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.
The use of human subjects in research include the use of bodily materials, such as cells, blood or urine, tissues, organs, hair or nail clippings, even if you did not collect these materials, residual diagnostic specimens, including specimens obtained for routine patient care that would have been discarded if not used for research , and private information, such as medical information, that can be readily identified with individuals, 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 senior capstone research using human subjects undergo IRB review. Capstone projects will be reviewed in the same manner as all research involving human subjects. Please click on here to determine whether your research qualifies for exempt review, or will need to undergo expedited or full IRB review.
How do I determine what level of review is required?
There are three types of review for research involving human subjects: Exempt, Expedited and Full. Click here to review the criteria for review, as well as the specific categories of exempt research.
Where does the IRB get it 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:
- Approve, require modifications to, secure approval of, defer action on, or disapprove research protocols involving human subjects,
- Require progress reports from the investigators,
- Oversee the conduct of research,Suspension or termination of IRB approval of protocols that are found to be noncompliant 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; and placing a “partial clinical hold” on the research, requiring the cessation of some aspect of the research (e.g., a particularly risky arm of a study, or stopping additional enrollments) until the non-compliance issues have been resolved and an adequate corrective action plan implemented,
- Compliance audits,
- Notification of currently enrolled subjects,
- Providing additional information to past subjects,
- Modification to research protocols,
- More frequent continuing review or monitoring,
- Monitoring of the consent process,
- Changes in consent process or documents,
- Requirement that currently enrolled subjects re-consent to participation,
- Request more information prior to making a final decision,
- 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. Students and faculty are required to submit IRB applications before embarking on any data collection. Staff should see the Director of Institutional Research if they wish to apply for IRB approval.
Ramifications for Students
- Credit may be withheld: Schools at their discretion 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.
- Articles may not be published: Most professional journals require evidence of IRB approval when considering articles for publication.
- Funding may be withheld: IRB approval is required if you are a participant in a grant program. These programs will not release funds without IRB approval.
Ramifications for Faculty and Staff
- 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?
“I want the fastest review possible as I am leaving town to conduct my research next week.”
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 and meeting dates posted on our website.
What happens after the IRB reviews my project?
After the IRB meeting, the committee prepares letters advising investigators about the status of their projects. Investigators with projects receiving full approval at the meeting receive approval letters following the meeting. Investigators with projects requiring additional work receive letters outlining what needs to be done to prepare an approvable submission. Sometimes projects are tabled because there was insufficient information or inappropriate information so that the IRB could not make a decision on approval.
How long does the New Project review take?
Generally speaking it takes four to six weeks for an IRB project to be approved. Though this may seem like a long time, the materials must be distributed to the IRB panels a week before the meeting, and then they are considered at an IRB meeting. Most projects require revisions. Sometimes they are minor. An application that is complete, with all attachments, and proofread with no typos can be reviewed more quickly than a project submission that is incomplete or poorly prepared.
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. Any 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.
The protocol may be changed without prior IRB approval only when there is an apparent immediate hazard to a patient, however, the IRB must be notified by letter as soon as possible of such a change and review is required immediately.
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 chair of the committee at irb@adrian.edu.
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.