Frequently Asked Questions (FAQs)
Frequently asked Questions
- When is an institution considered to be “engaged in research”?
- Who is covered by a Federal wide Assurance?
- Do the human research regulations apply to non-U.S. institutions?
- Who are “investigators”?
- What are investigators’ responsibilities during the conduct of an approved research study?
- Are investigators responsible for obtaining and documenting informed consent?
- Are investigators responsible for obtaining continuing review of research?
- When should investigators submit a continuing review?
- When should investigators submit a completion report?
- What records should investigators keep, and for how long?
- What is informed consent and when, why, and how must it be obtained?
- What are the basic elements of informed consent?
- What does it mean to minimize the possibility of coercion or undue influence?
- What constitutes coercion or undue influence when students are involved in research in a college or university setting?
- What constitutes coercion or undue influence when employees are the subjects of research?
- Can an electronic signature be used to document consent or parental permission?
- Is a faxed copy of the signed consent or parental permission form acceptable to document informed consent?
- What are the criteria under 45 CFR 46.116(c) for waving or altering some or all of the required elements of informed consent or parental permission?
- When may the requirement for documentation of informed consent or parental permission be waived or altered?
- How do the human subject research regulations define “children”?
- Do both parents need to provide permission for their child to participate in research?
- What is child assent, and how do the requirements vary with the age of the research subjects?
- What happens if a child reaches the legal age of consent while enrolled in a study?
- I’m a PVAMU student interested in conducting my own research project do I need IRB approval before I can begin?
- Can I be listed as the Lead Researcher on the IRB Application?
- Should I submit a new IRB application, or be added to my Faculty Advisor’s protocol?
- How should investigators submit amendments to approved protocols?
- Is IRB review necessary if my study involves anonymous surveys or interviews?
- What categories of Research may be reviewed by the IRB through an Expedited Review Process?
- How do I apply for IRB review?
- How long does it take to obtain IRB Approval?
- How will I be notified when my IRB application is approved?
- How long is my approval good for?
- What is an unanticipated or adverse event and when should it be reported?
- On the IRB protocol form, what is meant by “target population” and “maximum anticipated sample size?”
Yes. Students conducting human subjects’ research require IRB approval or registration before they can initiate their project. Please consult with the Office of Research Compliance staff if you are unsure whether your project constitutes human subjects research.
Yes. PVAMU doctoral students can be Lead Researchers/Investigators on human subjects’ protocols with Faculty Advisors identified on the protocol. Faculty Sponsorship is required for all research applications from outside investigators that desire access to the university student population.
When a student’s research project consists of the collection and/or analysis of data that is part of the scope of an existing faculty member’s IRB approved research, the student can be added to the Faculty member’s protocol, rather than submitting as Lead Researcher on a new IRB Application.
Yes. An application is required if you plan to conduct anonymous survey or interview research.
Please refer to How to Submit an IRB Protocol.
For information, please refer to the Protocol Review Process.
An official IRB approval letter will be sent by e-mail to the Principal Investigator when all requirements are met.
Most Full Committee and Expedited protocols are approved for one year from the date of review or approval (the IRB may grant a shorter approval period). Continuation of an approved protocol requires submission of the Continuing Review Form.
The “Number of Participants (target population)” includes the total number of individuals the researcher intends to recruit or invite to participate in the research study. The “Maximum anticipated sample size” is the number of individuals the researcher expects to enroll in your research study. For example, if the target population is every student at PVAMU, the target population would be 9,000. If a researcher expects 10% of the students at PVAMU to enroll in the research study, the maximum anticipated sample size would be 900.
Office of Research Compliance
Wilhelmina Delco Building, Room 120
Contact Telephone Numbers: (936) 261-1553