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Taking Part in a Clinical Trial in China: Questions to Ask Before You Sign

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When the research team gives you an informed consent form, read it with your questions in mind before deciding whether to take part. Ask the study doctor to explain your treatment options, risks, and safety arrangements. For questions about your rights or disputes that cannot be resolved, contact the ethics committee listed on the consent form. You can still ask questions or change your decision after signing.

Key points

  • Ask the center for the informed consent form reviewed by the ethics committee for this study. Ask for explanations in language you understand and time to ask questions and consider your decision. Keep a copy after signing.
  • Find out what each group will actually receive, the risks, and your options if you do not take part. The study may benefit you, or it may offer no direct benefit.
  • Taking part is voluntary. You can withdraw at any time. Discuss safe treatment discontinuation, follow-up care, and what will happen to data and samples already collected with the study doctor as soon as possible.
  • Chinese drug clinical trial regulations prohibit charging participants trial-related fees. Check separately how treatment and compensation for research-related harm, reimbursement of reasonable participation expenses, and other medical costs will be handled.

Which consent form have I received?

Check the study name, study number, hospital and campus, version number, and date. Ask the research team whether this is the current version reviewed by the ethics committee for this center. Routine care, the main study, and optional substudies may require separate consent. Ask the team to mark which parts are required for the main study and which you can choose separately. A registration number or promotional material alone cannot replace a consent discussion specific to the center.

If you are not comfortable with Chinese, ask whether the center can provide written materials and an interpreter in a language you understand, and how the translation corresponds to the official documents. Ask the interpreter to convey your questions and the researchers’ answers fully. You may also invite someone you trust to accompany you. An interpreter helps with communication; an impartial witness, who may be required in certain situations when a person cannot read, has a different role. The center should arrange the process according to applicable requirements. If you do not understand, pause signing and ask for another explanation.

What might I receive? What are my options if I do not take part?

Ask the study doctor to explain, in relation to your condition, what question the study aims to answer, which medicines or procedures are still being studied, the possible benefits, known risks, and uncertainties. Ask about the benefits and drawbacks of standard treatment, symptom management, and other options. Do not stop medicines or change treatment on your own while deciding.

If there are different treatment groups, ask exactly what each group receives, whether assignment is random, the chance of being assigned to each group, and who knows the assignments. If a placebo is used, ask whether it replaces treatment or is given alongside other treatment. Ask what rescue treatment is available if your condition worsens or you develop serious symptoms, and how emergency doctors can contact the research team. Random assignment does not guarantee that you will receive the study medicine you hope for.

Review the visit schedule and ask which biopsies, blood tests, scans, hospital stays, or restrictions on medicines are added for the study, and how long they are expected to last. The study doctor and your current treating doctor should jointly assess whether you need to stop any current medicines or wait for a period of time. If you are traveling across borders for care, also ask which visits must take place at the study center, whether any can be completed where you live, and how long you need to stay near the center.

How are costs, allowances, and research-related harm handled separately?

Ask the center for an itemized written explanation covering screening, study medicines, tests, hospital stays, routine care, travel and accommodation, and follow-up after withdrawal. For each item, it should state its purpose, who pays, whether you must pay upfront, what receipts are needed, and whom to contact. Check coverage, prior authorization, and exclusions separately with your insurer.

Article 8 of China’s Regulations for the Implementation of the Drug Administration Law states that drug clinical trial sponsors and trial institutions must not charge participants fees related to the clinical trial. For applicable life science and medical research involving humans, the ethical review measures also prohibit research-related charges and require appropriate reimbursement of reasonable expenses incurred through participation. You need to check, item by item, which rules apply to the study, whether a particular test is research-related, and how travel, accompanying-person expenses, and costs incurred outside China are handled. Do not treat labels such as “routine test” or “self-pay” as the final basis for deciding who should pay.

If you are asked to pay a cost you believe is research-related, request an itemized bill and the basis for the charge. Ask the principal investigator, clinical trial institution office, or ethics committee to review it. If questions remain, you can consult the relevant local authority. Treatment and compensation or damages for research-related harm are separate from treatment for ordinary illness and travel allowances. Ask where to seek care if a problem occurs, who contacts whom, who pays first, how the relationship to the research is assessed, and how disputes are reviewed. For severe or rapidly worsening symptoms, go to the nearest emergency department first, then contact the research team as soon as possible.

How will my samples and personal information be used?

Ask the team to identify which tests or samples are required for the main study and which are for optional future research. For blood, tissue, genetic information, and medical records, ask about their purpose, how long they will be stored, who can use them, whether they will be shared or transferred outside China, whether they will be used in future research, whether results will be returned to you, and how identifying information will be protected. Decide whether to consent only to the main study or separately to future use based on the actual choices in the documents. If optional choices are not clearly separated, ask for clarification first.

If you later want to withdraw a particular permission, tell the research team exactly which one. Ask for a written explanation of whether unused samples can be withheld from further use or destroyed, and what will happen to data already analyzed, shared, or required by law to be retained. Do not assume that all existing records can be deleted after you withdraw.

What happens to my care if I want to withdraw?

The applicable Chinese ethical review measures allow research participants or their guardians to withdraw unconditionally at any stage and require that they be told about the relevant rights. You can tell the research team that you want to stop study treatment, withdraw from the study, or discuss whether you are willing to continue certain safety visits and contacts. The applicable ethical review measures require participants to be told that they can withdraw at any time without giving a reason and without being treated unfairly as a result. You do not need the research team’s approval to withdraw. You should still make an informed decision about whether to accept recommended follow-up.

Contact the study doctor as soon as possible. Explain when you last took the medicine and what symptoms you currently have. Ask whether you need a safe discontinuation plan, a final examination, or monitoring, and whom to contact if problems occur after stopping treatment. Do not change your medicines on your own; the doctor should make arrangements based on the specific treatment. Agreeing to a safety check does not mean reversing your decision to withdraw.

Before signing, you can ask: Who will assess the next treatment plan when treatment is completed, serious side effects occur, the disease progresses, or the study ends early? Is continued access to the medicine available, for how long, and who will pay? If it cannot continue, who will help arrange a referral? Continued access to the study medicine depends on the study, your individual circumstances, and actual supply; it cannot be guaranteed.

Before returning to your home country or transferring to another hospital, ask the research team to prepare a treatment and handover summary. It should include the study number, treatment received and its last date, current medicines, unresolved adverse events, pending results, the next examination, and contact details. Ask the receiving doctor to confirm that they have received the information, whether they can take over your care, and who will follow up on results. Doctors on both sides should jointly arrange care during the waiting period.

Can I explain the key points in my own words before signing?

Check that you understand the study’s purpose and uncertainties, each group’s treatment, major risks and alternatives, additional procedures, costs and arrangements for harm, uses of samples and information, withdrawal, and whom to contact. Before study-specific procedures begin, ask the research team to explain and complete the applicable informed consent process. Ask who will tell you, and how, if new information emerges that could affect your safety or continued participation. If you still have questions, mark the relevant clauses and ask the researcher to explain them. Discuss them with your treating doctor or someone you trust before deciding. Request a copy of the signed consent form and contact details, and note the version.

Consent is an ongoing conversation. The 2023 ethical review measures require renewed informed consent when the research changes substantially, research-related risks substantially increase or new risks are added, or a participant’s level of legal capacity to act increases. When you receive a new version, ask what has changed and how it affects you before deciding whether to continue.

Frequently asked questions

The coordinator says I should sign first and the doctor will explain later. Is that okay?

If questions about treatment, risks, or alternatives have not yet been explained by qualified staff, do not rush to sign. Ask the research team to arrange answers and allow time for you to consider your decision. Arrangements for procedures done solely for research should also be explained beforehand.

Can a family member sign for me? What about children or people who cannot decide for themselves?

Accompanying you as a family member does not automatically give someone authority to sign on your behalf. Ask the center to verify the person’s status as a guardian or representative and the required documentation under applicable law and the approved process. The applicable Chinese ethical review measures require that, alongside obtaining the guardian’s consent, the person be informed to the extent they can understand and their agreement be obtained. For trials covered by drug clinical trial Good Clinical Practice (GCP), minors who can decide whether to participate must also give their own consent. Their objection or decision to withdraw generally takes precedence, but the provisions include limited exceptions for therapeutic trials involving serious or life-threatening diseases. Ask the research team and ethics committee to explain the conditions that apply to this study. Rules may differ for other circumstances involving decision-making capacity.

Can I still receive medical care if I decline to participate?

Declining to participate is your choice. Ask the doctor to explain care and referral options outside the study. If you feel pressured or believe you are being treated unfairly, contact the institution’s ethics committee or the relevant authorities. Do not interrupt necessary treatment because you have not signed.

Can I refuse only future research using my samples?

Some future research is optional, while some tests are part of the main study protocol. Ask the team to mark each choice in the documents and explain the consequences of refusing it. Do not assume that every additional component can be declined separately.

If I feel unwell during the trial, is that research-related harm?

Not necessarily. Whether it is related requires professional assessment. Seek care first for severe symptoms, then contact the research team and keep medical and expense records. The applicable Chinese ethical review measures require timely, free treatment for research-related harm, with compensation or damages handled according to law and agreement. Professionals must still assess causation and responsibility case by case. Ask about treatment, costs, and the review process for research-related harm.

Does stopping the medicine mean stopping all follow-up?

Not necessarily. State your choices separately for medicines, examinations at the hospital, telephone contact, and use of your information. Discuss the safety implications and available arrangements with the study doctor.

The center says I will definitely be able to continue the medicine free of charge after the study. Can I rely on that?

Request written arrangements for the specific study. Confirm who decides, how long the supply will last, where you will collect the medicine, and how monitoring and costs will be handled. Ask the doctor at your destination to verify whether continued care can be coordinated. The end of the study or changes in your circumstances may affect the actual arrangements.

Sources

Date checked: November 6, 2026. For a specific study, refer to the applicable rules, documents reviewed by the ethics committee, and explanations from the research team.

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