Your rights and protections in a clinical trial
You deserve clear information and space to decide. Clinical research has safeguards to reduce risks, but they cannot remove every risk or promise personal benefit. You can choose whether taking part feels right for you.
https://www.hopestage.com/research/learn/your-rights-and-protections-in-a-clinical-trial
Sources and last reviewed: 16 November 2026
Key takeaways
- Ask who reviewed the study and how to contact someone independently.
- Consent is a conversation that continues throughout participation.
- Leaving a study and deleting information already collected are different questions.
On this page
Independent ethics review
An ethics committee reviews whether the research is acceptable: its purpose, foreseeable risks and possible benefits, who is invited, the consent information and privacy arrangements.
The names differ by country: in the United States, Institutional Review Board (IRB); in Australia, Human Research Ethics Committee (HREC); in France, Comité de protection des personnes (CPP), a participant protection committee. These bodies review research independently of the people running it. The applicable review process depends on the country and research type.
Ask for the reviewing committee’s name, approval reference and confirmation that approval covers your site and the current study documents. Ethics approval does not mean the study is risk-free or that it will help you. A public registry listing is not proof that HopeStage has verified ethics approval. HopeStage is not an ethics authority.
Get the details before deciding
Informed consent means receiving understandable information, discussing it and choosing freely. It is an ongoing conversation, not just a signature.
Ask for the participant information sheet, the written explanation of the study, and a copy you can keep. It should explain what you would do, the duration and visits, possible risks and benefits, alternatives including not joining, costs, any payment or reimbursement, and how your information will be used.
Ask questions, request simpler wording or language support, take time to decide and talk with someone you trust. You can ask again after joining. Relevant new information that could affect your willingness to continue should be shared during the study.
You can say no or decide to leave
Participation is voluntary. You can decline or withdraw. Ask how leaving would work, what happens to any payment or reimbursement, and how your usual care will continue.
If you want to leave, discuss it with the study team so any study treatment can be stopped safely and recommended safety follow-up explained. Do not stop or change medication on your own. A suggested follow-up visit is something to discuss, not a reason to pressure you to stay.
Stopping study treatment, ending further visits or contact, and requesting deletion of information are separate choices. Explain which activities you want to stop and which, if any, you agree to continue. Information already collected may need to be retained; withdrawal does not automatically delete it.
What differs between countries?
These are country-specific examples, not one worldwide rule.
- United States: for research covered by US Department of Health and Human Services (HHS) consent rules, refusal or withdrawal must not bring a penalty or loss of benefits you are otherwise entitled to. Its Office for Human Research Protections (OHRP) guidance allows already collected data to be retained and analysed. Trials regulated by the Food and Drug Administration (FDA) have additional requirements.
- Australia: official participant guidance says you can leave at any time without affecting your ongoing medical care. Ask the team about the implications of withdrawal and whether data can be withdrawn.
- France: article L1122-1 of the Public Health Code states, for research within its scope, that refusal or withdrawal can occur at any time without liability or detriment because of that decision. Ask about the care arrangements after withdrawal. Data erasure has exceptions under privacy law.
- These protections do not promise continued access to an experimental treatment or study-specific services. Ask what care and entitlements apply to your situation.
Safety during the study
Ask how safety will be checked, who reviews concerns and how to report symptoms or side effects between visits. Keep the study contact details, including any out-of-hours instructions.
Report changes or concerns promptly, even if you are unsure whether the study caused them. Monitoring may include visits, tests and review of reports. Arrangements depend on the study’s risks and design. Some trials use an independent safety monitoring board; not every study has one.
Ask what would happen if new risks emerged or the study needed to pause. Monitoring helps identify and respond to problems; it cannot prevent every problem.
Questions, complaints and urgent help
Different concerns need different contacts. Keep these details with your study information.
- Routine questions: contact the study team about visits, procedures, costs or information you do not understand.
- Concerns about your rights or how the study is being run: use the independent ethics office or institutional complaints contact in the participant information sheet. You can raise a concern without first resolving it with the research team.
- No independent contact listed? Ask the team for the reviewing ethics office or the institution’s participant complaints service and its contact details. If necessary, find the institution’s research governance or complaints office through its official website, using the study name and identifier.
- Urgent medical problems: seek appropriate urgent medical help through local emergency services or urgent care. Do not wait for an email reply or a complaints review. Notify the study team when it is safe to do so.
Privacy and your personal information
Ask who can see identifiable information, what is shared with other organisations or countries, where it is stored, how long it is kept and whether future research use is planned.
A code in place of your name does not necessarily make information anonymous. Ask who holds the link to your identity and what privacy risks remain.
Before joining, ask what happens after withdrawal, whether new information will still be collected, and whom to contact about access, correction or deletion. Some records must be kept for legal or research reasons; information that can no longer be linked to you may be impossible to retrieve. Ask for an explanation of any limits that apply.
Questions to ask before you decide
- Who reviewed and approved this study, and does that cover my site?
- Can I take the participant information sheet home and discuss it with someone I trust?
- What are the main risks, possible benefits and alternatives, including not joining?
- What visits, procedures, time and costs are involved, and is any payment or reimbursement available?
- How do I report side effects or get help between visits?
- What happens if I want to leave, including safe treatment changes and usual care?
- What happens to information already collected, and what can I ask to have deleted?
- Who can I contact independently if I have a concern?
Questions and answers
Does ethics approval guarantee the study will help me?
No. Review is a safeguard, not a promise of benefit or an absence of risk. Ask about the uncertainties in this particular study.
Will all my information be deleted if I leave?
Not necessarily. Stopping further participation and requesting deletion are separate steps. Ask what can be removed and what must be retained, under the rules that apply to your study.
Explore the current directory
There is no need to decide now. If you wish, explore study records and use these questions with the responsible team. For help finding a guide or understanding study wording, contact HopeStage through the guide library. HopeStage does not verify your rights or handle ethics complaints.
Explore study records when you feel ready