Research involving human subjects is based on a commitment to advance human welfare, knowledge and understanding, and to examine cultural dynamics. Someday, you or a family member may want to take part in a research study. The information here may help you make the right decision.
Research Participants
Acronyms (CCTS, OHRP, etc.)
- CCTS: UK Center for Clinical and Translational Sciences
- IRB: Institutional Review Board
- OHRP: Office for Human Research Protections
- AAHRPP: Association for the Accreditation of Human Research Protection Programs Inc.
- SU2C: Stand Up To Cancer
Information About Participating in Research
- University of Kentucky (UK) Center for Clinical and Translational Science (CCTS) -
- About Research Participation (U.S. Department of Health and Human Services (DHHS))
- "Are You Thinking About Being in a Research Study?" (Collaborative Institutional Training Initiative (CITI) module) includes:
- What are the types of research that include human subjects?
- What are my rights as a human subject?
- What questions should I ask before I decide about being a human subject?
- What is the informed consent process?
- What is expected of you after you have said 'yes' to being a human subject?
- Who protects people who agree to be research subjects
- Definitions of Commonly Used Terms (Collaborative Institutional Training Initiative (CITI) "Are You Thinking About Being in a Research Study?" module)
- Center for Information & Study on Clinical Research Participation (CISCRP) - a non-profit organization focused on educating and informing the public about clinical research participation)
- Advice to Legally Authorized Representatives of Adult Participants in Medical Research
- Advice to Legally Authorized Representatives of Adult Participants in Nonmedical Research
- National Cancer Institute (NCI) Tissue Donation video
- Patient Resources (CenterWatch)
- What Does Randomization Mean for Research Volunteers? (DHHS)
- Participating in Social & Behavioral Health Research (DHHS)
What is a Clinical Trial?
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:
- University of Kentucky (UK) Center for Clinical and Translational Science (CCTS) -
- National Institutes of Health (NIH) - Clinical Research Trials and You
- National Cancer Institute (NCI) - Clinical Trials Questions and Answers for Prospective Participants
- National Institutes of Health (NIH) ClinicalTrials.gov - Learn About Clinical Studies
Regulations to Protect Research Volunteers (OHRP)
Learn about the regulations that protect research volunteers, why we have them, and who enforces them.
For Parents and Kids
- Children's Hospital Boston Clinical Trials
- What is Medical Research? (Comic Book)
- The Kids Files Page (NIH) – Features the Video Game The Paper Kingdom
- Would Your Child Benefit from a Clinical Trial? (FDA)
- Special Protections for Children as Research Subjects (Office for Human Research Protections (OHRP))
- For Parents and Children (NIH)
Información sobre la investigación - en Español
- Ser Voluntario en Estudios Clínicos: Es Su Decisión
- Consejos para representantes legalmente autorizados de los participantes adultos - Médica investigación
- Consejos para representantes legalmente autorizados de los participantes adultos - Comportamiento y ciencias sociales investigación
- Acerca de La Participación en Las Investigaciones Científicas (La Oficina de Protecciones para la Investigación Humana (OHRP, en inglés))
- Participando en Investigaciones Sociales y de Conducta Relacionadas a la Salud (DHHS)
Ensayos Clínicos
- Introducción a los ensayos clínicos (Institutos Nacionales de la Salud (NIH))
- Ensayos clínicos tutorial interactivo (NIH)
- Estudios Clínicos: Preguntas y respuestas (FDA)
Para Los Padres
Reglamentos para la protección de personas que participan en investigaciones científicas
Oficina de Protecciones para la Investigación Humana (OHRP)
Aprenda acerca de los reglamentos que protegen a aquellos que participan en investigaciones científicas, por qué tenemos dichos reglamentos, y quién los hace cumplir. Este material fue diseñado para el uso público, y le invitamos a que lo comparta o distribuya libremente.
- ¿Por qué tenemos reglamentos para proteger a las personas que participan en investigaciones?
- ¿Cuáles son los reglamentos más importantes que protegen a los participantes?
- ¿Qué oficina federal supervisa y hace cumplir los reglamentos del HHS?
- ¿Hay investigaciones que no sean controladas por la Common Rule?
- La protección de los voluntarios es una responsabilidad compartida
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" under Federal Regulations in the IRB Survival Handbook]. 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: The Belmont Report].
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]
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 (well-being) first and embraces standards that are higher than required by law.
Ensuring the University of Kentucky continues to demonstrate high standards of human research protections by reaccreditation requires a yearlong review process including a rigorous application process, detailed records-review, and site inspection by an AAHRPP review team. UK has maintained its standing of excellence since 2007 with full reaccreditation in 2020, and pending full reaccreditation in June 2025.
The researchers, ORI staff, IRB members, and administrators interviewed at the most recent AAHRPP site visit (December 2024), affirmed our efforts to conduct human research that is scientifically sound, regulatory compliant, and consistent with the highest ethical principles.
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.
In order to maintain accreditation, organizations must fully demonstrate a level of human research protections and safeguards that meet all specified standards which are categorized into three domains (Organization, Institutional Review Board (or Ethics Committee), Researcher and Research Staff). UK's accreditation status is active for five years, with annual reports due each June until reaccreditation is due again.
Volunteer for a research study at UK
Learn about current study opportunities at the UK Center for Clinical and Translational Science Current Studies
Join the IRB?
If you have an interest in research and ethics, volunteering to serve on an IRB is a way to protect the rights, safety, and welfare of research participants. IRBs include scientist, non-scientist, and members that are not affiliated with UK, who represent diverse members of the community. See detailed descriptions below and contact Pam Stafford if interested in being an IRB member (859-323-7399).
The nonscientist is vital – research review cannot proceed without a nonscientist present. This member’s role is to ensure that research materials are readable and that participants will understand what they are volunteering for. This committee member must be:
A nonscientist (training, background, and occupation are in nonscientific fields);
- Able to prepare for and attend most committee meetings; meetings are set for a particular weekday and are held about 3-4 weeks apart;
- Able to attend occasional education sessions; and
- Comfortable with basic computer operations.
- Nonscientist Member Brochure
The unaffiliated member brings a unique perspective to the table. This member’s role is to represent the public’s concerns – to serve the public community’s interests rather than the university’s. This committee member must be:
- Not affiliated with the University of Kentucky, either directly or through an immediate family member;
- Able to prepare for and attend most committee meetings; meetings are set for a particular weekday and are held about 3-4 weeks apart;
- Able to attend occasional education sessions; and
- Comfortable with basic computer operations.
- Unaffiliated Member Brochure
Resource Videos
English
What is Medical Research?
How is Medical Research Different from Medical Care?
Deciding to Participate in Clinical Trials
Questions to Ask Before Volunteering in Clinical Trials
Explaining Randomization in Clinical Trials
Research with Medical Records and Samples from Medical Care
Participating in Social and Behavioral Health Research
How IRBs Protect Human Research Participants
Informed Consent for Research: What to Expect
Research with Children: What Parents Need to Know
Protecting Your Privacy in Human Research
Español (Spanish)
¿Qué son los ensayos clínicos?
En qué se diferencian la investigación médica y el tratamiento medico
¿Qué son los ensayos clínicos?
¿Qué preguntas debe hacer?
Explicación de la aleatorización en ensayos clínicos
Uso investigativo de muestras e información derivadas de la atención medica
Participando en investigaciones sociales y de conducta relacionadas a la salud
Cómo los IRB protegen a los participantes humanos en investigaciones
El consentimiento informado: ¿De qué se trata?
La investigación científica con niños: Lo que los padres necesitan saber
La protección de su privacidad en investigaciones con seres humanos
English vid 2
Clinical Trials
Biopsies
Trial Phases
Randomized Control Trials
Placebos
Informed Consent
Standard of Care
Español (Spanish)
Ensayos Clínicos
Biopsias
Fases
Ensayos Controlados Aleatorizados
Placebos
Consentimiento Informado
Estándar de Cuidado
Contact Us
UK Office of Research Integrity Staff Directory
UK Center for Clinical and Translational Science Current Studies
Subject Concerns, Suggestions, or Questions
It is IRB policy that a safe confidential, and reliable channel for current, prospective, or past research participants, their representatives or others, is provided that permits them to discuss problems, concerns, and questions; obtain information; or offer input with an informed individual who is unaffiliated with the specific research protocol.
Each IRB approved informed consent document includes the ORI Research Compliance Officer's toll-free phone number (1-866-400-9428) as a subject's primary contact point for this purpose.