Students should not be listed as co-investigators.

State the purpose of your study. Please also describe if there are specific aims or objectives, or research questions that will guide your study.

Explain briefly how the data you plan to collect ties in with your research questions – toward what ends are you collecting the data and how do those data connect to the research questions you seek to answer. Provide the scientific or scholarly background for, rationale for and significance of the proposed research based on the existing literature and how it will add to existing knowledge.

If your study will have multiple phases or sequential aims, please describe the purpose of each phase and whether you are only seeking IRB approval for certain phases of the study at this time. If the initial phase of your study will involve preliminary activities such as literature review, please make that clear.

Briefly describe the inclusion/exclusion criteria (age range, gender, language, etc.) that define the participants you plan to include in your study population.

Indicate specifically whether you will include any vulnerable populations. You may not include members of these populations as participants in your research unless you indicate this in your inclusion criteria.

• Adults unable to consent/Cognitively Impaired
• Individuals who are not yet adults (specify exact age range of children to be enrolled)
• Pregnant women (where the activities of the research may affect the pregnancy or the fetus)
• Prisoners or other detained individuals

Briefly describe the anticipated total number of participants. If there will be multiple study sub-groups, describe how many participants you plan to enroll in each sub-group.

Provide a justification for the sample size – explain why this number of participants is needed to answer your research questions.

Be specific and spell out for the IRB how the recruitment process and any eligibility screening procedures will occur.

Explain step-by-step how you will:

1. Locate individuals who might be eligible to participate in your study;
2. How, where, and when contact will be made with people who might be eligible to participate in your study; and
3. How you will access/collect information to determine which people are eligible to participate in your study

If you plan to use online websites/platforms (e.g., Facebook or LinkedIn) for recruitment, specify which online venue you will use to post recruitment information and whether prior approval is required to post recruitment materials.

Some crowdsourcing platforms and survey panels include participants from outside the United States– if you plan to use a crowdsourcing platform/survey panel that could include individuals who reside outside the U.S., you must specify whether you will set the study qualifications to only include U.S. residents or not. If you will be sending recruitment materials using a listserv, please check with the listserv administrator whether this is allowed.

If you will be contacting potential participants directly (by email, letter, phone, etc.) explain how you will obtain their contact information. Explain whether any other organizations or individuals beyond the Northwood research team will be involved in recruitment activities.

Eligibility screening activities:

“Screening” is the term used to describe activities performed to ensure participants are qualified for the study. Screening activities may involve interaction or intervention with potential study participants (e.g., an online screening survey, a telephone interview), and/or accessing information about potential study participants from records (e.g., medical records, educational records). Researchers must protect the privacy of the potential participant and the confidentiality of information collected about him/her during the screening process. Explain how the screening process will occur (e.g., telephone interview, online questionnaire, etc.) and what you will do with the data for people who are eligible and do participate in your study and for people who turn out not to be eligible for your study or are eligible and decide not to participate. Attach a copy of the screening questions/criteria to your IRB submission.

A research location is defined as a location or place where the research procedures will be conducted by the Northwood researchers. Examples: lab space at Northwestern, schools, community centers, public venues, online, etc.

If your research will take place in multiple states within the United States, please explain.

Indicate that all required permissions and/or approvals are already obtained or will be obtained at each research location prior to project implementation. Please keep in mind that if you will be doing research in other organizations, you will likely be required to submit IRB applications there as well.

If your study will collect data through or from online/internet sources, please describe specifically which survey platforms or websites you plan to use for data collection (e.g., Qualtrics survey panels, internet chat rooms and support groups, etc). If you will be doing research using online activities, explain whether you anticipate your participants might be located outside the United States.

Where there are external institutions or individual external investigators involved in carrying out the research, a plan needs to be in place as to which institutions/individuals need IRB review of their activities, and which IRB will be responsible for reviewing those activities. To make those determinations, the IRB needs to know where activities will take place and who will be doing which activities on the study.

For each institution involved, briefly describe which activities that institution will be carrying out for this study (including recruitment, consent, data collection, data analysis (specify whether data to be analyzed will be identifiable or de-identified)).

If you will be collaborating with an individual who is not affiliated with another institution (e.g., an independent contractor or consultant), describe which study activities will be carried out by that individual.

Describe the processes you have in place to ensure successful coordination of activities among collaborating institutions. How will modifications to study procedures be communicated to collaborating institutions and approved prior to implementation? How will participating institutions be kept abreast of any problems, interim results, or the eventual closure of the study?

If the research will involve individuals who are vulnerable or susceptible to coercion or undue influence, describe any applicable additional safeguards included to protect their rights and welfare.

Vulnerable populations include prisoners, cognitively impaired adults, and pregnant women where the research activities are expected to affect the pregnancy (other populations may be vulnerable as well – that is not an exclusive listing of participants who may be considered vulnerable).

If members of the research team have roles that can give rise to concerns about undue influence with participants (such as physician-patient, teacher-student), please explain the steps you will take to minimize the possibility of undue influence/coercion.

Describe the process you will use to obtain informed consent (written, verbal, online, etc.) from participants, including where and when the consent process will occur. If consent will be obtained in different ways for different participant groups or study phases, describe the consent process that will be used for each participant group and/or study phase.

Consent is not merely a document – it is a process, in which the participant gains an understanding of the research procedures and the potential study benefits and risks in order to make an informed, voluntary decision on whether to participate in a research study.

The standard is that consent should be documented by having the participant sign a consent form after having the study explained to them, the opportunity to have any questions answered, and time to think about whether to agree to participate.

For some studies, not obtaining consent is appropriate (for example, studies that only involve analysis of secondary data). For some studies, omitting certain information in the consent process may be necessary to render the research feasible and to produce valid data (research that is using deception as a technique).

If you want to request a complete waiver of consent OR an alteration of consent, please explain why:

1. The study is no more than minimal risk to the participants;
2. The research could not practicably be carried out without the requested waiver or alteration
3. The waiver or alteration will not adversely affect the rights and welfare of the participants; and
4. Whether participants will be provided with additional pertinent information after participation (i.e., whether debriefing will occur)

Debriefing primarily applies to studies that use deception/incomplete disclosure – if participants will not be debriefed, just say “debriefing is not applicable to this study.”

There is no requirement to compensate research participants. If you will compensate participants, describe any financial or other compensation that will be provided to participants.

Describe the payment method, including how much money or other compensation will be provided for which activities, as well as when (the timing) compensation will be provided. If you will use a lottery/raffle process to provide compensation, please describe that process and how many participants will receive compensation.

Describe whether compensation will be prorated if there are multiple research activities or if a participant withdraws from the study before finishing. If your study will involve multiple visits/interactions, it is recommended that compensation be provided at regular intervals and not be contingent upon completing the entire study.

Describe any costs that participants may be responsible for because of participation in the research, such as parking, cellphone-related costs, etc. If the research involves more than Minimal Risk to participants, describe the available compensation in the event of research related injury.

Describe the type of recording being utilized, why the type of recording is necessary to the research, and whether recording is mandatory or optional to participate in the research.

Describe how the recordings will be utilized in the research (e.g., data analysis only or data analysis and presentations). If the intent is to use recordings or images for public presentation or publication, you must obtain the participants’ consent to those uses of the data.

Describe how and where the recordings will be stored, who will have access to them, and if/when they will be destroyed.

If audio/video-recording is mandatory for participation, a rationale must be provided here and the consent form must include this detail.

Explain the potential benefits that could result from your research – indicate if there is no direct benefit to participants. Include discussion of potential benefits to society or others.

Note: participation in the research itself and payment for participating in the research are not benefits and cannot be described as research benefits in the consent process.

Describe the reasonably foreseeable risks, discomforts, hazards, or inconveniences related to the participants’ participation in the research. Describe the probability, magnitude, duration, and reversibility of the risks.

Consider physical, psychological, social, legal, and economic risks as well as community or group harms. Note: a breach of confidentiality is a common risk in social and behavioral research.

Participant Privacy:

Describe the steps that will be taken to protect participants’ privacy interests. “Privacy” refers to a person’s desire to place limits on with whom they interact or to whom they provide personal information. For example, will you conduct interviews that ask sensitive questions in areas where the interview cannot be overheard by others?

Discuss the following elements, as applicable to your study:

1. Will participant identifiers (e.g., name, residential address, phone numbers, email address, etc.) be included and stored with the data? Will identifiers be stripped at some point? Keep in mind that some participants may be identifiable from video or audio-recordings.
2. If no direct participant identifiers will be collected, will you use a coding system with a key? Where will the key to the coding system be stored and who will have access to the key?
3. Do you plan to transcribe audio-recordings, and if so, will you delete the audio-recordings when transcription is completed?
4. How will data be transported from point of collection to point of storage?
5. Where and how will data be stored? How long will the data be stored? What will happen to the data at the end of your study?

Describe the qualifications of the research team to conduct this research. The IRB is looking for information such as area(s) of expertise, past research experience, relevant certifications, etc.

For international research or research with vulnerable populations, describe your qualifications (e.g., training, experience, oversight) to conduct the research and your knowledge of the local study sites, culture, and society.

Note: If you specify a person by name, a change to that person will require prior approval by the IRB. If you specify people by role (e.g., coordinator, research assistant, co-investigator, or pharmacist), a change to that person will not require prior approval by the IRB, provided that person meets the qualifications described above to fulfill their roles.