Biospecimen Issues:
For Patients and Advocates

Informed Consent

When researchers want to collect your tissue for the sole purpose of carrying out research they need to ask for your consent.

1) Tissue may be collected within a clinical trial either on a voluntary basis or sometimes even 'mandated' or 'required' to participate in the clinical trial. It is important that you weigh the risks and benefits of participating in the trial when tissue acquisition requires biopsying tumor in areas of the body difficult to access (lung, liver etc). This is especially true for studies that require numerous or sequential biopsies.

2) You should also be aware that if you are having routine treatment at your hospital it is common practice to store any tissue that is left over. One reason for this is to allow doctors to go back and re-examine the tissue if you have to come back to the hospital for further treatment.

However, these samples also provide useful material for research studies and you should be told if there is a chance that your tissue may be used in this way. If you don't want this to happen you have a right to decline any requests for research to be conducted with your tissue.

		Patients are generally willing to provide their tissue for research purposes. However, there are ethical, legal and logistical issues that complicate the process of obtaining patients' informed consent while maintaining their privacy.

This is an area in which patients and advocates alike need to play a roll in. While researchers are focused on the science, advocates can help articulate the concerns many patients will have when asked to donate tissue. Many if not most patients would be happy, even proud, to donate tissue for research if their misgivings can be addressed.

Following are areas of concern for biospecimen informed consent

• Ethical, scientific and legal issues reviewed by on-site Institutional Review Boards (IRBs) require patients to understand how their tissue may be used and provide their signed permission. Each hospital handles informed consent differently but it is important to know that you can always contact your local IRB if you have concerns.
• The informed consent process itself may be confusing and distressing to patients dealing with a cancer diagnosis. Staff members at the hospital or clinic need to be sensitive to this and provide patients with the necessary time and support to make an informed decision.
• There may be long-term privacy /confidentiality issues associated with donating tissue, and patients need to be aware of and understand these issues. Within a biospecimen repository, the ability to easily identify the source of specimens may range from fully anonymous specimens to specimens whose source can be easily identified.

The easier it is to link specimens to their donors, the greater the risk to donors' privacy and confidentiality. However, this also makes specimens more valuable to researchers because they contain outcome data. Thus, the policies and procedures established for the collection and distribution of specimens should reflect the level of risk and possible harm posed to donors.

Under the Health Insurance Portability and Accountability Act (HIPAA) Privacy Rule, covered entities may use or disclose, without restriction, any health information that is de-identified by the removal of 18 specified identifiers enumerated in the Privacy Rule.

Things you need to know before you give consent

It is important for you to understand the issues below so you can balance any risk you may incur with the possible benefits for society.

The information gained from your donation probably will not benefit you but it may well benefit patients in the future. Tissue donations are treated as a gift from you to the researcher: You are not paid for the donation and once donated, the specimen often doesn't legally belong to you. Ownership is being tested in the court system and to date courts have ruled in favor of research ownership.

• Researchers are obliged to use your donation in the agreed-upon way. The researcher is also responsible for keeping the donated tissue safe.
• Researchers are required to inform you if they will receive financial gain from the use of your sample (most often they do not).
• Your sample may be kept and used for future research. This will be specified in the consent document, so be sure you understand this.
• You should be told how long your sample will be kept and who will be responsible for it.
• Laws exist to protect your privacy. One example is the Health Insurance Portability and Accountability Act (HIPPA).
• If your sample has been completely anonymized then it can no longer be identified as belonging to you and therefore you can't choose to withdraw it or have any say in what happens to the sample in future.
• If your sample can still be linked to you (by your name or some identifying number), then any future research using that sample will need to be reviewed and approved by the ethics committee.
• There may be a small risk of bruising, swelling or infection if your donation involves a biopsy.