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MAIN POINTS Participants should be informed that an autopsy will be requested upon their death. Investigators should explain that a participant's expression of autopsy wishes is: Not a consent to autopsy Not required for study participation Participants should express their wishes about an autopsy to their families and encourage the families to take their wishes into account.

NIH GUIDELINES: "To obtain vital information about the safety and efficacy of gene transfer, subjects should be informed that at the time of death, no matter what the cause, permission for an autopsy will be requested of their families. Subjects should be asked to advise their families of the request and of its scientific and medical importance."

DISCUSSION
The autopsy request is one aspect of long-term follow up that is unique to gene transfer. Autopsies can yield important information that may enable a better understanding about the long-term effects of gene transfer intervention at the time of death.

Potential participants should be informed that at the time of their death, regardless of cause, an autopsy will be requested. The investigator should explain that they are not being asked at this time to consent to autopsy nor is it required for study participation. However, participants should be encouraged to express their wishes about an autopsy to their families so that families are prepared to take those wishes into account at the time of the participant's death.

When possible and appropriate, investigators may wish to further specify the nature and extent of postmortem testing that is likely to be of greatest interest for a particular study or whether a "partial autopsy" would be of value. If such a limited postmortem examination would be of scientific value, granting permission for specific testing only may be a desirable option for some participants and, at the time of the participant's death, for their families.

SAMPLE LANGUAGE

Sample 1

When you die, no matter what the cause, investigators will ask your family if they can do an autopsy. An autopsy will help the investigators learn more about the safety and efficacy of gene transfer. Please advise your family about your wishes regarding autopsy.

Sample 2

Because you are a study participant, investigators will ask your family for permission to do an autopsy when you die, even though this may be years after the study. This may help investigators learn about the effects of gene transfer. By signing this consent form, you are not forcing your family to agree to this. You should talk about this request with your family and advise them of your wishes.

Sample 3

Your investigator will ask your family for permission to perform an autopsy when you die, no matter what the cause. The evaluation of your organs after your death is a very valuable method to learn more about the good and bad effects of gene transfer. A "partial autopsy," in which needles are used to take samples of specific organs, may also be helpful. This type of autopsy does not require surgical incisions. You should talk about the possibility of autopsy with your family and health provider, and advise them of your wishes. The investigator may be able to tell you or your family what kind of autopsy information will be most helpful for this study. The study sponsor will pay all costs of the autopsy.