Do I need IRB Review? If your research meets one of the following criteria, it needs IRB Review:

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1 Do I need IRB Review? If your research meets one of the following criteria, it needs IRB Review: Designed to generate generalizable knowledge; Puts participants at risk greater than the minimal risks of everyday life; Involves special populations including minors under 18 years of age; Will be disseminated in written form or public presentations, including in- class presentations Faculty are encouraged to contact the IRB to determine if review is needed for course- related projects involving human beings. What is Research? Research is defined by the federal regulations, as "a systematic investigation including research development, testing and evaluation, designed to develop or contribute to generalizable knowledge." What are the levels of Review? The IRB conducts three levels of review, as described below. The IRB will determine which level of review your proposal will receive. Exempt from Review - Certain projects, such as those that involve only survey, questionnaire or interview procedures and anonymous participation, may be categorized as no risk and may be exempt from review. The IRB determines if an application meets the exempt criteria. No research with participants under age 18 can be exempt. Expedited Review - Applications that involve no more than minimal risk to human subjects may be eligible for an expedited review by the IRB administrator or chair. Full Committee Review - Applications that involve more than minimal risk or those in which the identity of participants is at risk require a full IRB review. IRB Logistics: Students submit their proposals via Navigator. Proposals are sent to faculty for approval to send on to the IRB. You must approve students proposals in order for the IRB to receive the proposal. Faculty submit proposals via Polaris. IRB applications are reviewed within two weeks of receipt to the Institutional Review Board. Requests for revision are sent electronically via the online application by a member of the IRB Committee to the applicant s Salem State . Research, including data collection, may not begin until the proposal is successfully reviewed. IRB approval letters with review level are sent to the applicant s Salem State . IRB Proposal Preparation: All of the following information and supporting documentation is required for successful review. Here, we review what is required for each element of the IRB proposal, using the headings of each element of the proposal: Summary of goals, purpose and methodology of your research and hypothesis to be tested: In this section of the proposal, you are orienting your readers to your project. Your primary

2 goal in this section is to Bbe sure the proposal states the research purpose, goals, methodology and hypothesis to be tested (as appropriate). The over- arching research question must be clearly worded and identifiable The proposal must provide enough information for us to understand the basic methodology of the study Disclosure statement and/or consent forms (consent, parental consent, assent): If you are planning to conduct direct research with human subjects your proposal must include either a disclosure statement or consent form. This is required in order to provide participants with a full understanding of their rights, support resources and contact information, research risks and benefits, and a general explanation of the procedures to be asked of participants. The proposal must include a detailed explanation of how disclosure will be given or consent made. Certain language is required to be included in the disclosure or consent including a confidentiality statement regarding Massachusetts and Federal reporting laws. This language can be found in the sample forms on the IRB website. Investigators must offer a copy of the consent or disclosure to their participants, and should keep copies of signed forms in a locked cabinet or password protected file for three years after completion of the project. Sample disclosure statement and consent forms can be found on the Forms page. If you are confused about whether to use a consent versus a disclosure form, please read on. If the research involves only survey, questionnaire or interview procedures where the participants will remain anonymous (no names given) and there is minimal risk in participation, a disclosure statement describing research procedures given to a participant may substitute for the consent form. A disclosure statement is not sufficient if participants are tape recorded, even if risks are minimal. A consent form is required for audio/video taping, research with vulnerable populations (minors, persons not competent to give informed consent), research that is not anonymous or more than minimal risk. Statement of procedures for participants (i.e. what participants will be asked to do): Your proposal should address all research procedures in a clear, basic and concise format. Procedures must be stated such that it is clear what will happen to participants in each phase of the project. The proposal should also include information on the time commitment required for participation in order for potential participants to understand the expectation for their involvement. Information on the time commitment should also be included in your consent, disclosure or assent forms. Information on research participants including how participants are chosen and criteria for inclusion or exclusion: Your proposal should included detailed information about your study participants, starting with the inclusion and exclusion criteria you plan to use. Your criteria for study participation must be clearly stated and ethical. Information on how research will ensure confidentiality and/or anonymity of participants and their data: Anonymity or confidentiality of participation must be clearly stated. Please note

3 that confidentiality and anonymity are not the same thing. For more information on the difference between these concepts, see below. Your proposal must include sufficient detail to explain how anonymity and/or confidentiality will be assured such as the secure storage of data, tapes and notes in a locked cabinet or password protected digital file. If audio or video recording will be used, the security of the tapes must be included in the section on confidentiality, and permission to audio or video tape participants must be obtained via consent. Confidentiality or anonymity via the secure storage of data, tapes and notes in a locked cabinet or password protected digital file must be detailed and included within the consent or disclosure and the proposal If data collection will take place via Survey Monkey or Qualtrics, the proposal and consent or disclosure must state that IP tracking will be turned off and SSL encryption will be enabled. Please note that Google and Facebook are not secure data collection mechanisms. Anonymity: Providing anonymity of information collected from research participants means that either the project does not collect identifying information of individual subjects (e.g., name, address, address, etc.), or the project cannot link individual responses with participants identities. A study should not collect identifying information of research participants unless it is essential to the study protocol. o Anonymity cannot be guaranteed if any personally identifiable (PII) information will be collected see below for a list of PII. Confidentiality: Maintaining confidentiality of information collected from research participants means that only the investigator(s) can identify the responses of individual participants. Regardless, the researchers must make every effort to prevent anyone outside of the project from connecting individual subjects with their responses. Ways to Protect Confidentiality: If it is essential to collect and link identifying information (e.g., subjects' names) to subjects responses (e.g., questionnaire answers), researchers must do their best and may need to be creative to provide the utmost confidentiality of subject data. Some examples of practices that may be implemented to increase the level of confidentiality include: Use study codes on data documents (e.g., completed questionnaire) instead of recording identifying information and keep a separate document that links the study code to subjects identifying information locked in a separate location and restrict access to this document (e.g., only allowing primary investigators access); Encrypt identifiable data; Remove face sheets containing identifiers (e.g., names and addresses) from survey instruments containing data after receiving from study participants; Properly dispose, destroy, or delete study data / documents; Limit access to identifiable information; Securely store data documents within locked locations; and/or Assign security codes to computerized records.

4 Examples of Personally Identifiable Information (PII): Name Addresses Employer's name or address Relatives' names or addresses Date (e.g., birthdate, date of death, etc.) Phone / fax numbers E- mail addresses Social security numbers Member / account numbers Voiceprints Fingerprints Full face photos & comparable images How does SurveyMonkey adhere to IRB guidelines? Please read the information at the hotlink, above. How do I turn off the IP addresses collection on the responses in SurveyMonkey (to maintain anonymity in survey data collection)? What does SurveyMonkey do with my collected data or s? Can I use Google Forms or Facebook to collect data? Neither Google Forms or Facebook are secure methods of online data collection because confidentiality cannot be assured. The IRB supports the use Survey Monkey and Qualtrics for online data collection with IP address tracking turned off and SSL encryption enabled. Nature and amount of potential risk involved in participation, and how that risk will be minimized: You must state the nature and amount of risk that a study participant will face even if the risk is very minimal. The proposal must also explain how risks will be mediated. Your description of the risks should be included in your consent, disclosure or assent forms. Potential benefit of research and/or society of the proposed research, and how it outweighs the risks: Your proposal must state the benefits of participation in the research, not just the benefit to society. Additionally, you must provide a statement on how the benefits will outweigh potential risks. Data collection instruments such as surveys, interview protocols and recruitment flyers: You must upload the final version of all recruitment materials and data collection instruments. If interviews or focus groups will take place, an interview guide is required as part of the proposal s supporting documentation. If data will be collected by survey or interview guide/protocol, a copy of the survey/interview guide/protocol is required as part of the proposal s supporting documentation Any changes made to these materials made after IRB approval will need to be re- submitted

5 through the modifications procedure. Please see the modification form on our forms page. Recruitment flyers or social media outreach text must be uploaded for review as part of the proposal s supporting documentation. Information required for flyers includes: IRB Approval Date (to be determined post review); Clear research title and any limiting criteria If you want to hang flyers to recruit participants on campus: To do this, you must receive permission from the student involvement and activities office located in the Ellison Campus Center. Flyers must also conform to the student involvement and activities posting policy Your recruitment flyer must also contain: IRB Approval Date Clear research title Any limiting criteria Brief description of research project Faculty Advisor name and contact information Researcher name and contact information IRB contact information Information on how to participate in the project and time commitment for participation Agreement letter(s) from collaborating organizations If you are collaborating with a specific Salem State entity (i.e. Office of Veteran s Affairs), drawing on a specific population or with a secondary organization including a school requires a signed agreement letter from the school principal or superintendent on school letterhead. The signature must be original, not typed. The letter must provide sufficient information to confirm the author understands and supports the proposed research. If the proposed research will be conducted in school settings and will include minors with an expectation that parental consent will be waived based on the school s use of a blanket consent form, the agreement letter must include a provision for such a waiver. How do I file an extension for an approved project? You must submit an extension form to the IRB administrator. See hotlink. There are changes to my project since it was approved. How do I file a modification form? Changes in scope, participants, methodology, principal investigator, risk, consent, etc. should be submitted to the IRB for approval. Submit a modification form to the IRB administrator.

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