Sample Applications and Protocol Development Resources
Sample IRB Application Materials
Examples: The following Sample IRB Submission Research Descriptions and Pertinent Forms provided solely for education purposes. They do not include template language reviewed or endorsed by the IRB. There is no guarantee that use of the language or descriptions will be accepted by IRB without revision. Each research proposal is unique with varying regulatory and ethical issues. If you choose to use some of the language in your IRB submission, include only what applies to your research. Do not include any described processes or procedures unless they apply and you are able with qualified staff, systems, or infrastructure to implement in the conduct of your research protocol.
Sample Consent Key Information Page
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 at the 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 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 ones 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 with the possibility of reduced quality of life. If key information includes a potential risk, be sure to include the implication 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 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 was 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.
Key Information Page Examples for Simulated Studies:
• Comparative Effectiveness Research [PDF]
• Placebo-Controlled Clinical Trial [PDF]
• Research Biobank [PDF]
• Healthy Volunteer Medical [PDF]
• Healthy Volunteer Nonmedical [PDF]
• Nonmedical testing and survey [PDF]
Other Protocol Templates, Tools, and Development Resources
- UK E-IRB Video Tutorials to aid in navigation and use of the E-IRB system
- 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
- NIH/FDA Clinical Trial Protocol Template [WORD]
- 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 Toolkits
- 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
- Harvard Catalyst: The Harvard Clinical and Translational Science Center - Sample Informed Consent Language Library: Describing Technologies Used in Research [PDF]
Sample IRB Submissions from Other Academic Institutions
- Connected & Open Research Ethics (CORE) Resource Library – in addition to 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 [PDF]
- National Institute of Allergy and Infectious Diseases