ࡱ> ORN{ a-bjbjzz .@a%  fffffzzzz$,z4()4+4+4+4+4+4+4$V69TO4fO4ffd4 ff)4)4n/2pk.0 4z4040\9\9@22\9f2(O4O44\9  ,: ̽ College Human Subjects Internal Review Board (HSIRB) Tips Please consider these issues before submitting your proposal. In this document, we provide some additional information about some of the more common questions/challenges that proposers face as they design and compose their research proposals. We encourage all proposers to review this document to see how these issues relate to their particular research designs before they begin and/or submit their proposals. GENERAL The Proposal Form requires information that also appears in the Informed Consent Form. Authors can copy and paste relevant sections from one section to the other. Note, however, that the tone and voice of the informed consent form is typically addressed to a lay audience and therefore should be worded specifically to your research audience while the proposal itself has a more formal, professional tone. Pay attention to voice when drafting the different sections of the research proposal. A script or protocol for any standardized contact with individual subjects, including but not limited to introductory phone calls, must be included in the proposal. Copies of all questionnaires or standardized tests and/or photos/visual stimuli given to subjects must be included with the HSIRB proposal. Please try to convert all of these documents to Word documents. If this is not possible, please scan the documents so that they can be submitted electronically. If the stimulus is an object, a photograph of the object generally suffices. If you are using video or audio instruments, please provide links to the files, or you may submit disks (links are the preferred format). Please make sure that you have obtained permission to use copyrighted instruments. Student proposers, please check with your faculty adviser for details about requesting and obtaining permission. The HSIRB cannot legally approve research projects that violate copyright laws. In order to protect participants anonymity and/or confidentiality, proposers must provide details about how they intend to safeguard the data during the research collection process and analysis. Proposers typically keep their data (whether the data is paper surveys, transcripts, video or audio recordings, test results, etc.) stored in a locked cabinet/compartment in a secure location (for example, in an office). Proposers must also report the list of individuals who will have access to the data, such as research assistants, faculty advisers, etc., if the proposer is not the sole collector and analyst. Data from online surveys and transcripts of online text or chat interviews must be collected, stored in their unedited entirety, reviewed, disposed of, etc. with the same attention to anonymity, confidentiality, and security as printed survey forms. If you are collecting information in these ways, you must provide details about how you intend to protect anonymity and confidentiality. A standard way, for example, to protect online collection of data is to prevent tracking of computer ids. Students, please review these protection practices with your faculty adviser. Any written or spoken aspect of the study conducted in a language other than English must be documented in the proposal in the target language(s) and English translation(s). PROCEDURE Research Conducted at Sites Other Than ̽ College: Research conducted at sites/institutions other than ̽ College often requires approval by the institutions administrators. Include evidence of such permission in the proposal. Typical sites for research include schools, churches, community centers, etc. A letter of support from the administrator(s) typically suffices. In some cases, the site may require the submission of the research proposal to its own IRB committee. Proposers should seek permission from outside institutions very early in the process in order to clear this hurdle before submitting their proposals to ̽s HSIRB. Possible Communication Challenges: Potential difficulties in communicating with and gathering information from subjects due to language difficulties, hearing disabilities, mental or intellectual impairment, and similar conditions must be addressed in the proposal. A short explanation of the procedures to be followed in such situations should suffice. This does require careful consideration of the research instrument and the sample population. Proposals Involving Deception: All instances of active or passive deception must be identified and fully explained in the proposal. The explanation must justify the deception, describing why it is necessary. Passive deception might involve, but is not limited to, lying by omission or providing subjects with a misleading project title. A debriefing statement that will be presented to deceived subjects must be included in the proposal. INFORMED CONSENT Informed consent must be collected from all subjects, including those whose identities will be unknown to the researcher, unless data collection involves: Only the use of professionally documented, generally accepted, cognitive, diagnostic, aptitude, or achievement tests. Only interviews with or surveys of elected or appointed government officials, or candidates for such positions. Only the observation of public behavior. Only existing data, documents, records, or specimens. The act of consent requires either that the participant receive, read, sign, and return to the researcher a copy of the study's informed consent form, or opt-in explicitly to a written or an online survey or text/chat interview. The informed consent form must: Be addressed directly to the participants; do not use the third person. Be written in everyday language. Avoid technical terms and professional jargon that subjects may not understand. Outline all aspects of the study, including the: subjects responsibilities, potential for mental or physical harm, form that data will take (e.g. written, recorded, etc.) and intended use of the studys results Clear instructions for and descriptions of the consequences of opting out at any stage. Contact information for the researcher (and any instructor) who can help with questions about the study and sources of help for mental or physical harm that may result from the study. For more details about the informed consent form/letter please see the HSIRB informed consent template which can be accessed at  HYPERLINK "http://home.moravian.edu/public/HSIRB/" http://home.moravian.edu/public/HSIRB/. The distinction between anonymity and confidentiality must be clear. Subjects are anonymous if their identities are unknown to the researcher. Confidentiality refers to the researchers promise that subjects identifiable information will not be made public. Subjects must be made aware of the legal limits to confidentiality, specifically mandatory reporting of certain behaviors. Few undergraduate researchers would conduct the types of research projects that would require mandatory reporting of behavior, but reviewing the conditions under which mandatory reporting is required should be part of the student/faculty adviser proposal design dialogue. Please see the document, Ethical Issues in Research on Illegal Activities, posted on the HSRIB website for a discussion of What Constitutes Sensitive Research?, Protecting the Anonymity and Confidentiality of Research Subjects, When Must You Report Illegal Activity, and Drafting Your Research Proposal and Working with an IRB to review some of the legal limits of confidentiality. Consult with your faculty adviser and with the HSIRB to see if you need to include a statement about the limits of confidentiality. Studies involving subjects who are younger than 18 who are NOT full-time ̽ College students must obtain consent from the participant and from his or her legal guardian. Because adult-child research situations can involve intrinsic coercion, special care must be taken to ensure that children understand that they can refuse to participate at any point. Remember, gaining informed consent from a parent is not sufficientinformed consent must also be obtained from the child participant. Subjects who have particular mental or physical conditions (e.g. pregnancy, high blood pressure, anxiety attacks) may suffer unintended and unpredictable negative effects from a study. It is wise to include a disclaimer statement directed to those individuals if they may unintentionally end up in your sample. Such a statement can read as follows: This study involves no conditions that are known to affect those with differently than they affect other subjects. However, it is understood that this condition may be associated with unanticipated reactions to seemingly benign behaviors and situations. Therefore, those with are reminded of their rights to cease participation in the study at any time. If you have any questions about any of the information provided above, do not hesitate to talk to your faculty advisers, your colleagues, or with members of the HSIRB committee. Please also contact the HSIRB if you need clarification about aspects of your proposal that are not specifically addressed in this tips sheet. Students, we encourage you to raise your questions initially with your instructor/faculty adviser. Contact information for the HSIRB is available on the HSIRB website:  HYPERLINK "http://home.moravian.edu/public/HSIRB/" http://home.moravian.edu/public/HSIRB/. 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