For most research, informed consent is documented using a written document that provides key information regarding the research. However, even if a signed consent form is required, it alone does not constitute an adequate consent process. The informed consent process is an ongoing exchange of information between the investigator and the subject and could include, for example, use of question and answer sessions, community meetings, and videotape presentations.
In all circumstances, however, individuals should be provided with an opportunity to have their questions and concerns addressed on an individual basis. The consent process and its documentation should be revised when deficiencies in its accuracy or completeness are noted, when new information about reasonably foreseeable risks and potential benefits becomes available, or when other additional information becomes known that will improve the consent process. Such revisions must be reviewed and approved by an IRB prior to the revised consent being utilized except when necessary to eliminate apparent immediate hazards to subjects 45 CFR Yes, in certain circumstances it is possible to obtain legally effective informed consent in an urgent or emergency care setting.
For a particular research study, the answer depends on 1 the expected medical condition of the prospective subject population; 2 the nature of the research; 3 whether there is sufficient time for the potential subjects or their legally authorized representatives to consider participation; and 4 whether the circumstances for obtaining informed consent appropriately minimize the possibility of coercion or undue influence.
For example, what is the likely health and emotional condition of the patient population being considered for the proposed research e. What is the likely ability of this population during the consent process to process information, ask questions, and consider the risk involved?
What is the timing of the consent process and is it so close to the receipt of care that the patient might blur the distinction between treatment and research? Because individuals receiving urgent or emergent medical care frequently may be vulnerable to coercion or undue influence, even if temporarily, additional protections may be required to ensure the subject's consent to participate in research is truly voluntary and sought under circumstances that minimize the possibility of coercion or undue influence 45 CFR In addition, in some cases, it might be possible to obtain consent from a legally authorized representative e.
In certain emergency circumstances, the Secretarial waiver of informed consent under 45 CFR It should be noted that if the research is regulated by FDA, the Secretarial waiver permits the research to be conducted under a comparable provision.
Additional elements are described at 45 CFR When determined to be appropriate by the Institutional Review Board IRB , subjects must be provided with one or more of the following additional elements of information during the informed consent process see 45 CFR It is up to the IRB to determine in a particular instance whether some or all of the above additional elements must be included as part of the informed consent process for a particular study.
The IRB should make this determination based on the nature of the research and its knowledge of the local research context. If the IRB determines that additional elements are appropriate to the research study, this additional information should be considered just as essential as the eight basic elements of informed consent described in the HHS regulations at 45 CFR However, OHRP is aware that these terms are sometimes used by investigators or IRBs to describe a process in which consent or parental permission requirements have been altered or waived, or for which the requirement to document consent or parental permission has been waived.
However, under conditions specified in the regulations at 45 CFR In addition, under conditions specified in the regulations at 45 CFR Note that the regulations at 45 CFR For example, a researcher conducting a survey that does not qualify for an exemption under 45 CFR The survey materials clearly state that by responding to the questions and mailing the survey back, the recipients have agreed to participate in the research.
However, the materials accompanying the questionnaire do not include all of the elements of consent listed at 45 CFR If the IRB has approved this alteration of the consent process and has waived the need for documentation of consent, then such procedures are permissible under the regulations. By sending back a completed survey the recipient has implied that he or she consents to participate but has not signed an informed consent document. For example, researchers collecting survey and behavioral data from children at school provide parents with information regarding the study by mail and ask the parent s to return a form if they do not want their child to participate.
Sometimes this practice is referred to as an opt out procedure, which is not consistent with the regulatory requirement for seeking and obtaining parental permission. If the IRB determines that the conditions for waiver of parental permission can be met, then the IRB could waive the requirement for parental permission under 45 CFR Even though not required by the regulations, an IRB may require that parents be given the opportunity to refuse permission even when the IRB has waived the regulatory requirement to obtain parental permission.
This requirement applies to all nonexempt human subjects research not eligible for a waiver of the consent requirements. Coercion occurs when an overt or implicit threat of harm is intentionally presented by one person to another in order to obtain compliance.
For example, an investigator might tell a prospective subject that he or she will lose access to needed health services if he or she does not participate in the research. Undue influence , by contrast, often occurs through an offer of an excessive or inappropriate reward or other overture in order to obtain compliance.
For example, an investigator might promise psychology students extra credit if they participate in the research. If that is the only way a student can earn extra credit, then the investigator is unduly influencing potential subjects. If, however, she offers comparable non-research alternatives for earning extra credit, the possibility of undue influence is minimized. In addition to undue influence that can arise with the offering of rewards, undue influence also can be subtle. For example, patients might feel obligated to participate in research if their physician is also the investigator, or students might feel pressure to participate in research if everyone else in the class is doing so.
It is up to the IRB to use its discretion in determining which circumstances give rise to undue influence. For example, an IRB might consider whether the informed consent process will take place at an appropriate time and in an appropriate setting, and whether the prospective subject may feel pressured into acting quickly or be discouraged from seeking advice from others. Because of their relative nature and lack of clear-cut standards on the boundaries of inappropriate and appropriate forms of influence, investigators and IRBs must be vigilant about minimizing the possibility for coercion and undue influence.
Reasonable assessments can be made to minimize the likelihood of undue influence or coercion occurring. For example, IRBs may restrict levels of financial or nonfinancial incentives for participation and should carefully review the information to be disclosed to potential subjects to ensure that the incentives and how they will be provided are clearly described. Known benefits should be stated accurately but not exaggerated, and potential or uncertain benefits should be stated as such, with clear language indicating how much is known about the uncertainty or likelihood of these potential benefits.
Thus, inducements that would ordinarily be acceptable in some populations may become undue influences for these vulnerable subject groups. Paying research subjects in exchange for their participation is a common and, in general, acceptable practice.
However, difficult questions must be addressed by the IRB. Remuneration for participation in research should be just and fair. However, the specifics of each protocol will influence how those determinations are made. Both researchers and IRBs need to be familiar with the study population and the context of the research in order to make reasonable judgments about how compensation might affect participation.
Wherever the remuneration is set, it will influence the decisions of some more than others. In particular, it will be more important to those for whom it will make a significant financial difference. Information submitted to IRBs should indicate and justify proposed levels and purposes of remuneration, which also should be clearly stated in the accompanying consent forms. Some institutions have adopted policies regarding the recruitment and payment of volunteers.
IRBs and investigators should ensure that the consent process includes a detailed account of the terms of payment, including a description of the conditions under which a subject would receive partial or no payment e. For example, if the study is conducted over a period of 6 months, there might be a monthly or bi-monthly payment.
Or, if the study involves 12 sessions, there might be payment after every two sessions. The above principles would apply to remuneration offered to parents whose children are prospective subjects. The level of remuneration should not be so high as to cause a prospective subject to accept risks that he or she would not accept in the absence of the remuneration.
The second sentence has been deleted to clarify that remuneration to subjects may include compensation for risks associated with their participation in research and that compensation may be an acceptable motive for agreeing to participate in research. In addition, the previous version contained the following sentence, which has been struck because it is focused on IRB considerations under 45 CFR Yes, in certain circumstances. Non-monetary incentives e.
Informed consent always must be voluntary 45 CFR Overt coercion e. However, it might be permissible to provide incentives to participate that do not constitute undue influence. To make this determination, IRBs should know who the subject population will be, what incentives are being offered, and the conditions under which the offer will be made.
The regulations require that the investigator seek consent only under circumstances that minimize the possibility of coercion or undue influence 45 CFR The Office for Human Research Protections OHRP recommends that institutions have policies in place that clarify for students and faculty that any participation of students in research must be voluntary.
Reasonable levels of extra credit or rewards may be offered for participating in research. If extra credit or rewards are offered for participation, students must be provided with and informed of non-research alternatives involving comparable time and effort to obtain the extra credit in order for the possibility of undue influence to be minimized. However, if participation in research is a course requirement, students must be informed of non-research alternatives involving comparable time and effort to fulfill those requirements in order for the possibility of undue influence to be minimized.
Moreover, students must not be penalized for refusing to participate in research 45 CFR Extra credits or other rewards are often offered as an incentive to encourage participation. Students who sign up for such pools have not legally consented to participate in a research study since they have not been provided with sufficient information concerning the exact study in which they would participate. Thus, signing up to be in a subject pool is only a first and preliminary step by which individuals can indicate their willingness to be considered for research participation.
The student must also provide informed consent, unless the consent requirement is waived by an IRB once he or she is being considered for a specific study 45 CFR Furthermore, individuals in the pool must be free to decline participation in any available research projects without penalty 45 CFR The issues involving employees as research subjects are essentially identical to those involving students as research subjects: that is, investigators and IRBs must be cautious about the potential for coercion or undue influence and the need to protect confidentiality.
For some research projects, the IRB may approve a request to waive the documentation of informed consent. This means that the study team must provide a subject with the required consent information, but the study team is not required to obtain the subject's signature on the informed consent document. Subjects should be offered a copy of the consent information for their records even when a signed document is not required for the project. Under the Common Rule , there is an addtional requirement for the IRB approval of an informed consent documentation waiver request:.
It is not appropriate to request a waiver of documentation of informed consent for human subject projects that collect biospecimens. There are times when the usual informed consent rules do not apply. This varies from state to state and may include:. See Advance Directives for more detailed information on this process.
This choice should be made to the extent permitted by the law. Sometimes, the patient may be unconscious or unable to make an informed decision.
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