7.1 General Provisions
It clearly should be kept in mind that, although there are both governmental and University regulations that require the subject or the subject's legally authorized representative to give consent prior to the subject's participation in a study, the principal reason for informing subjects about a study is that they have a moral and ethical right to know what is to be done to them and what dangers this entails before they give their consent. An experiment or other forms of research entail something that is done to the subject, and, therefore, differs from the usual clinical practice where something is done for the patient. The use of human subjects is a privilege (a favor) granted to the investigator, rather than a right.
An investigator shall seek such consent only under circumstances that provide the prospective subject or the representative sufficient opportunity to consider whether or not to participate and that minimize the possibility of coercion or undue influence. An individual does not abdicate any rights by consenting to be a research subject. A subject has the right to withdraw from a research project at any time or to refuse to participate without loss of benefits to which the subject would otherwise be entitled. Further, a subject has the right to receive appropriate professional care, to enjoy privacy and confidentiality in the use of personal information and to be free from undue embarrassment, discomfort, anxiety, and harassment.
It is recommended that, whenever possible, the principal investigator obtain informed consent from the participants themselves. The investigator must seek consent only under circumstances that provide the prospective subject sufficient opportunity to consider whether or not to participate (i.e., participation in projects must be voluntary).
Unless the IRB issues a specific waiver (see Section 7.6), written informed consent of subjects is required for all non-exempt research projects where there is any risk to the human participants. If a subject is not legally or physically capable of giving informed consent, a legally authorized representative may do so. Careful consideration will be given to the representative's depth of interest in and concern for the subject's rights and welfare.
7.2 The Consent Form
7.2.1 Stationery: The informed consent form must be written on official Sacred Heart University stationery.
7.2.2 Language, style and level: The informed consent form should be written in the second person. When combined with conditional language and the invitation to participate, use of the second person communicates that the investigator believes there is a choice to be made by the prospective subject. Use of the first person may be interpreted as presumption of subject consent before consent has been legally obtained.
The information that is given to the subject or the representative shall be in language understandable to the subject or the representative. It should be remembered that terms commonly used by members of a profession are a part of the professional's language, a language many people outside that profession do not understand. Common words in medicine, such as catheter, intravenous (let alone IV), prognosis, or symptomatology are not understood by many lay persons. Terms in the fields of psychology/sociology such as cognitive style, attribution and social sufficiency are also misunderstood. If there is any doubt that a term may not be understood, a definition should be added, e.g., "intravenous (given directly into a vein by way of a needle) ", or "4 cc (a teaspoon)." If some of the anticipated subject population does not understand English, appropriate translation should be provided.
The informed consent form must not contain any exculpatory language through which the subject or the subject's representative is made to waive or appear to waive any of the subject's legal rights, or through which s/he releases or appears to release the research investigator, the sponsor, the institution or its agents from liability for negligence.
7.2.3 Length: The informed consent form should be lengthy enough to explain consent factors adequately but not so lengthy as to lose the attention of the subject or to cause confusion. It is preferred that the consent form not exceed one side of the paper; if it is longer, it should be printed on both sides of the same sheet. If it is necessary to use multiple sheets, a blank for the subject to initial should be placed at the bottom of all sheets where the signature blank does not appear.
7.3 Elements of Informed Consent
The most common reason for delay of approval of a proposal is an inadequate consent form. It is, therefore, recommended that all investigators review carefully the elements of information that should be communicated to the prospective consenter and utilize the checklist for consent form review (Appendix A). An informed consent form must be structured to fit each project. In general, however, the consent form should be written to include the appropriate elements of information in the same sequence as described in this document. Each element (or appropriate combination) should be identified by a subheading in bold type. (45 CFR 46.116)
7.3.1 Invitation: The consent form should begin with a clear invitation (not a request or demand) to the individual to participate in the research study.
7.3.2 Basis for subject selection: The consent form should state why the prospective subject has been selected. This statement should help the subject assess the nature and importance of participation. When appropriate, the approximate number of subjects involved in the study and the criteria for subject exclusion should be stated.
7.3.3 Overall purpose: The consent form must contain a clear statement of the overall purpose of the research, which should help the subject assess the importance of the study relative to individual values. When appropriate, this statement should include not only the immediate purpose of the study, but also any larger, ultimate purpose.
7.3.4 Explanation of procedures: The explanation of procedures section of the consent form should include the following:
(1) A description of each research procedure and how often it will be performed.
(2) Identification of any procedure that is experimental.
(3) Identification of the individual(s) who will perform the procedures and/or interact with the subject. Procedures involving human subjects should be performed only by qualified individuals. Biomedical research involving human subjects must be conducted under the supervision of a clinically competent, licensed individual.
(4) A statement of where the research will be conducted, when the research will be conducted, and how much time will be required of the subject.
(5) If the research study involves incomplete disclosure or deception, all subjects should be debriefed as soon as possible after participation. The consent form for non-disclosure/deception studies should normally contain a statement concerning when and where the debriefing session will be held.
(6) The explanation of procedures section should not contain detailed instructions to the subject. Detailed instructions should be placed on a separate form.
7.3.5 Description of risks and discomforts: Risks can be classified generally as physical, psychological, social, legal, and economic. A risk is a potential harm that a reasonable person, in what the investigator knows or should know to be the subject's position, would be likely to consider significant in deciding whether or not to participate in the research. Both immediate and latent risks of any procedure involving human subjects must be clearly and adequately described. The estimated probability, severity, average duration and reversibility of any potential injury should be stated. Any discomfort and/or pain (physical and/or psychological) associated with any procedure involving human subjects must be clearly and adequately stated. Certain populations of subjects may be at greater risk than others. The investigator should consider the potential risk characterization of the subject population when describing risk(s). If there are no known risks associated with the research, this should be so stated.
7.3.6 Description of benefits: If any substantial benefits to the subject or to others reasonably can be expected, they should be described. It must be stated in the description that the benefits are hoped for and not guaranteed by the investigator. Financial compensation or economic benefits should not be described in the same section as physical, health, psychological or social benefits. If there are no benefits to the subject, it must be stated.
7.3.7 Disclosure of alternatives: When a component of the protocol is designed to enhance the well-being of the subject, the consent form must state any appropriate alternative procedures or course of treatment that might be advantageous to the subject.
7.3.8 Assurance of confidentiality: This section of the consent form should state that any information that is obtained in connection with the study and that could identify the subject will remain confidential and will be disclosed only with the subject's permission. If the investigator intends to release any information, the consent form must state the persons or agencies to whom information will be furnished, the nature of the information to be furnished, and the purpose of the disclosure. When appropriate, the ultimate disposition of data should be described. Particular care should be exerted with respect to data in the form of media, such as audio or visual recordings.
7.3.9 Financial obligations: This section of the consent form should state clearly all financial obligations of the subject with respect to both the study and any related therapy. If there is the potential of additional cost to the subject from participation in the study, it must be disclosed. If there is no cost to the subject, it should be so stated.
7.3.10 Financial compensation: Any economic benefits to the subject should be clearly stated. Economic benefits include cash payments, free physical examinations, free treatment, free medications, treatment at lower cost, free food, etc. Cash payments should be stated in dollar amounts and any condition such as partial payment or no payment for early termination and bonuses for completion should be stated. The nature and amount of financial compensation must not constitute undue inducement of the subject.
7.3.11 In case of injury: For research studies 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.
7.3.12 Voluntary participation, subject withdrawal: The consent form must contain 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. The following standard non-coercive disclaimer should be used: "Participation is voluntary. Your decision whether or not to participate will not affect your _______________(insert "present or future clinical care at" or "present or future relationship with" as appropriate)SacredHeartUniversity (and/or other named institution as appropriate). If you decide to participate, you are free to withdraw your consent and to discontinue participation at any time."
7.3.13 Offer to answer questions: The consent form must contain an offer to answer all immediate and subsequent questions that the subject may have.
7.3.14 Conclusion: The consent form must contain the following standard consent statement in bold type:
"YOU ARE MAKING A DECISION WHETHER OR NOT TO PARTICIPATE. YOUR SIGNATURE INDICATES THAT YOU HAVE DECIDED TO PARTICIPATE, HAVING READ THE INFORMATION PROVIDED ABOVE. YOU WILL BE GIVEN A COPY OF THIS CONSENT FORM TO KEEP."
Signature of Subject Date
Signature of Witness Signature of Investigator (if required)
The signature of a witness is required for all research studies involving more than minimal risk. If possible, the witness should be someone who is not involved in the study.
7.3.15 Identification of investigator(s): The name, professional degree(s), and office
telephone number(s) of the investigator(s) must be provided. For research studies involving more than minimal risk, the home/cell phone number(s) of the investigator(s) must be provided. An explanation of who to contact for answers to pertinent questions about the research and research subjects' rights, and who to contact in the event of a research-related injury to the subject should be made clear.
The identification of investigator(s) section of the informed consent form should be placed at the end of the consent form following the standard consent statement.
7.3.16 Additional elements of informed consent: When appropriate, one or more of the
following elements of information shall also be provided to each subject:
(1) 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;
(2) anticipated circumstances under which the subject's participation may be terminated by the investigator without regard to the subject's consent;
(3) any additional costs to the subject that may result from participation in the research;
(4) the consequences of a subject's decision to withdraw from the research and procedures for orderly termination of participation by the subject;
(5) 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. (45 CFR 46.116-117)
(NOTE: The informed consent requirements in this policy are not intended to preempt any applicable Federal, State, or local laws which require additional information to be disclosed in order for informed consent to be legally effective.)
7.4 Assent of Minors
7.4.1 If the subject is under the age of 7, only a Parental (legal guardian) Consent Form is required. The Parental Consent Form should include all relevant elements of informed consent as outlined previously and be written in a style that indicates it is the parent or legal representative who is consenting to allow the minor to participate in the study. The Parental Consent Form must contain the following standard consent statement in bold type:
"You are making a decision whether or not to allow _____________________________ (name of minor) to participate. Your signature indicates that, having read the information provided above, you have decided to permit ________________________ (name of minor) to participate. You will be given a copy of this consent form to keep."
Relationship to Subject
Witness (if required) Signature of Investigator
7.4.2 If the subject is 7 to 12 years of age, both a Child's Assent Form and a Parental Consent Form are required. The Child's Assent Form must be brief and contain extremely simplistic language written at the appropriate age level. Only the following elements must be present on the Child's Assent Form: (1) a statement of the purpose of the research, (2) a description of the procedures to be applied to the minor, (3) a description of the discomforts the minor may experience, (4) a description of any direct benefits to the minor, (5) a statement that the minor does not have to participate if he/she does not wish to participate, (6) a statement that the minor is free to withdraw at any time, (7) a statement that the minor should discuss whether or not to participate with his/her parents prior to signing the assent form, (8) an offer to answer all questions, and (9) a concluding assent statement. Only the minor and the investigator should sign the Child's Assent Form. The parent or legal guardian of the minor should be given a copy of the assent form.
7.4.3 If the subject is 13 to 18 years of age, both a Youth's Assent Form and a Parental Consent Form are required. (In the State of Connecticut, a minor attains majority at age 18. Pregnancy does not confer majority status.) The Youth's Assent Form must be written at the appropriate age level and contain simplified versions of the same elements present on the Adult Consent Form. In addition, the Youth's Assent Form must contain a statement that the minor should discuss whether or not to participate with his/her parents prior to signing the assent form. Only the minor and the investigator should sign the Youth's Assent Form. The parent or legal guardian of the minor should be given a copy of the assent form. (45 CFR 46.408)
7.5 Documentation of Informed Consent
7.5.1 Except as provided in Section 7.6, informed consent shall be documented by the use of a written consent form approved by the IRB and signed by the subject or the subject's legally authorized representative. A copy shall be given to the person signing the form.
7.5.2 Except as provided in Section 7.6, the consent form may be either of the following:
(1) A written consent document that embodies the elements of informed consent described in the previous section. 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; or
(2) A short form written consent document stating that the elements of informed consent have been presented orally to the subject or the subject's legally authorized representative. 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 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.
7.6 Alternatives or Waiver of Written Informed Consent
7.6.1 An IRB may waive the requirement for the investigator to obtain a signed consent form for some or all subjects if it finds 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. 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. (45 CFR 46.116-.117)
7.6.2 An IRB may approve a consent procedure which does not include, or which alters, some or all of the elements of informed consent set forth above, or waive the requirement to obtain informed consent provided the IRB finds and documents that:
(a) the research or demonstration project is to be conducted by or subject to the approval of state or local government officials and is designed to study, evaluate, or otherwise examine: public benefit or service programs, procedures for obtaining benefits or services under those programs, possible changes in or alternatives to those programs or procedures, or possible changes in methods or levels of payment for benefits or services under those programs; and
(b) the research could not practicably be carried out without the waiver or alteration.
7.6.3 An IRB may approve a consent procedure which does not include, or which alters, some or all of the elements of informed consent set forth in this section, or waive the requirements to obtain informed consent provided the IRB finds and documents that: (a) the research involves no more than minimal risk to the subjects and involves no procedures for which written consent is normally required outside of the research context; (b) the waiver or alteration will not adversely affect the rights and welfare of the subjects; (c) the research could not practicably be carried out without the waiver or alteration; and (d) whenever appropriate, the subjects will be provided with additional pertinent information after participation.