This section is optional, unless the inclusion/exclusion criteria relate to subject safety (i.e. avoiding enrollment of those for whom participation may be risky or unsafe), important as a measure to prevent unintentional enrollment of vulnerable subjects (such as those under 18), or necessary for the scientific conduct of the study (e.g., study requires participants fit certain criteria, such as recruiting a specific clinical population).

Be sure to inform people if screening procedures may result in participants being excluded from continuing with the study.

Use layperson’s terminology; avoid scientific or research jargon and acronyms.

Avoid using technical wording copied/pasted directly from the IRB application or grant proposals.

The description should be clear and easy to follow. The use of bullet points, tables, section headings, numbered steps, etc., is encouraged if it helps with readability.

For surveys, interviews, focus groups, include a description of the types/nature of questions subjects will be asked or the topics to be addressed.

If groups of participants may complete different procedures and the procedures will be assigned/determined after obtaining consent, then describe each of the procedures that participants may complete and the mechanism for determining which they will complete (e.g., randomization).

If participants or their actions will be recorded (audio, video, screen capture, etc.) this must be described, including whether participants are required to allow the recording in order to participate or whether the recording is optional.

Including photographs of equipment to be used or other visual aids to help promote understanding is encouraged.

If applicable, describe procedures that may occur over multiple days/sessions.

Include all active and passive study procedures, including requesting consent to access records or to collect information about them from a third-party. If the study involves the ongoing, passive collection of data (e.g., via browser plug-ins), then describe the procedures for subjects to stop the researchers from collecting this information, e.g., uninstalling plug-in, contacting the researchers.

E.g., “If you agree to participate, you will be asked to complete a survey that should take approximately 30 minutes. The survey will ask demographic questions (e.g., age, gender) and about your feelings regarding riding the subway.”

Risks or discomforts vary greatly by study procedures, and include, but are not limited to such things as:

• embarrassment or emotional discomfort from answering sensitive questions during a survey or interview;
• harm from a loss of confidentiality;
• motion sickness/simulator sickness;
• muscle or joint pain/soreness from exercise;
• pain, bruising, light-headedness and possible infection from a blood draw;
• allergic or other reactions caused by stimuli or devices (e.g., headaches, seizures, etc.);
• skin irritation from application of sensors or wearing activity trackers.

Risks or discomforts should be clearly outlined, using layperson’s terminology.

When applicable, include any measures to mitigate the risk/discomfort.

If there are no foreseeable risks/discomforts, please inform participants accordingly. Note that there’s a risk of a breach of confidentiality any time personally identifiable information is linked to study data.

Participants often do not directly benefit from participation in research.

The description of benefits should include the degree and likelihood of the benefits and may not be overstated.

Do not list compensation as a benefit (see compensation section).

If a person is to receive money or another token of appreciation for their participation, explain when it will be given and any conditions of full or partial payment (e.g., “If you decide to not continue your participation in the study, you will be compensated $5 for each visit”). Include whether participants will receive payment if they withdraw early or skip any questions/procedures (e.g., “You may skip any questions and still receive full compensation” or “You must answer all questions in the survey to receive compensation”).

Include accurate, detailed information about the compensation. For instance, if a gift card or non-cash payment will be used, then provide details about it, e.g., $10 Amazon gift card.

Include statement if participants will be reimbursed for any study related expenses, such as travel.

If a raffle/drawing may be used, then include the likelihood of winning, e.g., “You will have a 1 in 10 chance of receiving compensation from the drawing.”

If “attention checks” or similar criteria will be used to determine compensation, then acknowledge it here, e.g., “The survey includes questions to ensure participants are answering questions accurately. If you do not answer these questions correctly then you may not receive payment.”

Please review the NYU Research Expenditures Involving Participant Support Costs and Human Subject Payments (FAQs) for additional conditions and requirements.

Describe the extent to which confidentiality of information identifying the participants will be maintained (e.g., completely confidential, not confidential, not confidential if the participant chooses)

Avoid overly specific plans for keeping data confidential that may need to be modified in the future, such as plans to store data in specific locations or that access to data will be limited to certain individuals (i.e., do not say that only the researchers will have access, as the IRB or study sponsor may require access). It’s most important to describe the extent of confidentiality, rather than the mechanisms/procedures for keeping data secure.

Unless you are absolutely certain that you wish to do so, DO NOT specify any plans to destroy data. Destruction of identifiers is typically sufficient to ensure confidentiality; retaining the de-identified data is usually acceptable (and often preferable). Destruction of the actual data may be appropriate in highly unusual situations where the data cannot be de-identified and retention presents unreasonable risk to subjects. Data retention should comply with NYU’s Retention of and Access to Research Data Policy.

If applicable, include conditions in which the researchers may not maintain confidentiality/privacy, such as instances in which laws require mandated reporting.

Generally, if identifiable information is not collected, then participants will not be given access to information collected about them.

If participants will be given access, then describe how this will occur, e.g., by requesting directly from the study team, the investigator will share information with participants if there is a concern, participants can access their information at all times via study applications, etc.

If the data collected may relate to diagnostic criteria or be a part of a formal assessment (e.g., Montreal Cognitive Assessment), then this should be acknowledged and it should state whether these assessments can be used for formal diagnostic or assessment purposes.

Example 1: the effect of time of day on reading comprehension.

Example 2: whether people make economic decisions differently when working in a group versus individually.

Example 3: how viewing pictures of natural disasters affects fear of terrorism.

(briefly describe procedures in an easy to understand, numbered format)

Example: two hours of your time: 30 minutes to complete the questionnaire and approximately 45 minutes for each of the two interviews. The interviews will be held two weeks apart.