Scientific Aspects:
- Is the hypothesis stated?
- Is the research design appropriate?
- Does the information to be collected provide a means to answer the hypothesis?
Risk: Benefit Consideration:
- What are the risks and potential benefits to the subjects and/or to society?
- Do the benefits outweigh the risks?
- How are subjects and/or their data protected from risks?
Recruitment Process:
- Is the study population defined and is it appropriate for the hypothesis to be tested?
- Do you plan to recruit through a Central office, program, club or course or an agency or institution outside Central (for example, a K-12 school, social club, nursing home, or university)? If so, obtain proper permission/documentation of support.
- How will you inform potential participants about your study and invite them to participate in it? Include all written and scripted language that will be used to solicit participation.
Informed Consent
Process issues:
- Will you obtain signed consent or request a waiver of signed consent?
- Will you provide consent with a written form and/or an oral briefing?
Content:
- Is all information in the form consistent with information in the research protocol?
- Is the CD written in language easy to understand by the potential participants, without jargon and clear of any spelling, typographical or grammatical errors?
- Does your form or oral script include the required content areas and is it organized into sections so that information can be easily followed?
a) Introduction of researcher and his/her role at Central and/or research site.
b) Explanation of purpose of study (students: include course/program requirement project satisfies, such as Master’s program special project).
c) Description of all research activities required of participants.
d) Explanation of how long the project will last and what kind of time commitment is required of participants.
e) Description of any potential risks and/or benefits of the study, and information about compensation (if any) for participation.
f) Suggestion for seeking assistance such as support services (such as, Central Counseling & Wellness Center, trusted friend).
g) Statement that participation is completely voluntary; that refusal to participate in any part of the research will involve no penalty; that potential participants may withdraw at any time without penalty.
h) Contact person and telephone number should participants have questions about the research (PI or faculty advisor).
i) IRB Contact information should participants have questions about their rights as research participants.
j) A final consent statement and place for date and signature OR if waived, for indication of consent (for example: for online surveys)
If appropriate, include:
- Statement about limits to confidentiality (for example, if researcher is a mandated reporter).
- Information about audio or video taping and final disposition of tapes.
- A document for informing/soliciting the assent of minors.
Submission Addenda:
Are all of the following included with the completed IRB Submission Form?
Recruitment Materials:
- Flyers
- Text of verbal or written 'invitations to participate' - emails, scripts, letters, etc.
- Facebook postings
Informed consent documents* (ICD):
- Written or electronic ICD
- NOTE: Studies involving minimal-risk to participants are eligible for a waiver of signed consent. Unless the PI, faculty advisor, gatekeeper or external IRB insist on collecting signed consent documents, the IRB will consider the use of an informed consent information sheet--one that has the same content and format of a traditional consent document but no signature lines. Since the documents are not signed the PI need not collect and/or retain the documents.
- Minor assent document (if applicable)
All data collection instruments:
- Questionnaires,
- Surveys,
- Description of cognitive or physical exercises/interventions.
Documentation from external and internal collaborators (if applicable):
- Gatekeeper letters- documentation of support, permission and/or agreement to facilitate recruitment or data collection.
- IRB approval from an external institution.
NIH Tutorial Certificate of Completion
For more information, contact the IRB Administrator at IRB@ccsu.edu.