Information for Applicants and Research Advisors

Special Guidelines
Applicants proposing to conduct research in their classrooms or research involving children must follow special procedures. Applicants should carefully review the information provided on the “Research in K-12 Schools” and “Research Involving Children” pages under the SUBMISSION Guidelines section of this website.
Applicants proposing to conduct online surveys must follow the guidelines in the “Conducting Online Surveys” page under the SUBMISSION Guidelines section of this website.

Researcher Responsibilities

Education – Complete the CITI Training Course (https://www.citiprogram.org) prior to the start of any human subject research activity
Design and conduct ethical research in accordance with the fundamental ethical principles of Respect for Persons, Beneficence, and Justice outlined in the Belmont Report
Correctly complete IRB application (Provide ALL necessary documents for review to the IRB)
Obtain IRB approval prior to initiation of research
Ensure that recruitment activities are not initiated prior to IRB approval or after the expiration date of IRB approval. Researchers are responsible for enrolling only the number of subjects that were indicated and approved in the protocol.
Ensure that the research is conducted as approved and obtain prior approval for modifications
Obtain informed consent from research participants and other required parties
Document informed consent by providing subject with a copy of the signed form and keeping a copy in the study records
Report adverse events and any non-compliance immediately to IRB
Disclose any conflicts of interest of research team members
Retain research records securely for five (5) years after closure of the IRB approved protocol

Faculty Research Advisor Responsibilities

Preparation of Students for the Role of Researcher – The Faculty Research Advisor is responsible for instructing students in the ethical conduct of research and assisting students in the preparation of IRB applications. The Faculty Research advisor must complete The CITI Human Subjects trainning course. The Faculty Research Advisor ensures that their advisees:

design a study that minimizes the risk to human subjects,
understand the elements of the consent process,
develop a readable consent form,
plan appropriate recruitment strategies for identifying subjects, and
establish strict guidelines for protecting anonymity and confidentiality.

Scientific Review – The Faculty Research Advisor is responsible for the scientific review of the research study. The Faculty Research Advisor signature on the IRB application serves as the verification that the research design is sound and the study hypothesis is reasonable. Prior to submission of a student protocol to the IRB, the advisor should review the protocol and all supporting documents including consent forms, recruitment materials and study instruments. The faculty research advisor signature affirms that:

the research uses procedures consistent with sound research design,
the study design can be reasonably expected to answer the proposed question, and
the importance of the knowledge expected to result from the research is known.

The IRB reserves the right to require scientific review on a study-by study basis.

Conduct of Research – The Faculty Research Advisor shares with the student researcher the responsibility for the ethical conduct of research. The Faculty Research Advisor takes an active role in providing supervision for the duration of the project and ensures that their advisees conduct their research in accordance with the IRB approved protocol. The Faculty Research Advisor:

reviews all changes to the research, ensures that changes are submitted to the IRB, and that approval is obtained before a change is implemented;
reports any adverse events or other research-related problems to the IRB as soon as possible;
ensures that continuing review requirements are satisfied when applicable and that the study is properly closed.