified as involved with the research;
 Make sure the consent process and documentation review includes cultural considerations and are appropriate
for the population being recruited;
 Ask for review of expertise of the research team with the country being analyzed.
Remember that what may be appropriate in the US may not be appropriate in the country where the research is being
conducted and vice versa. If you cannot complete your review taking into consideration the local context consider the
following to assist you: (1) ask the IRB office to provide more information; (2) ask for a reviewer from the country
where the project is being completed, (3) consult a foreign IRB member who is from the country or (4) request a
review of the project by the consulate or ministry of health of the country.
(2) Genetic Research.
Genetic research provides the scientific world with amazing advances however; inherent risks are also just as great.
Members should pay additional attention to the following 111 findings in particular:
 Risks: Non-physical risks must be considered when reviewing this type of research. Non-physical risks include:
use of identifiers directly or in-directly, disclosing genetic test results, etc. Information should also be provided
how these risks are to be minimized as much as possible and additional protections in place such as genetic
counseling and data security;
 Consent process: The consent process should be described clearly and include all risks and benefits proposed in
the research plan. Additional protections such as genetic counseling should be described. If information is not to
be provided to subjects, it should be clear and provide a justification for not providing the information; and
 Privacy and confidentiality: Information should be provided to ensure subjects’ privacy and confidentiality is
upheld. This should include, who has access to information, if a certificate of confidentiality is necessary, any
implications to other relatives of the subject and how test results will be provided.
(3) Data and Tissue Repositories: The IRB reviews data and tissue repositories that are used for research purposes.
Two types are routinely seen, one, where the data or tissue repository is being established (typically expedited review) or
two, a full board review project that includes data/specimens collection for future use. The IRB reviewer should ensure the
following information is included:
(1) How the information/specimens is/are collected?
(2) Who has access to the information/specimens and for what purposes in the research?
(3) Where storage will occur?
(4) How long will it be stored? Etc.
If this information is not included in the protocol, ask for the information. Often there is a separate protocol for this part of
the study. The information specific to the banking should mirror the information that would be found in any consent. It
may be included in the main consent or be a separate consent form. Either way it should cover the purpose, the
risk/benefits, alternatives, costs, confidentiality, right to withdraw the specimen and other requirements of the Federal
Regulations.
(4) Consent Process: To ensure that the finding of “Informed Consent will be sought from each subject” can be made,
reviewers must provide information, from the research plan provided by the PI, that confirms how informed consent will be
sought. If Members cannot explain from the protocol how consent will be sought, it is not appropriate to assume or to say
the finding is met. If evidence cannot be found, the finding cannot be determined and the study should be deferred.
(5) Genetic Information Nondiscrimination (GINA) Act: GINA is a federal law that prohibits discrimination in health
coverage and employment based on genetic information. A research exception is included in the Act where a health
insurer or group health plans engaged in research may request a genetic test but NOT require the test. This information
must be clear in the plan and consent. For genetic research projects that are up for continuing review, the act must be
considered. If the proposed project is related to a health insurer or group health plan is reviewed, additional modifications
based on the act may be needed. The 111 findings must be determined for approval. Consent language has been
proposed by OHRP which is currently being reviewed by the IRB staff.
(6) Revised Capacity to Consent Policy Effective March 2009
The policy has been revised to the following: research may now involve subjects who lack capacity to consent if his/her
health care proxy does not specifically state that the individual does NOT want to be involved in research. In other words,
if the proxy is silent to involvement in research or permits involvement in research, the proxy may consent on behalf of the
subject. What has not changed: the IRB must find that the study can only be conducted in a population that; lacks
capacity to consent, a court-appointed legally authorized representative/guardian will be considered first and the IRB must
determine that the research provides potential therapeutic benefit to the subjects.
Reference: IRB Member 2009 Refresher Power Point