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Confidential Records and/or Pathological/Diagnostic SpecimensFederal regulations and IRB policy are not intended to supersede any other current institutional policies concerning the use of confidential records and/or tissues in research.
Federal regulations and IRB policy are not intended to supersede any other current institutional policies concerning the use of confidential records and/or tissues in research.
Confidential 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.
Pathological/diagnostic specimens mean blood, biopsy tissue or other specimens obtained for any purpose other than the proposed research.
Whenever 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.)
The 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 in writing.
Non-authorized investigators 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.
The records/specimens 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 sensitive.
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.
If 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 are met:
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.
The subject identifiers will be maintained under strict confidentiality and will be destroyed as soon as possible.
If 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 potential subject.
An 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.
