|Describe the following:
1) How will consent/assent be obtained place. (e.g., signing a consent form in person, online consent form as front page for online survey, etc.)
2) If applicable, what procedures are in place to reduce coercion (e.g., if extra credit is offered, what non-research alternatives are available to students who do not wish to participate in research).
3) If participants are vulnerable populations, explain how you will follow research ethics guidelines for obtaining consent. (If applicable).
4) If a request for a waiver of consent or waiver of documentation of consent is being sought for this proposal, describe here how the request comports with Federal guidelines as outlined in 45CFR46-listed criteria for a waiver found at: http://www.hhs.gov/ohrp/humansubjects/guidance/45cfr46.html#46.116 .
|SECTION I: Risks to Subjects|
|IRBs must evaluate the risk-benefit ratio of proposed human subject research. In approving a protocol, IRBs must determine that the benefits outweigh the risks and that risks to subjects are minimized.
Research risk is the probability of harm occurring as a result of participation in research. In non-technical language, address the following:
1) The types of risks (e.g., physical, psychological, social, economic, legal, etc.) the subject may reasonably encounter. Include any likelihood that questions may be sensitive or stressful to the participants.
2) Estimate the frequency/likelihood and magnitude of those risks (cite relevant literature, if available).
3) Describe the procedures/process which will be used to reduce or minimize risks:
a. How the data will be safeguarded (e.g., data is anonymous, assigning pseudonyms, aggregate reporting, etc.).
b. How will subjects be explicitly informed if data will NOT be anonymous (Put “N/A” if using anonymous data)
c. What actions would you take if a participant gets hurt or upset?
|SECTION J: Deception/Incomplete Disclosure|
|If you cannot adequately state the true purpose of the study to the subject in the informed consent, deception/ incomplete disclosure is involved.
1) Describe the deception/incomplete disclosure of information to the subjects.
2) Explain why such deception/incomplete disclosure is necessary.
3) Explain the debriefing process, or explain why there will not be a debriefing process.
|SECTION K: Benefits|
|Describe any direct benefits participants could potentially receive (excluding compensation for participation). If there are no direct benefits, explain what other potential benefits are gained from the research (benefits to society). This cannot be left blank.|
|SECTION L: Subject Incentives/Compensations|
L1. Does this study involve incentives or compensation to the subjects? For example cash, class extra credit, gift cards, or items. [__] Yes [__] No
L2. If yes, provide details about the nature of the payment (e.g. type, amount, when it will be provided to subjects, contingencies for payment, payment schedule, etc.), what records will be retained regarding payment and who will these records be provided to (e.g. signed payment receipt, names and social security numbers provided to accounts payable for check payments, etc.):
|SECTION M: Additional Information|
Use this area to add any additional information that you believe is relevant to the IRB’s review of your study.
|SECTION N: Investigator Assurances|
|As a PI or Co-PI, I certify the following:
· I have reviewed this protocol submission and acknowledge my responsibilities as Principal Investigator.
· The information in this submission accurately reflects the proposed research.
· I will not initiate this study until I receive written approval from the IRB.
· I will promptly report to the IRB any unanticipated problems and adverse events, as well as any findings during the course of the study that may affect the risks and benefits to the subjects.
· I will obtain prior written approval for modifications (amendments) to this protocol including, but not limited to, changes in procedures and/or changes in personnel.
· I have completed the CITI Social and Behavioral Investigator Training Module and have read the Belmont Report.
· All research personnel involved in the study have been appropriately trained in human subjects’ protection. I accept responsibility for assuring adherence to applicable Federal and State research regulations and APUS polices relative to the protection of the rights and welfare of the subjects enrolled in this study.
· I have obtained, or will obtain, all necessary permissions from study sites.
· Unless given Exempt Status, I understand that this study is subject to continuing review and approval by the IRB which will occur at least yearly.