For patients & families
Understand the study. Know your rights. Make your choice.
Research depends on volunteers. Your decision should be informed, unhurried, and free from pressure. This guide helps you prepare for a conversation with the study team.
Start here
What participation means for you
You do not need to decide today. Start by asking questions and understanding what a particular study would involve.
- Visits and time
- Ask how often you would visit, what tests are needed, and how long participation lasts. The schedule differs by study.
- Care and possible benefit
- You may have scheduled check-ins and safety monitoring. An investigational treatment and closer follow-up do not guarantee better health.
- Risks and costs
- Discuss side effects, treatment alternatives, insurance charges, travel, and any reimbursement before joining.
- Your choice
- Participation is voluntary. You can ask questions, discuss the study with your usual doctor, and choose to decline or leave.
What is clinical research?
Clinical research studies health in people. A clinical trial tests an approach such as a medicine, device, procedure, or change in care. An observational study gathers information without assigning a study treatment.
Research and regular medical care have different goals. Your usual care focuses on your needs. Research also aims to answer a question that may help future patients. An investigational treatment is being studied; it has not necessarily been shown to work for your condition.
Words you may hear
- Protocol
- The written plan for the study: who can join, what happens, and how safety is checked.
- Randomization
- Assignment to a study group by chance. Neither you nor your doctor may choose the group.
- Placebo
- A comparison treatment without the active study medicine. A placebo does not always mean that standard care is stopped; ask what each group receives.
- Blinding
- Some people involved do not know which treatment was assigned. This helps reduce bias when results are assessed.
What are the different phases?
Drug studies often progress through phases. Each phase asks a different question. Phases may overlap, and device, procedure, and observational studies may use other designs.
Before human trials
Laboratory and preclinical research
Scientists study a possible treatment before testing it in people. These findings do not prove that it will work in humans.
Phase 1
Safety and dose
Early studies examine side effects, dose, and how the body handles a treatment. Depending on the treatment, they may involve healthy volunteers or people with the condition.
Phase 2
Early evidence of benefit
Researchers study people with the condition to look for possible benefit and learn more about safety. The treatment may still be ineffective or harmful.
Phase 3
Comparison with other care
Larger studies compare an approach with standard treatment or another appropriate comparison. Researchers gather evidence about benefits and risks.
Phase 4
After approval
Studies and monitoring continue after a medicine is approved to learn about longer-term safety and use.
A later phase is not a promise of better care or personal benefit. Not every treatment progresses to approval. Ask which phase your study is in and what is already known.
Can a trial offer closer attention to your care?
A trial may offer scheduled visits, study-related tests, and regular contact with a research team. In some studies, you may have access to an investigational treatment. These features can provide a structured way to monitor your health, but the exact support varies by study.
Closer monitoring does not guarantee a better outcome
Some heart studies have found better outcomes among trial participants. Those comparisons do not prove that joining the trial caused the difference: participants may differ in health, eligibility, or access to care. Reviews comparing similar people receiving similar treatments have not found a consistent benefit from participation alone.
The study treatment may help, have no benefit, or cause harm. You may receive a comparison treatment. Extra visits and tests can also take time, involve discomfort, or add costs. Ask how research visits will fit with your usual care.
What happens if I am interested?
- 1.
Ask about the study
Start with a general inquiry. The team explains availability and the first steps. An inquiry does not enroll you.
- 2.
Discuss screening
Screening checks whether you meet the study rules. The team explains any consent needed before study-specific screening tests. Not everyone screened will qualify.
- 3.
Decide after reviewing the information
You discuss risks, possible benefits, alternatives, costs, and your responsibilities before making a decision.
- 4.
Attend study visits
Visits may include examinations, questionnaires, blood tests, or other assessments. Tell the team about symptoms and changes in your health. Ask whom to contact between visits.
- 5.
Complete follow-up
The team explains what happens when treatment ends or if you leave early, including safety follow-up and how your regular care continues.
Informed consent is a conversation
Informed consent is an ongoing process, not just a signature. The team explains the study in language you can understand. You should have a chance to ask questions and consider your choices.
- Review why the study is being done, its length, and which procedures are experimental.
- Discuss known risks, possible benefits, other treatment options, and what remains uncertain.
- Ask about costs, payment, privacy, and what happens if you are injured.
- Ask for an interpreter or other help understanding the information if needed. You may wish to involve someone you trust.
- Only agree when your questions have been answered and you want to take part. Keep a copy of the consent document.
- Ask about new information during the study. Important changes may require another consent discussion.
Signing does not remove your right to leave. You should not be asked to give up your legal rights. Ask how to stop safely and whether information already collected must remain in the study records.
Protecting people is a serious responsibility
An institutional review board (IRB) reviews the study and its participant protections. It considers risks, consent information, and fair selection of participants. The investigator and sponsor also have duties to follow the protocol and monitor safety. Some studies use an independent safety-monitoring committee.
These safeguards reduce risk; they cannot remove all uncertainty. Ask which IRB oversees your study and how to contact it with a concern about your rights.
You have a voice
- You may decline or withdraw without penalty or loss of benefits to which you are otherwise entitled.
- You can ask questions and report symptoms, concerns, or pressure to participate.
- You can ask how your records will be used, who may see them, and what limits apply to confidentiality.
- You should receive contacts for study questions, research-related injury, and participant-rights concerns.
How did trials and safeguards develop?
Comparing treatments has helped medicine advance. But research history also includes abuse, deception, and racism. Recognizing that history is essential to understanding consent and independent oversight today.
1747
An early comparison of treatments
James Lind compared remedies for scurvy in sailors. His work is an early example of testing treatments through a planned comparison.
1947
The Nuremberg Code
After Nazi medical experiments, the Nuremberg Code emphasized voluntary consent and safeguards for people in research.
1964
The Declaration of Helsinki
The World Medical Association established ethical principles for medical research. The declaration has been revised, most recently in 2024.
1972
The exposure of the Tuskegee study
The U.S. study of untreated syphilis ran from 1932 to 1972. Black men were not properly informed and were denied available treatment. Its exposure helped drive demands for stronger protections.
1974–1979
Stronger U.S. protections
The National Research Act created a commission whose work led to the 1979 Belmont Report. Its principles are respect for people, reducing harm while considering benefit, and fairness.
Questions to bring to the research team
- What is the study trying to learn, and why might I qualify?
- What will each group receive? Could I receive placebo?
- What are the risks and my options if I do not join?
- How many visits are needed, and how much time will each take?
- What costs, travel expenses, or payments should I expect?
- Who will manage my usual care and any treatment changes?
- Who pays for care if a research-related injury occurs?
- Who can access my records, and will I learn the study results?
- How do I leave, and whom do I contact about my rights?
Common questions
Does joining mean I will get better?
No. A trial asks a question because the answer is not yet certain. Closer monitoring and an investigational treatment do not guarantee benefit.
Can I change my mind?
Yes. Contact the team about a safe plan for stopping treatment and follow-up. Some data already collected may need to be retained.
Is the trial free?
Not necessarily. Study costs, routine care charges, insurance coverage, and reimbursement differ. Get the details before joining.
Can I discuss it with my own doctor?
Yes. Ask how your usual clinician and the research team will coordinate your care.
Should I email my medical records?
No. Use email for general questions. The team will explain an appropriate way to share records if they are needed.
Ask about taking part
Only contact details and the study or condition of interest are requested. Please do not provide medical history, medications, diagnoses, or records.
Email our research office to ask about taking part. You can start with a general question; you do not need to send medical records.
Email the research office →info@azcrf.org
Read our privacy notice. Sending an inquiry does not enroll you in a study.
Looking for study information? Browse the trial directory →