Institutional Review Board
Calvin University affirms the importance of research involving human test subjects. Additionally, the university affirms that human research subjects should be treated with profound dignity and respect befitting their creation in the image of God. To protect these values, the university provides for an Institutional Review Board (IRB).
What does the IRB do?
The IRB reviews all research involving human subjects, performed under college/university auspices, for compliance with federal government principles and with ethical standards. “Research” means a systematic investigation designed to develop or contribute to generalizable knowledge. Research projects that involve the use of humans as subjects must be approved by Calvin's IRB.
How does the IRB process work?
Before starting a research project, you must complete and submit the following documents for IRB approval:
- Form A: Proposal Cover Sheet - required for all proposals, renewals and revisions (Word .docx)
Checklist for New Proposals (.pdf)
Checklist for Renewals (.pdf)
- (Supplementary) Form B: Required for course-based and center-based research (Word .docx)
Guidelines for Course-Based Research (.pdf)
- Proof of human subjects protection training (this certificate must be submitted with every proposal and for all investigators).
Go to citiprogram.org and follow the instructions below:- Click on Register
- Select Calvin University as organization
- Agree to terms and affirm affiliate of Calvin University
- Fill in your information
- Create username and password
- More information to fill in, but you only need to fill in info where there is an asterisk
- Choose your training – Most will choose Human Subjects Research
- Social & Behavioral Research
Proposals describe the research plan, explain the provisions to protect participants, and outline what steps will be taken to comply with federally mandated legal and ethical guidelines. Each question in the protocol should be answered using non-technical language so that IRB members will have ample information to understand the proposed research project.
Research proposals are given three possible types of approval:
Exempt
Research that falls under this category must be reviewed by the IRB, but will be exempted from further IRB review and no additional review will be required for the project unless there are changes in the research protocol. However, before a proposal is exempted from further IRB review, the IRB may request additional information about the proposal, and/or may require changes in the consent form, participant recruitment methods, or other aspects of the procedure. It is implicit within the concept of exempt research that there must be very little, if any, associated risk. The following are exemption categories:
- Research conducted in established or commonly accepted educational settings, involving normal educational practices, such as:
- research on regular and special education instructional strategies, or
- research on the effectiveness of or the comparison among instructional techniques, curricula, or classroom management methods.
- Research involving the use of educational tests (cognitive, diagnostic, aptitude, achievement), survey procedures, interview procedures or observation of public behavior, unless:
- information obtained is recorded in such a manner that human subjects can be identified, directly or through identifiers linked to the subjects, and
- any disclosure of the human subjects' responses outside the research could reasonably place the subjects at risk of criminal or civil liability or be damaging to the subjects' financial standing, employability, or reputation.
*Survey or interview research involving children is not eligible for exemption, nor is the observation of a minor’s public behavior unless the investigator does not participate in the activities being observed. Additionally, research involving prisoners cannot be eligible for exemption.
- Research involving the use of educational tests (cognitive, diagnostic, aptitude, achievement), survey procedures, interview procedures, or observation of public behavior that is not exempt under paragraph (b)(2) of this section, if:
- the human subjects are elected or appointed public officials or candidates for public office, or
- federal statute(s) require(s) without exception that the confidentiality of the personally identifiable information will be maintained throughout the research and thereafter.
- Research involving the collection or study of existing data, documents, records, pathological specimens, or diagnostic specimens, if these sources are publicly available or if the information is recorded by the investigator in such a manner that subjects cannot be identified, directly or through identifiers linked to the subjects.
- Research and demonstration projects which are conducted by or subject to the approval of Department or Agency heads, and which are designed to study, evaluate, or otherwise examine:
- public benefit or service program
- procedures for obtaining benefits or services under those programs
- possible changes in or alternatives to those programs or procedures, or
- possible changes in methods or levels of payment for benefits or services under those programs.
- Taste and food quality evaluation and consumer acceptance studies,
- if wholesome foods without additives are consumed or
- if a food is consumed that contains a food ingredient at or below the level and for a use found to be safe, or agricultural chemical or environmental contaminant at or below the level found to be safe, by the Food and Drug Administration or approved by the Environmental Protection Agency or the Food Safety and Inspection Service of the U.S. Department of Agriculture.
Expedited
Research activities that (1) present no more than minimal risk to human subjects, and (2) involve only procedures listed in one or more of the following U. S. Department of Health and Human Services Categories of Research that may be Reviewed Through an Expedited Review Procedure, may be reviewed by the IRB through the expedited review procedure authorized by the U.S. Department of Health and Human Services 45 CFR 46.110 and 21 CFR 56.110. The activities listed should not be deemed to be of minimal risk simply because they are included on this list. Inclusion on this list merely means that the activity is eligible for review through the expedited review procedure when the specific circumstances of the proposed research involve no more than minimal risk to human subjects.
The categories in this list apply regardless of the age of subjects, except as noted.
The expedited review procedure may not be used where identification of the subjects and/or their responses would reasonably place them at risk of criminal or civil liability or be damaging to the subjects' financial standing, employability, insurability, reputation, or be stigmatizing, unless reasonable and appropriate protections will be implemented so that risks related to invasion of privacy and breach of confidentiality are no greater than minimal.
The expedited review procedure may not be used for classified research involving human subjects. Classified research is defined as research sponsored by a Federal government entity that involves restrictions imposed, by agreement or otherwise, on the distribution or publication of the research findings, or results for a specified period or for an indefinite duration following completion of the research.
Full Review
When a project has a greater-than minimal risk to participants, the IRB must discuss the proposal in detail during a Full Board meeting. Examples of projects that require Full Board Review:
- includes vulnerable populations (minors, pregnant women, incarcerated persons, or person with diminished decision-making capacity)
- includes sensitive subject matter that leads to greater participant risk (disclosing private or illegal behavior, etc.)
- includes measures that might cause a high level of discomfort or distress (recollections of trauma or abuse, mental health challenges, etc.)
What credentials do investigators need?
All investigators involved with the project (even students) must complete the CITI on-line training for research with humans subjects (link below). Include a CITI certificate dated within three years of the project's proposed start date. Save a copy of the certificate that appears at the end of the training to include with your proposal. Submit as a hard copy or a PDF.
IRB Resources
Calvin Documents
- Proposal cover sheet (.pdf)
- IRB Mandate (.pdf)
See also our Informed Consent Checklist and our Proposal Template.
When using humans as research subjects you must first obtain their informed consent. Use this checklist to effectively create an informed consent form.
Sample Informed Consent forms can be found here (.pdf).
- A statement explaining the purpose of the research
- A statement of the expected duration of the subject’s participation
- A description of the procedures to be followed
- A description of any reasonable foreseeable risks or discomforts to the subject, including invasion of privacy
- A description of any benefits resulting from the research, either to the subject or to others
- A statement that informs subject of his/her right not to be a subject in a research project that is also a teaching exercise
- A statement informing subject about how his/her anonymity will be guarded; i.e., that their confidentiality will be protected by assigned code numbers, by limitations of who has access to data, by data storage in locked cabinets, by locked computer files, etc.
- A statement that the subject’s participation is voluntary, and that his/her refusal to participate will involve no penalty or loss of benefits to which the subject is otherwise entitled, and that the subject may discontinue participation at any time without penalty or loss of benefits to which the subject is otherwise entitled
- If written informed consent is required, a place for the subject to sign and date the form and a statement that a copy of the signed consent form will be given to the subject for his/her records
- If the subject is a minor, a statement of parental responsibility in consenting to the child’s participation in the study with a place for the parent to sign and date the form in addition to the participant’s signature
- The name, address, and telephone number of the principal investigator of the research project, and his/her affiliation with Calvin University. If the principal investigator is a student, the name and telephone number of the faculty advisor is also required.
- A statement informing the subject that inquiries regarding the nature of the research, his/her rights as a subject, or any other aspect of the research as it relates to his/her participation as a subject can be directed to Calvin’s Committee for the protection of Human Subjects in Research.
Submit a digital copy and one signed hard copy of your full and complete proposal to the IRB chairperson (see below) 3 weeks before the planned start of your study.
Please minimize the use of technical jargon; the IRB members may not be specialists in your academic discipline.
If you have already answered any of the following questions, you may refer the reader(s) to that description instead of repeating the information below.
Describe the project’s:
- goals
- design
- hypotheses and/or research questions
- location
- procedures
- how data will be obtained
Describe your participant population(s).
Include
- (a) age, sex, and approximate number
- (b) inclusion/exclusion criteria, if any,
- (c) method of recruiting, and
- (d) inducement to participate.
Describe how data will be analyzed and disseminated.
Describe security procedures for privacy and confidentiality (attach additional pages if necessary).
Identification of Risks to Participants
Please describe any foreseeable risks (physical, emotional and social) to the participants. Include any methods or devices that will be used to limit participant risk. Describe any distress that might be caused by the research. If distress is a possible outcome, describe the planned procedures for debriefing the participants after the research is conducted.
If you would like to request a waiver of written informed consent, please explain how the use of written consent would impede the research or needlessly jeopardize the participants’ confidentiality. Explain how you will guarantee that oral consent has been secured. Researchers proposing to use oral consent must provide a copy of the consent document that will be read to participants. The consent document should include the statement that completion of the research exercise will confirm the participants’ consent to participate. Please describe the consent process by explaining when and how the participants’ consent will be obtained. Describe additional steps that will be taken to ensure the participants’ right to withdraw without penalty at any time and to guarantee their privacy and ensure confidentiality. Attach the consent form to this application. If participants include minors or other populations who may not be able to give consent for themselves, describe how parents/guardians will be informed of the study and give their consent. If the research is part of an in-school or institutional study, what will teachers, officials, or administration be told about the study, and how will their permission be obtained?
Attach complete copies of any interview or questionnaire instruments that will be used.
Board Members
2024–2025
- Paul Moes, faculty scientist and committee chair
- Stacy DeRuiter, faculty member, at large
- Emily Grantham, faculty member, nonscientist
- Angela Jason, research scientist
- Emily Madsen, community member
