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:
Proof of human subjects protection training (this certificate must be submitted with every proposal andfor 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 user name 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:
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.
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 categories », may be reviewed by the IRB through the expedited review procedure authorized by 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.
If the proposed research does not meet the criteria for exempt status or expedited review, the proposal will need to be reviewed by the IRB committee. If you are submitting a proposal for a study with a vulnerable population and/or a study that involved more than minimal risk please allow at least one full month to be reviewed by the full IRB committee.
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.
