Table 1.

Basic content and review points of the informed consent form for cancer clinical studies.

No.	Basic contents	Review points
1	General information	Title, version number and date, and information about the study site.
2	Nature of study	Clinical studies are exploratory in nature.
3	Background and objectives	① Background and current situation. ② Objectives.
4	Procedures	① The estimated duration of the study and total number of participants planned to be enrolled. ② Study process, including stage (screening period, treatment period and follow-up period), experimental intervention measures/procedures, possibility of random allocation to each group, and description of all traumatic operations, with a focus on describing the experimental content that differ from conventional medical practice, including the process of experimental intervention, sample collection, and exploratory content. For clinical studies of multidisciplinary treatments in particular, explanation of experimental (such as adjuvant or concurrent targeted/immune new drugs) and standard (such as surgery, radiotherapy, and interventional therapy) treatments should be given, and then specifically describe the treatment process. ③ Notification for obtaining biological samples, including collection purpose, method, and quantity; testing and storage site; whether the test results are returned; and approximate time needed for testing. If necessary, a sub-informed consent form for the testing of biological samples can be designed separately (details in Module 18 “Notification of obtaining biological samples”). ④ For the possibility of continuation of study interventions after disease progression or crossing over to other treatment groups, if a relevant process exists, writing a separate sub-informed consent form is recommended (details in Module 19 “Continuing treatment after disease progression” and Module 20 “Crossover after disease progression”). ⑤ Frequency and approximate duration of on-site visits and telephone follow-ups for participants after the end of the study treatment. ⑥ The expected situation and reasons why the participation in the trial may be terminated, and the specific grouping will be provided after unblinding at the end of the study. ∗ The description of study intervention in a non-interventional study is not applicable. A statement should indicate that the study process will not affect the routine diagnosis or treatment.
5	Matters requiring participants' cooperation	Participants should be compliant with the study's procedures, including making on-time visits, adhering to diet/concomitant medication requirements, and informing physicians of any problems or discomfort during the study.
6	Alternative treatments	In interventional clinical studies, participants should be clearly informed about alternative therapies in the event that they do not participate in or withdraw from the study. The existing standard treatment should be fully described, especially for patients with treatment-naïve advanced tumors or resectable tumors.
7	Risks and discomforts of participation	① Safety information, including expected adverse reactions. For special treatments such as immune checkpoint inhibitors, CAR-T cell therapy, and oncolytic virus therapy, immune-related adverse events should be described clearly. For surgery, radiotherapy, and interventional therapy, the possible risks should be described in detail according to the specific treatment site and style. For multidisciplinary clinical studies, adverse reactions that may be additionally increased by experimental content compared with standard treatment should be addressed. ② Expected risks of invasive examination in the protocol and possible inconvenience to the participants. ③ Some specific interventions or treatments (such as innovative therapies and combined therapies) may have risks that are currently unanticipated. ④ A statement should indicate that the intervention measures or treatments may cause unanticipated risks to the embryo or fetus if the participant is pregnant or becomes pregnant during the trial. ∗ The anticipated risks of the study interventions in non-interventional studies are not applicable, and participants are informed that participation in the study does not add any additional risk to routine medical activities.
8	Possible benefits of participation	① Reasonably expected benefits (for individuals and the whole social group). If there is no expected benefit to the participants, it is necessary to inform them. ② Persuasive language should not be used, and compensation should not be described as a benefit.
9	Relevant expenses of participation	① Relevant expenses for participating in the study. ② All study medications/devices and study-related tests will be provided by the sponsor at no cost. The investigational drugs/devices and examination items specified in the study's protocol of registration will be provided free of charge. For combined medications, surgery, radiotherapy, interventional therapy, and other basic treatments, participants will be informed about the items provided free of charge or the reasons for not providing them, and if they exceed the routine clinical practice of the study site, they will be provided freely (eg., if the surgical style or radiotherapy plan specified in the protocol is different from the guideline or standard treatment).
10	Compensation	① All compensation will be paid to participants as scheduled and based on the actual number of visits (generally a fixed amount). ② Compensation should not be withheld until the end of the study.
11	Indemnities	In the event of any injuries related to the trial, the participants shall receive free medical treatment and/or indemnity.
12	Right to voluntarily participate in or withdraw from the study	Participation in the study is voluntary, and the participants may refuse to participate in or withdraw from the study at any time without penalty or loss of any benefits to which the participant is otherwise entitled.
13	Privacy and confidentiality	① The monitor, auditor, ethics committee, and government administrative department may consult the participant's original medical records directly to verify the procedures and/or data of the clinical study to the extent permitted by the current laws and regulations. ② To the extent permitted by the current laws and regulations, the participants' personal identity information will be kept confidential, and these records will not be disclosed. ③ In real-world studies and clinical studies involving big data, protective measures for personal information should be described.
14	Treatments upon completion of the study	Regarding treatment measures for participants after the discontinuation or completion of the study, especially for those with clinical benefits, participants should be informed of the need to discuss subsequent alternative treatments with the study physician or to enter the extended dosing phase (please refer to the Consensus on extended dosing after clinical trials of registered anti-cancer drugs issued by the Chinese Anti-Cancer Association). ∗ Not applicable for non-interventional studies
15	Provision of new information and contact information	① Participants should be informed of any significant new information about the study in a timely manner, including the latest progress and new adverse reactions, and they should have an opportunity to voluntarily decide whether to continue the study and re-sign the informed consent form after receiving the information. ② The study physician's name and phone number should be provided (out-of-hours phone numbers are required for high-risk studies). ③ A contact person on the ethics committee and their phone number should be provided.
16	Language description	① The language should be easy to understand, conform to the general public's level of understanding, and not be too lengthy. ② The meanings of the terms “patient” and “participants” should be clearly defined.
17	Notification of biopsy procedures (if applicable)	① The biopsy procedures and related risks should be specified in the “study process” and “study risks.” ② The bearer of biopsy expenses, the location of biopsy tests, whether the participants are informed about the results, and whether the participants are compensated shall be described in the corresponding module.
18	Notification of obtaining biological samples (if applicable)	(A separate sub-consent form should be prepared if necessary) ① Whether the purpose of collecting biological samples is routine medical treatment or entirely for research purposes, and whether it belongs to the pre-screening or the screening phase of the study should be specified. ② The method of collection and the volume of collection should be indicated. The collection volume of biological samples will meet the requirements of the Human Genetic Resources Management Department. The number of tissue sections collected will not affect the subsequent pathological diagnosis of participants; when the sections cannot be provided or a biopsy is required for other reasonable reasons specified in the protocol, the participants should be fully informed. ③ The name and location of laboratories and whether there are additional risks and economic burdens, especially for centralized tests performed outside medical institutions (for details, please refer to the Consensus on central laboratory usage in anti-cancer drug clinical trials issued by the Chinese Anti-Cancer Association). ④ Approximate time for feedback of test results: the central evaluation results necessary for judging the participant's eligibility and/or the follow-up diagnosis and treatment should be reported in a timely manner. ⑤ The storage place, storage period, and when the biological samples will be destroyed should be specified. ⑥ If the samples will be used for genetic studies, this should be clearly specified.
19	Continuation of treatment after disease progression (if applicable)	(A separate sub-consent form should be prepared if necessary) ① The purpose of treatment continuation after disease progression. ② Conditions for treatment continuation after disease progression, follow-up methods, and other treatments. ③ Relevant risks, including the risk of treatment failure. ∗ Not applicable for non-interventional studies
20	Crossover treatment after disease progression (if applicable)	(A separate sub-consent form should be prepared if necessary) ① Purpose and background of crossover treatment after disease progression. ② Conditions for crossover treatment and eligibility screening procedure; relevant procedures if disease progression must be confirmed by central imaging. ③ Follow-up methods and other optional treatments. ④ Possible risks and benefits of the new treatment group. ∗ Not applicable for non-interventional studies