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The Research Protocol should be detailed enough for the IRB members to fully understand who the subjects are, the benefits and risks to those subjects, and the procedures the researchers will follow to minimize risk, to maintain privacy and confidentiality, and to mitigate any adverse effects. The list of protocol requirements below is intended to ensure that the IRB members have enough information to evaluate those risks.

Note: It is NOT in the purview of the IRB to evaluate experimental design, so IRB approval does not imply endorsement of methods.

The Research Protocol should include:

• Brief project description
• The setting of the research (school, clinic, classroom, hospital, etc.)
• Anticipated dates of study, which should be consistent with the dates listed in Form A and should be after anticipated IRB approval.
• Complete subject description including:
• Number of subjects
• Ages (e.g. adults over 18, minors over 12, vulnerable populations, etc.)
• Characteristic information (e.g. ESL students, athletes, specific occupation, etc.)
• How subjects will be identified, recruited, and selected
• All research procedures including:
• Permissions from the site used (if applicable)
• Methods for obtaining informed consent
• Informed consent letter
• Methods for protection of anonymity or confidentiality
• Methods for protection from, or in response to, harm
• Data collection procedures (when, who, and how)
• Data analysis methods
• All instruments, tools, and materials that participants will interact with (survey/interview questions, recruitment flyers, debrief paperwork, etc.)
• All possible benefits and risks to subjects
• Where results will be disseminated
• Where data/results will be securely stored for 3 years

An informed consent letter is essential in research involving human subjects, as it ensures participants understand the study and their rights. The following elements should be included:

1. Study Title and Purpose:
• A clear explanation of the research’s purpose and objectives, including what the study aims to achieve.
2. Researcher Information:
• Names and contact information of the principal investigator(s) and any relevant research staff.
3. Description of Procedures:
• A detailed explanation of what participation will involve (e.g., interviews, surveys, experiments), including the duration, frequency, and location of the procedures.
4. Potential Risks and Discomforts:
• A transparent outline of any foreseeable risks, discomforts, or adverse effects that may occur as a result of participation. Even if no more risk than would be encountered in everyday life is anticipated, it is impossible to predict how any individual will react to some questions. Participants should always be advised to withdraw from the study if any adverse reaction is felt. Students can be directed to on-campus counseling services.
5. Potential Benefits:
• A description of any potential benefits to participants or to society from the research, while emphasizing that personal benefits are not guaranteed.
6. Voluntary Participation Statement:
• A clear statement that participation is voluntary, with no penalty for declining to participate or withdrawing from the study at any time without consequences.
7. Confidentiality and Data Privacy:
• An explanation of how personal data and responses will be handled, stored, and kept confidential, including any limitations to confidentiality (e.g., mandatory reporting or data sharing agreements).
8. Compensation (if applicable):
• Information about any compensation or reimbursement for participation (e.g., monetary payment, gift cards) and any conditions tied to receiving it.
9. Right to Withdraw:
• A statement confirming the participant’s right to withdraw from the study at any point, without providing a reason or facing any penalties.
10. Contact Information for Questions or Concerns:
• Contact information for someone participants can reach out to if they have questions about the study or their rights (usually the principal investigator and the IRB office).
11. Consent to Publication/Use of Data:
• If applicable, a section explaining how the data will be used (e.g., in publications or presentations) and whether it will be anonymized.
12. Signatures:
• A space for the participant’s signature and date, indicating their agreement to participate after reading and understanding the letter.
• If necessary, a section for the researcher’s signature or that of a witness.
13. Statement on Alternative Procedures (if applicable):
• If there are alternative ways the participant can receive similar services or outcomes without participating in the study, this should be clearly stated.
14. Disclosure of Conflicts of Interest (if applicable):
• Any potential conflicts of interest (e.g., funding from organizations with a stake in the outcomes) should be disclosed.

These elements ensure that participants are fully informed and can make a voluntary and educated decision about joining the study.