records are those which include, but are not limited to, any individual
medical, dental, academic, criminal, personnel or other record which is not a
public record under state law.
specimens mean blood, biopsy tissue or other specimens obtained for any purpose
other than the proposed research.
possible, potential subjects should be informed of potential use of such
materials upon entry into the program or institution in which the materials
will be collected and should give general consent to such research. However,
under certain conditions, confidential records and/or pathological specimens
may be studied. (Depending upon the classification of the study, the
investigator may be required to obtain consent in a particular study.)
researcher and the official custodian of the records/specimens should carefully
address the confidentiality of such studies.
Authorized Investigators: Only
authorized investigators have access to confidential records or
pathological/diagnostic specimens to be used for research purposes when subject
identifiers are present.
An authorized investigator is:
Any UNK faculty
member, student or staff member who has professional access to the materials in
a non-research context (for example, treatment, counseling, education)
Any UNK faculty
member, student, or staff member who is working with a person who has
ethical/legal access to the materials in a non-research context and who will
assume responsibility for maintaining confidentiality safeguards as certified
have access to such materials only when
the following conditions are met:
Approval is obtained
to use the records/specimens from the official custodian of the materials.
are blinded (subjects cannot be identified either directly or indirectly
through identifiers linked to the subject), or the investigator obtains prior informed consent from the subject.
Exempt Research Using Confidential Records and/or Specimens: All of the following must be met in order for the proposed
research to be considered Exempt:
The research is not
The investigator is
considered an authorized investigator or the material is blinded.
Subjects cannot be
identified directly or indirectly.
Non-Exempt Research Using Confidential Records and/or Specimens: Research will be reviewed at the Expedited level or by the full-board when subjects can be identified
directly or indirectly.
subject identifiers must be temporarily maintained to permit identification of
additional material for the study, the IRB may grant a waiver of informed consent when the following conditions
The investigator is
considered an authorized investigator.
The study is no
greater than minimal risk.
The waiver of informed
consent will not adversely affect the rights or welfare of the subjects.
The research cannot
feasibly be carried out without the waiver.
Only minimum subject
identifier data is recorded.
identifiers will be maintained under strict confidentiality and will be
destroyed as soon as possible.
subject identifiers are recorded to select a prospective subject population and
the investigator intends to subsequently solicit informed consent to participate in a prospective study,
only an individual with the appropriate professional relationship with the
potential subject (for example, counselor, teacher) should contact the
investigator who does not have such a relationship should obtain assistance
from someone who does. Once a potential subject has agreed to release his or
her name, negotiations for informed consent can begin as in any other research protocol.