HOW TO PRINT To print this page, use your browser's print button. To print the entire document, download the PDF or click here and use your browser's print button. SAMPLE LANGUAGE Sample 1 - Long-term Follow-up Sample 2 - Long-term Follow-up Sample 3 - Significant Findings
MAIN POINTS Long-term follow-up should be explained to potential participants. Researchers should make efforts to keep track of participant whereabouts to facilitate long-term follow-up. If new, significant findings are generated, investigators should: Report significant findings to past, current, and future participants Re-contact current participants and remind them that they can withdraw at any time Modify the consent form for potential participants

NIH GUIDELINES: "To permit evaluation of long-term safety and efficacy of gene transfer, the prospective participants should be asked to agree to long-term follow-up that extends beyond the active phase of the study. The informed consent document should include a list of persons who can be contacted in the event that questions arise during the follow-up period. The investigator should request that subjects continue to provide a current address and telephone number.

The subjects should be informed that any significant findings resulting from the study will be made known in a timely manner to them and/or their parent or guardian including new information about the experimental procedure, the harms and benefits experienced by other individuals involved in the study, and any long-term effects that have been observed."

DISCUSSION
Long-term Follow-up: Because gene transfer is innovative and its long-term risks are not well understood, it is important to try to obtain long-term toxicity data on participants and to provide to participants any new significant clinical information that might affect their future care.

Investigators need to inform prospective participants that they will be expected to participate in long-term follow-up that extends beyond the active phase of the study. Investigators should explain the rationale for long-term follow-up and describe the specific follow-up activities planned, including the desire to collect information about new cancers, blood disorders, autoimmune diseases, and neurologic disorders. Long-term follow-up may be viewed by participants as a benefit, a burden, or both. Potential participants need to understand what long-term follow-up activities will occur, how long follow-up will continue, and what, if any, procedures they will be asked to undergo.

Both the design and extent of long-term follow-up and its discussion in the consent form and process should always be tailored to the specific study design and vector used.

Although participants have the right to withdraw from research, they should be encouraged (but not required) to provide follow-up information even if they do not complete the gene transfer administration. Additional discussion about participants who withdraw from the study can be found in the Voluntariness section.

Facilitating Long-term Contact: To make long-term follow-up possible, participants should be asked to provide a current address and telephone number to the research staff, as well as the names and addresses of their current primary care provider and someone whom the research staff can contact to locate them. They should also be encouraged to contact the research staff when their contact information changes. Investigators may want to consider other ways to maintain current contact information, such as holiday cards or a newsletter, and inform participants of such efforts to maintain contact at the time of consent. The need to retain contact information for long-term follow-up raises privacy and confidentiality concerns, which are addressed in the Privacy section of this guidance.

Government Requirements: Gene transfer studies are subject to oversight by other Federal agencies, such as the Food and Drug Administration, which may have specific requirements for the duration of long-term follow-up. Investigators should know the current FDA policy regarding long-term follow-up, and the impact of these requirements on the participant should be discussed.

Significant Findings: If significant information is generated during or after the study that may be pertinent to a potential participant's decision to enroll or a current participant's continued involvement in a study, the investigator should consult the Institutional Review Board to determine whether the new findings are significant enough to:

• Revise the consent form;
• Inform already enrolled participants about the new information; and
• Initiate a re-consent process in which current participants are informed that they can refuse further gene transfer interventions in the study because of the new findings.

SAMPLE LANGUAGE

Sample 1 - Long-term Follow-up

Long-term follow-up in gene transfer research allows for the collection of important information on the long-term safety and effects of the gene transfer intervention used in this study. The long-term follow-up planned for this study will occur [frequency] for [length of time]. It includes [study-specific information, as available; e.g., drawing a small amount of blood once a year; completing a health history questionnaire every year; having a biopsy of the injection site every five years; etc.]. The investigators will try to make it easier for you to participate in long-term follow-up by [study-specific information as available, e.g., using mail and telephone to collect some information; arranging with your local doctor to collect blood or biopsy specimens and send them to investigators; etc.].

Sample 2 - Long-term Follow-up

At the end of the experimental phase of the study you will be asked to participate in the long-term follow-up phase for the rest of your life. Once a year you will be asked to have your blood drawn (~[amount]) and answer questions about your general health and medical condition. The investigators may ask you to report any recent hospitalizations, new medications, or the development of conditions or illness that were not present when you enrolled in the study and may request that physical exams and/or laboratory tests be performed if necessary. We will also ask you to participate in the long-term follow-up phase if you leave the study early.

Sample 3 - Significant Findings

We will give you any new information we learn during this study that might affect your willingness to stay in the study. This includes new information about the procedures used, the [gene transfer intervention], or side effects other participants in the study may have had.