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 INFORMATION section of this website.
Applicants proposing to conduct online surveys must follow the guidelines in the “Conducting Online Surveys” page under the SUBMISSION INFORMATION section of this website.
- Education – Complete the online tutorial offered by the National Institutes of Health (http://phrp.nihtraining.com/users/login.php) and obtain a Certificate of Tutorial Completion Or 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 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.
IRB Committee Member Responsibilities
The IRB is charged with review of proposed research protocols in order to ensure that the rights of human subjects are protected and that risk of harm to subjects is minimized. The framework for protection of human subjects is set in Federal regulation.
IRB members review all assigned research protocols to ensure that:
- Risks to subjects are minimized
- Risks to subjects are reasonable in relation to anticipated benefits
- Selection of subjects is equitable
- Informed consent is properly obtained from all prospective subjects and documented
- Subject’s privacy and confidentiality are protected
- Appropriate additional safeguards are incorporated for any vulnerable subjects