Section 17: Genetic Materials

17.1 Collection and Storage of Genetic Materials

For the purpose of this manual, "Genetic Materials" are defined as human tissue samples (saliva, blood, serum, tumor, etc.) on which genetic-related research, such as identification and location of specific genes, study of gene products, inherited human traits, or identification and analysis of DNA mutations, may be performed.

It should be noted that research involving genetic materials may require the Institution Biosafety Committee approval prior to beginning the research.

17.1.1 Previously Acquired Samples

1. Previously acquired samples and genetic material, collected without identifiers may be used, without further IRB approval, if future use was generally discussed in the original consent form.
2. If identifiers are present, experiments not described in current protocols must be submitted for IRB review.

17.1.2 Prospectively Acquired Anonymous Samples

For research in which samples (blood, tissue, saliva, etc.) will be prospectively acquired without identification, the following issues must be presented in the consent form and discussed with the research subjects.

1. How anonymity of the samples will be accomplished. Some basic information, such as age and gender, may be retained with the sample;
2. Ownership of genetic material (usually the University);
3. The general scope of the investigations, but new avenues of investigation in the future are permissible if this possibility is presented and explained during the consent process;
4. Whether the sample or its genetic material will be shared by other investigators
5. That information specific to individual subject cannot be shared due to sample de-identification. However, information that accrues from the study that is valuable to society will be shared through publications.

17.1.3 Identified Samples

As for research acquiring anonymous samples, research utilizing samples collected with identifiers must clearly presented in the consent form and discussed with research subjects. The following issues should be considered and discussed as appropriate:

1. If genetic material is linked to the donor by specific identifiers, ownership of the material will generally remain with the institution. If a commercial use is anticipated for the genetic material, the individual must be notified. The general policy of ownership should be stated in the consent form using the following wording:

"I understand that additional or "leftover" (blood, serum, tumor, etc.) tissue may be used for future research which may result in financial gain for the University and the Principal Investigator. I also understand that my donated tissue will be one of many that are used in the research and it will be virtually impossible to attribute findings to any one sample. I understand, however, that I am not otherwise waiving any of my legal rights by participating in this study."

1. If identifiers are present, new experiments (not described in the original consent form) must be reviewed by the IRB and new consent obtained from the research subject regardless of the details of ownership.
2. The Principal Investigator may include a provision in the consent form for new experiments not requiring new consent if identifiers are irrevocably removed from the samples. If the PI anticipates future experiments without identifiers, this possibility should be presented in the original consent form. The methods for removal of identifiers must be approved by the IRB. Removal of identifiers must not be employed as a method of avoiding ownership issues.
3. A satisfactory method for sharing or withholding information gained by the research must be in the research protocol and clearly indicated in the consent form.
4. Details for sharing or not sharing the genetic material with other investigators must be present in the protocol and clearly indicated in the consent form.
5. The length of time the genetic material will be maintained must be indicated in the consent form.