Policies and Guidelines
- Exempt Research
- Non-Exempt Research
- Federal Guidelines
- Modifications to Your Study
- Completion of Your Reserch
- Guidelines For Reporting Unanticipated Problems And Adverse Events
Mission of NDNU Institutional Review Board:
The NDNU IRB Committee endeavors to safeguard the rights of ALL human participants and, as such, we trust that the respective individual(s) charged with oversight of the research project(s) will in turn endeavor to safeguard the legal, ethical, moral, psychological, emotional, physical, mental, and otherwise not herein stated, rights, dignity and well-being of the anticipated human participants in their own and their students' research. To ensure participant rights are upheld, written informed consent is the preferred mode of conducting any type of research to ensure that participants are fully informed of their rights. That is the industry standard and common best practice, irrespective of the type of research conducted. This standard has also been federally mandated via the Office of Research Integrity (ORI), Belmont Report, and the Department of Health and Human Services.
IRB approval is not a given right, but rather a privilege - we are under federal, ethical, and legal mandates that preclude automatic acceptance of any and all proposals. We rely on the information that is presented to us as being true and accurate and make our decisions based on such information. Ultimately, the responsible investigator and/ or supervisor/ research advisor are expected to uphold the rights of the participants in the project. Similarly, we appreciate the responsible party (ies) taking initiative and accountability to ensure that all participants' rights are upheld and that no discriminatory, unethical, illegal issues arise. Understanding and cooperation are expected.
The following policies, procedures and guidelines have been drafted in compliance with federal guidelines set forth by the Office of Research Integrity (ORI), Department of Health and Human Services (OHHS), Office for Human Research Protections (OHRP) and the Belmont Report. All parties conducting any type of research with human participants, whether exempt or non-exempt status are responsible for reading and abiding by these policies, procedures, and guidelines.
What is the IRB?
- The NDNU IRB (Human Participants) is comprised of members appointed via the Provost's office and reports directly to the Provost. It does not fall under the faculty governance structure due to its legal and ethical responsibilities, for which the Provost's office is ultimately responsible.
- The purpose of the IRB is to ensure that the legal and ethical rights, dignity and well-being of all human participants are safeguarded for any type of research that is conducted by any constituents of the NDNU community, or by external parties at NDNU, encompassing NDNU community members as participants. The IRB needs to ensure that the principles of respect for persons, beneficence and justice, as outlined in the Belmont Report (1979) are upheld.
- Specific policies, procedures, and guidelines, and appropriate documentation need to follow federal guidelines.
- All parties, whether as NDNU faculty, students, staff, or administrative status, or as a community member of NDNU, who conduct any form of research, whether academic, non-academic, or institutional, must adhere to the policies, procedures, and guidelines of the IRB, as these are federally mandated. Failure to do so will result in disciplinary action, stated forthwith.
- The NDNU IRB committee shall consist of eight members, with the following federally mandated requirements: At least five members shall represent diversity in race, gender, cultural background and sensitivity to rights and welfare of human participants. At least one member shall be able to address vulnerable populations, (children, handicapped, etc). At least one member shall come from a scientific discipline, and at least one shall come from a non-scientific discipline. Finally, at least one member shall not be otherwise affiliated with the institution. (See federal guidelines). In the event of a tie (i.e. four (4) members in favor of approving the research proposal and four (4) members against approval of the research proposal), the IRB Chair will take the proposal to the Provost or Associate Provost, depending upon availability, to make a final decision.
- In addition to a membership that adheres to federal guidelines, the Provost's Office will create a committee wherein there will be at least one representative from each school, ideally with two undergraduate and two graduate faculty, the Director of Institutional research, and one non-NDNU affiliated external member on the committee, each of whom will serve staggered terms, as determined by the Provost's office, and tracked by the Provost via a consultative process with Deans and current IRB Chair.
- At least one member of the IRB should be well-versed in the federal guidelines and legal and ethical components of conducting research with human participants (See human participants requirements).
- The Provost, in consultation with Deans and the current IRB chair, reserves the right to add additional members and to determine appointment to the committee, term of appointment, and eligibility of members in order to ensure an appropriate balance of diversity, expertise, and other requirements as mandated by federal guidelines.
Please note that indicated interest in serving on the committee does not guarantee appointment to the committee - the Provost ultimately decides the makeup of the committee.
- The guidelines will be available primarily electronically via the campus web. A hard copy format will be available from the Provost's office or from the IRB Chair.
- Anyone who wishes to conduct research at NDNU or as an NDNU representative (i.e. a student, faculty, staff, or administrator doing research involving human participants) must consult the IRB policies, procedures, and guidelines prior to engaging in such activity. At the beginning of each academic term, all faculty whose classes may conduct research are requested to include IRB reference in their syllabi. Note that all NDNU students conducting research with human participants must comply with IRB guidelines. Similarly, any faculty, staff or administrator engaging in any form of research under the purview of IRB must also follow policies and procedures.
- For external investigators wanting to conduct research on the NDNU campus or involving NDNU students, staff, faculty, or administrators, or for research involving human participants to be conducted on the NDNU campus, properties or in programs directed by NDNU, you must provide a copy of the home institutions' IRB approval or exemption (if applicable) and the study protocol to the Provost and the IRB Committee Chair prior to conducting any research. Consultation must occur between the Provost and at least two NDNU IRB Committee members before approval of an external investigator's study will be granted. If there is no concurrence between these parties, the protocol and home institution's IRB approval or exemption will be forwarded to the IRB Committee for full review.
- A flowchart to determine what constitutes Exempt versus Non-Exempt research is available. For both Exempt and Non-Exempt research, the proper application procedure must be followed, with checklists and supporting documents submitted to the IRB Chair early in the term, prior to study implementation, for each study. (Please see link to Forms: Application Cover Page, Non-Exempt Research Checklist and Exempt Research Checklist, and Project Details).
- Document (link) entitled Is My Project "Research" defines research and what is subject to IRB Review (either under Exempt, Expedited or Full Review status) and what is not considered research. Please note that projects that are considered research involve a systematic investigation and are designed to contribute to generalizable knowledge.
- The IRB Committee will keep a log of all approved IRB studies (Exempt, Non-Exempt, Expedited and Full Review) and will send a reminder via email to the principal investigator two months prior to the anticipated study completion date or two months prior to the one year anniversary date of the study's approval, whichever comes first. The investigator will be asked to submit a summary of findings. The summary must answer the questions "Did I deviate from the originally approved study in any way, and if so, how?" It must also contain information from Abstract or an updated Method section with findings incorporated, not to exceed two pages. The summary of findings should be submitted to the IRB Committee no later than two weeks after the completion date or two weeks after the one year anniversary of the study's approval date, whichever comes first. Note that federal guidelines mandate that data collection must be completed within one year of the original date of submission (§ 46.109 (e) and § 46.110 (b) in federal guidelines for IRB.
- The principal investigator of any Exempt or Non-Exempt Expedited or Full Review study will have a one year timeline to complete the collection of data related to his/her proposal. If the principal investigator has not completed the collection of data in one year, then it is the principal investigator's responsibility to notify the IRB Committee Chair in writing no later than two months prior to the one year approval anniversary date and resubmit documentation ( see Study Renewal/Continuation Form) to the IRB Committee to gain approval for continuation. (Please note the one year limit for completion relates to collection of data, not the completion of the entire study.)
Rejection of Study by IRB:
If a proposal is rejected, the IRB will state the reason why in a response letter (inclusive of email communication) and include a copy of the response letter in the IRB committee minutes.
Some reasons for rejection include:
- Incomplete proposal (missing parts, unaddressed questions, missing informed consent or debriefing statements, etc.)
- Inadequate explanation of the research proposal, procedures, materials, participant selection, confidentiality, etc.
- Inappropriate use of research that may impact the rights or well-being of the anticipated human participants.
Re-submission of IRB Proposals:
- Concerns in the original proposal will be communicated to the PI via a letter from the IRB Chair and must be subsequently addressed by the responsible party for resubmission of the proposal, which will then be reviewed at the next expedited review (if applicable) or full review cycle.
- Other times, significant changes may be indicated, in which case the timeline for resubmission rests solely with the responsible party. All IRB concerns need to have been addressed in writing in the resubmitted proposal or in an addendum.
Please note that principal investigators are required to keep their research data for a minimum of three years. If the research is published, the principal investigator is required to keep the data for a minimum of seven years post publication.
Notre Dame de Namur University expects professional and ethical behavior from all participants in institutionally sponsored activities. Research misconduct includes the willful or unintentional failure to follow appropriate IRB guidelines, policies and procedures at NDNU. The IRB committee will do its best to disseminate information about policies, procedures, guidelines and timelines; ultimately, the responsibility rests with the party or parties engaging in research, including faculty in charge of oversight of students. In addition, the IRB committee will work with the chair of the Faculty Development Committee as well as deans to ensure that IRB information is appropriately disseminated to affected parties. Failure to comply may result in disciplinary action via the Provost’sOffice.
All institutional members will report observed, suspected or apparent research misconduct to NDNU’s Research Integrity Officer (RIO). If an individual is unsure whether a suspected incident falls within the definition of research misconduct, he or she may meet with or contact the RIO via the Office of the Provost at (650) 508-3494 to discuss the suspected research misconduct informally, which may include discussing it anonymously and/or hypothetically.