Safeguarding Participant Data

Because the UW Twin Registry’s very existence relies on the continued participation of the twins, the UW Twin Registry is vigilant about protecting participants’ rights to privacy and the confidentiality of the data they provide. The UW Twin Registry, based on guidelines set forth by the UW Office of Human Subjects, has implemented a system that strictly limits direct contact between investigators and UW Twin Registry twins. This system involves 2 options: 1) UW Twin Registry personnel (defined as the UW Twin Registry Scientific Operations Manager or personnel who are directly and solely under the supervision of the Scientific Operations Manager) will contact UW Twin Registry members on behalf of the investigators (“supervision” in this case refers to oversight of all UW Twin Registry-related activities and not necessarily supervision for payroll and other human resources purposes) -or- 2) a non-UW Twin Registry study coordinator will contact Registry members on behalf of the investigators AFTER UW Twin Registry personnel have received verbal assent from a twin to share their information and be contacted for participation in a study.

Personal identifying information of UW Twin Registry members are not shared directly with investigators for sample-only or data analysis-only research. Once the data are collected, the dataset is forwarded to the investigators using study-specific unique identifiers. For clinical protocols that require direct interaction of UW Twin Registry twins with investigators, UW Twin Registry personnel will make the initial contact with the twins of interest, who have been screened based on some established criteria, on behalf of the investigator. The purpose of this contact is to introduce the study to the Registry twin pairs of interest and to obtain either their signed agreement (i.e. consent forms) or verbal assent indicating their willingness to be contacted by the investigator for potential enrollment in the study. Once consent forms or verbal assent are obtained by the UW Twin Registry, contact information may be released to investigators for subsequent scheduling of clinical examinations or other study procedures. Consent forms need to be obtained from UW Twin Registry members by the investigator or other research personnel prior to enrolling twins who previously provided verbal assent.

All UW Twin Registry personnel have signed confidentiality agreements to ensure they are compliant with Washington State privacy laws. Additionally, all non-UW Twin Registry personnel (e.g., a non-UW Twin Registry study coordinator) must also be compliant with Washington state privacy laws and sign a confidentiality agreement. All investigators who work with UW Twin Registry twins and data derived from the twins are expected to observe the highest professional standards of confidentiality. All UW Twin Registry data are considered privileged and confidential and cannot be shared or released without prior written approval from the UW Twin Registry Director. In some cases, the UW Twin Registry may request that the investigator obtain a Certificate of Confidentiality from the U.S. Department of Health and Human Services to provide additional protection for participant data.

In cases of potential unethical practices by an investigator, the UW Twin Registry will contact the appropriate authorities (i.e. Institutional Review Board officials) to request an investigation that could result in the study being halted. If the complaint is verified, the UW Twin Registry will deny the investigator further access to the Registry. Complaints of unethical practices by UW Twin Registry personnel will also be reported to the IRB and appropriate action will be taken.

All personal identifying information (i.e. names, addresses, telephone numbers) obtained from UW Twin Registry participants enrolled in a study must be returned to the UW Twin Registry or anonymized, obliterated, or otherwise destroyed. The non-UW Twin Registry study coordinator (and in some cases the investigator) must provide a letter certifying to the destruction or return of this information. Personal identifying information must be returned to the UW Twin Registry when no further contact is required with the participant. Schedules for handover of participant personal identifying information can be developed according to the specific needs of each project.