Consent Forms - Key Information Section

Key Information:

 

Consent forms are the tool researchers use to share important information about their studies with would-be participants. The aim is to create a document that explains the research agenda so that would-be participants can choose for themselves whether they would like to participate. The Key Information section, found at the beginning of the consent form, provides a concise and focused presentation of the key (most important, most relevant) information about the research to help potential subjects decide if they might or might not want to participate.

Key Information sections are required at Penn State when:

  • A consent form is longer than 2000 words OR

  • A consent form is 5 pages long when single spaced

  • The requirement for a Key Info section exists at Penn State, even if your sponsor model consent does not include a Key Info section.

  • If your sponsor model consent includes a Key Information section, it may be used as long as it addresses the 7 questions listed to the right. It is ok if the section is named differently or if it is formatted or arranged differently.

    • Some discretion is allowed regarding the word and page counts. Please contact your analyst before choosing to exclude a Key Information section.

Key Information section must provide concise and specific responses to the following questions:

  1. Why is the person being invited to take part in research study?

  2. What is the purpose of the research study?

  3. How long will the study last?

  4. What will participants need to do as part of the study?

  5. What are the main risks of taking part in the study?

  6. What are the possible benefits to participants?

  7. What happens if the person chooses not to participate? 

  • Even for complicated interventional trials, 1-4 sentences are typically sufficient to answer each of the above questions.  

 

As with all sections of a consent form, Key Information should be written in clear, jargon-free language that can comfortably be read by persons with an eighth-grade literacy level. Since literacy levels vary by region, state, or country, best practices are to write your consent form for persons with a sixth-grade literacy level. We want to be sure that our consent forms are understandable, and that we are working to include as many different communities as possible.

 

Downloadable PDF. Please feel free to use the examples to help draft your consent form Key Information section. Please remember that consent forms are unique to each study, and that all information in the consent form must be reflected in the IRB protocol submission.

 

Best practices for how to write answers to the key information questions:

  • Let the would-be participant know why you are talking to them specifically.
  • Keep it simple. This is not an explanation of the research design or study objectives.
    1.    Example: We are asking you to volunteer for this study because you are a healthy person between 30 and 50 years of age.
    2.    Example: We are asking you to take part in this voluntary research study because you have been diagnosed with peripheral artery disease.
    3.    Example: We are asking you to volunteer for this study because you are an undergraduate student in the PSYCH104 class.

 

  • Think about how you would explain the main point of your study to someone who is not a scientist. 
  • What do you want would-be participants to know about what the study is trying to achieve?
    1. Example: The purpose of this voluntary research study is to compare people 30 to 50 years of age with different health statuses. We are trying to determine how diabetes is connected to people's movement. We are going to enroll people ages 30 to 50 who are either healthy or with diabetes diagnosed by a doctor. 
    2. Example: The purpose of this voluntary research study is to learn about the effects and safety of an investigational drug in patients with advanced heart failure.

 

  • Think about the difference between how long you anticipate processing data outcomes versus collecting data where participants are involved.
  • Help would-be participants understand the length of time you are hoping they will be available to participate in your research.
    1. Example: We are asking volunteers to be available for six months of time. The study will begin at day one and end at six months.
    2. Example: If you agree to participate, it will take about 12 months to complete the study. You will be asked to return to the research site 4 times.

 

  • Think about all of the tasks, events, procedures, etc, that you are going to ask of your participants. 
  • Tell them the key items that they will be requested to do should they join the study. Include the most invasive, the most uncomfortable, the most risky, the most time consuming, the most frequent. Be sure to list what you think would be most important for subjects in deciding whether or not they would want to do the research.
  • It is okay if you are going to ask them to do multiple tasks, events, procedures, etc if they are part of the study.
  • Be sure to include what specifically you are asking them to do.
    1. Example: For this study, we are asking all participants to give blood, wear a personal activity device on their wrist, and keep an activities diary. We will ask participants to do a blood sugar test three times during the study. 
    2. Example: Participants will be asked to take the study medication by injection under the skin twice daily, provide blood and urine samples, undergo physical exams, get a chest x-ray, and have 3 colonoscopy procedures.  You may also be asked to collect stool samples at home, depending on your symptoms.

 

  • Name the key risks of the study. Include the risks that are the most serious or most frequent. Risks could be risks associated with a drug or device or with a study procedure.  
  • Think about which risks would be most important to a person in deciding whether or not to participate in the study. 
  • A complete listing and description of all the risks is found later in the consent. They do not need to all be listed here.
  • Even if your study is minimal risk, a response is required. It is never accurate to state that there are no risks. 
    1. Example: For this study, we are testing a new drug. This is the first time the drug will be tested in humans so we do not have a lot of information about risks or side effects. We do know that mice being given the medication showed signs of decreased appetite and energy, and they demonstrated restless sleep.   
    2. Example: The main risk of this research is loss of confidentiality.
    3. Example: For this study, the main risks to know about are those associated with the study drug, which include stroke, headache, changes in your blood, and increased thoughts of suicide. Additional risks from the implant procedure include blood loss, damage to your nerves (which may be irreversible), and unplanned amputation.

 

  • For some studies, there are no known benefits to the would-be participants. That's okay to say because you are telling participants what is known to be true. 
  • The goal is to be as clear, concise, and as truthful as possible when describing potential benefits. You want would-be participants to be able to think about both the risks and benefits, and decide for themselves if they would like to be in the research.  
    1. Example: There are no benefits to you from taking part in this research. Results of the study may benefit other people in the future by helping us learn more about mental health in college students.  
    2. Example: We cannot promise any benefits to you from taking part in this study. However, possible benefits include an improvement in your symptoms and reduced inflammation in your colon.  Results of the study may benefit other people in the future by helping us learn more about Irritable Bowel Disease. 

 

  • There are two required sentences that must be included: Participation in research is completely voluntary. You can decide to participate or not to participate.
  • Following the first two required sentences, respond to the possibility of alternative projects, should there be any. Are there alternatives to the study that someone can do instead? Should they not want to participate, is there something else they could do? If so, this is where you share that information.
  • Maybe there are no alternatives and that's okay too. Just be sure to remind folks that the study is voluntary and they can choose for themselves to participate or not.​
    1. Example: Participation in research is completely voluntary. You can decide to participate or not to participate.  Instead of being in this research study, your choices may include: taking standard of care medications, or deciding not to treat your condition
    2. Example: Participation in research is completely voluntary. You can decide to participate or not to participate. You may choose not to take part in this research study. 

 

For additional information about Key Information sections, please see HRP-109 or HRP-580.