Frequently Asked Questions (FAQs) About Human Subject Research
Frequently Asked Questions About Human Subject Research
What is the IRB? The IRB is a committee of faculty, staff and community members from diverse backgrounds
who review research protocols involving human subject participants to ensure that
the rights of the participants are protected, that they are not subject to unreasonable
harm (physical and emotional), and that information about them is kept confidential.
What is a PI? A Principal Investigator (PI), the person conducting the research, is responsible
for the research project, for the behavior of all the researchers and compliance with
IRB policies and procedures.
What is research? Research means a systematic investigation, including pilot research, testing and evaluation,
designed to develop or contribute to general knowledge. This includes collection of
scholarly materials for theses and dissertations done by students, and investigations
carried out by faculty and staff for publication and/or presentation.
How do I know if I should submit a research protocol to the IRB? All human subject research, as defined in Question #3, requires IRB approval. If there
is any question, it is always best to contact the IRB Chair at: irb@middlesex.mass.edu. to verify whether you need to have your project reviewed.
When should I submit my review request to the IRB? It is advisable to submit your application for review to the IRB as soon as possible.
Approval must be received before any research activities may begin (recruitment or
data collection). The review process may take several weeks and will depend upon the
comprehensiveness of the application. To insure timely review, it is recommended that
the PI carefully read the MCC IRB Policies and Procedures and complete each section
of the application completely, as appropriate. Only PIs are qualified to sign the
PI Assurance and Signature Page as well as the Informed Consent Form. Call the IRB
Chair if you have any questions during the application process.
What is informed consent? Informed Consent is the opportunity to insure that the individual(s) participating
in the research project are provided with the full and frank disclosure of all the
facts, probabilities, options and opinions which a reasonable person might be expected
to consider before giving his/her consent. Informed consent is usually obtained through
a document that fully discloses the nature of the research, explains the risks (both
physical and psychological) and benefits and allows the individual to voluntarily
decide whether to participate in the research study or not.
What is the difference between anonymous and confidential? Anonymous means that the data collected by the researcher cannot be linked to the
participant. Confidential means that the researcher maybe able to identify a participant's
data but will not reveal the participant's identity to anyone else. Person-to-person
interviews, for example, are never anonymous.
Can the Board stop me from conducting my research? Yes. The IRB has the authority to disapprove, suspend, or terminate research that
is not carried out according to its requirements or may be associated with unexpected
serious harm to subjects. Any such action will include a statement of the IRB's reasons
for its action and will be reported promptly to the PI, the IRB Administrator, and
the funding agency.
My research with human subjects is not funded. Do I still have to submit an application
to the IRB? Yes. All research that involves human subject/participants must be reviewed and approved
by the IRB regardless of funding.
Who is responsible for reporting any problems that may occur during the conduct of
approved human subject research activities? PIs are responsible for reporting to the IRB Chair any serious or continuing noncompliance
with federal regulations, College policies, injuring injury to subjects, unanticipated
problems, or changes in research activities. While the PI maintains this responsibility,
anyone who becomes aware of any serious or continuing noncompliance in the conduct
of approved research should bring this to the attention of the IRB Chair.
Does the IRB continue to review research once it has been approved? Yes. The Board conducts annual/continuing reviews of applications at one year intervals
for Expedited or Full Review projects that continue for longer than one year. For
projects with higher risk, the review may be more frequent. Exempt status applications
do not require any further action unless there is a change in the research that changes
the exempt status.
If I make changes in my protocol, does the IRB have to review and approve it again? Yes. Any changes must be reviewed and approved by the IRB. In most cases, this can
be done quickly through the expedited review process or by approval from the IRB Chair
or designated representative.
How can I speed my application through the IRB? Carefully read the MCC IRB Policies and Procedures and complete each section of the
application completely, as appropriate.
What training is required for PI's? Human Subjects Protection Training is mandatory for all investigators. The Collaborative
Institutional Training Initiative (CITI Program) is a free option for members of the
Middlesex Community College community. Register at: https://about.citiprogram.org/en/homepage/ and select the Human Subjects Research course. All PI's must complete training prior
to submitting an application to the IRB. Proof of completion must accompany the application.
Certification is valid for three years from the date of the initial training. Please
refer to the website and the link below for more information: https://www.middlesex.mass.edu/irb/training.aspx.
I want to publish a picture. Does that require IRB review? No, that is not human subject research. You should determine if you need a photo release.
Refer to the College's guidelines regarding photography and media.
Is IRB approval required for research that is conducted by students and involves human
subjects? Yes. If student research meets the definition of research and involves human subjects,
it must be approved by the IRB. Student researchers who are conducting human subject
research as part of their degree work must be knowledgeable of human subject research,
including ethics, and must meet the mandatory training requirement. Course projects
that are developed solely for academic requirements do not require IRB approval. Student
projects that will be developed as research to share outside of the institution will
require IRB approval. Student researchers, who intend to gather data as part of evaluations,
assessments, service, reporting, classroom assignments, educational inquiry or practice
AND intend to use the data as research data for the purpose of publishing or sharing
with a research community outside the institution, must obtain IRB approval from the
MCC IRB PRIOR to conducting the activity.
Is my classroom research considered research? If your classroom research is used only to evaluate teaching methods and student opinions,
to evaluate classroom activities, or to gain feedback on student learning, then you
do not have to apply to the IRB for approval. If you intend to make your results public,
then it is considered research and you do need IRB approval. If a student (or students)
is conducting the research, the faculty member must serve as Principal Investigator.
Is assessment of teaching and learning considered research? Research involves manipulation of the environment, is always voluntary, uses systematic
data collection, requires informed consent, and contributes to generalizable knowledge.
Assessment provides institutions with information about students' progress towards
educational goals. The primary purpose of assessment is to inform teaching and learning
and allows for recognizing strengths and weaknesses and areas for improvement. Assessment
work that contributes to generalizable knowledge by being publicly available is research
and is considered by OHRP a commonly accepted educational practice which is usually
exempt from IRB oversight. Exempt status requires a short IRB form that must be completed
before the assessment work begins. Exemption means the work is not overseen by the
IRB (after it is determined the work is exempt). Assessment work that is not made
public does not need to be reviewed by the IRB.
If I'm collecting samples of student work for assessment of my course. Do I need to
submit an application to the IRB? As described above, assessment work that is not publicly available does not need to
be reviewed by the IRB. You may want to gain permission from the student, however.
Contact the Dean of Assessment for guidance.
Who should I contact if I have questions? Contact the IRB Chair for assistance at irb@middlesex.mass.edu. The website also contains
helpful information at https://www.middlesex.mass.edu/IRB.
