Obtaining the consent of a subject is a process that goes far beyond asking for a signature on a document. Potential participants must understand the nature of the study, the risks, discomforts, inconveniences, and potential benefits involved if they are to make an informed decision. We ensure respect for persons by providing information needed for thoughtful consent for a voluntary act.
Expect update in early 2018
- Changes to required elements of consent, and organization of consent forms.
- Additional criterion for consent waiver or alteration.
INFORMED CONSENT TEMPLATES
- Checklist of Federally Required Elements of Informed Consent
- Children in Research
- Stacking documents in eResearch
- Telephonic Consent
- Foreign Language Short Forms (updated July 2018)
Informed Consent Templates:
- Standard Informed Consent Template
- Specialty Informed Consent Templates
- Assent Template
INFORMED CONSENT GUIDANCE AND RESOURCES
- FDA Guidance on Emergency Research with Exception from Informed Consent
- Frequently Asked Questions (OHRP)
University of Michigan:
- Emergency Research with Exception from Informed Consent
- Guidelines for Stacking Documents in eResearch
- Non-English Speaking Subjects
- Plain Language Medical Dictionary
- Reconsenting Study Subjects
- Telephonic Consent
- Waiver under OHRP, FDA & HIPAA Regulations
- Who can Consent or Provide Permission for Participation in Research
- Foreign Language Short Form Consents (version 10-4-10)
- See the New Releases and Updates page for changes and requirements to amend
INFORMED CONSENT PROCESS
Informed consent is an ongoing process that begins with recruitment and continues through the completion of the study.
The first step is to provide potential subjects with general information about the nature of the study and why they might be suited to participate. The recruitment flyers, websites, and phone scripts are part of this process. All recruitment materials must be reviewed by an IRB prior to implementation.
Once someone indicates interest in joining a study, details should be presented by a study team member who is knowledgeable about both the study and informed consent.
- Provide information about the research in language the subject can understand. Encourage questions and query for understanding. Note that for children (see Guidance about children) and for those who do not understand written English language documents, this requires additional steps (which require IRB approval). See the IRBMED's guidance for non-English speaking/reading subjects.
- Provide an explanation of the difference between treatment and research.
- Provide time for subjects to consider all options. The riskier the study, the more time that is usually required.
- Provide answers to all of the subject's questions before the decision is made.
- Provide documentation about the research (including calendars, instructions, etc.) that the subject can refer to later. A copy of the consent document must be provided to the subject (or the subject’s legally authorized representative) and the original signed consent document should be retained in the study records. Note that the regulations do not require the subject's copy to be a signed copy, although a photocopy with signature(s) is preferred. All materials provided to subjects need IRB approval.
- Provide on-going opportunities to re-affirm consent throughout the study. Remind the subject about important information. Provide new information as it becomes available. Ask the subjects if they still want to participate. Document these interactions.
At each study visit encourage subjects to ask questions and raise concerns. Thus, informed consent becomes an ongoing, interactive process, rather than a one-time information session. Following good clinical practice (GCP) these discussions should be recorded in the subjects' records.
Important note for UMHS studies: A copy of the complete (every page) signed consent form should be placed in the UM medical record of subjects, particularly when the research intervention may affect other treatment or care (in most cases this means scanning the document into MiChart; click here for instructions). However, doing so may not be appropriate in all cases (for example if identification of the subject as a study participant might put the subject at risk of criminal prosecution or harm to reputation).
- Office of Human Research Protections (OHRP)
- National Cancer Institute, 'A Guide to Understanding Informed Consent'
- Food and Drug Administration (FDA)
TIPS ON PREPARING UNDERSTANDABLE INFORMED CONSENT DOCUMENTS
The informed consent document is an important tool in the informed consent process. The goal is to have a document, understandable to the subjects or their legal representatives, that explains what will happen to them as part of the study, when it happens, and why.
Target readability levels of consent forms should be between 6th and 8th grade. Examples of this level are found in the popular press, e.g. Newsweek or USA Today. Computer programs that analyze grade level, like the Flesh Kincaid method, are useful tools but cannot be relied upon in whole because informed consent documents often use words of a higher level (like the name of a procedure) that you will also explain in lay terms.
The sections below, Tips and Examples of protocol language ‘translated’ to subject-friendly language, are to assist you in achieving an understandable document. Also refer to the IRBMED Simplification guide for more lay terms. Refer to the Education page for information about the IRBMED workshop, Informed Consent 201.
Special thanks to the Center for the Advancement of Clinical Research for contributions in the material below.
- Use one of the IRBMED provided templates (above).
- Review the IRBMED template instructions (above). Alternate text for many sections is provided in the instructions to tailor the document appropriately for the type of study being described. The federally required elements of consent are also provided.
- Use multiple consents tailored for each study group in unblinded studies where different subject groups undergo significantly different procedures or schedules.
- Use subheads within sections that require extensive detail.
- Use a logical order for the topic within each section. For example, in the risk section, begin with research related risks that are expected, likely, and serious. Conclude with rarely expected risks and convey the likelihood.
- Insert hard page breaks if the page breaks at a place that makes it hard for the reader to follow such as right after a subhead.
- Do not use text smaller than 12 point.
- Use at least 1.5 spacing between paragraphs.
- Discuss only one or two ideas per paragraph.
- Keep paragraphs short.
- Avoid compound sentences.
- Use shorter, simpler words whenever they can convey appropriate meaning.
- Define or explain medical terms, procedures, and technical or complex words.
- Use U.S. measurements for metric measurements, or both. State 2 teaspoons rather than 10 MLs.
- Use regular time not military time. For example, say 1 p.m. rather than 1300 hours.
- Do not use exculpatory language, that is, language that indicates somebody (the researchers or UM) is free from blame.
- Write in the ‘second person,’ For example, instead of "The patient will be asked some questions about her medical history, then she will have a small amount of blood drawn,” state, "You will be asked some questions about your medical history, then a small amount of your blood will be drawn."
- Do not imply ‘cut and paste’ protocol sections or include elaborate details of the procedures of the protocol.
- Do not include highly scientific objectives or hypotheses that are of little relevance to the participants. These may bias your results or confuse participants.
- Consider what the participant would want to know.
Examples of protocol language versus subject-friendly language text
|Protocol or Scientific Language||Subject Friendly Language|
|If there is a history of hypertension, alternative methods of contraception are indicated.||If you have high blood pressure, use some other kind of birth control|
|This study is being conducted to assess the impact of DFG-995 and/or therapeutic intervention on the DXK Anxiety scale, to assess efficacy.||The study will compare treatment with a drug, treatment with counseling, and no treatment, to see which treatment works best to treat anxiety.|
|We believe that therapy will be most effective for highly anxious participants pre-disposed to confusion and depression.||Many people find that work and family stress makes them feel anxious and sad.|
|To participate, you must have medically documented anxiety or depression, not requiring hospitalization; no clinically significant medical condition judged by the investigator to compromise safety, and no atypical anxiety syndromes due to anticholinergic drugs, or metabolic neurogenetic disorders, or other degenerative diseases.||To participate, you must be feeling anxious or sad. You should not participate if you have ever been hospitalized because of these kinds of feelings. If your anxiety is caused by a medical problem, you may not be able to participate.
There are many reasons why you may not be able to participate. It is important to discuss your full medical history with the study doctor. We must also review your medical record.
|At visit 1 you will have your blood pressure taken lying down and standing up. You will answer questionnaires “overall anxiety scale” and “SAGM”. Your blood will be drawn for tests of iron, creatinine, hematocrit, liver function and other tests. You will be Randomized to group A, B, or C
At visit 2 if you are in group A, your visit will occur in 4 weeks and you will have your blood pressure measured lying down and standing up. If you are in group B, your visit will occur in 6-12 weeks, after you have been assigned a counselor, and you will have your blood pressure measured while lying down and standing up…At visit 3 you will have your blood pressure measured…etc.
|During the study, you will be randomized into one of three groups. Random means by chance, like flipping a coin. You have an equal chance of being in any of the three groups.
Below is an explanation of what will happen at each visit, no matter what group you are in. Then there is a section explaining what extra things will happen depending on what group you are in.
Also consider using tables, flow charts, graphs, or calendars in addition to text.
|During the study, you may be prescribed aspirin for headaches. Aspirin can cause stroke, stomach upset, death, ulcer, or severe allergic reaction.||During the study, you may be prescribed aspirin. Aspirin often causes mild stomach upset. In very rare cases, it can cause stroke, death, ulcer, or severe allergic reaction. To reduce this risk, we will monitor you for side effects whenever aspirin is given.|
|No studies exist regarding the possible teratogenicity of study drug during pregnancy.||It is not known whether study drug could cause birth defects.|
|This study involves filling out surveys, so there are no risks to this study.||You may feel uncomfortable answering questions that contain personal information. You may choose not to answer those questions.|
|The likelihood of contracting an infection is less than 1%.||The chance of infection is less than 1%, which means less than one in one hundred people get an infection|