Guidelines for Informed Consent

Recommended Formatting and Elements For An Informed Consent Document To Be Used In Research Involving Human Participants

 

This document recommends the standard formatting and content that should be used in most standard consent forms.  Further information about informed consent can be found in the regulations at 45 CFR 46.116-117 and the Office of Human Research Protections (OHRP) guidelines that can be found at the following two addresses:

 

http://www.hhs.gov/ohrp/humansubjects/guidance/45cfr46.html#46.116

http://www.hhs.gov/ohrp/humansubjects/guidance/45cfr46.html#46.117

 

Consent Process

 

Informed consent is a process and a consent form is only an aid to this process.  The most important consideration is to present information in a manner that enables potential participants to voluntarily decide whether or not to participate as a research subject in the proposed activity.

 

Consent Language

 

The consent language must be at the reading level of the population that is being asked to participate.  A reading level in the range of the sixth to the eighth grade is most likely the maximum level for the general population.  

 

Consent language should be in the second person.  Use of the first person (e.g., "I understand that...") can be interpreted as suggestive, could be used as a substitute for sufficient factual information, and can constitute coercion.

 

Consent Documentation and Date

 

Consent documents must be signed and dated by the participant or the participant's legally authorized representative.  A copy must be given to the participant and the researcher must keep a copy for three years after the completion of the research.

 

The consent document must be dated in some manner to identify the most recently approved (IRB) version.  This can be done with a header or footer, a version number that includes a date, or an IRB stamp with a date.  All human subjects research, and the corresponding consent that is used, can be approved for a maximum period of one year.  Projects that extend past one year must renew their IRB approval and the consent has to be re-approved as part of the renewal.  It is the investigator's responsibility to ensure that only the most recently approved consent document is used

 

Additional considerations

 

The suggested format on the next page is applicable to most circumstances but there are additional elements of informed consent that apply in some circumstances.  There are circumstances where the requirement for informed consent and the requirement for written informed consent can be waived. The assent of minors must be considered when they participate in research and the language of the consent document should be adjusted to convey the fact that the parent(s)/guardian is giving consent for the participation of the minor they represent.

 

Guidelines for Creation of an Informed Consent Document for Research Involving Human Participants

 

Title of the Research:       

(Use the same title on all IRB and study materials.)

 

Purpose of the Research:       

(Explain that the individual is invited to participate in a research study and the purpose of the research.)

 

Study-related Procedures:       

(Explain what individuals would be asked to do if they agree to participate in the research.  The description should specify any procedures that are experimental, which aspects of the study are required or optional, the expected frequency and duration of participation and the process of randomization or other relevant design issues. The participant should be informed of the nature of information that will be obtained and specifically informed when such information involves sensitive issues such as illegal activities or issues that could be harmful to the individual if revealed.)

 

Alternative procedures or courses of treatment (if any):        

(Describe alternative procedures or courses of treatment (if any) the participant may choose rather than those in the research study.)

 

Potential risks, discomforts or inconvenience:       

(This section should describe any reasonably foreseeable risks, discomforts or inconvenience that may result from participation, including the possibility of a breech of confidentiality.)

 

Potential benefits:       

(Describe potential benefits to the participant (if any) and to others.)

 

Confidentiality of records:       

(Describe how and the extent to which research records and biological specimens will be protected.  This should include who will have access, how access will be limited and protected, post research plans for records and/or biological specimens, exceptions to confidentiality and the rights of participants to access or determine the use of their confidential records and/or biological specimens.  Unless the research has obtained a "Certificate of Confidentiality" or a "Medical Research" designation the consent should only promise that personally identifying information will be protected "to the extent allowable by law."  Without such protections such information can be subject to subpoena.  Some studies inherently need such extra protection because of the sensitive nature of the information collected and the potential harm to the participant if the investigator is required to release it. Studies that may uncover suspected child abuse or neglect should state the legal obligation to report it if the investigator is subject to this reporting requirement.  It should be stated that the IRB may need to access records for audit or investigation and certain research sponsors may need such access if that is the case.)

 

Compensation for research-related injury (this is only required for research involving more than minimal potential risks:       

(Describe whatever voluntary treatment and compensation will be offered if the research involves the potential for more than minimal research-related risk (i.e. physical, psychological, social, financial, or otherwise).  If no treatment or compensation will be offered in such circumstances the language should state that none would be offered. Participants should not be given the impression that they have agreed to and are without recourse to seek satisfaction beyond the institution's voluntary chosen limits, by any language that waives or appears to waive their legal rights.)

 

Contact information:       

(Provide information about who to contact for questions about the research, who to contact in case of a research-related injury and who to contact about their rights as a human research subject.  In the case of research reviewed by more than one IRB, only one contact needs to be listed for questions about the rights of human research subjects.  If MDHHS is the only IRB involved the direction should be to contact the Michigan Department of Health and Human Services Institutional Review Board at 517-241-1928 or MDHHS-IRB@michigan.gov. Address information can be listed as: South Grand Building 5th Floor, 333 S Grand Ave, Lansing, MI 48933.

 

Voluntary participation & right to withdraw:       

(The consent document should state 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.)

 

Signature:        

(Language before signature line should simply state, "I voluntarily agree to participate in this study" or "Your signature below indicates your voluntary agreement to participate in this study") It should also be stated that a copy of the consent will be provided to the participant.

 

Date of IRB approval of this consent:         

 

Expiration date of IRB approval of this consent:          

 

 

April, 2015