The following is a list of the elements that should be present in the informed consent in order for
samples to be submitted to the NIDDK Central Repository. Along with the listed elements, the NIDDK is
providing some model language from various IRB-approved or published consensus documents. The
model language is intended only as a guide or an example, and the NIDDK does not recommend any
specific text. Each IRB has its own specific guidelines for acceptable informed consent language. In
addition, it is important to note that investigators working with special populations or outside the U.S.
may have special restrictions related to repositing of samples.
-
Provide a description of the Repository
Example: We are asking you [or your child] to provide a sample of ______, which will be sent
to the
NIDDK Central Repository, a research resource supported by the National Institutes of Health. The
Repository collects, stores, and distributes biological samples and associated data from people with
many kinds of disorders, from unaffected family members, and from other healthy people. The
purpose of this collection is to make samples available for use in research for this study and healthrelated
research in the future, after the current study is completed. Sending samples to the
Repository may give scientists valuable research material that can help them to develop new
diagnostic tests, new treatments, and new ways to prevent diseases.
-
Provide a description of how the subject’s privacy will be protected.
Example: The Repository will take measures to protect your privacy, although no guarantee of
confidentiality can be absolute. Before the researchers in this study send samples to the Repository, each
sample will be given a code number. Your name, or your child’s name, and all personal identifying
information, such as address, social security number, and date of birth, will be removed. Therefore, the
Repository will not be able to give out your name, or other information that identifies you or your child,
to the scientists who receive the samples. However, the Repository and scientists will have some data about
you, such as age, sex, diagnosis, [fill in any other data types], race, and outcomes of the initial study.
-
Provide information about potential risks and benefits of participation, including potential
commercialization.
Example: You will not receive any direct benefit or payment for participating, but your
sample may
benefit the future health of the community at large or some particular group. Because other
researchers will not have access to your identity, neither you nor your physician will get the
eventual results of studies that might be performed using your sample. It is possible that data
resulting from use of your sample may eventually be used in a research publication. In that event,
your name or other identifying information will not be included, as this information will not be
available to the researchers. It is important for you to understand that there is a small chance that some
research may yield results that may indirectly have a negative impact on insurability,
employability, and/or family relationships of some individuals or groups of people. Sometimes,
research results in findings or inventions that have value and may be patented or licensed, which
could give a company the sole right to make and sell products or offer testing based on the
discovery. Some of the profits from this may be paid back to the researchers and the organizations
doing this study, but you will not receive any financial benefits nor will the NIDDK.
-
Confirm the voluntary nature of the subject’s participation.
Example: Your donation is voluntary, and if you choose not to participate there will be no
penalty or loss of benefits to which you are entitled.
-
Describe how data and samples already collected will be managed if a participant withdraws
consent to continue participation in the study.
Example: You can change your mind and withdraw consent to participate in this study up until
the
end of the study. When study researchers receive written instructions from you to withdraw
consent to continue participation in the study, they will not collect any more data or samples on you
for the purpose of the study. Data and samples collected up until the time that you withdraw may
be retained and used in order for the study to be scientifically valid. Data and samples sent to the
NIDDK Repository will be given a unique code number and identifiable information will be removed.
Data and samples that have been stripped of personal identifiers cannot be retrieved.
IRBs at institutions may request additional information about the repository. The following are a list of
informational items about the repository that might be useful in preparing an IRB application.