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Completing the Research Design and Procedures Section

What is the purpose of the Research Design and Procedures section?

The Research Design and Procedures section of the initial review application asks study teams to describe the overall purpose and aims of their study as well as to provide a brief overview of study procedures and/or interventions. If the study will involve clinical interventions with subjects, study teams must describe alternatives to participation, how the subject population is treated clinically, and what study procedures are being doing for research purposes only.

When does the Research Design and Procedures section display?

The Research Design and Procedures section will display for the following application types: Full review, Exemption, and Non-exempt medical records  applications. The Research Design and Procedures section is the fifth section of the initial review application.

How should study teams answer question 1.4 in the Research Design and Procedures section?

Study teams should provide a concise overview of what procedures and interventions the study will involve. The answer to this question should be detailed enough for any reader to understand the overall design of the study as well as what procedures the human subjects undergo or how the specimens, data, or images derived from human subjects will be used for research purposes. The answer to this question should be in language accessible to readers without a specialist's knowledge of the research topic.

• Describe the proposed treatment(s) involved, including the schedule and dosing. Identify those procedures that will be performed specifically for the study, such as pharmacogenetic or pharmacokinetic testing.
• Any experimental procedures should be clearly described and labeled as such.
• If the study uses control or experimental group or different treatment arms, clearly describe what participation will be like for each of the groups or study arms.
• if individual subjects or cohorts of subjects will vary in the treatment they receive during the study, describe this (e.g., dose escalation schemes for treatments).

For clinical Studies	Describe the proposed treatment(s) involved, including the schedule and dosing. Identify those procedures that will be performed specifically for the study, such as pharmacogenetic or pharmacokinetic testing. Any experimental procedures should be clearly described and labeled as such. If the study uses control or experimental group or different treatment arms, clearly describe what participation will be like for each of the groups or study arms. If individual subjects or cohorts of subjects will vary in the treatment they receive during the study, describe this (e.g., dose escalation schemes for treatments).
For non-exempt medical records studies	Describe what data will be used and what will be done with the data for research purposes.
For other non-clinical studies	Describe what happens to subjects and when. If the study uses control and experimental groups or different treatment arms, clearly describe what participation will be like for each of the groups or study arms. If the study team does not directly interact with subjects and instead uses specimens, data, or images derived from human subjects, describe what specimens, data, or images will be used and what will be done with them for research purposes.

How should study teams answer questions 2.1 and 2.2 in the Research Design and Procedures section?

The IRB uses the information provided by study teams about alternatives to study participation and how the population is treated clinically to assess how the proposed research treatment compares to the treatment patients would receive if they did not take part in the research study. For studies that do not involve any clinical interventions with subjects, checking "Not Applicable" in response to these questions is typically appropriate.

Study treatments may be significantly different from standard treatments in terms of the drugs or devices used, the timing and length of the proposed treatments, and the risks and efficacy of the treatments. In contrast, study treatments also may be very similar to what would be considered standard therapy. In this case, it is important to specify the similarities and differences between the study treatment and standard care. The IRB will consider whether the difference in the potential efficacy and safety of the research treatment compared to the treatment outside of the research study is appropriate for the proposed study population. If subjects are treatment naive, the IRB also will consider whether participating in the research study could affect their access to standard treatments. The responses to questions 2.1 and 2.2 should be sufficiently detailed to allow the IRB to assess the magnitude of the differences between the research and standard treatment as well as the potential impact of the research treatment on a patient's future care.

For clinical studies	In response to question 2.1: Address the range of standard treatments for the subject population that will be enrolled in the study that are available to them at UW-Madison or other clinics or hospitals. Be sure to identify specific treatment regimens. Do not simply cut and paste from the alternatives section of the consent document. If subjects enrolled in the study do not have any standard treatments available to them or if eligible subjects will have exhausted all other available treatments prior to being enrolled in the study, state this. In response to question 2.2: Describe the usual treatment for the patient population at UW-Madison and any commonly accepted treatment standards for the patient population within the US that differ from the UW-Madison standard.
For non-exempt medical records studies	Choose "Not Applicable" for questions 2.1 and 2.2
For other non-clinical studies	Choose "Not Applicable" for questions 2.1 and 2.2