Protocol Development Resources

Examples: Federal Common Rule IRB Regulations require that potential subjects be first presented with “a concise and focused presentation of the key information that is most likely to assist a prospective subject or legally authorized representative in understanding the reasons why one might or might not want to participate in the research. This part of the informed consent must be organized and presented in a way that facilitates comprehension.”

To help investigators comply with the regulatory requirements, consent templates that begin with a Key Information Page followed by a Detailed Consent are provided in the "All Templates" menu option of an E-IRB application. Information about the template is available under Consent FAQs on the Human Subjects FAQs webpage. The templates or examples may be revised once federal guidance is provided on the interpretation and application of the 2018 Common Rule Regulations.

The Key Information section of the UK Template focuses on key reasons why a potential participant would and would not volunteer for a research study. The reasons will not always be a benefit or a risk. For low-risk research, the impetus to participate may be altruistic, while the main deterrent might be inconvenience. An advantageous or proven alternative treatment may be more likely to affect one's decision to participate in a study that involves an experimental intervention or randomization to a placebo group. When choosing what information is key to present first, the investigator may consider personal experience, consult empirical research, or seek input from participants, support groups, or community members. Choose information that would help a potential subject weigh the main pros and cons of volunteering. For instance, a patient with a serious illness may wish to weigh the potential increased life expectancy against the possibility of reduced quality of life. If key information includes a potential risk, be sure to include the implications of the risk. Simply listing a risk may not be adequate without providing a consequence, given the context of the study. A breach of confidentiality may have minor repercussions for a survey study, while the same occurrence with whole genome sequencing could affect the potential for insurability or employability.

The following are examples of Key Information pages created for education purposes only. They are not exact representations of actual studies. Study topics and subject matter were chosen to illustrate concepts that may be key for participant consideration. The IRB has not reviewed or endorsed the examples. The examples do not include the entire consent document.

Sample Informed Consent Related Documents

The following are examples of sample informed consent documents for simulated studies. They are for educational purposes only. They are not exact representations of actual studies. Study topics and subject matter were chosen to illustrate concepts that may be key for participant consideration. The UK IRB has not reviewed or endorsed the examples.

UK ORI Parent Permission Sample

Research investigators may use or adapt the following sample survey to obtain feedback from study participants to support quality improvement of human subject protection practices and the informed consent process. The REDCap electronic data capture tool is available for UK researchers to use to set up a secure, web-based version of the survey.

{Special instructions are contained within brackets throughout this template. These instructions provide information on what should be added to that space.}

{In the header of the document, add: Survey from (insert PI name) and IRB # (insert protocol number).}

Human Subject Protection: Research Participant Satisfaction Survey

{Insert investigator name} is seeking your opinion on your experience participating in their recent research study. The following survey includes 15 questions and should take around 10 to 15 minutes to complete. You are free to answer all, some, or none of the questions, and you may write additional comments at the end of the survey.

{Insert investigator name} will use the information you provide to learn how to better protect and inform research participants. Every effort will be made to prevent anyone who is not on the research team from knowing that you have given us this information or what the information is. You will not be treated differently by {insert investigator name} because of the answers you give to the questions in this survey, or if you decide not to answer the questions in this survey.

If you have concerns about your experience in the research, or want to talk to someone about your rights as a volunteer in the research, please call the Office of Research Integrity at 859-257-9428, or toll-free at 1-866-400-9428 between the business hours of 8 am and 5 pm EST, Monday-Friday. Thank you!

1. Did you know that you participated in a research study?
   • Yes
   • No
   • Not Sure
2. Do you remember signing a consent form to take part in a research study?
   • Yes
   • No
   • Not Sure
   • Not Applicable
3. Do you feel like you were provided with enough information to make a decision about whether to take part in the research study?
   • Yes
   • No
   • Not Sure
4. Which one of the statements listed below best describes your options if you decided to quit the research study?
   1. You could drop out at any time and for any reason.
   2. You could only drop out of the research study if {insert investigator name} let you drop out?
   3. You're not sure what the policy was for dropping out of the research study.
   4. Other: {insert space for text entry}
5. Who reviewed the consent form with you?
   • Study Coordinator/Nurse/Staff
   • Researcher/Study Doctor
   • Student
   • No one
   • Other: {insert space for text entry}
   • Not Applicable
   • Not Sure
6. Did anyone on the research staff pressure you to sign the consent form?
   • Yes
   • No
   • Not Sure
   • No Opinion
7. Did the consent form or the research staff tell you about possible risks, discomforts, or inconveniences expected from being in the study?
   • Yes
   • No
   • Not Sure
   • Not Applicable
8. Did the consent form or the research staff tell you about possible alternatives to being in the study, such as other non-research treatments or options?
   • Yes
   • No
   • Not Sure
   • Not Applicable
9. Did you have enough time to read and ask questions about the consent form?
   • Yes
   • No
   • Not Sure
   • Not Applicable
10. Were all of your questions answered by the research staff?
    • Yes
    • No
    • Not Sure
    • Not Applicable
11. Did the research staff give you a copy of the consent form after you signed it?
    • Yes
    • No
    • Not Sure
    • Not Applicable
12. Did you know that participating in the research study was voluntary and that you didn't have to take part in the study if you didn't want to?
    • Yes
    • No
    • Not Sure
    • No Opinion
13. Do you think the study staff would have treated you differently if you had stopped the study early?
    • Yes
    • No
    • Not Sure
    • No Opinion
14. Did you know who to call on the research staff if you had questions or concerns during and after the study?
    • Yes
    • No
    • Not Sure
    • No Opinion
15. Did you know you could call the University of Kentucky Office of Research Integrity if you had questions or concerns about your rights as a research participant?
    • Yes
    • No
    • Not Sure
    • No Opinion

If you have additional comments, please list them below.  {insert space for text entry}

UK E-IRB Video Tutorials
aids in navigation and use of the E-IRB system

IRB Application Submission Prep Checklist

TransCelerate Common Protocol Template Toolkit
with Library Files of Common and Suggested Text including sample text pertinent to healthy volunteers, patients, pediatric populations, Alzheimer’s disease, Asthma, Diabetes, and TQT Studies  

NIH Clinical e-Protocol Writing Tool

Connected & Open Research Ethics (CORE) Resource Library
Library of information technology guidance, sample protocols, sample consent forms. Includes resources related to research using mobile technologies, social media, internet research.

National Institute for Health Research Support Services

NIH National Institute of Dental and Craniofacial Research Toolkit

NIH National Cancer Institute Cancer Therapy Evaluation Program (CTEP) Protocol Development Tools

NIH National Institute on Aging (NIA) Clinical Interventional Study Protocol Template

Connected & Open Research Ethics (CORE) Resource Library
In addition to the resources described above, CORE has IRB-approved, researcher-submitted content provided to serve as examples.

Doris Duke Fellows Sample Submissions

ELON University - Sample Ethnographic Submission

National Institute of Allergy and Infectious Diseases