Frequently Asked Questions
What is a human subject?
A ‘human subject’ is a living individual about whom an investigator obtains either data through intervention or interaction with the individual or identifiable private information. Legal requirements to protect human subjects apply to a much broader range of research than many investigators realize including interviews with persons, observation of behavior, and medical chart review, even if the information was not specifically collected for the study in question.
How do I know if I am conducting research with human subjects?
Research is defined as “a systematic investigation when human beings or their environment is manipulated; when information is sought from them directly (as through interview, examination, or questionnaire) or indirectly (as through observation); and when information concerning specific, individually identifiable human beings is asked for from third parties whether through access to files, data banks, or other depositories—or through direct inquiry.”
Does student research need to go through IRB review?
Yes. It is required that student research using human subjects undergo IRB review. Student projects will be reviewed in the same manner as all research involving human subjects. Human subjects research must be reviewed in order to be eligible for presentation at Ribbons of Excellence Day.
How do I determine what level of review is required?
Who can serve as a Principal Investigator?
Only full or half time faculty members can serve as Principal Investigators on an IRB application. Only one Principal Investigator is permitted per project. The Principal Investigator will be responsible for the ethical treatment of subjects and communicating with the IRB. Any feedback on IRB applications will be addressed to the PI, who is then responsible for communicating that information to any Co-Investigators.
Students are not permitted to serve as Principal Investigators. Staff members who wish to conduct human subjects research should contact the Director of Institutional Research.
Where does the IRB get its authority?
Authority for the IRB is granted through the federal regulations that require any institution that receives federal money for research to establish Institutional Review Boards.
What does the IRB have authority to do?
The Institutional Review Boards have the authority to:
- Make changes to application procedures
- Approve, require modifications to, secure approval of, defer action on, or disapprove research protocols involving human subjects,
- Request more information prior to making a final decision
- Require progress reports from the investigators,
- Oversee the conduct of research, suspension or termination of IRB approval of protocols that are found to be non-compliant with institutional policies and procedures, state laws, and/or Federal laws or regulations, taking into consideration the welfare of currently enrolled subjects,
- Place restrictions on serving as an investigator on human subjects protocols,
- Conduct reviews and inquiries regarding research activities as needed to obtain information necessary for the fulfillment of their responsibilities under the institutional assurances,
- Referral of the issue to VPAA office, or
- Other actions as appropriate
What happens if I don’t apply for IRB approval for my project before doing research?
Engaging in human subject research without IRB approval has serious ethical implications and violates college and federal policies. Researchers are required to submit IRB applications before embarking on any data collection.
Ramifications of not obtaining IRB approval:
- Credit may be withheld: Adrian College, may refuse to grant students course credit for research conducted without IRB approval.
- Capstone or thesis work will not be accepted: Students must present evidence of IRB approval for their projects involving human subjects. Degrees will not be awarded for work based on non-IRB reviewed projects.
- Funding may be withheld: Federal sponsors, and virtually all private sponsors, require IRB approval as a condition of funding. Sponsors may postpone review of proposals for which review is not complete or pending at the time of proposal submission.
- Articles may not be published: Most professional journals require evidence of IRB approval when considering articles for publication.
- The College will not support unapproved research: Liability issues arising from unapproved research become the responsibility of the investigator. Persons conducting unapproved research are deemed to be acting outside the scope of authority granted them by the College. The College will not, therefore, provide an investigator of an unapproved project the resources to answer a liability complaint.
- Suspension of Research: The College can suspend all research activities for a specified time frame as a disciplinary measure.
How can I get the fastest review possible?
IRB approval takes a minimum of two weeks. The type of review is determined by federal guidelines that include evaluating the risks of the research project, what is involved, whether information is collected anonymously or confidentially, and other factors. Depending on the type of review, some can only be carried out at scheduled meetings of the IRB. Investigators need to plan ahead when doing research and submit to the IRB so there is adequate time for review and approval before data collection is planned. Please review the submission information and meeting dates posted on our website.
What happens after I submit my IRB application?
Depending on the level of review, applications may be read by one, two, or all members of the IRB. All full reviews and selected other applications will be discussed by the entire committee during its regular meetings. In some cases additional experts are consulted.
Applications may be approved as is, approved pending minor changes, or deferred because major changes are required or insufficient information was included in the application. Principal Investigators will be notified of the committee’s decision via e-mail. The committee communicates only with the Principal Investigator, who is then responsible for communicating the committee’s feedback with any Co-Investigators. If the Principle Investigator disputes any changes requested by the IRB they may meet with the committee at its next regularly scheduled meeting.
If the IRB requests changes, the Principle Investigator will e-mail the revised application to the IRB at firstname.lastname@example.org. The IRB then reviews the application to see if it fulfills the committee’s requests. The IRB may request additional drafts of the application. When final approval is given, the Principle Investigator will then send a signed hard copy of the entire application to the IRB chair. When the final application is received, the IRB will then prepare an official letter of approval.
What procedures must I follow if I want to make changes to my study?
All changes to an approved study must be submitted for review and receive IRB approval before the changes can be implemented. Minor changes may be submitted in the form of a memo. Extensive changes to the application form or informed consent must be resubmitted along with an outline of the proposed changes. The addition of investigators must also be reported to the IRB along with the appropriate investigator training certificate.
What is informed consent?
Informed consent is the process by which a fully informed research subject can determine whether they wish to enroll in a research study. It is based on the legal and ethical rights of humans to make voluntary and autonomous decisions about whether they wish to be a research subject.
Informed consent is required for all research studies unless specifically waived by the IRB. In order to participate in a research study, human subjects must understand that they are part of a research project, that participation is voluntary, and that they may withdraw at any time without penalty. They must also understand the procedures involved, time commitment, benefits and risks, and the extent to which confidentiality is maintained. This information is presented to prospective subjects in consent forms.
What is assent?
Assent is basically the same as consent yet involves minor children who are not authorized to give legally valid informed consent because of their age. Assent is written in child-friendly language and describes the research participation, risks, benefits, and other elements of consent.
How do I check the status of my submission?
You may e-mail the committee at email@example.com.
Who needs to complete the investigator training?
The primary investigator, co-investigators, and anyone who will work with or have access to data must complete the investigator training. Click here to go directly to investigator training.