Types of research and important considerations
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The NIH definition of a clinical trial is: “a research study in which one or more human subjects are prospectively assigned to one or more interventi…
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An observational study is one where researchers either collect information from participants prospectively or review data that was already collected.…
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Exempt research involves human subjects and meets the requirements of one or more exemption categories within federal regulations for protecting huma…
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Secondary research refers to the use of biospecimens or data collected from humans for purposes other than the current research. This means that the …
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Genetic research refers to a wide range of research techniques that examine the genetic makeup of human beings, including whole genome or whole exome…
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As an NIH investigator conducting international research, you have specific requirements and responsibilities. For non-exempt research conducted outs…
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Informed consent forms are crucial for ensuring that individuals understand and voluntarily agree to participate in a research study. Writing a clear…
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Before you begin your study, you must select the people who will work with you to implement the study and analyze the data at the NIH. All individual…
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Subject recruitment activities and materials introduce prospective subjects to the research study. You need to describe the recruitment plan in the p…
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Compensation is payment provided to research participants for their time, effort, and inconvenience. It may also include reimbursement for out-of-poc…
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Privacy means you control when, how, and to what extent you share yourself (physically, behaviorally, or intellectually) with others. It also refers …
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All non-exempt human subjects research protocols must include a Data Safety Monitoring Plan (DSMP) that matches the size, risk level, and complexity …
The protocol includes all the details that must be followed and recorded throughout the project's entire lifecycle. This ensures consistency in data collection, analysis, and reporting. It also covers many regulatory requirements and policies related to human subjects research (HSR). Therefore, "protocol" refers to both the written description and the research activity itself.
Writing the protocol and consent documents helps you solidify your study design, assess the feasibility of completing the study, and plan the analysis of the data. Using templates for both the protocol and consent documents can help you meet all regulatory requirements and create an organized plan for your study. This will also make the regulatory review process more efficient.
We have developed seven different protocol templates for various types of new research protocols. While none of the templates will be perfect for your specific study without some modification, you can adapt them to fit your needs. Mark sections that are not applicable as such and add any necessary additional sections.
Related Resources
What information should be included in protocols submitted to the NIH IRP IRB? AKA: How to write a protocol 101
Presented by Tiffany Gommel and Nicole Grant
Responsibilities of the Principal Investigator Part 1: What You Need to Know and Do Before Your Protocol Starts
Presented by Nicole Grant