California Experimental Subject's Bill of Rights :. Regulations: 45 CFR Read News Watch YouTube. That the only record linking the subject and the research would be the consent document, and the principal risk would be potential harm resulting from a breach of confidentiality. Each subject will be asked whether the subject wants documentation linking the subject with the research, and the subject's wishes will govern; or.
That the research presents no more than minimal risk of harm to subjects, and involves no procedures, for which written consent is normally required outside of the research context. In cases in which the documentation requirement is waived, the IRB may require the investigator to provide subjects with a written statement regarding the research. The IRB shall determine that adequate provisions are made for soliciting the assent of the children, when in the judgment of the IRB the children are capable of providing assent.
If the IRB determines that the capability of some or all of the children is so limited that they cannot reasonably be consulted, or that the intervention or procedure involved in the research holds out a prospect of direct benefit that is important to the health or well-being of the children, and is available only in the context of the research, the assent of the children is not a necessary condition for proceeding with the research. To sign up for updates or to access your subscriber preferences, please enter your contact information below.
The description should not understate the probability and magnitude of the reasonably foreseeable risks and discomforts. If applicable, the consent document should include a description of the reasonably foreseeable risks not only to the subject, but also to "others" for example, radiation therapy where close proximity to subjects post procedure may be of some risk to others.
When appropriate, a statement must be included that the clinical investigation may involve currently unforeseeable risks to the subject or to the subject's embryo or fetus, if the subject is or may become pregnant. A description of any benefits to the subject or to others which may reasonably be expected from the research. The description of potential benefits should be clear, balanced, and based on reliable information to the extent such information is available.
This element requires a description of the potential benefits not only to the subject for example, "This product is intended to decrease XXX; however, we cannot guarantee that you will benefit" , but also to "others" for example, "your participation in this research may not benefit you but may benefit future patients with your disease or condition".
Overly optimistic representations of the clinical investigation may be misleading and may violate FDA regulations that prohibit promotion of investigational drugs and devices see 21 CFR FDA considers payment to subjects for participation in clinical investigations to be compensation for expenses and inconveniences, not a benefit of participation in research.
If payments are provided, the consent process should not identify them as benefits. Alternative Procedures or Treatments. A disclosure of appropriate alternative procedures or courses of treatment, if any, that might be advantageous to the subject.
To enable an informed decision about taking part in a clinical investigation, consent forms must disclose appropriate alternatives to entering the clinical investigation, if any, that might be advantageous to the subject. Prospective subjects must be informed of the care they would likely receive if they choose not to participate in the research. This includes alternatives such as approved therapies for the patient's condition, other forms of therapy e.
Standard of care may include uses or treatment regimens that are not included in a product's approved labeling or, in the case of a medical device cleared under the k process, in the product's statement of intended uses. When disclosing appropriate alternative procedures or courses of treatment, FDA believes a description of any reasonably foreseeable risks or discomforts and potential benefits associated with these alternatives must be disclosed.
Where such descriptions or disclosures can contain quantified comparative estimates of risks and benefits e. The agency does not believe that imposing such a strict requirement for every case would be realistic or appropriate. It may be appropriate to refer the subject to a healthcare professional who can more fully discuss the alternatives, for example, when alternatives include various combinations of treatments such as radiation, surgery and chemotherapy for some cancers. This referral should be completed prior to the subject signing and dating the consent form.
FDA recognizes that, while an individual subject may be eligible for more than one clinical investigation, that determination and the decision as to which trial would be most appropriate for a particular subject would need to be made on a case-by-case basis. FDA believes that the discussion of other trials for which the subject may be eligible is best left to the informed consent discussion rather than the informed consent document and may need to include the subject's primary care provider.
As applicable, the informed consent process should advise that participation in one clinical investigation may preclude an individual's eligibility to participate in other clinical investigations for the same or other indications.
When there are multiple clinical investigations for evaluating the treatment of a particular disease, the sequence in which a subject may participate in the protocols may be important and should be discussed with the subject and the subject's primary care provider, if appropriate. A statement describing the extent, if any, to which confidentiality of records identifying the subject will be maintained and that notes the possibility that the Food and Drug Administration may inspect the records.
The consent process must describe the extent to which confidentiality of records identifying subjects will be maintained 21 CFR FDA may inspect study records, for example, to assess investigator compliance with the study protocol and the validity of the data reported by the sponsor.
See also 21 CFR FDA generally will not copy records that include the subject's name unless there is reason to believe the records do not represent the actual cases studied or results obtained. When FDA requires subject names, FDA will generally treat such information as confidential, but on rare occasions, FDA may be required to disclose this information to third parties, for example, to a court of law.
Therefore, the consent process should not promise or imply absolute confidentiality by FDA. Compensation and Medical Treatment in Event of Injury. 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.
For clinical investigations involving more than minimal risk, the informed consent process must describe any compensation and medical treatments available to subjects if injury occurs. Because available compensation and medical treatments may vary depending on the medical circumstances of the individual subject or the policies of the institution, the consent process should include an explanation to subjects of where they may obtain further information. An example of an adequate statement is, "the sponsor has made plans to pay for medical costs related to research-related injuries" followed by an explanation of how to obtain further information.
If no compensation is available, the consent process should include statements such as: An explanation of whom to contact for answers to pertinent questions about the research and research subjects' rights, and whom to contact in the event of a research-related injury to the subject.
The consent process must provide information on how to contact an appropriate individual for pertinent questions about the clinical investigation and the subjects' rights, and whom to contact in the event that a research-related injury to the subject occurs. This information should include contact names or offices and their telephone numbers. FDA recommends that the individual or office named for questions about subjects' rights not be part of the investigational team.
Subjects may be hesitant to report specific concerns or identify possible problems to someone who is part of the investigational team. In addition, the consent process should include information on whom to contact and what to do in the event of an emergency, including hour contact information, if appropriate.
If contact information changes during the clinical investigation, then the new contact information must be provided to the subject. This may be done through a variety of ways, for example, a card providing the relevant contact information for the clinical investigation. A statement that participation is voluntary, that refusal to participate will involve no penalty or loss of benefits to which the subject is otherwise entitled, and that the subject may discontinue participation at any time without penalty or loss of benefits to which the subject is otherwise entitled.
This element requires that subjects be informed that they may decline to take part in the clinical investigation or may stop participation at any time without penalty or loss of benefits to which subjects are entitled. Language that limits the subject's right to decline to participate or withdraw from the clinical investigation must not be used.
If special procedures should be followed for the subject to withdraw from the clinical investigation, the consent process must outline and explain the procedures 21 CFR Also note that subjects may not withdraw data that was collected about them prior to their withdrawal, as discussed in Section V.
I, Data Retention upon the Withdrawal of Subjects. The regulations identify additional elements of informed consent to be included, when appropriate. When appropriate, one or more of the following elements of information shall also be provided to each subject:.
The following elements are appropriate to provide to prospective subjects when the IRB determines the information is material to prospective subjects' decisions to participate:.
A statement that the particular treatment or procedure may involve risks to the subject or to the embryo or fetus, if the subject is or may become pregnant which are currently unforeseeable. When appropriate, the consent process must contain a statement that the particular test article or procedure may involve risks to subjects or to the embryo or fetus, if the subject is or may become pregnant that are currently unforeseeable.
If long-term safety studies such as bench and animal testing are not completed, the informed consent process should explain that researchers have not completed studies that may identify potential risks, for example, carcinogenicity or teratogenicity. Involuntary Termination of Subject's Participation.
Anticipated circumstances under which the subject's participation may be terminated by the investigator without regard to the subject's consent. When appropriate, the consent process must inform the subject of anticipated circumstances under which the investigator may end the subject's participation without the subject's consent.
Such circumstances may arise if, for example, the subject is unable to comply with procedures required by the clinical investigation, if the subject no longer meets the eligibility criteria for continuing in the study, or if the site withdraws from the study.
If a subject is withdrawn from the study, the clinical investigator should explain to the subject the reasons for withdrawal, discuss other available treatment or research options, and, if appropriate, discuss plans to follow the subject after withdrawal for side effects. Additional Costs to Subject. Any additional costs to the subject that may result from participation in the research. If subjects may incur additional expense because they are taking part in the clinical investigation, the consent process must explain the added costs.
Subjects should be made aware that insurance or other reimbursement mechanisms might not fund the medical care they receive because they are participating in a clinical investigation even when the care is the standard care they would otherwise receive if not participating in a clinical investigation. Additionally, insurance or other forms of reimbursement might not pay for care related to complications or injuries arising from participation in a clinical investigation.
See also section III. If funds will be available to cover costs not covered by insurance or other forms of reimbursement, the consent form should describe how these funds will be made available to subjects or direct subjects on how to obtain further information. Because these issues may be complex, it may be appropriate to refer the subject to a knowledgeable financial counselor or reimbursement specialist to explain the costs and the insurance and reimbursement issues prior to signing the consent form.
Beyond the costs directly related to participation in the research, it may be appropriate to identify additional costs that the subject may incur, such as loss of income when the subject takes time off from work to participate in the clinical investigation and transportation costs. In some cases the cost of an investigational product may be charged to the subject. In clinical investigations involving investigational devices, the sponsor is permitted to recover the costs of research, development, manufacture, and handling of investigational devices see 21 CFR FDA may authorize sponsors in certain clinical investigations of drugs to recover the direct costs of making the investigational drug available, such as costs to manufacture, ship, and handle e.
Consequences of Subject's Decision to Withdraw. The consequences of a subject's decision to withdraw from the research and procedures for orderly termination of participation by the subject.
When appropriate, the consent process must describe the consequences of a subject's decision to withdraw from the clinical investigation and the procedures for orderly termination of participation by the subject. For example, when withdrawal from a clinical investigation may adversely affect the subject, the informed consent process must explain the withdrawal procedures that are recommended in order to ensure the subject's safety, and should specifically state why they are important to the subject's welfare.
For some clinical investigations, an intervention should be withdrawn gradually or the investigator may recommend follow-up to ensure the subject's safety when an investigational intervention is prematurely terminated due to a subject's withdrawal. In these cases, the consent process must explicitly inform the subject of the potential adverse effects of premature termination of the investigational intervention.
If applicable, the consent process must explain whether a subject who withdraws early will receive future payments. Providing Significant New Findings to Subjects. A statement that significant new findings developed during the course of the research which may relate to the subject's willingness to continue participation will be provided to the subject. The consent process must, when appropriate, include a statement that significant new findings that may relate to the subject's willingness to continue participation, such as new risk information, will be provided to the subject.
Significant new findings may include an unexpected adverse event or an adverse event occurring at greater frequency or severity than previously stated in the consent process. FDA encourages the inclusion of this statement in the consent form for clinical investigations where knowledge of risk is limited, for example, clinical investigations of the first use in humans, novel therapies, and new molecular entities, or complex clinical investigations that involve significant risk.
The approximate number of subjects involved in the study. The informed consent process must state the approximate number of subjects who will be involved in the clinical investigation, when appropriate. For example, a subject's decision may be influenced by knowledge that the clinical investigation is a small initial trial of the product such as a phase 1 or 2 drug clinical investigation or a device feasibility clinical investigation where only a small number of subjects participate.
When seeking informed consent for applicable clinical trials, as defined in 42 U. This will notify the clinical trial subject that clinical trial information has been or will be submitted for inclusion in the clinical trial registry databank under paragraph j of section of the Public Health Service Act.
This Web site will not include information that can identify you. At most, the Web site will include a summary of the results. You can search this Web site at any time. All informed consent forms and processes for "applicable clinical trials" 26 initiated on or after March 7, , must contain the above quoted statement. Requirement for Written Documentation of Informed Consent.
A copy shall be given to the person signing the form. When obtaining informed consent, informed consent must be documented by a signed and dated written consent form except under two specific circumstances, as described in FDA's regulations at 21 CFR When written informed consent is required, the use of electronic, including digital, signatures is permitted under FDA's regulations, provided it is in compliance with applicable regulations.
Additionally, the IRB may require the investigator to provide subjects with a written statement regarding the clinical investigation. FDA recommends that when an IRB waives the documentation requirement for informed consent in circumstances where there is minimal risk of harm as allowable under 21 CFR Alternative Methods of Obtaining Informed Consent.
Traditionally, informed consent has been obtained in a face-to-face interview using paper consent forms. New technologies are becoming available that may serve as an alternative to the paper consent form in the informed consent process. Parties interested in pursuing alternative methods of obtaining informed consent are encouraged to contact FDA. Even in the context of paper consent forms, there may be certain circumstances when an alternative to a face-to-face consent interview may be appropriate.
For example, such an alternative may be appropriate when the subject or the subject's legally authorized representative is unable to visit the investigational site to sign the consent form, or if the screening procedures for the clinical investigation require prior activity, such as fasting, that requires consent but does not require a visit to the investigational site. When written informed consent is required, informed consent cannot be obtained solely by telephone.
For studies involving no more than minimal risk, and no procedures for which written consent is normally required outside the research context, oral consent from a subject or a subject's legally authorized representative is permissible under 21 CFR When oral consent is used, FDA recommends that documentation of the process information provided, name of individual obtaining consent, date consent obtained be included in the study records see 21 CFR Methods other than a face-to-face consent interview may be acceptable if those methods allow for an adequate exchange of information and documentation, and a method to ensure that the signer of the consent form is the person who plans to enroll as a subject in the clinical investigation or is the legally authorized representative of the subject.
For example, the consent form may be sent to the subject or the subject's legally authorized representative by facsimile or e-mail, and the consent interview may then be conducted by telephone when the subject or subject's legally authorized representative can read the consent form during the discussion.
After the consent discussion, the subject or the subject's legally authorized representative can sign and date the consent form and return the document to the clinical investigator by facsimile, scanning the consent form and returning it through a secure e-mail account, or by posting it to a secure internet address.
The signed document should be filed with the subject's case history. In addition, the person signing the consent form must receive a copy of the consent form 21 CFR Although FDA regulations do not require the subject's copy to be a signed copy, FDA recommends that a copy of the signed consent form be provided.
In addition to signing the consent form, the subject or the subject's legally authorized representative must enter the date of signature on the form 21 CFR The person signing the consent form must receive a copy of the consent form 21 CFR This form may be read to the subject or the subject's legally authorized representative, but, in any event, the investigator shall give either the subject or the representative adequate opportunity to read it before it is signed.
When this method is used, there shall be a witness to the oral presentation. Also, the IRB shall approve a written summary of what is to be said to the subject or the representative. Only the short form itself is to be signed by the subject or the representative. However, the witness shall sign both the short form and a copy of the summary, and the person actually obtaining the consent shall sign a copy of the summary. A copy of the summary shall be given to the subject or the representative in addition to a copy of the short form.
The regulations provide for obtaining written informed consent by two different methods: a long form that embodies all the elements of informed consent see 21 CFR The long form embodies all the elements of informed consent as required under 21 CFR When the long form is used, a copy must be provided to the person signing the form, that is, the subject or the subject's legally authorized representative.
An IRB may approve a short form to be used in appropriate situations where the elements of informed consent required by 21 CFR For example, IRBs may consider approving the use of a short form in situations where the subject or the subject's legally authorized representative is unable to read due to illiteracy or blindness see section V. D, Physically Challenged Subjects. When the short form is used, the IRB is required to approve a written summary of the information to be presented orally.
The information presented orally is to be the same quantity and quality of information as when a long form is used. Use of the short form requires that a witness be present to the oral presentation of information to the subject or the subject's legally authorized representative. FDA recommends that an impartial third party, not otherwise connected with the clinical investigation for example, clinical staff not involved in the research or a patient advocate , serve as the witness.
FDA recommends that the witness be present physically or by some other means, for example by phone or video conference during the entire consent process, not just the signing of the consent form. The purpose of the witness is generally to attest to the voluntariness of the subject's consent and the adequacy of the consent process by ensuring that the information was accurately conveyed and that the subject's questions were answered.
The subject or the subject's legally authorized representative only signs and dates the short form. The witness must sign both the short form and the summary, and the person obtaining consent must sign the summary.
IRBs, clinical investigators, and sponsors have responsibility for ensuring that the informed consent process is adequate and meets FDA's regulatory requirements. The regulatory requirements represent the minimum information to be provided to potential subjects for informed consent. IRBs, sponsors, and investigators should consider providing additional information as appropriate.
A critical part of this responsibility is for the IRB to ensure there is an adequate informed consent process that protects the rights and welfare of subjects participating in clinical investigations 21 CFR Review of All Informed Consent Materials. IRBs must review all materials used in the informed consent process. The IRB's review is to ensure that information given to subjects as part of the consent process contains the elements identified in 21 CFR When reviewing clinical investigations, IRBs must ensure that the consent process minimizes the possibility of coercion and undue influence 21 CFR When a clinical investigation involves subjects who are likely to be vulnerable to coercion or undue influence, IRBs must determine that additional safeguards have been included in the clinical investigation to protect their rights and welfare.
For example, local circumstances may necessitate the inclusion of additional information relevant to the informed consent process for potential subjects from that particular community. HHS recommends that IRBs consider whether subjects should be informed of any financial relationships or interests that are associated with the clinical investigation, such as payments for services, equity interests or intellectual property rights.
IRBs should determine whether subjects should be provided with information regarding the source of funding, funding arrangements, financial interests of parties involved in the clinical investigation, and any financial interest management techniques applied. The IRB should consider the kind, amount and level of detail of information to be provided to subjects. The IRB has the authority and responsibility to require that information given to subjects as part of informed consent be in accordance with 21 CFR Investigators must use an IRB-approved written consent form when documenting informed consent, in accordance with 21 CFR Thus, the IRB should review the adequacy and appropriateness of all wording in the consent materials, as well as the overall length and presentation of information.
Consent forms that are long, complex, legalistic, and have a high reading level 39 may overwhelm potential subjects and may inhibit reading of the full document and understanding of the relevant information. A description of any foreseeable risks or discomforts to the subject A description of any benefits to the subject, or society, that may reasonably be expected from the research. If appropriate, a disclosure of appropriate alternative procedures or treatments, if any, that might be advantageous to the subject.
A statement describing the extent to which confidentiality of records identifying the subject will be maintained. For research involving more than minimal risk, an explanation of the compensation and medical treatments available if injury occurs, and where further information may be obtained.
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