The IRB Process Southern New Hampshire University

When do you need an IRB Review?  If your research study includes:  Human Participants  Generalizable Knowledge

Human Participants  Direct interaction with a living person  Interviews  Surveys  Focus Groups  These can be formal or informal  Do not have to be done in person  Includes observations of human behaviors

Generalizable Knowledge  The knowledge learned from research that may be shared with or applied to populations not involved in the study.

Generalizable Knowledge YES  Sharing survey results with the general public  Presenting information gained at a conference  Published research NO  Sharing survey results with survey participants  Presenting information in class gained from a course assignment

Before IRB Review  Come up with a research question  What interests you?  Can you add to information already known on a given topic?  What is your perspective?

Before IRB Review  Identify the principal investigator(s)  Principal investigator(s) are the researcher or team of researchers involved in the project

Before IRB Review  Obtain a cooperating professor  Someone on the SNHU faculty  Has expertise in your area of study  Must be willing to supervise a research project This professor will be your guide through the research process, make sure it is someone you and/or your team are able to cooperate with for the entire project.

Before IRB Review  Pre-Research  Abstract  Be able to explain what your research is, why it is important, and how you will obtain results.  Literature Review  Look at other research on your topic.

Before IRB Review  Create (as needed):  Surveys  Interview questions  Observation criteria  Think about how these instruments will guide your research  Who will be involved as participants?

IRB Review Packet  Found on the SNHU IRB Web PageSNHU IRB Web Page  Go to: my.snhu.edu, click on Offices, click on Academic Affairs, find the Institutional Research Review Board (IRB) link near the bottom left  All forms needed for a review packet can be found on this page.

IRB Review Packet  Download and fill out  IRB Request for Review  Any necessary attachments  Informed Consent or Waver of Consent  Assurances of Principal Investigator

IRB Review Packet  IRB Request for Review Form  No more than one page per section  Use your pre-research to guide your answers  All sections may not pertain to your research  If you are unsure ask your advisor for guidance

IRB Review Packet  Necessary Attachments  Does your research involve:  Employees and Students? Fill out Attachment A  Illiterate Subjects? Fill out Attachment B  Children? Fill out Attachment C

IRB Review Packet  Will your research be conducted overseas?  Fill out Attachment F  Make an appointment, as soon as possible, to speak with Thomas Beraldi, Office of the Provost

IRB Review Packet Informed Consent  Researchers should assume they will need consent  Use the guidelines and template provided on the IRB web site Waver of Consent  Consent may be waved only:  If being linked to the research through a consent form could potentially harm participants

Vulnerable Populations Inability to Understand  Children  Elderly  Diminished Capacity to Consent Coercion  Undocumented Persons  Incarcerated Persons  Limited use of English These are the most common venerable populations dealt with at SNHU, this is not an exhaustive list.

Confidentiality vs. Anonymity Confidentiality  Research participants identity is known only by the researcher(s) Anonymity  Research participants identity is unknown

IRB Review Packet Assurances of PI Student  Must be filled out by each investigator  Must be signed by directing (cooperating) professor  Please also include the printed name of the directing professor Assurances of PI Faculty  Must be filled out by each investigator  Must be signed by the dean or V/P  Please also include the printed name of the dean or V/P

IRB Review Packet The final packet should include:  IRB Request for Review  Any necessary attachments  Informed Consent or Waver of Consent  Assurances of Principal Investigator electronic copies (PDF or DOCX) of all forms to

During IRB Review  You will receive an acknowledgement of receipt from  The acknowledgement will include the proposal title and all investigators names  An IRB review level will be determined

During IRB Review  Types of review:  Exempt- no review needed  Takes up to 2 weeks  Expedited- some review needed  Takes up to 2 weeks, involves 1 or 2 IRB committee members  Full- full review needed  Takes up to 4 weeks, involves the full IRB committee

After IRB Review  You will receive an from indicating approval or denial of your proposal  Some proposals may be approved with comments. Comments must be addressed before continuing research.

1) Research Question 2) Research Advisor3) Pre-Research 6)Receipt of Packet Acknowledgement 5) Send as a PDF or DOC to 4)IRB Review Packet 7) Review Level Determined 8) Exempt or Expedited-2 weeks Full Review-4 weeks 9) Packet returned with comments and signatures The IRB Process Overview

Do not interact with any participants until your proposal is signed and returned. If it is found that you have done this, your research will not be sponsored by Southern New Hampshire University.