Learn About Ethical and Legal Aspects

Protect Human Research Participants

Informed Consent
What is informed consent?
Informed consent is a process for making sure that patients and caregivers who give information to a registry understand how that information will be used. Registry participants sign a form stating they understand the reason for participating in your registry. By signing the form, participants show that they agree to voluntarily share their personal and rare disease information.

You are responsible for informing participants about the information you intend to collect and how the information will be used. You also need to explain who will have access to the information and how the registry might affect participants. You must answer registry participants’ questions and give them regular updates about the registry after they’ve signed the informed consent form.

How does informed consent apply to registries?
If you plan to share participant information from your registry with researchers who are developing treatments for rare diseases, you must get participants’ informed consent. Without informed consent from registry participants and their legal guardian, you can’t give patient data to researchers.

Institutional Review Board (IRB)
What is an IRB?
An IRB is responsible for protecting the rights and welfare of people who participate in research studies. An IRB is a group of people with diverse backgrounds, such as healthcare professionals, patient advocates, and non-science professionals.

The IRB will review studies, including clinical trials that use registries, before the studies begin recruiting participants. Based on its review, the IRB either approves or does not approve each study.

The IRB can require changes to the study plans. These changes typically ensure that risks to participants are limited and the study collects informed consent. The IRB might also require changes to protect participants’ privacy and make sure that the study follows all relevant laws and rules. The IRB also has the authority to monitor the research once it starts.

How does the IRB apply to registries?
If you plan to share participant information from your registry with researchers, an IRB must first review the clinical trial that your participants are being asked to join.

The Federal Policy for the Protection of Human Subjects (‘Common Rule’)
What is Common Rule?
The Common Rule is a federal policy that protects personally identifiable information of participants in federally funded research studies. Personally identifiable information is information that could be used to identify the participant.

How does the Common Rule apply to registries?
If a researcher invites your registry members to participate in a federally funded study, the researcher has to follow the Common Rule.



Know U.S. Laws & Regulations
HIPAA Basics – Privacy and Security U.S. Department of Health and Human Services (HHS) (link)
Be Informed of International Laws