ࡱ> >@={ %bjbjzz .2.....BBBB^Bnzzzzziii$!#T.iiiii..zz(i .z.zirTz`&js.>0n $ $ $.Xiiiiiiiiiiniiii $iiiiiiiii : 2013-2014 HSIRB Informed Consent Form Instructions and Tips The HSIRB Informed Consent Form Template is a general outline meant to inform proposers of the information that must be communicated/included in informed consent forms/letters. In this document, the committee provides some additional information and clarification about the various points in the template. General Comments: Although the template is numbered, informed consent forms rarely appear in this format. Our decision to number the points was for ease of communication and to facilitate proposer review of the document. You should replace any of the text in the template with words that reflect your particular research project. Replace the numbered format with unnumbered paragraph format. You can also change the order in which you address the various numbered points. Unless the study involves only the observation of public behavior, all subjects, even those whose identities will be unknown to the researcher, must receive, read, and sign a copy of the study's informed consent form and return the form to the researcher, or opt-in explicitly to a written or an online survey or text/chat interview. If an informed consent form is needed, following the HSIRB template and these additional instructions will increase the likelihood of your informed consent form meeting all of the committees requirements. Many research projects include participants from different institutions or meeting different sample characteristics. Therefore, proposers often have to compose more than one informed consent form, each tailored to the different sample population. So, for example, proposers conducting research in schools often have to compose different forms for school administrators, teachers and students. Your forms/letters need to be appropriate for the different categories of participantslanguage and references may vary between the three forms in this example. Persons under the age of 18, prisoners, and certain other individuals require an authorized guardian or legal representatives signature on an informed consent form. If researching in K-12 schools, you must also obtain principal, teacher, and guardian (if the research includes student human subjects) informed consent signatures. These signers are likely to need separate informed consent forms. Although K-12 student human subject signatures are not required, the researcher must include an informed consent statement to be read or provided to the student participants. All of the standard information required in the informed consent form must also be covered in the oral narrative. Some first-year college students may be under 18 years of age. Moravian Colleges policy treats all students as if they are at least 18 years of age for the purpose of HSIRB approved research. Even so, depending on your research proposal, you may ask that anyone under 18 not participate if you might be concerned about liability issues, confession to illegal activity, or for any other reason that you might want to exclude minors. Additional Comments By Numbered Points: How do you explain why you are conducting the research? Some research is required in courses. Some research is by professional educators, researchers, and marketers. But whatever the reason, let your human subjects know who you are and why you are doing your project. But what if your research project involves deception? In this case, proposers can enter the true research title on the HSIRB Proposal and use a different title on the participants informed consent form. In these cases, the true title is often revealed as part of the debriefing process. Briefly explain what will happen. This should be much shorter than the HSIRB proposal explanation, but it does have to provide enough detail/information that your subjects have a realistic understanding about what is required by their participation. They must be fully informed so that they can give informed consent. Provide an accurate description of the time commitment. Does your survey, video screening, interaction, or other research tasks really only take ten minutes to complete? Will the human subjects have to return for a second session or debriefing? Have you really checked the actual time of involvement? All instruments needs to be pre-tested. Think carefully about the risks a participant might face, especially participants who might be pregnant, have allergies, or are taking some medications. Since all human activities involve risk, you should include a statement about risk in the informed consent forms such as: Your role in this study involves no anticipated risks greater than those you might experience in everyday activities. If the HSIRB committee identifies a risk you did not consider, your proposal will be returned for revision. Unanticipated psychological and physical injuries may occur, so make sure you provide all of the required contact for support services outlined in the template. Your research will likely benefit someone, but not necessarily the participant directly. Sometimes human subjects receive course credit, extra credit, other incentives or payment. Sometimes a research benefit is that the human subject helps advance knowledge in a field. A benefit might be that the human subject will aid the researcher in completing course-work. Researchers often describe the benefit to themselves or to the body of knowledge about a topic even if the individual participant is unlikely to get some direct benefit. If you are collecting signatures, coding surveys, or in some way keeping track of your human subjects, you must describe how those records will be protected from others eyes. Even if you are not keeping track of your human subjects, research records may have a negative impact on your human subjects if seen by people outside your research group. Will your materials be locked in an office until the end of the research? Will the documents be shredded? Will they be kept for further research? Human subjects may decline to participate in your project before, during, and after the research. If they do decline to participate, they cannot lose any benefits that they would have been entitled to if there had been no research project. However, what will happen to any benefits (extra credit, payment, or other participation benefit) if the human subject withdraws before the completion of the project? Are you including something (video, audio tape, written statements) that the human subject would be able to withdraw from your research at a later date? Are there consequences to that? You need to think carefully about these issues and include instructions for participants if they choose to withdraw from the project. If the process of withdraw and the instructions for withdrawal of information even after initially completing the project are complicated, you can compose a separate withdrawal form that will be made available to participants upon their withdrawal and/or completion of the project. Instead of appearing in full text in the informed consent form, it can be referenced but accessible at a later date. If you choose to create a separate withdrawal instruction form, this form needs to be submitted with the completed proposal at its initial review stage. 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