Guide for Filling out the IRB Application Form This guide is meant to help you avoid some of the common mistakes made in filling out the IRB application. If you have additional questions, please do not hesitate to contact the current IRB Chair listed on the Bridgewater College IRB website. Instructions can also be found imbedded in the on-line application by hovering over the “?” next to each section. The IRB Application becomes the permanent record of the compliance of the investigator(s) with laws and regulations protecting the rights and welfare of human participants in research. Sufficient detail of the proposed protocol must be included to permit the IRB to render a decision about whether the safeguards in the research protocol protect the rights and welfare of human participants and benefits justify any risks. Please complete the application below and submit the appropriate number of copies to the IRB Administrator. Applications are accepted at any time, though the time to complete the review process depends on the level of review required, as determined by the IRB (See the FAQ on the IRB website for a discussion of Exempt, Expedited and Full review). Exempt reviews will normally be completed within ten business days. Expedited or Full reviews submitted less than one week prior to a scheduled monthly meeting of the IRB will be completed at the subsequent monthly meeting. (See the schedule of monthly meeting dates on the IRB website). All investigators who will interact with human subjects are required to complete the NIH online course on protecting human research participants - "Protection of Human Research Subjects: Computer-Based Training for Researchers." The NIH training website can be found at: http://phrp.nihtraining.com/users/login.php. The NIH certificate of completion should be submitted by all researchers involved in the research process, including principal investigator, faculty sponsor, and campus contact(s). We will also accept CITI training on human participation research.
Please check whether the project falls into the Exempt, Expedited or Full review category according to the definitions below. Feel free to contact the current IRB Chairperson if you have questions about how to categorize your research. PLEASE NOTE: In most cases, research involving children or other vulnerable populations is likely to require expedited or full review. Exempt Review (Applications can be submitted at any time). Common examples include: education research on normal educational practices; research with existing data that is publicly available; survey research, interview or observational research where the participants either cannot be identified, or the release of information would not be harmful to them. This level of review applies only to research that presents no more than minimal risk to participants. Expedited Review (Applications can be submitted at any time). Common examples: research that involves deception or experimental manipulation; research that includes collecting voice, video, digital, or image recordings; survey or other research that seeks personally sensitive information that if released could place the participant at risk; non-invasive clinical, medical, or sports-training research. In all cases, expedited review is possible only when there is no more than minimal risk to the participants. Full Review (All applications must be submitted one week prior to the scheduled IRB meeting). Common examples: any research that presents more than minimal risk to the participants such as invasive medical procedures. Principal Investigator: This is the person who will oversee the project. You may have two or more PIs if several people will be sharing this responsibility. Select one to list in this box on the form and list others in the investigator’s box following. Principal Investigators who are not student, staff or faculty at Bridgewater College will not have access to the on-line system. In this case you can access the MSWord version of the application on the IRB website. In filling out the form, all boxes are meant to be expandable. Please do not worry if explanations run onto additional pages or alter the look of the form. E-mail your completed form to the IRB Chair. Start and End dates: Please list dates that occur at least one week after the next IRB scheduled meeting date. When your project is approved, the approval will last indefinitely if the project is Exempt and for one year for Expedited or Full. After one year, you will need to submit a Continuance form to the IRB in order to renew your approval. Faculty Sponsor: This is a Bridgewater (or other institution) faculty member who is overseeing the project when the PI is a student. All Faculty Sponsors are required to complete the online NIH training on human participant research to ensure they are familiar with federal research regulations. You will need to attach the Faculty Sponsor’s completion certificate to the application.
Grant Funding: If you are receiving any external funding to complete your research project you must indicate that in this section. This includes both internal and external funding sources. Investigators: These are people who will recruit participants, directly gather data, process data with identifying markers, or otherwise interact with human participants. Student projects or smaller faculty projects will usually leave this section blank. All investigators (including faculty sponsors and non-BC investigators) are required to complete the online NIH training on human participant research to ensure they are familiar with federal research regulations. You will need to attach Investigator completion certificates to the application. Campus Contacts: These individuals may distribute emails to listservs, post flyers, or otherwise disseminate information to potential participants on campus. Campus Contacts do not need to complete the NIH online training, however, the must fill out the Campus Contact Agreement form found on the website. It is important that the Campus Contact act only as a disseminator of printed information designed by the researchers. They may not change messages in any way or directly interact with participants. Questions should all be referred to appropriate investigators. Procedural Information: This section ask for information about the purpose of the study and the methods that will be used to collect data. This information helps the IRB evaluate the benefits and risks involved in the study. Section I: The principal way the IRB evaluates the appropriateness of research is by weighing its benefits against its risks. In this section, please demonstrate the benefits of your research by showing how the project will advance knowledge and enhance our understanding of your subject. Please clearly state your research questions or hypotheses and explain how the project fits into existing knowledge. It is expected that you will cite other research in this section. Section II: In this section please list the ways in which this research might directly benefit the participants. For example, if the study involves health or psychological screenings and the results will be shared with participants, you might list the resulting increase in personal knowledge as a benefit. Note: Benefits to the researcher, such as practice learning how to administer tests, or completing a degree should not be listed as benefits of the study. Section III: In this section, please describe the procedures that will be used in the study as fully as possible. You should break down the description with sub-headings, including: � Recruitment Procedure � Consent Procedure � Data Collection Procedure � Debriefing Procedure (if appropriate) � Compensation Procedure (if appropriate – including any prize drawings) Section IV: Please check which of the methods you will use to collect data in this study. This section helps the IRB quickly
assess the level of risk the project will involve. Please make sure that you have fully described in Section III any procedure that is checked in Section IV. Participant Information: This page asks you to pull out key information from Section III to help the IRB better understand who will participate in the study, whether benefits and risks will be fairly distributed and whether potential participants will have ample opportunity to opt out of the study. Section V: Certain groups are considered particularly vulnerable because they may have limited mental or psychological ability to consent to research, or they may have insufficient social power to resist coercion. In this section, we are asking you to indicate if you will be recruiting participants who may be vulnerable so we can pay special attention to whether the risks to them are being handled appropriately. Section VI: The Belmont Report specifies that risks and benefits should be equally distributed among demographic groups. Thus, if a specific population is targeted by the research, there should be a sound rationale for doing so. Therefore, in this section we are asking you to check any groups that you will be specifically recruiting. Section III should include a full explanation of why and how you are targeting specific demographic groups. Section VII: In this section, we are asking you to check the types of recruiting methods you will be using (as described in Section III). The IRB is concerned with whether any coercion will take place during recruitment. Please make sure that all potential participants have a reasonable option to refuse to participate. Note that one-on-one requests of friends are not necessarily free from the risk of coercion. Friends generally feel strong social pressure to help each other out. However, the IRB understands the difficulty in recruiting from a small campus like Bridgewater’s without involving friends or acquaintances. Therefore, we ask that any requests of potential friends to participate be made in a group manner rather than personally/one-on-one, to make it easier for people to ignore the request if they choose. Examples include: � A post on a Facebook page or other online venue � A large group email with the address list hidden (individual emails are not OK) A situation that can be particularly tricky in terms of coercion is when professors want to solicit participation from their current students. Professors cannot require study participation as part of a class. Students must be able to opt out of the research, and it is important that the identity of the students who opt out of the study be hidden from the professor, at least until grades for the course have been assigned, if not indefinitely. Please include copies of all recruitment letters, emails, posts or (in the case of classroom requests) scripts as attachments at the end of your application.
Section VIII: In this section, please indicate what type of compensation will be offered to participants. The two main concerns for the IRB here are (1) that the compensation is not excessive, that is, too great to refuse and thus becoming a form of coercion and (2) that any drawings will be conducted in such a way as to protect participant confidentiality. Section IX: The Belmont Report establishes that participants should be aware of what they will be asked to do in a research study before they agree to participate. While it is possible that deception may be used in certain experimental studies, the deception must be justified in terms of the anticipated benefit of the knowledge that will be gained through the study. The way we ensure that participants are aware of the risks, benefits and procedures of a study before they agree to be part of it is usually by having participants sign a Written Consent form. There is a template on the IRB page showing the standard elements of a written consent form: procedure, length of participation, risks, protections against risks, benefits, statement of ability to withdraw at any time, contact information for researcher(s) and the IRB. Please attach a copy of all consent forms as an appendix to your application. In some cases, especially with populations that are not fully literate, it may be more appropriate to use Oral Consent. If this is the case for your study, be sure to attach a copy of a script that will be read to participants. The script should include all of the elements of a standard written consent form. In the space provided, please also indicate the reason why oral consent is the most appropriate option for your study. In some instances, informing participants about the nature of the study beforehand is appropriate, but gathering writing consent will compromise the anonymity of the participants. For example, an online survey should include a consent statement at the beginning of the survey with a check box indicating that participants have read the explanation of the study. However, it is not desirable to have people electronically sign their names, since this would be the only way the research would be able to link answers to individuals. In this case, check Waiver of Documentation of Consent and explain how this waiver will better protect the anonymity of participants. When research involves the observation of people’s behavior in public settings, it is often not necessary to ask for their consent to be part of your study. To gain consent may compromise the study if people alter their behavior because they know they are being observed. If you think this might be the case for your study, check Waiver of Consent and explain why you are requesting this exception. A waiver of consent will not be granted if the observation is to take place in a private setting, such as a house or exclusive club. Protection of Confidentiality Information: Every study involving human participants needs to consider how to best protect the confidentiality of participants. This is particularly important when the disclosure of personal information to the public may result in the participants suffering social sanctions. This page asks you to specifically address how participant information will be kept confidential during
data collection, analysis and reporting. Section X: If participants will disclose information about people who are not part of the study, researchers need to be diligent about protecting the privacy of those individuals as well as those that are directly involved in providing data. This section asks you to indicate whether participants will disclose such information so the IRB can determine the level of confidentiality risk involved in the study. Section XI: This section asks you to specifically address some of the key threats to confidentiality in research studies. Names: Whenever possible, researchers should collect data in such a way that the data is not directly labeled with participants’ names. Identification numbers should be used instead of names when different pieces of data need to be matched by individual. Qualitative interviews should be conducted in a completely private location where others will not accidentally walk in on the interview or hear participant responses. Transcription: If proper transcription protocol is not followed, participant identity may be inadvertently revealed. Researchers should indicate that: � Transcription will take place in complete private or with the use of headphones (so that others cannot accidentally overhear what a participant says. � If a participant mentions another person by name in a recording, the real names will not be typed into the transcription (pseudonyms should be used). Storage: Consent forms (which have participant names) should not be stored attached to the data collected from that individual. Consent forms and data should be locked in a file cabinet or desk whenever possible. If a locked drawer is not available, consent forms and data should be stored in a locked room, out of casual view of someone who might enter the room. Reporting: Names should not be attached to specific pieces of data in the written report of the study. Pseudonyms should be used for qualitative data and aggregate results should be reported for quantitative data. Federal Requirement: This section asks you to acknowledge that you understand that it is a federal requirement that you store consent forms for at least 3 years. Minimizing Risk Information: In addition to risking participant confidentiality, some studies risk harming participants emotionally or physically. In general, it is not required that a study carry no risk, but rather that (1) the risk presented is not greater than what a person might reasonably expect to encounter in everyday life or (2) the potential benefits of the knowledge gained from the study far outweigh the risks to individual participants. In any case, the emotional and physical risks associated with a study should be minimized as much as possible. This page asks you to explain the anticipated risks and the actions you will take to minimize those risks.
Section XII: In this section, list the participant risks you anticipate. Please include not only physical harm, but discomfort or emotional distress that might be caused by the research procedures. In addition, consider whether any harm might be done to the social status of a particular group of people if information about that group is released to the public. Section XIII: In this section, explain how you have taken precautions to minimize the potential risks described in Section XII. For example, participants should be offered the opportunity to stop participation in the study if they become uncomfortable. If the research has the potential to trigger underlying psychological trauma, all participants should be offered printed information about how to seek professional counseling. Unless alternatives are specifically warranted, studies involving BC students should provide information about BC counseling. Another way to minimize risks or feelings of discomfort is to provide participants opportunities to have control over the procedure, such as choosing the location of interviews. Attachments Uploader: Use this feature to attach all relevant documents, including but not limited to consent forms, recruitment documents, data collection instruments, NIH (or CITI) human subjects training certificates. You can add and remove documents until you have submitted your application, once you submit you will not be able to make changes to your application or the attachments.
