Types of Studies
The VET Registry receives numerous inquiries from investigators
for potential studies involving the twins. These inquires are initially
handled by the Registry project manager and are then passed on to the
Registry director and epidemiologist. Investigators are told that direct
contact between an investigator and the twins is not permitted without
prior written agreement from the twins. If the investigator is interested
in developing a new study using the twins the Registry coordinator then
describes the process. After a new study obtains funding and is approved
by the Advisory Committee, the Registry staff, and the investigator develop
a data collection plan. Twins are typically allocated to data collection
in batches that represent a third or quarter of the total needed. This
allows the Registry to monitor data collection activities and balance
the competing needs of multiple studies for access to twins.
The Registry strictly prohibits investigators direct having access
to twins. All contact with Registry twin pairs is either by Registry
staff or through an approved 3rd party contractor. The 3rd party contractor
serves as an intermediary between the investigator and the twins and
works in close coordination with the Registry. The 3rd party contractor
must sign a letter of agreement regarding the privacy and confidentiality
of information collected from the twins. The Registry provides twin
names, addresses and telephone numbers to the 3rd party contractor in
order to contact twins. This personal information can never be released
to investigators and the 3rd party contractor must destroy all data
collected, after being transmitted to the Registry.
Survey or Interview Projects
After full human subjects approval an informational
letter is mailed to Registry members describing the new survey project
on VET Registry letterhead. This letter bears signatures of the Registry
Director, the investigator and the project leader at the 3rd party
contractor. The twins are provided with complete and accurate information
about any new study before they are asked if they are willing to participate.
The Registry maintains strict control on how twins can be solicited
for individual research projects. Twins who have agreed to participate
in any study are permitted to withdraw at any time. If the project
is solely based on a mailed questionnaire then the survey questionnaire
is included with the letter sent to the twins along with a business
reply envelope. If it is a telephone survey the twins are told that
within 2-3 weeks they will receive a telephone call to conduct the
interview. Sometimes twins are provided with an appointment letter
that they can return indicating the dates and times that are best
to call them.
In-person assessments
Following human subjects approval an informational
letter is mailed to Registry members describing the new in-person
assessment protocol. This letter bears the signature of the Registry
director, the investigator and the project leader at the 3rd party
contractor. This letter is on VET Registry letterhead stationary and
describes the study to the twins. The mail-out packet also contains
a release form for twin signature and a actual consent form for the
in-person assessment protocol. (The consent form is for informational
purposes only.) The twin is asked to sign and return the release form
that authorizes the Registry to release their name to the investigator
to provide more information about the in-person assessment to the
twin and, if he is agreeable, schedule the assessment. The 3rd party
contractor then forwards the signed released form to the Registry.
It is only when the signed release forms are obtained from both members
of a pair that the identifying information is released by the Registry
to the investigator. The in-person assessments in the past have typically
involved the twins traveling, usually by airplane, to the home institution
of the investigator. The process of scheduling the twins for the in-person
assessments is very complex and tends to take several months after
the signed release forms are obtained. In general the twins have been
examined at the same time but this is not a requirement.
Discussion
The VET Registry has been a highly productive
resource for genetic epidemiologic studies. As custodian of the
Registry, the
VA is responsible for managing the resource
and maintaining its viability for the future. The Registry has evolved
over time and the number
and type of studies has increased in size and
complexity. While the first studies that used the Registry collected
data by mail and telephone
interview it is now common for projects to
involve clinical and laboratory assessment.
A number of systems have been implemented to manage the VET Registry.
These systems include a set of databases that are secure and allow ready
identification of twin participation in current and previous research
projects. A newsletter is used to stay in regular contact with twin
pairs and provide feedback to the twins. An Advisory Committee of senior
scientists provides oversight to the Registry and conducts an external
review of all new projects. Human subject protections are in place that
strictly limit access to twins and require projects to use approved
3rd party contractors to serve as intermediaries between the investigators
and twin pairs.
The VET Registry is actively pursuing several new directions for the
future. As the twins age it is likely that new projects will be initiated
that focus on the common physical health problems of older age. The
Registry is seeking projects studying chronic diseases such as hypertension,
diabetes, heart disease, and arthritis.
|
