Assignment 3

Protocol

In order to get ethical clearance for doing research with, on, or about human-subejcts (or even using data about people) you must complete an application that documents the methods that will be used and the data that will be collected. These applications are submitted to an Institutional Review Board (IRB) who then provides feedback and ultimately approves your application so that you can begin collecting data. IRB applications can be burdensome and time-consuming to complete, but they also force us, as researchers, to carefully consider numerous aspects of how we will collect, analyze, and manage data about people.

Step 1: Draft of Protocol

For the final assignment of this class we are going to complete and IRB application for approval to do human-subject research. As a first step in this process you will answer some preliminary questions about the design of your research project (Note: These are questions taken directly from the UW IRB office’s application for conducting human-subject research):

Participants:

Describe the general characteristics of the subject populations or groups, including age range, gender, health status, and any other relevant characteristics.
Describe the specific criteria you will use to decide who will be included in your study from among interested or potential subjects. Define any technical terms in lay language.
Describe the specific criteria you will use to decide who will be excluded from your study from subjects who meet the inclusion criteria listed above. Define any technical terms in lay language.

Research Setting:

Describe the reason(s) why you selected the sites where you will conduct the research.
Culturally-appropriate procedures and an understanding of local context are an important part of protecting subjects. Describe any site-specific cultural issues, customs, beliefs, or values that may affect your research, how it is conducted, or how you obtain or document consent.

Recruiting and Screening Participants:

Describe how you will identify, recruit, and screen subjects. Include information about: how, when, where, and in what setting. Identify who (by position or role, not name) will approach and recruit subjects, and who will screen them for eligibility.

Procedures:

Using lay language, provide a complete description of the study procedures, including the sequence, intervention or manipulation (if any), drug dosing information (if any), use of records, time required, and setting/location.
For all types of data that you will access or collect for this research: Identify whether you are obtaining the data from the subjects (or subjects’ specimens) or whether you are obtaining the data from some other source (and identify the source).

Draft (turn in)

You should provide answers to these in a text document (Word, PDF, etc are all fine). You do not need to cite any literature in your answers. In fact, your answers should be as simple and concise as possible - try not to use more than 2 paragraphs for each answer, and as the instructions read, these should be answers that use “lay” or simple terminology. The due date for this assignment is November 20th.

Step 2: Final Draft of Protocol

For the final draft of this assignment you will complete an IRB application. The form can be found, as a Word document here.

I have provided a sample of one of my own research studies for you to see what a completed IRB application looks like.

PDF of my Application

To complete the IRB application you should answer ONLY the questions that are circled in blue. Most of your answers above can be plugged in directly to the form so that much of what you have left to complete are questions about sampling and data protection.

Final Draft (turn in)

Turn in the completed Word document. Be sure to save your document using a new file name.

Note: Once you are done with this application the only thing you need is a faculty sponsor who can help you submit the application to UW’s IRB. (Hey - Your professor is a faculty sponsor ask him) Once it is approved you are ready to collect, analyze, and publish data about your research! Welcome to the beautiful world of professional research!

Final Grading Rubric

Below is a description for how your final assignment will be graded. If you have questions please contact your TA.

Completion of IRB application (2 pts)

Answers are given to all required questions–the ones with their numbers circled–on the IRB application.

Participants (3 pts)

Describe relevant characteristics of the subjects of your research, and the criteria which will be used include/exclude possible participants. If you are working with human subjects, explain which aspects of your participants’ identities are relevant to your research. If you are working with documents or other non-human objects, describe the documentary materials that you will use in your work.

Characteristics of the subjects (relevant participants’ identities/the documentary materials) (1 pt)
Inclusion criteria (1 pt)
Exclusion criteria (1pt)

Research setting (3 pts)

Justify the site selection. If applicable, describe the local context that may affect your research. If you are working with human subjects, describe how you will obtain and manage consent from your participants.

Justify the site selection. (1 pt)
Describe how to obtain and manage consent. (2 pts)

Please note: The IRB form states that Section 3 is completed only if investigators will conduct research procedures outside of UW and Harborview. For the purposes of this assignment, all circled questions in this section should be completed.

Recruiting and screening participants (3 pts)

Describe how subjects will be identified (1 pt), recruited (1 pt), and screened (1 pt).

Procedures (5 pts)

Provide a complete description of the study procedure in lay language. (3 pts) Explain the data that will be collected. (2 pts)

Privacy and Confidentiality (2 pts)

Describe the plan to address possible privacy concerns of subjects.

Risk Benefit Assessment (2 points)

Describe the risks of harm (1 pt) and anticipated benefits (1 pt) to the participants of the research procedures.