Bioethics issues in human studies

Informed consent

Information that has to be provided to the participant

State of discussion

Before requesting an individual's consent to participate in research, the investigator must provide the following information in language or another form of communication that the individual can understand [11]:

1. that the individual is invited to participate in research, the reasons for considering the individual suitable for the research, and that participation is voluntary;
2. that the individual is free to refuse to participate and will be free to withdraw from the research at any time without penalty or loss of benefits to which he or she would otherwise be entitled;
3. the purpose of the research, the procedures to be carried out by the investigator and the subject, and an explanation of how the research differs from routine medical care;
4. for controlled trials, an explanation of features of the research design (e.g., randomization, double-blinding), and that the subject will not be told of the assigned treatment until the study has been completed and the blind has been broken;
5. the expected duration of the individual's participation (including number and duration of visits to the research centre and the total time involved) and the possibility of early termination of the trial or of the individual's participation in it;
6. whether money or other forms of material goods will be provided in return for the individual's participation and, if so, the kind of amount;
7. that, after the completion of the study, subjects will be informed of the findings of the research in general, and individual subjects will be informed of any findings that relates to their particular health status;
8. that subjects have the right of access to their data on demand, even if these data lack immediate clinical utility (unless the ethical review committee has approved temporary or permanent non-disclosure of data, in which case the subject should be informed of, and given, the reasons for such non-disclosure);
9. any foreseeable risks, pain or discomfort, or inconvenience to the individual (or others) associated with participation in the research, including risks to the health or well-being of a subject's spouse or partner;
10. the direct benefits, if any, expected to result to subjects from participating in the research;
11. the expected benefits of the research to the community or to society at large, or contributions to scientific knowledge;
12. whether, when and how any products or interventions proven by the research to be safe and effective will be made available to subjects after they have completed their participation in the research, and whether they will be expected to pay for them;
13. any currently available alternative interventions or course of treatment;
14. the provision that will be made to ensure respect for the privacy of subjects and for the confidentiality of records in which subjects are identified;
15. the limits, legal or other, to the investigators' ability to safeguard confidentiality, and the possible consequences of breaches of confidentiality;
16. policy with regard to the use of results of genetic tests and familial genetic information, and the precaution in place to prevent disclosure of the results of a subject's genetic tests to immediate family relatives or to others (e.g., insurance companies or employers) without the consent of the subject;
17. the sponsors of the research, the institutional affiliation of the investigators, and the nature and sources of funding for the research;
18. the possible research uses, direct or secondary, of the subject's medical records and of biological specimens taken in the course of clinical care;
19. whether it is planned that biological specimens collected in the research will be destroyed at its conclusion, and, if not, details about their storage (where, how, for how long, and final disposition) and possible future use, and that subjects have the right to decide about such future use, to refuse storage, and to have the material destroyed;
20. whether commercial products may be developed from biological specimens, and whether the participant will receive monetary or other benefits from the development of such products;
21. whether the investigator is serving only as an investigator or as both investigator and the subject's physician;
22. the extent of the investigator's responsibility to provide medical services to the participant;
23. that treatment will be provided free of charge for special types of research-related injury or for complications associated with the research, the nature and duration of such care, the name of the organization or individual that will provide the treatment, and whether there is any uncertainty regarding funding of such treatment;
24. in what way, and by what organization, the subject or the subject's family or dependants will be compensated for disability or death resulting from such injury (or ,when indicated, that there are no plans to provide such compensation);
25. whether or not, in the country in which the prospective subject is invited to participate in research, the right to compensation is legally guaranteed;
26. that an ethical review committee has approved or cleared the research protocol.