What are the basic elements to be provided in the informed consent process?
- A statement that the study involves research, an explanation of the purposes of the research and the expected duration of the subject’s participation, a description of the procedures to be followed, and identification of any procedures which are experimental.
- A description of any reasonably foreseeable risks or discomforts to the subject.
- A description of any benefits to the subject or to others (may be indirect benefits) which may reasonably be expected from the research.
- A disclosure of appropriate alternative procedures or courses of treatment, if any, that might be advantageous to the subject.
- A statement describing the extent, if any, to which confidentiality of records identifying the subject will be maintained.
- For research involving more than minimal risk, an explanation as to whether any compensation and an explanation as to whether any medical treatments are available if injury occurs and, if so, what they consist of, or where further information may be obtained.
- An explanation of whom to contact for answers to pertinent questions about the research and research subject’s rights, and whom to contact in the event of a research-related injury to the subject.
- A statement that participation is voluntary, refusal to participate will involve no penalty or loss of benefits to which the subject is otherwise entitled, and the subject may discontinue participation at any time without penalty or loss of benefits to which the subject is otherwise entitled. All consent forms must state explicitly that subjects may withdraw at any time.
What are the elements of the informed consent process?
Recruitment and screening of a subject through the subject’s involvement in research, including:
- Providing specific information about the study to subjects in a way that is understandable to them.
- Answering questions to better ensure subjects understand the research and their role in it.
- Giving subjects adequate time to consider their decisions.
- Obtaining the voluntary agreement of subjects to take part in the study. The agreement is only to enter the study, as subjects may withdraw at any time, or decline to answer specific questions or complete specific tasks at any time during the research.
What is exculpatory language?
Subjects my not be asked to waive or even appear to waive any of their legal rights. They may not be asked to release a researcher, sponsor, or institution from liability for negligence. Institutions may provide information about how liabilities will be covered.
What are the 4 criteria for a waiver of informed consent?
- The research involves no more than minimal risk to the subjects.
- The waiver or alteration will not adversely affect the rights and welfare of the subjects.
- The research could jot practicably be carried out without the waiver or alteration.
- Whenever appropriate, the subjects will be provided with additional pertinent information after participation.
What is deception?
The intentional misleading of subjects or withholding of four information about the nature of the study. This may include the purpose of the research, the role of the researcher, or what procedures in the study are actually experimental. Subjects have the right to full disclosure as soon as possible.
How does one ensure comprehension of consent information?
- Write the consent form using an appropriate reading level.
- Conduct the consent process in the subject’s primary language.
- Consider cultural issues.
- Consider alternative presentation methods (describe basic structure of study; use images to present ideas; drama and storytelling; use of Internet technology).
How does the principle of respect impact informed consent?
The principle of respect for persons requires that participation in research be truly voluntary, free from coercion or undue influence. Even when a study is innocuous, subjects must be informed that they do not have to take part and they may choose to stop participating at any time.
What are the major issues when using incentives?
Payment may become unduly influential if it is so high that it overrides other considerations for potential subjects. Determining whether incentives are unduly influential depends on the research context and the financial and emotional resources of the subject. Another potential problem for researchers is that if incentives are too attractive, subjects might misrepresent themselves in order to participate in the study.
What are 2 methods for documentation of informed consent?
1: The subject or the subjects legal representative signs a form containing all the required elements of consent and any other elements necessary to provide complete disclosure. (The person who signed the consent form is given a copy as a reference and reminder of the information conveyed.)
2: the consent is done orally and is documented by an impartial witness. This process uses two documents: short form written consent document stating that the required elements of consent have been presented orally to the subject or the subjects legally authorized representative, and a written IRB approved summary of what will be sent to the subject for the subjects representative. The subject signs the short form. The witness signed both forms. The person actually obtaining consent finds the summary. Copies of the short form and the summary are given to the subject. (Audio, video, and non-literate subjects using a mark to consent are options)
What is a waiver of documentation of informed consent?
Documentation of the consent process is not always required. Note, however, that waivers of documentation are not waivers of the consent process itself. Documentation maybe waived under two circumstances:
- The principal risks are those associated with the breach of confidentiality concerning the subjects participation in the research, and the consent document is the only record linking the subject with the research.
- study participation presents minimal risk of harm to the subject and the research involves no procedures requiring consent outside the context of participation in a research study (e.g., a phone survey about environmental education).
