Alder Graduate School of Education (Alder GSE) is committed to protecting the rights, welfare, and privacy of individuals who participate in research activities conducted by the graduate school or under its auspices. In order to fulfill this commitment, Alder conducts human subject research under a registered Federalwide Assurance with the Office of Human Research Protections, 00028975.
The Institutional Review Board (IRB) is the research oversight committee charged with ensuring that human subjects research is conducted in compliance with the applicable federal, state, and institutional policies and procedures. As part of its charge, the IRB has adopted the following four-step protocol to ensure researchers are conducting research that protects the rights, welfare, and privacy of individuals who participate in research activities.
- Obtain Training:
Alder GSE has chosen to subscribe to the Collaborative Institutional Training Initiative (CITI) for all of its online-based human research training. All Alder GSE researchers who are engaged in human research must complete an educational program on ethics and procedures for the use of human subjects research from CITI before the IRB may review a submission. - Plan and Collaborate:
Research Done at an External Site:
An external site is a site or location not owned by or under the direct authority of Alder where the investigator would not normally have privileges to conduct human research activities.
Submission Requirements:
In order to ensure that the appropriate procedures are followed, the IRB collects information on “external sites.” This submission should be completed for every project that involves recruitment and/or data collection at a school or business (including non-governmental organizations and not-for-profit agencies).The IRB may require a letter of authorization prior to conducting its review but most often will require written authorization before approval is granted. Researchers should begin working with research sites early in project development. - Develop and Submit:
Researchers should be prepared to provide the Alder IRB with a description of the project’s purpose and procedures and all materials that will be provided to participants and used to collect information. - Post Approval and Reporting:
Reporting an Adverse Event: The Principal Investigator (PI) bears direct responsibility for the implementation and conduct of the research and for ensuring the protection of human research participants. The PI must promptly report any harm or injury (physical, psychological, social, or economic) or unanticipated problems or incidents involving risks to subjects or others to the IRB.
Reporting Non-Compliance: Serious non-compliance or major protocol deviations must be reported to the IRB within five (5) business days of the investigator’s or research staff member’s learning of the event.