Research is defined as a systematic investigation. Systematic investigations include development, testing, and evaluation that is done with the goal to develop or contribute to generalizable knowledge. A project requires IRB review if it 

• meets the definition of research
• involves interaction or intervention with human subjects 
• collects and handles  participants’ private identifiable information.

Members of the IRB will make a final determination as to whether a project constitutes human subjects research. The information researchers provide to the IRB will be assessed in making this determination.

Generalizable knowledge includes findings that are intended to have a theoretical and/or practical impact in a discipline. If you disseminate information with the goal of influencing practice, behavior, future research, and/or theory, you are contributing to the generalizable knowledge. 

A human subject is a person who is participating in research. The participation can take many different forms from answering survey questions, participating in an experiment, providing biospecimens and many others.

When a human subject is providing data through physical procedure or if there is a manipulation of one’s environment, we say there is intervention. Interaction includes personal or interpersonal communication between the researcher and human subjects. The interaction can be face to face or remote (e.g. online survey). The interaction can be confidential OR anonymous.

Private information is information about a human subject (either personal information that identifies the subject or information about their behavior that occurs in a research setting) that an individual can reasonably expect will not be made public. Such information can include identifiable information such as names, addresses, age as well as other information such as medical record, answers to the surveys, biospecimen results. 

Some activities are not classified as human subject research. They include certain public health activities, legal research, literary criticism, historical research as well authorized operational activities in support of homeland security, defense and other national security missions. Such activity must be determined and authorized by respective government agencies.

Private information is information about a human subject (either personal information that identifies the subject or information about their behavior that occurs in a research setting) that an individual can reasonably expect will not be made public. Such information can include identifiable information such as names, addresses, age as well as other information such as medical record, answers to the surveys, biospecimen results. 

Some activities are not classified as human subject research. They include certain public health activities, legal research, literary criticism, historical research as well authorized operational activities in support of homeland security, defense and other national security missions. Such activity must be determined and authorized by respective government agencies.
Please refer to the IRB policy for more information. You can also contact the Caldwell University IRB at irb@caldwell.edu

interaction

interaction

When a human subject is providing data through physical procedure or if there is a manipulation of one’s environment, we say there is intervention. Interaction includes personal or interpersonal communication between the researcher and human subjects. The interaction can be face to face or remote (e.g. online survey). The interaction can be confidential OR anonymous.

The informed consent process is a basic ethical requirement that reflects the ethical requirement of beneficence or respect for persons. This requirement and other ethical requirements are described in the Belmont Report. In essence, informed consent is an education process between the researcher(s) and human subject(s) and this process continues throughout the study. Informed consent process ensures that potential participants will understand what the research seeks to accomplish and can make a decision to participate in research knowledgeably and voluntarily. The elements of informed consent are mandated in the regulations at 45 CFR 46.116, 38 CFR 16.116, and 21 CFR 50.25

A subject’s consent is considered informed if a person has a reasonable understanding of that to which he/she is consenting. 

The consent process should: 

• Provide complete information about the nature of the research and the subject’s participation
• Ensure adequate comprehension on the part of potential subjects
• languages if your human subjects are not fluent English speakers
• Allow the subject’s voluntary choice to participate

To ensure adequate comprehension of potential participants, human subjects should be presented with a consent document written at the 8th-grade reading level. Moreover, human subjects should be presented with information in a language they understand. If subjects do not speak, understand, or read English then consent documents must be translated into a language they can understand. 

The IRB may waive the requirement to obtain a signed informed consent form if it finds that either:

• The only record that links the subject to the research is the consent form and the most serious risk would be a breach of confidentiality; and
• The research involves no procedures for which written consent is normally required outside of the research context and the procedures carry no more than minimal risk.

Unless waived by the IRB, consent from subjects must be obtained freely and without coercion and/or undue influence.

The following information MUST be provided to potential research subjects.

1) A statement that the study involves research, an explanation of the purposes of the research;  the expected duration of the subject’s participation, a description of the procedures to be followed and identification of any procedures which are experimental.

2) A description of any reasonably foreseeable risks or discomforts to the subjects.

3) A description of any benefits to the subject or to others which may reasonably be expected from the research. 

4) A disclosure of appropriate alternative procedures or courses of treatment, if any, that might be advantageous to the subject. 

5) A statement describing the extent, if any, to which confidentiality of records identifying the subject will be maintained. 

6) For research involving minimal risk, an explanation as to whether any medical treatments or compensation are available if injury occurs and, if so, what they consist of or where further information may be obtained.

7) An explanation of whom to contact for answers to pertinent questions about the research and research subject’s rights, and whom to contact in the event of a research-related injury to the subject. 

8) A statement that participation is voluntary and refusal to participate will not involve penalty or loss of benefits to which the subject is otherwise entitled, that the subject may discontinue participation at any time without penalty or loss of benefits to which he/she is otherwise entitled, and that the subject will receive a copy of the signed informed consent.

The consent templates on the IRB page include these required elements. The researcher must adequately address each required element in their informed consent document. If the required elements are not adequately stated in the consent document, the IRB will be unable to grant approval for the research. Once approved, only the versions that were included in the approved protocol should be used. Any changes to approved consent documents require IRB approval.

Please review this file to fill out the form.

If you have any questions, please contact irb@caldwell.edu

Please review this file to fill out the form.

If you have any questions, please contact irb@caldwell.edu

If you are a course instructor  and have research activities that involve human participants in your course, you need to apply for an IRB approval. The IRB will consider two types of course exemptions: general exemptions and action research course exemptions. If you are teaching an action research course, use this annotation to help you fill out the application: Action Research Course Exemptions

If you are a faculty teaching non-action research course, use this file to help you with the application: Course Exemptions

If you still have questions, please contact the IRB at irb@caldwell.edu 

The University is now a member of the Collaborative Institutional Training Initiative (CITI). CITI provides self-paces, online courses and webinars for many research areas. Each course is made up with several modules and provides content and testing relevant to the various types of research. 

All investigators (PIs, faculty advisors, student-researchers, other key personnel) working with human subjects or data collected from human subjects are required to complete and maintain training requirements relevant to the type of research conducted. 

Beginning fall 2022 semester, all researchers filing for IRB approvals must complete the required CITI training in order for their research applications to be considered by the IRB. No other human subjects training will be accepted. The certification is valid for three years.

Please go to https://about.citiprogram.org/ to create your Caldwell University CITI account. Please use Caldwell University email address to register your account.

When the account is created, follow the following steps:

1. Follow the prompts to affiliate your account with Caldwell University. Once the affiliation is created, you will see the questionnaire with ten questions. 
2. If the questionnaire does not show up, scroll all the way to the bottom to find Learner Tools for Caldwell University toolbox and select “Add a Course”
3. If you believe that you should take a course on the “Responsible Conduct of Research (RCR) choose an appropriate one for your discipline course. Otherwise, choose NOT AT THIS TIME. 
4. For Question 2, Human Subjects Research chose one of the following options
   1. Everyone doing research with human subjects in nursing MUST take Biomedical (Biomed) Comprehensive course. 
   2. All other researchers who work with human subjects must take Social Behavioral Educational (SBE) course.
   3. Members of the IRB must take the course designed for the IRB members.
5. Continue answering the questions to select other courses you may need/want to take to learn about various areas of research. 
6. Once done, hit submit.

10. A link for the course you have selected should now be displayed under Course. Please click on that link to begin your self-paced course.
11. In the course, the list of individual modules under the course will be displayed. A brief quiz must be completed at the end of each module for the module to count toward the course completion. You must complete each module in order to pass the course. The course does not need to be completed in one sitting.

Once you are done with the basic RCR course, please take as many courses and webinars as you like to learn about research with human subjects. 

For questions about registration, courses, and anything else CITI, please contact irb@caldwell.edu