It can be challenging to ensure that participants receive all the information and background material necessary to understand and make a fully informed decision to participate in a registry. Materials, such as consent forms and supplemental reading, can help inform both participants and investigators about how participants data may be used. To examine methods to obtain informed consent for patient resgistries, ORDR sponsored the Informed Consent Models/Templates for Rare Disease Registries linked to Biorepositories meeting in December 2010. The agenda and presentations from this meeting are available at: http://rarediseases.info.nih.gov/files/Informed_Consent_Agenda.pdf.

Based on input from this meeting, ORDR has published recommendations for obtaining a patient's consent for participation in rare disease registries that are associated with biorepositories. Furthermore, the ORDR has developed an example informed consent document to assist groups that are developing registries that will participate with the GRDR program. This template can be modified to reflect the specific needs and aims of each registry and to incorporate language from the reviewing Institutional Review Board.

Participation in the GRDR Program

Patient organizations are requested to develop an informed consent process in compliance with recommendations for GRDR participation. This includes both the development and the approval of informed consent materials by participating registries and databases.

Informed Consent Documents

Participating registries and databases should be provide information to participants that explains the purpose and use of data contributed to the GRDR , ability for external researchers to access repository data, ownership of the repository data, and protection of patient's privacy, among other other elements recommended by the ORDR. Informed consent documents developed by the registry should include the elements described in the GRDR common consent form template (refer to the consent form template provided below) and should include the agreement by the participant to share their de-identified medical information with other databases for biomedical research. Organizations that have not already developed consent documents are encouraged to utilize the GRDR consent form template (below) which can be modified to reflect their organizational aims and regulatory or institutional language.

Informed Consent Approval

The GRDR requests that informed consent documents from participating registries and databases be approved by an institutional review board (IRB). IRB approval is sought as a safeguard to protect the interests of patients who participate, however, the type of review and approval may vary as it reflects the specific aims and uses of the registry/database. Organizations that do not have access to a local IRB may consider an appropriate external IRB service. Though not specifically endorsed by the GRDR program, examples of external IRB's include the following:

• Western Institutional Review Board (WIRB) - http://www.wirb.com/
• Chesapeake Research Review, Inc. (Chesapeake IRB) - http://chesapeakeirb.com/

Further Information

Resources related to informed consent are provided below. Additional information will be provided by the GRDR as the data repository is further developed.

Informed consent template for participating in rare disease registries (sharing de-identified data with GRDR)
This document contains the informed consent template for organizations that seek to participate with the GRDR program.

Informed Consent Process for Patient Participation in Rare Disease Registries Linked to Biorepositories
Informed Consent Workshop Proceedings