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Research Participants
Research involving human subjects is based on a commitment to advance human welfare, knowledge and understanding, and to examine cultural dynamics. Researchers, universities, governments and private institutions undertake or fund research involving human subjects for many reasons: for example, to alleviate human suffering, to validate social or scientific theories, to dispel ignorance, to analyze policy, and to understand human behavior and the evolving human condition. [Interagency Advisory Panel on Research Ethics]
Someday, you or a family member may want to take part in a research study. If this happens, the information here may help you make the right decision.
To jump to a topic, click on your choice in the menu below:
Information about Participating in Research:
- Becoming a Research Volunteer: It's Your Decision (OHRP) [HTML]
- Human Subject Protection - Know your rights & understand the researcher's responsibilities (FDA-CDER) [HTML]
- What should you ask before agreeing to participate in a research study? (OHRP) [HTML]
- Why Volunteer? (FDA) [PDF]
- Center for Information & Study on Clinical Research Participation (CISCRP--a non-profit organization focused on educating and informing the public about clinical research participation) [HTML]
- Advice to Legally Authorized Representatives of Adult Participants in Medical Research [PDF]
- Advice to Legally Authorized Representatives of Adult Participants in Nonmedical Research [PDF]
- Veterans' Participation in Research: Volunteering in Research (VHA) [PDF]
- I'm a Veteran. Should I participate in research? (Dept. of Veterans Affairs) [PDF]
A clinical trial (also clinical research) is a research study in human volunteers to answer specific health questions. Carefully conducted clinical trials are the fastest and safest way to find treatments that work in people and ways to improve health. Interventional trials determine whether experimental treatments or new ways of using known therapies are safe and effective under controlled environments. Observational trials address health issues in large groups of people or populations in natural settings.
More clinical trial information:
- Introduction to Clinical Trials (National Institutes of Health (NIH)) [HTML]
- Clinical Trials Glossary [HTML]
- Are Clinical Studies for You? (NIH) [HTML]
- Clinical Trials Tutorial (NIH Sponsored) [HTML]
- Clinical Trials: Questions and Answers (National Cancer Institute (NCI)) [HTML]
- Clinical Research Development & Operations Center (CRDOC) [HTML]
- Why Volunteer? [HTML]
Subject Concerns or Suggestions [HTML]
UK Office of Research Integrity Staff Directory
- Your Child and Medical Research (Children's Hospital Boston) [HTML]
- Drug Research and Children (FDA) [HTML]
- For Parents and Families of Children with Cancer [HTML]
- FAQ for Children in Research (NYU Child Study Center) [HTML]
- Special Protections for Children as Research Subjects (Office for Human Research Protections [OHRP]) [HTML]
- Educating Children, Their Parents, and Healthcare Providers about Pediatric Clinical Research (NIH Videos) [HTML]
Información sobre la investigación - en Español
- Ser Voluntario en Estudios Clínicos: Es Su Decisión [HTML]
- Consejos para representantes legalmente autorizados de los participantes adultos - Médica investigación [PDF]
- Consejos para representantes legalmente autorizados de los participantes adultos - Comportamiento y ciencias sociales investigación [PDF]
Ensayos Clínicos
- Introducción a los ensayos clínicos (Institutos Nacionales de la Salud (NIH)) [HTML]
- ¿Es indicado para ud. un estudio clínico? [PDF]
- Ensayos clínicos tutorial interactivo (NIH) [HTML]
- Estudios Clínicos: Preguntas y respuestas (FDA) [HTML]
Para Los Padres
What is an Institutional Review Board (IRB)?
The IRB reviews research studies involving human subjects. The IRB is federally mandated to ensure that proper safeguards are in place to protect human subjects enrolled in research studies [see Regulations Governing Human Subjects Research]. Additionally, three fundamental ethical principles are carefully considered during the IRB decision-making process to ensure the ethical practice of research involving human participants [see Ethical Foundation of Human Research Protection].
IRB membership is comprised of "...at least five members, with varying backgrounds to promote complete and adequate review of research activities commonly conducted by the institution. The IRB shall be sufficiently qualified through the experience and expertise of its members, and the diversity of the members, including consideration of race, gender, and cultural backgrounds and sensitivity to such issues as community attitudes, to promote respect for its advice and counsel in safeguarding the rights and welfare of human subjects." [45 CFR 46.107]
- UK IRB Membership [PDF]
What does Full Accreditation by AAHRPP Say About UK?
The University of Kentucky went through a rigorous process to become accredited in human research protections. Achieving full accreditation by the Association for the Accreditation of Human Research Protection Programs Inc. (AAHRPP) demonstrates UK’s commitment to the highest ethical standards in conducting human research. Accreditation signals to research participants that UK puts safety (wellbeing) first and embraces standards that are higher than required by law. See UK's press release announcing this momentous accomplishment [PDF].
Furthermore, accreditation means:
- UK is committed to the most comprehensive protections for research participants and the highest quality research.
- UK sought accreditation, because it is the right thing to do.
- Research participants receive more comprehensive protection from UK.
- UK applies the federal safeguards to all research that involves research participants.
- UK maintains efficient systems for monitoring participant safety (wellbeing).
- UK demonstrates the high quality of its human research protection program in meeting the rigorous accreditation standards and process.
- UK has a stronger, more cohesive research programs committed to continuous improvement.
- UK goes beyond what is required by law to protect human participants and ensure integrity of research.