Know About Data Privacy & Security

As a good data steward, you need to understand the importance of protecting the privacy of your registry members and securing their data. Data privacy protects the use of the data and puts policies in place to ensure that patient information is being collected, shared, and used in appropriate ways. Data security refers to protecting data and to having safeguards in place to prevent malicious computer attacks and unauthorized access to data.

RaDaR Review Data Protection Plan provides information about protecting your registry’s data.

Rules have been created to protect people who share their personal and rare disease information. As a registry owner, you should become familiar with the rules, regulations, and/or laws that have been created to protect data. The “Learn About Ethical and Legal Aspects“ section provides information about other rules and regulations you should be familiar with.

Chapter 7. Principles of Registry Ethics, Data Ownership, and Privacy in Registries for Evaluating Patient Outcomes: A User’s Guide [Internet], 4th edition provides more information about these rules and how they might pertain to registries

Overview

A registry is a database that collects and stores information about a group of individuals, most of whom are living with the same disease. Registries are a powerful tool for focusing research on a specific disease. One challenge of advancing the scientific understanding of rare diseases is finding enough people who eligible to participate in research studies. Establishing a registry can help tackle that challenge.

Check Whether a Registry Exists

Before starting your own registry, determine whether a registry already exists for your disease. Having only one registry fosters collaborations and prevents fracturing within a rare disease community, allows for the pooling of resources, reduces duplication of efforts, and avoids sources of competition. The population of individuals who are affected by a rare disease may be very small, and you don’t want to create competition for registry participants.

To find out whether your rare disease already has a registry search the internet, reach out to existing patient groups for that disease, and contact rare diseases umbrella organizations like the EveryLife Foundation for Rare Diseases , Global Genes, Genetic Alliance, and the National Organization for Rare Disorders (NORD) .

Tips for checking to see if a registry exists for your disease include the following:

• Search ClinicalTrials.gov by using the term “registry” and the name of your rare disease. ClinicalTrials.gov is maintained by the U.S. National Library of Medicine of the National Institutes of Health.
• Reach out to the Genetic and Rare Diseases Information Center (GARD), a program of the National Center for Advancing Translational Sciences (NCATS). GARD provides the public with access to current, reliable, and easy-to-understand information about rare or genetic diseases in English or Spanish.
• Perform a general internet search using the disease name and the term “registry.”
• Check with patient advocacy groups for the disease, which can be found by searching websites such as the Genetic and Rare Diseases (GARD) Information Center, or Disease Info Search.
• Search the RD-Connect Registry & Biobank Finder , an online global directory of existing rare disease databases, registries and biobanks. The RD-Connect Registry & Biobank Finder lets researchers locate rare disease patient registries and biobanks that store data on specific rare diseases.
• Search Orphanet: Registries and Biobanks to find registries and biobanks throughout the world. Orphanet was established in France and gradually grown to a consortium of 40 countries, within Europe and across the globe.
• Identify disease-specific and general patient registries using social media groups such as Rare Disease Patient Registry Coordinators .

If you discover a registry already exists for your rare disease, you will need to learn more about the existing registry.

• What are the goals of the existing registry?
  • Will your registry have a different set of goals?
• Who owns the registry and the data within the registry? Is it being shared openly?
• How large is the existing registry? (i.e., does it already contain a significant part of the population, or only one or two families?)
• Could you collaborate with the existing registry/registries? Joining forces is better than competing. Consider the possibility of creating a registry network.

Know What Information to Collect

The type of information you’ll want to collect for your registry depends on the registry’s goal(s), the resources available to the registry’s owner(s), and other factors.

Contact and Demographic Information
What is it?
Contact information includes the name, phone number, and email address of the registry participant (usually either the patient or the patient’s parents/guardians). Demographic information usually collected includes the patient’s age, sex, and ethnicity. A registry is usually not required to obtain approval to collect this information, although many registries provide a simple disclaimer.

Why collect it?
Collecting contact and demographic information allows you to find participants living with the rare disease, discover how many people have the disease, build trust, and organize and grow your participant community to support research.

Patient Experience
What is it?
This type of information includes the experiences, perspectives, needs, and priorities of patients. A registry may need to obtain institutional review board (IRB) approval before collected patient experience information can be used for research or publication.

Why collect it?
Collecting this information directly from patients and/or their caregivers allows you to learn more about what it’s like for people living with the rare disease. This information can be shared with researchers to help them understand the direct experiences of people living with the disease.

Clinical Data
What is it?
Clinical data includes information about the patient’s health and their health care. Clinical data may come from electronic health records, administrative records, health insurance claims, health surveys, or clinical trials. This information tends to have stricter data collection requirements for research use and publication; the Health Insurance Portability and Accountability Act of 1996 (HIPAA), IRB, and Federal Information Security Management Act (FISMA) requirements will affect clinical data collection.

Why collect it?
By collecting clinical data, your registry will develop partnerships with clinicians, researchers, and industry to facilitate and encourage natural history studies to track the course of the disease over time. Natural history studies provide a greater understanding of disease development, current management guidelines, and disease treatments.

Learn What Is a Registry

Registries collect contact and demographic information, patient experience, clinical data, and other types of information. The patient, the patient’s parent/guardian, or the patient’s doctor(s) may provide the information to the registry. The registry information can help you determine the following:

• How many people are living with the disease?
• Is the disease more common in males or females, children or adults, in certain ethnic groups, or in particular parts of the world?
• What are the experiences, perspectives, needs, and priorities of people living with the disease?
• How does the disease develop and progress?

This information can be used to develop a more comprehensive understanding of the disease, improve patient care, identify treatments, and advance research toward finding a cure.

When you create a rare disease registry, you bring together the entire community which includes patients, caregivers, clinicians, researchers, and industry. To create a registry that patients and caregivers want to join, and that clinicians, researchers, and industry want to use, it’s important to understand the varied needs of the stakeholders in the rare disease community.

Finding out what is known about your disease will assist you in setting your registry goals and creating a plan to build relationships with researchers. For most of the almost 7,000 identified rare diseases, scientists know very little. To build a successful registry, you’ll need to learn what is known about your rare disease, determine what research is already being done, and identify your registry stakeholders.

A registry is a database that collects and stores information about a group of individuals, most of whom are living with the same disease. Registries are a powerful tool for focusing research on a specific disease. One challenge of advancing the scientific understanding of rare diseases is finding enough people who eligible to participate in research studies. Establishing a registry can help tackle that challenge.

As soon as you decide to create a registry, become familiar with the ethical and legal responsibilities of running a registry. If you don’t follow the laws and rules from the beginning of your registry, your registry might not be usable for research or, ultimately, the treatment-approval process.

Make sure that your registry follows local, state, and federal laws and rules that cover the collection of personal and health information. In some cases, you need to follow international laws and rules as well. Which rules and regulations your registry needs to follow depends on the type of information the registry collects, how the registry will be used, and who gives and uses the information.

It might be a good idea to talk to a lawyer or ethics expert. These experts can help make sure that your registry follows the relevant laws and rules.