Informed consent is the ethical foundation and an essential component of demonstrating respect for research participants and is required by both federal regulations and 澳门老奇人论坛, unless a waiver is requested and approved.
These regulations are based on the belief that researchers are ethically obligated to fully inform potential study participants so that they can make a decision regarding participation that is based on a complete understanding of the risks and benefits of participation. In addition, informed participants are better participants; they are more serious about participating in a study and they are better able to understand what a researcher needs to know about them and what is required of them. The type and extent of the consent process will depend on the kind of research you are conducting and the level of risk that is involved.
The goal of the consent process is to facilitate a prospective participant鈥檚 or legally authorized representative鈥檚 understanding of the reasons why an individual might or might not want to participate in a research study. The responsibility for the investigator in the consent process is to:
The informed consent process and consent form must encompass key information, be well organized, and presented in a way that facilitates comprehension and includes a concise explanation of the following鈥�(excerpted from鈥痺ww.citiprogram.com):
This approach provides鈥�渒ey information鈥濃�痆46.116(a)(5(i))] essential to decision making that must appear at the beginning of the consent form and presented first in the consent discussion. Investigators are reminded to present informed consent information in sufficient detail and in a way that helps with subject comprehension, not just running down a list of risks and procedures.
In general, the Institutional Review Board (IRB) needs to have a detailed understanding of how participants will be recruited to participate, how the consent information will be presented to them, and how their consent will be documented.
The informed consent process and consent form must encompass key information, be well organized, and presented in a way that facilitates comprehension and includes a concise explanation of the following鈥�(excerpted from鈥痺ww.citiprogram.com):
This approach provides鈥�渒ey information鈥濃�痆46.116(a)(5(i))] essential to decision making that must appear at the beginning of the consent form and presented first in the consent discussion. Investigators are reminded to present informed consent information in sufficient detail and in a way that helps with subject comprehension, not just running down a list of risks and procedures.
The answers to these questions will help determine what approach you need to take in developing an instructive consent procedure.
To assist the understanding of consent forms by the subject, it is recommended that the language used is at a reading level of a 12-year-old (eighth grade reading level), keeping sentences simple and short when possible. (For instance, say 鈥淵ou will be asked to do鈥︹�� instead of "participation in the study will entail鈥︹��
Ask yourself, could that relationship (or the relationship of anyone on the research study team) make participants feel pressured to participate? If the possibility exists, do you need to adjust your consent process so that participants can decide freely? e.g. employer/employee, teacher/student, etc.
No informed consent may include exculpatory language through which the participant or representative is made to waive or appear to waive any of the participant's legal rights or release or appear to release to the investigator, the sponsor (if applicable), the institution, or its agents, from liability for negligence. E.g., If an informed consent contains language by which a subject waives his or her right to be compensated for injuries arising from participation in research, such language would meet the definition of exculpatory language because it has the general effect of freeing or appearing to free an individual or an entity from responsibility for malpractice or negligence, or blame, fault, or guilt.
Researchers may find that the use of deception, or incomplete disclosure, is a necessary tool for their study. Deception occurs when the initial informed consent process involves one or more of the following:
In these cases, the deception must be justified by the value of the research. If deception occurs, participants must be debriefed and given a Debriefing Form to document they are fully informed about the study and that they choose voluntarily to remain in or withdraw from the study and not allow the use of their collected data. Debriefing provides participants with a full explanation of the hypothesis being tested, procedures to deceive participants, and the reason(s) why it was necessary to deceive them.
Could they be in situations where consent is challenging because of a lack of autonomy (e.g. prisoners) or because consent could put them at risk?
Look at the template in the Resources section of the IRB website. You will find templates for 1) Assent for Mentally Incapacitated Adults and 2) Child Assent.
If so, your consent form needs to notify participants that their materials will be used elsewhere.