All students, faculty, and staff carrying out research involving interactions with human individuals must go through the Human Subjects Research Protection review process, which is designed to protect human research subjects from risk. You must have HRPO approval before recruiting any research participants or beginning your observations.
Guidelines for the on-line application process for Washington University faculty and students are available on the Human Research Protection Office (HRPO) home page on their website.
STEP 1: Complete the CITI Module
The first required step for all undergraduate, graduate, or faculty researchers working with human subjects is to complete an online education module (CITI). Based on Federal Regulations for working with Human Research Subjects, the education module is designed to sensitize researchers to their responsibilities as investigators and to foreground the rights of research subjects. Students planning to conduct research while abroad need to complete this module before leaving the country. No research should be conducted, and projects cannot be approved by the IRB, until all members of a project team have completed the mandatory education modules. To complete the CITI module:
- Access the HRPO website’s Human Subjects Education page
- Click on the button which says “Click Here to enter CITI.” This will take you to web page of the Office of the Vice Chancellor for Research
- Enter your WUSTL key and password to log in.
- Under “Education and Featured Programs” to the right, click on “Required Initial”
- Choose “Behavioral IRB” and then click “Login to CITI”
- It may take up to 3-4 hours to complete the CITI education module requirement.
STEP 2: Fill out an Institutional Review Board Application through myIRB
- Access the myIRB website
- Log in using your WUSTL key and password.
- For the purposes of your own application, you should be the ‘Principal Investigator’ or ‘Project Director’.
- Choose ‘Behavioral/Social Science’ as your project class.
- At the beginning of the application, in the first section on “Demographics,” you will be asked about the status you would like to apply to the project (Regular Review (expedited or full board) , Regular Review in Compliance with ICH-GCP, Overall approval, Concept approval, Exempt status, CIRB). If you plan to apply for exempt status, be sure to choose the exempt option here as this will open an abbreviated IRB application.
- Signatures on the Assurance Document: In addition to your own signature, human subject project proposals require two departmental level signatures before being submitted. First, your departmental faculty adviser or thesis adviser must approve the project. Then, the department HRPO representative must review and approve your application before you submit it and send it forward to the WUSTL Institutional Review Board (IRB). At the present time, Dr. Geoff Childs (firstname.lastname@example.org) provides the reviews and authorizations for the Anthropology department and must sign the assurance form.
SIT Research and the IRB
The majority of students who conduct research abroad must still apply for IRB approval. SIT programs allow you to obtain initial human subjects research approval, through local ethics committees in the host country, so that you can conduct research while outside of the U.S. You do not have authorization, however, to share or present the results of your research, as part of an honors thesis or otherwise, until you apply for IRB approval from Washington University. As a SIT student, you should submit an application through the myIRB system as soon after your return to campus as possible. In Section 1, #7, indicate that you have completed your research. In section 1, #8, write that you are requesting a transfer of a SIT IRB approval to the WUSTL IRB. Tie that request to your description of the purpose and procedures of the study, which should address your SIT research.
Many ethnographic research applications will be eligible for ‘Exempt’ status. Projects that are Exempt involve observations, interviews, and/or surveys of public behavior and practices where any disclosure would not place subjects “at risk of criminal or civil liability or be damaging to the subjects’ financial standing, employability, or reputation.” (45 CFR 46.101). Otherwise, it may be appropriate to apply for the ‘Expedited’ review. Under the ‘Expedited’ process, your application is reviewed by one individual rather than a multi-member committee. While this application process is less stringent than ‘Full review’ it is not necessarily fast, as the word ‘Expedited’ might seem to suggest. Note that the ‘Full’ review also is possible, but it sometimes can take weeks.
Oral consent is often considered appropriate for anthropological fieldwork because of lack of subject’s literacy or due to cultural suspicions regarding the potential for fraudulent manipulations of written permissions. With either oral or written consent, the participants are free to respond or not to the researcher’s questions, to tell the truth or otherwise, and to determine the level and nature of their interaction with the researcher. Participation is always entirely voluntary; participants maintain the freedom to disengage from research activities at any time.
If minors (under age 18 years of age, unless otherwise defined in your project area) are the targeted population, or if the individuals involved in your research are both identifiable and at possible risk to reputation or otherwise potentially at risk, you should use the ‘Expedited’ or even the ‘Full’ review.