Department of Health and Human Services
Office for Protection from Research Risks
TIPS ON INFORMED CONSENT
The process of obtaining informed consent must comply with the requirements of
45 CFR 46.116
. The documentation of informed consent must comply with
45 CFR 46.117.
The following comments may help in the
development of an approach and proposed language by investigators for obtaining consent and its approval by IRBs:
Informed consent is a process, not just a form. Information must be presented to enable persons tovoluntarily decide whether or not to participate as a research participant. It is a fundamental mechanismto ensure respect for persons through provision of thoughtful consent for a voluntary act. The procedures used in obtaining informed consent should be designed to educate the subject population interms that they can understand. Therefore, informed consent language and its documentation (especiallyexplanation of the study's purpose, duration, experimental procedures, alternatives, risks, and benefits) must be written in "lay language", (i.e. understandable to the people being asked to participate). Thewritten presentation of information is used to document the basis for consent and for the participants'future reference. The consent document should be revised when deficiencies are noted or when additional information will improve the consent process.
Use of the first person (e.g., "I understand that ... ") can be interpreted as suggestive, may be relied upon as a substitute for sufficient factual information, and can constitute coercive influence over a subject.
Use of scientific jargon and legalese is not appropriate. Think of the document primarily as a teaching tool not as a legal instrument.
Describe the overall experience that will be encountered. Explain the research activity, how it isexperimental (e.g., a new drug, extra tests, separate research records, or nonstandard means of management, such as flipping a coin for random assignment or other design issues). Inform the humanparticipants of the reasonably foreseeable harms, discomforts, inconvenience and risks that are associated with the research activity. If additional risks are identified during the course of the research,the consent process and documentation will require revisions to inform participants as they are recontacted or newly contacted.
Describe the benefits that participants may reasonably expect to encounter. There may be none other than a sense of helping the public at large. If payment is given to defray the incurred expense for participation, it must not be coercive in amount or method of distribution.
Describe any alternatives to participating in the research project. For example, in drug studies the medications) may be available through their family doctor or clinic without the need to volunteer for the research activity.
The regulations insist that the participants be told the extent to which their personally identifiable private information will be held in confidence. For example, some studies require disclosure of information to other parties. Some studies inherently are in need of a Certificate of Confidentiality which protects the investigator from involuntary release (e.g.,subpoena) of the names or other identifying characteristics of research participants. The IRB will determine the level of adequate
/human subjects/guidance/ documents
requirements for confidentiality in light of its mandate to ensure minimization of risk and determination that the residual risks warrant involvement of participants.
If research-related injury (i.e. physical, psychological, social, financial, or otherwise) is possible in research that is more than minimal risk (see 45 CFR 46.102[g]), an explanation must be given of
whatever voluntary compensation and treatment will be provided. Note that the regulations do not limit injury to "physical injury". This is a common misinterpretation.
The regulations prohibit waiving or appearing to waive any legal rights of participants. Therefore,for example, consent language must be carefully selected that deals with what the institution is voluntarily willing to do under circumstances, such as providing for compensation beyond the provisionof immediate or therapeutic intervention in response to a research-related injury. In short, participants should not be given the impression that they have agreed to and are without recourse to seek satisfactionbeyond the institution's voluntarily chosen limits.
The regulations provide for the identification of contact persons who would be knowledgeable to answer questions of participants about the research, rights as a research participants, and
research-related injuries. These three areas must be explicitly stated and addressed in the consent process and documentation. Furthermore, a single person is not likely to be appropriate to answer questions in all areas. This is because of potential conflicts of interest or the appearance of such.Questions about the research are frequently best answered by the investigator(s). However, questionsabout the rights of research participants or research-related injuries (where applicable) may best be referred to those not on the research team. These questions could be addressed to the IRB, an ombudsman, an ethics committee, or other informed administrative body. Therefore, each consentdocument can be expected to have at least two names with local telephone numbers for contacts toanswer questions in these specified areas.
The statement regarding voluntary participation and the right to withdraw at any time can betaken almost verbatim from the regulations (45 CFR 46.116[a]). It is important not to overlook the need to point out that no penalty or loss of benefits will occur as a result of both not participating or withdrawing at any time. It is equally important to alert potential participants to any foreseeable consequences to them should they unilaterally withdraw while dependent on some intervention tomaintain normal function.
documents -- http://ohrp.osophs.dhhs.gov/humansubjects/guidance/ictips.htm
Don't forget to ensure provision for appropriate additional requirements which concern consent. Some of these requirements can be found in sections 46.116(b), 46.205(a)(2), 46.207(b), 46.208(b), 46.209(d),46.305(a)(5-6), 46.408(c), and 46.409(b). The IRB may impose additional requirements that are not
specifically listed in the regulations to ensure that adequate information is presented in accordance with institutional policy and local law.
SAMPLE CONSENT FORM
You are invited to participate in a study of (state what is being studied.) We hope to learn (state what the study is designed to discover or establish.) You were selected as a possible participant in this study because (state why and how the subject was selected.)
If you decide to participate, the researcher and/or his or her associates will (describe the procedures to be followed, how long they will take and their frequency. Describe the discomforts and inconveniences reasonably to be expected. Estimate the total time required. Describe the risks and the benefits reasonably to be expected.)
(Describe appropriate alternative procedures that might be advantageous to the participants, if any.
Disclose any standard treatment that is being withheld.)
(If the participants will receive any compensation or any other benefits, describe the amount or nature.
If participants may incur costs because of participation, list them.)
Your decision whether or not to participate will not prejudice your future relations with the (name institution or agency). If you have any questions, please ask us. If you have any additional questions later (state of the name of the principal investigator and give a phone number or address,) will be happy to answer any of them.
Your signature indicates that you have read the information provided above and have decided to
participate. You may withdraw at any time without prejudice after signing this form should you
choose to discontinue participation in this study.
Signature of Parent or Legal Guardian
(Signature of Parent or Guardian is not required for participants who consent for themselves.)
Message to Participants: Any information that is obtained in connection with this study and that can be identified with you will remain confidential and will be disclosed only with your permission. (If the researcher will be releasing information to anyone for any reason, state the persons or agencies to whom
the information will be furnished, the nature of the information to be furnished and the purpose of the disclosure.)