Welcome to the Institutional Review Board (IRB) at Saint Anselm College. For detailed application information, upcoming meetings, frequently asked questions, or other information about us, please visit the links provided.
The mission of the IRB committee is to protect the rights, privacy, and welfare of human research subjects recruited to participate in research.
The function of the IRB committee is to review all human subject research to ensure that it is in compliance with federal standards for the protection of Human Research Subjects (45 C.F.R. Part 46) and that it is consistent with the policy and procedures of Saint Anselm College. Additional information as to what qualifies as human subject research is available on the FAQ page. There are four types of reviews provided by the IRB:
- Exempt review is for research activities involving human subjects that are exempt from the federal regulations governing human subject protections. Exempt research is limited to research that falls within one of the exemption categories defined in 45 Code of Federal Regulations (CFR) 46.101. Note that exemption status is determined by the IRB committee, not the investigator.
- Expedited review may be used for certain kinds of research involving (1) no more than minimal risk (2) minor changes in approved research (3) procedures listed in one or more of the categories outlined in the human subjects guidance 63 FR 60364-60367. Note that eligibility for expedited review is determined by the IRB chair, not the investigator. Detailed information on the expedited review process is available on the FAQ page.
- Full committee review is required for the remainder of the study applications. Examples include those with greater than minimal risk, or involving a vulnerable population. Studies can receive full IRB approval for a maximum of one year from the date of the last convened meeting when the protocol was reviewed. The committee meets once a month from August - May to review research proposals.
- Continuing review. Federal regulations require human subjects research protocols to be reviewed a minimum of once per year (21 CFR 56.109 and 45 CFR 46). Continuation of a research study beyond the approval period requires submission of a request for continuance to the IRB. It is the investigator's responsibility to submit a status report (PDF/150KB), and if appropriate, a request for continuance (PDF/154KB) in a timely manner. Additional information on continuing review can be found at the DHHS website.
Activities not subject to IRB review:
- non-intrusive observation of participants in public settings for non-research purposes
- data-gathering from class members solely for classroom purposes
- needs assessments or evaluation data intended to remain within the Saint Anselm College community.
Erik Cleven, Ph.D.
Chair, IRB Committee
Secretary, IRB Committee
Deadlines for Proposal Submission
The IRB meets each month during the academic year. In order to have your IRB research application put on the IRB agenda, you must send all necessary documentation in electronic format by noon on the appropriate deadline. See detailed information about what and how to submit an application.
Listed below is the deadline for the meetings of the 2018-19 AY:
- September 12, 2018
- October 10, 2018
- October 31, 2018
- November 21, 2018
- January 9, 2019
- January 30, 2019
- February 27, 2019
- March 27, 2019
Mission of the Institutional Review Board (IRB)
The IRB is a committee whose mission is to protect the rights, privacy, and welfare of human subjects recruited to participate in research.
Function of the IRB
The main function of the IRB is to review all human subject research to ensure that it is in compliance with the Department of Health and Human Services regulations for the protection of Human Research Subjects (45 C.F.R. Part 46) and to ensure that it is consistent with the policy and procedures of Saint Anselm College. The IRB has the authority to approve, require modifications in, or disapprove all research activities that fall within its jurisdiction as specified by both federal regulations and college. Please note that no research involving human subjects may begin until final IRB approval is granted.
Federal regulations dictate that the IRB membership have at least five members and its composition include (1) a member of both sexes (2) members that come from varied professions (3) at least one member whose primary concerns are in nonscientific areas (4) at least one member whose primary concerns are in scientific areas (5) at least one member who is not otherwise affiliated with the institution. One of the members serves as chair and is appointed by the executive vice president. Current membership includes (* denotes committee chair):
- Marie Bonin ('19)
- Hui-Ling Chen, Ph.D. (Director, Institutional Research)
- Erik Cleven, Ph.D., Chair (Politics)
- Daniel Daly (Theology)
- Pamela DiNapoli, RN, Ph.D., CNL (UNH Associate Professor and External Member)
- Luke Douglas ('18)
- Matthew Gonzalez, Ph.D. (Classics)
- Mary Mader, Ph.D., (Director, Sponsored Programs and Research)
- Antonia Nelson, Ph.D., RNC, IBCLC (Nursing)
- Elizabeth Rickenbach, Ph.D. (Psychology)
- William Ryerson, Ph.D. (Biology)
IRB Federal Assurance
An assurance of compliance is a written document submitted by an institution that is engaged in non-exempt human subjects research conducted or supported by the United States Department of Health and Human Services (HHS). Through the assurance, an institution commits to HHS that it will comply with the requirements set forth in the regulations for the protection of human subjects at 45 CFR part 46.
IRB Protection of Human Subjects Online Training Course
Saint Anselm College expects all researchers to conduct their work with the highest degree of integrity. To that end, the College has set forth minimum standards for mandatory research integrity training, including the following two requirements that are relevant to the IRB. Both courses are offered by the Collaborative Institutional Training Initiative (CITI) and are available to Saint Anselm faculty and staff. For information on how to register download/view the CITI registration guide (Word/33KB).
- All individuals conducting research with human subjects are required to complete the IRB "Protection of Human Subjects" online training course.
- All individuals with externally funded research are required to complete the "Responsible Conduct of Research" online training course.
If you have any questions or need assistance with the CITI training, please contact Mary Mader, Director of Sponsored Programs and Research at 641-7174.
How to apply for exempt review
Some research may be eligible for exemption from IRB review if all the activities associated with the research fall into one or more of six categories outlined in the federal guidelines 45 C.F.R. ş46.101. Note that determination of exemption status is made by the IRB, not the investigator. To apply for exempt review, send a short description of your research as an e-mail attachment to the chair of the IRB.
How to apply for expedited or full (convened) IRB review
- Download and complete the IRB Application Form (PDF/503KB)
- Complete Additional Application Requirements outlined below
- Submit an electronic copy with scanned signatures of the complete IRB application form and all supplemental materials as an e-mail attachment to firstname.lastname@example.org.
Please note that complete research applications must be received at least 14 days prior to the next scheduled IRB meeting to be included in the agenda. IRB applications will not be reviewed until the application and all supporting materials have been received. Handwritten application are discouraged. Expedited reviews can be completed at anytime during the month.
- Mandatory Research Integrity Training. Saint Anselm College expects all researchers to conduct their work with the highest degree of integrity. To that end, the college has set forth minimum standards for mandatory research integrity training, including the following two requirements that are relevant to the IRB. Both courses are offered by the Collaborative Institutional Training Initiative (CITI) and are available to Saint Anselm faculty and staff. For information on how to register download/view the CITI registration guide (Word/33KB).
- All individuals conducting research with human subjects are required to complete the Human Subjects online training course. Note that all principle investigators, responsible investigators, and co-investigators must enroll in the full training course by choosing either "Biomedical Research Investigators" or "Social and Behavioral Research Investigators." However, student research assistants who are working on research that has been deemed by the IRB to be no more than minimal risk are only required to enroll in the training module for "Students conducting no more than minimal risk."
- All individuals with externally funded research are required to complete the Responsible Conduct of Research online training course.
If you have any questions or need assistance with the CITI training, please contact Mary Mader, Director of Sponsored Programs and Research at 641-7174.
- Federal Guidelines. The IRB committee reviews all proposals to to ensure that they are in compliance with the Department of Health and Human Services regulations for the protection of Human Research Subjects (45 C.F.R. Part 46). Researchers are expected to have reviewed this document and written their proposal according to these federal guidelines.
- Student Research. Please note that student applications must be reviewed and signed by a supervising faculty member prior to submission (see application Section 2 under responsible investigators and Section 12 for signature page).
The Institutional Review Board (IRB) at Saint Anselm College is scheduled to meet in Room 001 in Joseph Hall every month of the academic year.
AY 2018-2019 Meeting Dates DATE
12:30 p.m. (All Dates Unless Noted)
September 26, 2018 September 12, 2018 October 24, 2018 October 10, 2018 November 14, 2018 October 31, 2018 December 5, 2018 November 21, 2018 January 23, 2019 January 9, 2019 February 13, 2019 January 30, 2019 March 13, 2019 February 27, 2019 April 10, 2019 March 27, 2019
Please note: Research applications must be received by noon at least 14 days prior to the next scheduled IRB meeting to be included in the agenda.
Frequently Asked Questions
*Note that throughout the answers provided below you will frequently encounter references to the acronym CFR, which refers to the Code of Federal Regulations. The CFR is published in the Federal Register, a publication of the Federal Government that codifies the general and permanent rules of executive departments and agencies.
Does my research require IRB review?
All research that includes human research subjects are subject to IRB review. Research is defined as a systematic investigation designed to develop or contribute to generalizable knowledge. A human subject is defined as a living individual about whom an investigator obtains data through intervention or interaction, or identifiable private information. For more detailed definitions see 45 CFR ş46.102. In short, if your research does not fit the definition of human subject research, then there is no requirement for IRB review. If your investigation does fit the definition of human subject research then it always requires some level of IRB review. The types of review are exempt , expedited, full, or continuing review. For more information on how to apply for IRB review visit the application page.
Is there an application deadline?
The IRB committee accepts applications year round. However, applications must be received at least 14 days prior to the next scheduled IRB meeting to be included in the agenda. Also note that the committee does not normally meet during June and July. View list of upcoming meeting dates.
What is expedited review and does my research qualify?
Expedited review is a procedure for certain kinds of research involving (1) no more than minimal risk (2) minor changes in approved research (3) procedures listed in one or more of the categories outlined in the human subjects guidance 63 FR 60364-60367. "No more than minimal risk" means that "the probability and magnitude of harm or discomfort anticipated in the research are not greater in and of themselves than those ordinarily encountered in daily life or during the performance of routine physical or psychological examinations or tests." Expedited review does not negate or modify the policies of the college or the HHS regulations (i.e. a full application is still required). Expedited review means that one or more experienced members of the IRB (often the chair) can review the study without it being considered at a convened meeting. When conducting expedited review, the chair may exercise the same authority of a full IRB committee except he/she cannot disapprove the research study. The IRB chair makes the determination of whether an application and protocol qualify for expedited review under 45 C.F.R. ş46.110.
How do I sign up for the Mandatory Ethics Training?
Saint Anselm College offers several online ethics training courses through the Collaborative Institutional Training Initiative (CITI), including the following two courses that are most relevant to the IRB:
- IRB Protection of Human Subjects (required of all individuals conducting research with human subjects)
- Responsible Conduct of Research (required of all individuals with externally funded research)
For information on how to register for either online course download/view the CITI registration guide (Word/33KB).
What will the IRB committee look for when reviewing my research proposal?
The objective for the IRB committee when reviewing your human subject research will be to ensure that it is in compliance with federal standards and that it is consistent with the policy and procedures of Saint Anselm College. To that end, there are few specific questions that reviewers will keep in mind when reviewing your research. These same questions are therefore useful for you to consider while writing your research plan:
- Have the risks to subjects been minimized using procedures that are consistent with sound research design?
- Are the risks reasonable in relation to anticipated benefits?
- Is the selection of subjects equitable?
- Are adequate procedures in place to ensure privacy and confidentiality?
- Is there a plan to monitor the data and safety of the subjects, if necessary?
- Will informed consent be sought and appropriately documented? Do proposed alterations or waivers of informed consent meet the criteria for approval?
- Are safeguards in place to protect vulnerable populations?
What if I need to revise an approved research protocol?
The IRB must review and approve all amendments to study protocols before the researchers can implement them. Amendments are reviewed the same way a new study is reviewed, that is, by the convened IRB or by expedited review, depending on how the changes affect the protocol. Minor modifications - those changes that are minimal risk and do not significantly alter the risk/benefits balance or other study elements - may be reviewed under the expedited review process. Major modifications, requiring full IRB review, are those that might increase the risk to participants or otherwise represent a substantive change, such as the inclusion of a vulnerable population, or change in treatment. Investigators seeking to amend their research protocol should provide the committee with a written explanation of the proposed changes, including justification as to why the modification is necessary and reasonable given the overall study design.
What should I do if my research study extends for longer than the one-year IRB approval deadline?
Continuation of a research study beyond the approval period (12 month maximum) requires submission of a request for continuance to the IRB. It is the investigator's responsibility to submit a status report (PDF/151KB), and if appropriate, a request for continuance (PDF/154KB) in a timely manner. Additional information on continuing review can be found at the DHHS website.
What is informed consent?
It is federal policy that no investigator may involve a human being as a subject in research unless the investigator has obtained the legally effective informed consent of the subject or the subject's legally authorized representative. See CFR §46.116 for general requirements for informed consent and a list of basic elements that are included in standard informed consent forms, and CFR §46.117 for directions on the documentation of informed consent. Please note that recruitment of subjects is part of the consent process because it begins the disclosure process. All recruitment strategies such as fliers, e-mail messages, newspaper ads, phone calls, and so on must be reviewed by an IRB before they are used.
Is there anything I need to report upon completion of my project?
Institutional Review Board (IRB) approval is granted for one year or the completion date of the project. Upon completion of a project investigators must submit a brief summary report of 1-2 paragraphs that includes the following:
- Date of completion
- Short narrative description of research activity
- Number of human subjects that took part in your study
- Description of any reported or adverse effects to human subjects
How long should I keep my research records upon completion of my project?
Investigators are responsible for retaining signed consent documents, IRB correspondences, and research records for at least 3 years after the completion of the research activity. Additional requirements must be met for FDA-regulated studies as specified in 21 CFR Part 312.62 (c).