What Parents or Guardians Need to Know About Enrolling in SUDC Research

SUDC research aims to uncover the causes of sudden unexplained deaths in children over 12 months of age, identify potential risk factors, and eventually develop ways to prevent future tragedies. Research areas may include genetics, neurology, cardiology, pathology, sleep science, family history, and/or environmental factors.

Families may be invited to participate in one or more of the following types of studies. Studies vary in focus and requirements.

Some examples include:

• Genetic: analyzing DNA from the child and biological parents.

• Medical History and Record Reviews: evaluating the child’s health history from birth through passing including autopsy investigation.

• Neurological: exploring diseases and disorders of the nervous system, which includes the brain, spinal cord, and nerves.

• Cardiac: focusing on diagnosing and treating diseases and disorders of the heart, blood vessels, and circulatory system.

• Immunology: studying the immune system and its functions, both in health and disease. It encompasses understanding how the body defends itself against infections and other threats, as well as how immune system malfunctions can lead to conditions.

• Surveys or interviews: exploring family experiences, history, or grief. Eligibility and participation may depend on your family’s individual situation and the study design.

You have the right to:

• Receive a clear explanation of the study before enrolling

• Ask questions at any time throughout the duration of the study

• Decline or withdraw from the study at any point without penalty

• Have personal privacy and data protections according to ethical and legal standards

• Know how the data and specimens, will be stored and shared. Participation is always voluntary

Informed consent is a crucial ethical and legal process that protects you and your child’s rights when participating in research. It ensures that personal, medical, and biological information are handled with care and in accordance with laws and research ethics. Before joining a study, you should receive clear, understandable information to help you decide whether to participate—and whether your and/or your child’s data or specimens may be used for future research.

Informed consent is a crucial ethical and legal process where potential participants are given complete, understandable information about a study before deciding whether to participate. It ensures voluntary agreement to participate after fully understanding the study’s purpose, procedures, potential risks and benefits, and the right to withdraw at any time. (NIH)

Key components of informed consent include:

• Clear explanation of the purpose of the research and procedures: Participants should understand the study’s objectives, methods, and their expected role.
• Description of potential risks and benefits: Participants need to be informed about any potential harm or discomfort, as well as potential benefits to themselves or others. 
• Information about confidentiality and data protection: Participants should understand how their personal information and research data will be handled and protected. In most research, participant information is de-identified, meaning your identity is not linked to the data.
• Voluntary participation and right to withdraw: Participants must know that their participation is entirely voluntary and that they can withdraw at any time without penalty or repercussions.
• Contact information: Participants should have access to contact information for the research team and any relevant ethics committees or regulatory bodies. You can ask questions at any time and receive honest, respectful answers.
• Protect participants’ rights and autonomy: By providing information and ensuring voluntariness, informed consent helps ensure that participants are not coerced into participating in research. 
• Safeguard against unethical practices: Informed consent is a fundamental ethical principle in research, and its proper implementation helps ensure that research is conducted ethically and responsibly If you’re ever unsure, ask:
  • How will my family and/or child’s data or specimens be stored?
  • Who will have access?
  • Who can access the identifiable information? Never hesitate to ask. We encourage you to share any questions or concerns along the way—your comfort, understanding, and trust matter.

It’s ok to ask many questions as you need to feel informed and comfortable. Consider asking:
• What is the purpose of the study?
• Who is conducting or sponsoring it?
• What will participation involve, and how long will it take?
• What type of data or specimens will be collected?
• Will I need to travel or submit any physical materials?
• How will my data and my child’s data be stored and protected?
• Will I receive any results or findings?
• When will I receive any results or findings?
• Are there any costs or compensation?
• Can I withdraw later if I change my mind?
• If I withdraw from the study, may I request the return of all data and specimens?

Some studies return individual findings, such as genetic test results or case review summaries. Others
only publish collective (aggregate) data. Ask the study coordinator:
• Will the results be shared with you?
• What results will be shared?
• How and when will they be provided?
• Will someone explain the results to me?
There is also the possibility that, even after you have received the results of the assessment, your case
may be revisited months or even years later as new insights and biotechnologies emerge.

Most studies are free of charge. Some may offer compensation for time or travel. Be sure to ask:
• Are there any out-of-pocket costs?
• Is travel required and covered?
• Is there compensation for participation?

This depends on the type of study. Some may take just a few minutes (e.g., an online survey), while
others may involve follow-up over months or years. You should ask:
• What is the time commitment?
• Is there a one-time or ongoing component?

Some studies require biospecimens, medical records, or interviews that may involve mailing materials or
visiting a medical facility. Others are conducted entirely online or over the phone. Ask:
• Will any travel be required?
• How are materials submitted?
• Can participation be done remotely?

Your participation can:
• Contribute to a better scientific understanding of Sudden unexpected death in children
• Help identify genetic or medical patterns that may one day lead to preventive measures.
• Inform best practices in investigation, care, and support for families.
• Honor your child’s life through meaningful legacy.
While research may not provide immediate answers, it brings us closer to a world where SUDC is better
understood—and ultimately preventable.

That’s completely okay. Grief is not linear, and participation in research is never an obligation. If and
when you feel ready, the SUDC Foundation can help guide you to opportunities that align with your
comfort level and interests.

If you have any questions, concerns, or complaints about a research study you are involved in, you always have the right to contact the Institutional Review Board (IRB) overseeing the study. The IRB is an independent committee that reviews and monitors research involving people to ensure it is conducted ethically and that participants’ rights and welfare are protected.

You can typically find the IRB’s contact information on the last page of your study consent form.

We’re here to:
• Help families explore current research opportunities
• Connect families with ethical, trusted research partners
• Answer questions and advocate for concerns
• Support you and your family before, during, and after participation
If you’re thinking about participating in research, we’re here to help. Reach out anytime, and together
we’ll explore the options that feel right for you, your family, and your child’s case