07 / PRIVACY & PARTICIPANT PROTECTIONYour privacy. Your rights.
Understand the rules and oversight that may apply to medical research, and how to ask questions before sharing health information or joining a study.
HIPAA · HHS / OCR
HIPAA is a U.S. law, not a certifying organization. HHS’s Office for Civil Rights enforces its Privacy, Security, and Breach Notification Rules for covered entities and business associates. For research, protected health information generally requires an authorization or another permitted legal basis. Applicability depends on the entity and activity.
HIPAA and research ↗Independent ethics review · IRB
Institutional Review Boards review research protocols and consent materials to protect participants’ rights and welfare. The applicable IRB and its contact details are identified in the study documents. Ask the research team about the review and approval applicable to any proposed study.
How IRBs protect participants ↗FDA · Clinical investigation safeguards
For clinical investigations within FDA jurisdiction, federal rules address informed consent and IRB oversight, including 21 CFR Parts 50 and 56. Consent is a discussion of the study’s purpose, procedures, risks, possible benefits, and alternatives—not simply a signature.
FDA informed consent guidance ↗OHRP · Common Rule
The Office for Human Research Protections supports protection of people in HHS-conducted or supported research. The Common Rule (45 CFR Part 46, Subpart A) establishes protections for research within its scope. Additional protections may apply to children and other specified populations. These rules do not automatically cover every privately funded study.
OHRP and the Common Rule ↗Before you decide to participate
- Ask about risks, possible benefits, alternatives, visit schedules, costs, and compensation before making a decision.
- Participation is voluntary. You may decline or withdraw without penalty or loss of benefits to which you are otherwise entitled. Discuss safe withdrawal and any required data retention with the study team.
- Consent to participate and HIPAA authorization to use health information have different purposes. The study team should explain the documents that apply to you.
- Use the investigator and IRB contacts in your consent materials for study concerns and questions about your rights.
Sharing information through this website
The interest forms request basic contact details and general business inquiries. They do not perform medical screening or collect study consent. Do not submit diagnoses, test results, insurance information, Social Security numbers, or medical records in the forms, chatbot, or general email.
For medical information, ask our team to arrange an appropriate channel and explain the applicable privacy documents. To correct or remove a website contact request, call 561-399-4781 and provide your reference number.
Read the form privacy noticePrivacy questions and complaints
Contact Integrated Health Research at 561-399-4781 to discuss a privacy concern or request the privacy documentation applicable to your care or study. Where HIPAA applies, you may also file a privacy or security complaint with HHS’s Office for Civil Rights.
HHS / OCR complaint information ↗Privacy safeguards and HIPAA rights
When applicable, the HIPAA Security Rule requires administrative, physical, and technical safeguards for electronic protected health information. HIPAA privacy rights can include access to records, requests for amendments, and certain limits or confidential communications, subject to legal conditions and exceptions. Ask the responsible provider or study team how these rights apply.
HIPAA Security Rule ↗These official resources explain regulatory frameworks. Their inclusion does not represent government endorsement, a HIPAA certification, or approval of a specific Integrated Health Research study. Study-specific protections are explained in the applicable consent and privacy documents.