Title: Model IRB Proposal Evaluation Worksheet
Course: sandbox_CPomianek

Q: Has the Principal Investigator (PI) included a training certificate with their proposal?
- Yes
- No
A: Yes

Q: Has the PI included a consent form with their proposal?
- Yes
- No
A: Yes

Q: Does the study seem feasible, given the PI's resources?
- Yes
- No
A: Yes

Q: Please include any specific comments about the feasibility of the project.

Q: Are the objectives of the study clearly communicate din the lay summary?
- Yes
- No
A: Yes

Q: Please include specific comments about the lay summary.

Q: Has the PI clearly described their relationship with study participants?
- Yes
- No
A: Yes

Q: Please include specific comments about the relationship between the PI and the study participants.

Q: Has the PI indicated that they are a superior to study participants?
- Yes
- No
A: No

Q: Has the PI indicated that there is a risk of coercion in this study?
- Yes
- No
A: No

Q: Do you perceive any potential for coercion in the relationship between the PI and the study participants?
- Yes
- No
A: No

Q: If there is any risk of coercion in this study, has the PI described how that risk will be minimized?
- Yes
- No
A: Yes

Q: Please include specific comments addressing the possibility of coercion in this study.

Q: Has the PI specified how many participants will be in the study (i.e. sample size)?
- Yes
- No
A: Yes

Q: Is the sample size justified and reasonable?
- Yes
- No
A: Yes

Q: Please include specific comments about the sample size in this study.

Q: Could participant privacy be compromised because of the proposed sample size?
- Yes
- No
A: No

Q: If participant privacy could be compromised because of small sample size, please comment on the PI's strategy for minimizing this risk.

Q: Are any study participants members of vulnerable populations?
- Yes
- No
A: No

Q: If any study participants are members of vulnerable populations, are steps taken to protect them?
- Yes
- No
A: Yes

Q: Please provide specific comments about the protection of participants who are members of vulnerable populations.

Q: Did the PI describe where and how they would recruit participants?
- Yes
- No
A: No

Q: Is the location and timing of participant recruitment appropriate?
- Yes
- No
A: Yes

Q: Did the PI include any necessary site permission letters?
- Yes
- No
A: Yes

Q: Did the PI justify any exclusion of potential participants?
- Yes
- No
A: Yes

Q: Please include any comments about the recruitment and exclusion of study participants.

Q: Did the PI clearly describe their method of data collection and include a copy of their research instrument(s)?
- Yes
- No
A: Yes

Q: Is the information collected appropriate to the research question?
- Yes
- No
A: Yes

Q: Does the PI propose to collect extraneous information (i.e. additional information that is not directly related to the research question)?
- Yes
- No
A: No

Q: If the PI is collecting extraneous information, do they justify the collection of this information?
- Yes
- No
A: Yes

Q: Please include any comments on the appropriateness of data collected in this study. That is, will these data answer the research question? Why or why not?

Q: Are measures are taken to protect the privacy of research participants?
- Yes
- No
A: Yes

Q: Are measures are taken to protect the confidentiality of data during and after the research?
- Yes
- No
A: Yes

Q: Are risks and benefits to potential participants adequately described?
- Yes
- No
A: Yes

Q: Are the broader impacts (i.e. benefit to society) of this research adequately described?
- Yes
- No
A: Yes

Q: Do you think that this research could pose any possible risks to any stakeholders in this research?
- Yes
- No
A: No

Q: Are all risks are minimized to the greatest extent possible?
- Yes
- No
A: Yes

Q: Are the risks of this research reasonable relative to its benefits?
- Yes
- No
A: Yes

Q: Please include any comments pertaining to the risks and benefits of this study.

Q: Are all consent and assent items written in clear and understandable language?
- Yes
- No
A: Yes

Q: Is an information sheet for participants included?
- Yes
- No
A: Yes

Q: Are risks and benefits associated with participation clearly and thoroughly described in the consent form and information sheet?
- Yes
- No
A: Yes

Q: Do the consent form and information sheet include a description of how the data and results of this study will be used?
- Yes
- No
A: Yes

Q: Do the consent form and information sheet include contact information for the PI and the IRB?
- Yes
- No
A: Yes

Q: Please include any comments pertaining to the consent form, assent form, or information sheet.

Q: What is the proposal number?

Q: Evaluation Summary (complete this question after completing the other questions in this assignment)

Please answer this question based on your own evaluation of the proposal. After you meet with your Model IRB Committee, you will decide as a group the final IRB action on the proposals you are reviewing and together you will complete a separate worksheet which will be given to the author of the proposal.

What action do you recommend for this proposal?
- Approve
- Approve with Revisions
- Table
- Disapprove
A: Approve

Q: Please include specific comments related to your action recommendation for this proposal.