The first step of the process is to plan the research project involving human participants or subjects. This needs to be well conceptualized before the process can go forward. If it is a student project, a faculty advisor must be included for consultation in the development of a protocol to be submitted to the IRB. In this process an effort should always be made to eliminate unnecessary risk or potential discomfort for participants. The guidelines detailed below are intended to help new investigators determine if the project falls under the purview of the IRB, and if it does fit within IRB, if the protocol should be proposed for Exempt, Expedited, or Full Board review. If applying for Exempt or Expedited review, you should understand the justifications for the category.
Training and Certification
平特五不中 College uses the for the training and certification of researchers wishing to engage in human subjects research. Use the option to log in through your organization, and indicate your affiliation with 平特五不中 College. You should then be able to log in using your single sign on (SSO) credentials.
The 平特五不中 College IRB is phasing in a new requirement for CITI coursework, as of Fall 2024. The IRB previously accepted courses on the responsible conduct of research (RCR). These courses are valuable for principal investigators and other researchers seeking to adhere to or inculcate a culture of professional and ethical research practices, and may continue to be required for applicants for federal funding.
The courses offers limited coverage of issues related to the protection of human subjects, however. The CITI courses on 鈥淪ocial-Behavioral-Educational Research鈥 or "Biomedical Research" offer much more comprehensive coverage of the protection of human subjects.
Therefore, any principal investigator, research mentor, or student researcher who has not previously submitted a CITI certificate of completion to the 平特五不中 College IRB is now required to submit a certificate of completion of the 鈥淪ocial-Behavioral-Educational Research鈥 (for most researchers) or "Biomedical Research" course. Moreover, if a previously-submitted certification of any individual expires, that person will be required to submit a certificate of completion of one of these two courses. CITI certificates must be renewed every three years.
Submitting Your Research Protocol
All research protocols, revisions, and amendments submitted to the 平特五不中 College IRB are evaluated by the IRB via the .
should use their regular 平特五不中 SSO credentials. First-time users can set their Profile to be classified as Faculty or Student.
The system will ask you for specifics about your protocol process, your participants, your procedures, potential risks and benefits of participating in your study, your data acquisition, storage, and security, your privacy protections, your consent process, compensation of participants, and so on. You will need to upload files with any survey or interview questions, assessment instruments, and consent forms.
Upon entering Axiom Mentor, select My Protocols on the left hand menu bar. There is a survey tool which helps to confirm that your project belongs within the IRB and then if it does, if it meets the requirements for Exempt, Expedited, or Full Board submission. The software will take in your responses and files to create the submission. Only faculty can complete the submission to the IRB. Student protocols must be submitted to the faculty advisor for vetting and final submission.
The first tab of the Axiom Mentor interface shows some information specific to 平特五不中 College, and includes a link to a template for an informed consent form.
Axiom Mentor guides for Student Submission of a New IRB Protocol and for Submitting a New Protocol (for Faculty and Students) help explain how to navigate the IRB software.
Timeline for IRB Review
Once submitted, your protocol will be reviewed by the IRB Administrator and possibly members of the IRB, after which, you will either be contacted to make revisions or given IRB approval. This review process takes time, a simple Exempt protocol done correctly might be approved in two weeks time, but a complicated Full Board protocol requiring revisions can take much longer. All IRB panel members have primary work outside the IRB process! You can see the stages and status of your protocols within Axiom Mentor. The full committee typically convenes only when the College is in session.
Privacy and Confidentiality Considerations
One of the most common reasons that the IRB asks for revisions of a research protocol is that the protocol does not spell out how the privacy of participants will be protected, or does not outline these protections in the informed consent form.
In some studies, the researchers identify the participants by a number, but retain a separate key that identifies the participant associated with each number by name. In these cases, it is important to protect the privacy of the participant, particularly if disclosure of their data would pose a risk of some harm to the participant. Therefore,
- The key should be kept separate from the data collected in the study.
- The key should be stored securely, such that a limited number of persons have access. If it is in digital form, it should be encrypted, and password protection may be used to limit access.
- The protocol should specify a reasonable timeline, at least in general terms, for the key to be destroyed.
- Other information including references to named individuals or groups such as recruitment records or lists of participants to be compensated should be destroyed when no longer required for the research.
Other studies may engage participants without identifying them in any way, so that there would be no way to associate data gathered on the participants with their names. In such cases, federal regulations allow the IRB to waive the requirement that participants enter their name, sign, and date the consent form, if the consent form would be the only way to link the person to the study and the principal risk would be from a breach of confidentiality. For full details, and for two other situations in which the requirement may be waived, see 45 CFR 46.117(c).