Frequently Asked Questions
Learn more about the definition of research, levels of review, consent vs. disclosure statements, extensions and modifications, and researchers not affiliated with the university.
What is Research?
Research is defined by the federal regulations, as "a systematic investigation including research development, testing and evaluation, designed to develop or contribute to generalizable knowledge."
According to the regulations, a human subject is a "living individual about whom an investigator (whether professional or student) conducting research obtains:
- Data through intervention or interaction with the individual, or
- Identifiable private information."
Learn more at CitiProgram, specifically, the module on Defining Research with Human Subjects-SBR.
What are the Levels of Review?
- Exempt Review: Certain projects, such as those that involve only survey, questionnaire or interview procedures and anonymous participation, may be categorized as no risk and may be exempt from the Federal Policy for the Protection of Human Research Subjects. The IRB Chairperson will determine if the checklist application meets the exempt criteria. No research with participants under age 18 can be exempt.
- Expedited Review: Applications that involve no more than minimal risk to human subjects may be eligible for an expedited review by the Chairperson of the IRB. If you want to be considered for an expedited review, initial the 'Expedited Review Line' on the IRB Application Cover Sheet form.
- Full Review: Applications that involve more than minimal risks or those in which the identity of participants is at risk require a full IRB review.
Should I use a Disclosure or Consent Form?
Informed Consent: Informed consent must be obtained from all human research participants. This generally means a participant must either: (1) sign consent form (sample attached) explicitly agreeing to participate in the research or (2) be read a disclosure statement (see section below). When a consent form is used, a copy of this signed consent form must be offered to the participant to keep. Consent for any potential participants under 18 years of age, or persons not competent to give informed consent, must be obtained from parent(s) or guardian(s). Investigators should keep copies of consent forms in a locked file cabinet for three years after the completion of the project.
Such consent forms should include the following information:
Paragraph 1: Sponsor or auspice and purpose of research
Paragraph 2: Time commitment, potential risks/benefits, what will occur in the research session
Paragraph 3: Voluntary participation and right to withdraw
Paragraph 4: Maintenance and limits of confidentiality
Signatures
Paragraph 5: Contact information or investigator and IRB
If you are asking the parent's consent, be sure to change the Consent Form to read my child's participation, not my participation.
Disclosure form instead of consent form: If the research involves only survey, questionnaire or interview procedures where the participants will remain totally anonymous (no names given) and there are minimal risks involved in participation, a disclosure form describing research procedures given to a participant may substitute for the consent form. A disclosure form is not sufficient if participants are tape recorded, even if risks are minimal. Disclosure forms should contain the same information as the consent forms, but they need only be read or given to participants. No signatures are required.
If I am a Principal Investigator who is not affiliated with Salem State University, but want to conduct research at Salem State, must I submit an application to the Salem State University IRB?
Yes. And, if you are affiliated with another college or organization, a copy of that college's or agency's IRB approval should also be submitted.
My research project will exceed twelve months. Can I submit one application?
Yes, one application can be submitted, but the maximum approval period is twelve months. Therefore, before the expiration date, you must file an application for an extension available at IRB and submit it to the IRB as noted below.
I need more time to complete my research beyond my approval date. I need to modify my original research proposal after it was approved. What do I do?
Go to IRB and complete the extension/modification form and submitted to the IRB, Office of Sponsored Programs and Research Administration, Salem State University, 352 Lafayette Street, Salem, MA 01970 or fax to 978.542.3001, attention IRB, or by email irb@salemstate.edu