Please note: All studies and their informed consent documents must have been reviewed and have been stamped approved by the CPHS prior to the enrollment of any human subjects. Only copies of the consent form that includes the appropriately dated CPHS approval stamp can and must be used when obtaining consent.
Documents for the informed consent process may take one of three forms, each to meet the needs of potential subjects:
Consent documents are signed by subjects 12 years and older. When necessary, they are signed or co-signed by the next of kin or guardians of adult subjects (in a descending order of priority: spouse, adult son or daughter; either parent; adult brother or sister). Minors are permitted to sign consent forms under applicable law.
Assent documents are signed by subjects 7 to 11 years of age provided the child is mature enough to understand the planned intervention. Verbal assent is to be obtained from children under the age of 7 whenever possible. Generally, the child's veto of participation is sufficient to make the child ineligible for inclusion in the study. However, the parent or guardian, with CPHS and physician approval, may override the veto if the intervention will benefit the child.
Parental Permission documents are signed by parents of children under age 18 or the legally appointed guardian. Consent of one parent is sufficient if research involves minimal risk; consent of both parents is necessary if the research involves more than minimal risk. However, if one parent is deceased, unknown, incompetent or reasonably unavailable, or if one parent has legal responsibility or custody of the child, one parent consent is acceptable.
Informed Consent/Assent/Permission Documents:
The following are the basic elements of informed consent which MUST be included in EACH consent document:
- A statement that taking part is voluntary, refusal to take part will involve no penalty or loss of benefits to which the subject is otherwise entitled, and the subject may stop taking part at any time without penalty, or loss of benefits to which the subject is otherwise entitled;
- 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 the identification of any procedures which are experimental;
- A description of any reasonably foreseeable risks or discomforts to the subject from the study procedures - these may be potential physical, psychological, legal or social risks;
- A description of any benefits to the subject or to others 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 is available for injury and an explanation as to whether 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 subjects’ rights, whom to contact in the event of a research-related injury to the subject, and a 24 hour phone number for the PI;
In this institution the following is MANDATORY language:
"If you suffer any injury as a result of taking part in this research study, please understand that nothing has been arranged to provide free treatment of the injury or any other type of payment. However, all needed facilities, emergency treatment and professional services will be available to you, just as they are to the community in general. You should report any such injury to (put the principal investigator's name and phone number here) and to the Committee for the Protection of Human Subjects at 713-500-7943. You will not give up any of your legal rights by signing this consent form."
**HOWEVER, the costs for care of a research-related injury when a subject is enrolled in a study sponsored by a pharmaceutical company, MUST be covered by the company. The following is mandatory "in case of injury" language for pharmaceutical company sponsored protocols:
"If you suffer any injury as a result of taking part in this research study, the sponsor of this study, (enter sponsor's name), will pay for reasonable and necessary medical expenses if the injury is a direct result of taking the study medicine or undergoing study procedures, and not due to the natural course of any underlying disease or treatment process. You should report any such injury to (put the principal investigator's name and phone number here) and to the Committee for the Protection of Human Subjects at 713-500-7943. You will not give up any of your legal rights by signing this consent form."
Additional elements of informed consent to be used when appropriate:
- 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 not known about at this time;
- Anticipated circumstances under which the subject's taking part in the study may be terminated by the investigator without regard to the subject's consent;
- Any additional costs to the subject that may result from taking part in the research;
- Describe reimbursement for expenses, parking, babysitting, etc. As well, describe compensation for taking part. If compensation is dependent upon completing certain portions of the study, give the schedule of payments. In no instance may this recruitment incentive be so large as to unduly induce subjects to remain in the study when they would otherwise have withdrawn.
- The consequences of a subject's decision to withdraw from the research and procedures for orderly termination of taking part in the study by the subject;
- A statement that important new findings developed during the course of the research which may relate to the subjects’ willingness to continue taking part will be given to the subject; indicate if subjects/controls will be given a summary of the results; indicate if subjects/controls will be told of problems uncovered by the study and if these will be told to a physician, agency, parent, employer. Indicate if provisions will be made for further care.
- The approximate number of subjects involved in the study (use the word "about" rather than "approximately" in the consent document).
- If the research will result in the development of a commercial product indicate what benefits, if any, will accrue to the subject from whom tissue has been taken.
The circumstances for obtaining consent must:
- provide ample opportunity for the subject to consider
- minimize the possibility of coercion or undue influence
- be done in simple and clear language directed to the level of the subject's understanding
- include no exculpatory language
** Special Notes **
2nd Person: The CPHS requests that the consent forms are written in 2nd person ("you"). It is preferred that the consent forms are read in the "you" format, rather than the "I" format.
Initials: It is CPHS policy not to accept consent forms that request subject's initials on each (or any) page of the consent document. It is the committee's view that this makes the consent form appear to be a legal document, which it is not.
Headings: It is preferred by the CPHS that headings are used when writing the informed consent form (see the sample that is provided).
Translations: Every effort should be made to translate the informed consent form using the preferred language of the potential subject involved. The verbal translation of an English consent form is not an acceptable means to obtain proper consent (since investigators are REQUIRED to provide subjects with a copy of their signed informed consent form for future reference). The CPHS does not require that a certified translation be submitted for review and approval, HOWEVER, we would prefer a certified translation for certain languages (i.e. Vietnamese, Chinese, etc).
Subjects who cannot read: When enrolling subjects who are illiterate, the consent document should be fully discussed with the subject and the subject should be given an opportunity to ask questions or for clarification. The person authorized to obtain consent may either:
- make a note that the subject cannot read but that the consent document was fully explained, the subject had adequate time to ask questions, and that he/she acknowledged that they understood what was explained and has agreed to participate,
OR
- if there is someone of legal age accompanying the subject,then that person can sign the consent document indicating that the consent document was fully explained, the subject was provided ample opportunity to ask questions, and that the subject understands what has been explained and has agreed to participate. The person signing the consent document should also include a note of what their relationship is to the subject.
Witness Signature Line: This is no longer being used - please do not add it to new consent forms and remove it from the older ones.
Time of Signature: This is a new requirement, the CPHS is asking that the subject indicate the time that the consent form was signed, in addition to the date.
Pharmaceutical Company Written Informed Consent Forms: Informed consent forms for pharmaceutical sponsored protocols that are written by the pharmaceutical company should not be submitted to the CPHS unless they are revised using the CPHS format and language as detailed above.
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