Merrimack's Institutional Review Board
The Institutional Review Board (IRB) is charged with safeguarding the rights and well-being of human subjects in research/projects conducted at or sponsored by Merrimack College.
Overview of IRB
An Institutional Review Board (IRB) is a committee, or board, of volunteers including scientists, non-scientists and community members, that ensures research protocols involving human subjects are ethical and that the rights of participants are protected. The federal Office of Human Research Protection (OHRP), through its process of approving and granting Federalwide Assurance for institutions that conduct human subject research, requires that an institution’s human subject activities and its Institutional Review Board (IRB) be designated under the Assurance, will be guided by the ethical principles in “The Belmont Report: Ethical Principles and Guidelines for the Protection of Human Subjects of Research”.
Merrimack College is committed to the pursuit of excellence in research, scholarship, and related professional achievement. The Merrimack IRB exists to ensure that all research participants are treated with respect and safety and because federal law requires that all research involving human participants (or source-identifiable biospecimens from human participants) receive IRB approval. Research projects falling under IRB review are varied and diverse and include disciplinary-based research in the biomedical and social-behavioral disciplines, in-class research at the undergraduate and/or graduate level, and community engaged research projects.
The College has provided a formal guarantee to the U.S. Department of Health and Human Services (DHHS) that it will follow procedures to assure the protection of all human subjects involved in research projects.
Responsibilities of IRB
- Developing and disseminating federally compliant policies for the protection of human subjects.
- Developing and implementing institutionally appropriate procedures for ensuring the protection of human subjects, in collaboration with other members of the Merrimack College community.
- Educating members of the Merrimack College community about the ethical and legal obligations associated with human subject projects.
- Conducting reviews of generalizable research projects to ensure that such research will be carried out in a manner that safeguards the rights and well-being of the subjects.
- Promoting professional development in research ethics for Merrimack College employees in support of their instructional, research and administrative work.
Merrimack College IRB Information
- Merrimack College Federalwide Assurance: FWA 00014062
- FWA renewal is: 09/30/2027
- IORG 0005707
- IRB 00006880, Expires 12/05/2025
Policies and Procedures
Ethics Reports
Below you will find important publications and information regarding human subjects research ethics.
Complete details on project types and review procedures can be found in the Merrimack College IRB Guidelines for Review of Research Involving Human Subjects document.
Reliance Agreement: A formal, written document that provides a mechanism for an institution engaged in research to delegate institutional review board (IRB) review to an independent IRB or an IRB of another institution. Institutions that are engaged in human subjects research, where one institution will rely on the other institution’s IRB, must agree to the terms of the Reliance Agreement before research can begin.
SMART IRB: Merrimack College does not currently have the ability to process Reliance Agreements through the SMART IRB platform. Please contact Merrimack’s IRB Administrator via email at [email protected] for assistance
This policy defines the rights and responsibilities of Merrimack College and its faculty, staff, and students with respect to ownership and administration of intellectual property. This policy is based on respect for those who are inventors and developers of creative works; it is therefore also intended to provide faculty with intellectual property guidelines that foster innovation and inspire creativity.
PI Academy Presentation: Student Research at Merrimack College
It is always advised to contact the Merrimack IRB via email at [email protected] if you are unsure if a class assignment warrants IRB review and approval.
Generally, standard class assignments do not need IRB approval because they are considered educational exercises, not research, as long as the data is not intended for publication or use beyond the classroom context; however, if a class project involves sensitive information, vulnerable populations, or is designed to be published, it may require IRB review, and it’s always best to consult your institution’s IRB guidelines to be sure.
Key points to remember:
- Purpose of the project: If the primary goal is to learn research methods and not to generate new knowledge for publication, it’s likely not considered research and doesn’t need IRB approval.
- Data collection methods: Standard surveys, interviews, or observations conducted within the classroom setting with minimal risk to participants are usually not subject to IRB review.
- Confidentiality and privacy: Even if IRB approval isn’t required, instructors should still emphasize the importance of protecting participant privacy and confidentiality.
When to consult the IRB:
- Sensitive topics: If the project deals with sensitive topics like health conditions, criminal behavior, or personal finances, it’s best to check with the IRB.
- Vulnerable populations: If the project involves children, pregnant women, prisoners, or other vulnerable populations, IRB approval is likely needed.
- Intent to publish: If students plan to publish their findings beyond the classroom setting, they should consult the IRB.
FERPA & Research:
Approval to use student educational record data in your research is contingent on your agreement to:
- Use the information only for purposes of your approved research project. Any new use of the information requires new approval.
- Provide adequate protection for the information to ensure that it is not compromised or subject to unauthorized access.
- Ensure that only members of the research team who have a legitimate educational interest access student records without signed permission from the parent or eligible student.
- Ensure that no one outside of the research team members who are specifically listed on the protocol have access to the personally identifiable information.
- Ensure that all data shared in aggregate form is properly de-identified to avoid unauthorized disclosure to third parties. IU’s disclosure avoidance procedure is to restrict any cell size that is smaller than 10 when paired with restricted data.
OHRP Human Subject Decision Tree
Even if you believe your research falls under non-human subject criteria, it’s crucial to consult with the IRB to ensure proper review and approval. Non-human subject research is considered when a research study does not involve any identifiable human subjects, meaning the data or specimens used are completely de-identified, with no linkable personal identifiers, and were either publicly available or collected without direct interaction with living individuals; essentially, the research is conducted on data that cannot be traced back to a specific person.
Submitting Proposals to the IRB
Guidelines
Complete details on project types and review procedures can be found in the Merrimack College IRB Guidelines for Review of Research Involving Human Subjects document.
- Merrimack College Federalwide Assurance: FWA 00014062
- FWA renewal is: 09/30/2027
- IORG 0005707
- IRB 00006880, Expires 12/05/2025
IRB Submission / Review Types: |
Exempt Reviews:
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Expedited Reviews:
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Full Board Reviews:
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Certification Requirements
Human subject research training is required by any individual submitting a proposal to the Merrimack IRB and by any individual listed on a research protocol. Starting in September 2018, the College began accepting CITI certification only. Either the Social & Behavioral Research or the Biomedical Research modules can be completed.
Researchers active in human subjects research must complete the certification every three years.
All Institutional Review Board (IRB) members are required to renew their certification every year.
Registering on CITI
First-time uses should click on “register” at the top right of the CITI website and follow the subsequent steps to register, using Merrimack College as your organization and your Merrimack College email address as your primary email.
Contact the IRB with questions.
The templates below are provided to guide you in developing your protocol and application documents. Please note that each document must contain specific information as shown in the templates.
The Merrimack College Institutional Review Board requires that each application include consent and/or assent forms that contain each of the sections included in the template(s).
- Informed Consent Template [Written]
- Informed Consent Template [Electronic]
- Informed Consent Template [Verbal Script]
- Parental Consent Template [Written]
- Child Assent Template [Written]
- Sample Letter of Authorization
Submitting an Application Using Cayuse Human Ethics
Faculty, students, and other researchers at the College have full access to the Cayuse Human Ethics system for submitting and reviewing IRB applications.
How to Enter the Site:
Cayuse has moved to a single sign on (SSO) system linked to your Merrimack login. Please note than when you do login to Cayuse Human Ethics the home page will appear somewhat blank. Please click on the ‘Products’ button on the upper right of the screen and choose ‘Human Ethics’. This will take you to the home page that you have worked with in the past.
For information and instructions on how to create, renew, modify, or close a study, click on the links to step-by-step video tutorials below.
Training
CITI Training
The Collaborative Institutional Training Initiative Program (CITI) provides online training opportunities for Merrimack College faculty, staff, and students as it pertains research and sponsored programs. It is required by all investigators to complete either the Social & Behavioral Research or the Biomedical Research modules prior to submitting their proposal to the Merrimack IRB and conducting their research. Merrimack College in collaboration with the CITI program currently offer the following training modules free of charge for Merrimack College faculty, staff, and students:
- Social & Behavioral Responsible Conduct of Resaerch
- Biomedical Responsible Conduct of Research
- Biomedical Data or Specimens Only Research
- Conflict of Interest
- Essential of Grant Proposal Development
- Social and Behavioral Research Best Practices for Clinical Research (GCP)
- Humanities responsible Conduct of Research
- IRB Member Training
- Physical Science Responsible Conduct of Research
- Responsible Conduct of Research for Engineers
Registering on CITI
First-time uses should click on “register” at the top right of the CITI website and follow the subsequent steps to register, using Merrimack College as your organization and your Merrimack College email address as your primary email.
Contact the IRB with questions.
REDCap is a secure web application for building and managing online surveys and databases. The software is specifically designed to support data capture for research studies and operations. Training videos can be accessed through REDCap.
Cayuse Training Site
A training site is available for users to familiarize themselves with the Cayuse Human Ethics application process. Please use the training version of the software before submitting a formal application. The site is an exact duplicate of the official Cayuse Human Ethics software site, but the two sites are not linked to one another.
Important note: You will not be able to submit an application for review from the training site.
Login to Cayuse’s Training Site
How to Enter the Training Site
- Log in with your Merrimack username.
- Use the password: merrimack (all lower case).
- Choose “Cayuse Human Ethics.”
Note: If you experience any difficulty reaching the Cayuse site, it is suggested that you try using a different browser.
Group Training for Faculty and Students
Would you like a member of the IRB to come to your class? Would you like us to sponsor a workshop to provide training on how to use the Cayuse Human Ethics software? Please contact us at [email protected].
Student CITI Requirements
Compliance and Regulatory Training
Overview
An Institutional Review Board (IRB) is a committee, or board, of volunteers including scientists, non-scientists and community members, that ensures research protocols involving human subjects are ethical and that the rights of participants are protected. The federal Office of Human Research Protection (OHRP), through its process of approving and granting Federalwide Assurance for institutions that conduct human subject research, requires that an institution’s human subject activities and its Institutional Review Board (IRB) be designated under the Assurance, will be guided by the ethical principles in “The Belmont Report: Ethical Principles and Guidelines for the Protection of Human Subjects of Research”.
Merrimack College is committed to the pursuit of excellence in research, scholarship, and related professional achievement. The Merrimack IRB exists to ensure that all research participants are treated with respect and safety and because federal law requires that all research involving human participants (or source-identifiable biospecimens from human participants) receive IRB approval. Research projects falling under IRB review are varied and diverse and include disciplinary-based research in the biomedical and social-behavioral disciplines, in-class research at the undergraduate and/or graduate level, and community engaged research projects.
The College has provided a formal guarantee to the U.S. Department of Health and Human Services (DHHS) that it will follow procedures to assure the protection of all human subjects involved in research projects.
Responsibilities of the IRB
- Developing and disseminating federally compliant policies for the protection of human subjects.
- Developing and implementing institutionally appropriate procedures for ensuring the protection of human subjects, in collaboration with other members of the Merrimack College community.
- Educating members of the Merrimack College community about the ethical and legal obligations associated with human subject projects.
- Conducting reviews of generalizable research projects to ensure that such research will be carried out in a manner that safeguards the rights and well-being of the subjects.
- Promoting professional development in research ethics for Merrimack College employees in support of their instructional, research and administrative work.
Merrimack College IRB Information
- Merrimack College Federalwide Assurance: FWA 00014062
- FWA renewal is: 09/30/2027
- IORG 0005707
- IRB 00006880, Expires 12/05/2025
