Investigator Responsibilities & Informed Consent
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Investigators have the primary responsibility for protecting the rights and welfare of human research subjects and are responsible for complying with all applicable provisions of their institution's Assurance. Investigators are expected to be knowledgeable about the requirements of the DHHS regulations, applicable state law, their institution's Assurance, and institutional policies and procedures for the protection of human subjects.
Investigators are responsible for:
Conducting their research according to the IRB-approved protocol and complying with all IRB determinations.
- Obtaining and documenting the informed consent of each subject or each subject's legally authorized representative, unless the IRB has waived these requirements.
- Ensuring that each potential subject understands the nature of the research and participation.
- Providing a copy of the IRB-approved informed consent document to each subject or the subject's legally authorized representative at the time of consent, unless the IRB has specifically waived this requirement. All signed consent documents are to be retained for at least 3 years after the completion of the research and according to institutional policy.
- Promptly reporting proposed changes in previously approved human subject research activities to the IRB. The proposed changes may not be initiated without prior IRB review and approval, except where necessary to eliminate apparent immediate hazards to the subjects.
- Reporting progress of approved research to the IRB as often as, and in the manner, prescribed by the IRB.
- Promptly reporting to the IRB any unanticipated problems involving risks to subjects or others or any serious or continuing non-compliance with the DHHS regulations or determination of the IRB.
A physician may provide emergency medical care to a patient without prior IRB review and approval, to the extent permitted by applicable federal, state, or local law. However, such activities may not be considered research nor may the data be used in support of research, except to the extent required under FDA regulations. Investigators should consult with the IRB to ensure that activities that meet the regulatory definition of non-exempt human subject research undergo IRB review and approval prior to the initiation of the activities.
Informed Consent
Unless specifically authorized by the IRB, no investigator may involve a human being as a subject in research covered by the DHHS regulations unless the investigator has obtained the legally effective informed consent of the subject or the subject's legally authorized representative.
Informed consent refers to the voluntary choice of an individual to participate in research based on an accurate and complete understanding of, among other things, its purposes, procedures, risks, benefits, alternatives, and any other factors that may affect a person's decision to participate.
The Consent Process:
Informed consent is not a single event or just a form to be signed. Rather, it is an ongoing process that takes place between the investigator and the subject.
The basic concepts of the consent process include:
- full disclosure of the nature of the research and the subject's participation, adequate comprehension on the part of the potential subject, and
- the subject's voluntary choice to participate.
General Requirements of Consent:
Informed consent must be prospectively obtained from the subject or a legally authorized representative of the subject (if allowed by state law).
Information must be conveyed in language that is understandable to the subject or the subject's legally authorized representative.
The subject must be given sufficient opportunity to consider whether or not to participate.
Consent must be sought only under circumstances that minimize the possibility of coercion or undue influence.
Informed consent may not include any exculpatory language. For example, subjects must not be made to give up legal rights or be given the impression that they are being asked to do so.
Comprehension:
The process of informed consent is central to the protection of human subjects involved in research. Informed consent involves more than signing a form, they must understand the study and what they are being asked to do. Therefore, consent documents should be written in language appropriate to the intended audience, avoiding jargon and technical or scientific terms.
Individuals may not be involved as research subjects unless a) they understand the information that has been provided and informed consent has been obtained, or b) the IRB has approved a waiver for informed consent of the subject.
Elements of Informed Consent:
DHHS regulations detail specific elements of information that must be provided to each research subject unless the IRB has approved a waiver or alteration of these requirements. Basic elements of informed consent include a:
- statement that the study involves research, an explanation of the purposes of the research, the expected length of the subject's participation, a description of the procedures to be followed , and identification of procedures which are experimental in nature;
- description of any reasonably foreseeable risks or discomforts to the subject;
- description of any benefits, to the subject or others which may reasonably be expected from the research;
- disclosure of appropriate alternative procedures or courses of treatment, if any, that are available 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 or medical treatments, are available to the subject if injury occurs and if so, what that may consist of or when further information can be obtained;
- An explanation of whom to contact for pertinent questions about the research and research subjects rights.
- An explanation of whom to contact in the event the subject experiences a research-related injury;
- A statement that participation is voluntary and refusal to participate will not result in penalty or loss of benefits to which the subject is otherwise entitle and the subject may withdraw at anytime without penalty or loss of benefits to which the subject is entitled.
Additional Elements:
Where appropriate, the following additional elements of informed consent must be provided to each subject:
- treatments or procedures that may involve risks to the subject, or to an embryo or fetus if the subject is or may become pregnant, that are currently unforeseeable;
- anticipated circumstances under which a subject's participation may be terminated by the investigator without regard to the subject's consent;
- any additional costs to subjects that may result from participation;
- the consequences of the subject's decision to withdraw from the research and procedures of orderly termination of participation by the subject;
- 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; and
- the approved number of subjects involved in the study.
Additional Protections for Vulnerable Populations:
Incompetent adults cannot give consent. This may include the developmentally disabled, the cognitively-impaired elderly, and unconscious or inebriated individuals. Only legally authorized representatives in accordance with state law can give consent for incompetent adults to participate in research.
Additionally, when some or all of the subjects are likely to be vulnerable to coercion or undue influence, such as children, prisoners, pregnant women, mentally disabled persons or economically or educationally disadvantaged persons, additional safeguards shall be included in the study to protect the rights and welfare of these subjects.
Documentation of Consent:
Except as noted below, informed consent must be documented by use of a written consent form approved by the IRB and signed by the subject or the subject's legally authorized representative. A copy will be given to the person signing the form.
The purpose of the written presentation of information in the consent form is to document the basis for consent and provide the subject future reference. The consent document should be revised when deficiencies are noted or when additional information will improve the consent process. All revisions must be reviewed and approved by the IRB before a revised consent form may be used to enroll a subject.
The information that is given to the prospective subject, or his/her legally authorized representative, must be in language understandable to the subject or representative.
Consent forms should be written at a level appropriate to the understanding of the subjects to be enrolled; technical language should be avoided.
OHRP strongly discourages use of the "first person" statement in consent documents (using, "I have been fully informed about..."). Such statements unacceptably ask subjects to make statements that the subject is not in a position to verify (e.g., the subject has no way to verify that the investigator has provided full and complete information).
The consent form is merely the documentation of informed consent and does not, in and of itself, constitute informed consent.
The fact that a subject signed a consent form does not mean that he/she understood what was being agreed to or truly gave their voluntary consent.
Waiver of Documentation of Consent:
The IRB may waive the requirement for written documentation of consent in cases where one of the following is met:
- The principal risks are those associated with a breach of confidentiality concerning the subject's participation in the research; and the consent document is the only record linking the subject with the research. Each subject will be asked if they want documentation to remain with them or with the research records, and the subject's wishes will govern.
- The research presents no more than minimal risk of harm to subjects and involves no procedures for which written consent is normally required outside the research context.
- The research could not practicably be carried out without the waiver or alteration.