ࡱ> ]_\{ \Dbjbjzz 4d\<&&nnnnnL4,,sss+++++++$B.0N+nsssss+nn+s:nn+s+')0q6k.S(++0,,i(6B1B1,))`B1n)sssssss++sss,,ssssB1sssssssss& 4: K Submitting an HSIRB Research Proposal Form 2013-2014 Guideline for Students Welcome to the research proposal process. This guideline will hopefully help you navigate the HSIRB approval process. If you are reviewing this sheet, it is highly likely that you already have a research topic and are working within a class or with a professor defining the project. In order to gather the forms you will need, please access the HSIRB website,  HYPERLINK "http://home.moravian.edu/public/HSIRB/" http://home.moravian.edu/public/HSIRB/. Spend some time with the website to review the proposal process, get a sense for the proposal process and review timetable, and find some helpful links to interesting research websites that discuss protections for human research subjects. Once you access and review this website, these are the documents which you will need to complete your proposal. Proposal form (this is available as a Word document and should be completed and submitted as a Word document) HSIRB Tips.doc (This is a helpful instruction document that reviews common problems/challenges proposers face when completing the proposal form. This document should be read by every proposer before they begin completing the proposal form.) Informed consent template (reviews the information that you must cover in the informed consent letter) Informed consent instructions (provides additional information about completing the informed consent form/letter) Alternatively, the documents are available via the p-drive under the folder, hsirb. Reminder about the review process timeframe: Please note, once complete proposals are submitted, it can take up to two weeks (14 days) for the HSIRB committee to complete its initial review. Most proposals require at least a few minor edits/modifications. Depending on how quickly the proposer makes these required changes, full approval can be delayed by an additional week, bringing the total review time up to three weeks. Please plan accordingly, especially if you are completing a research project as part of a class project. And make sure that you regularly check your emails once you have submitted your complete proposal so you can respond to requests from the HSIRB in a timely manner. Time delays often result from submission of incomplete proposals (missing forms) and failure to respond to emails requesting additional information. Responding quickly to requests for additional information and/or clarification helps streamline the process. The Proposal Form: Parts I & II: Make sure you carefully review all of the information on the first page of the proposal form and follow the submission instructions. Make sure you read the proposal form carefully; fill in all of the blanks; and answer all of the questions. We will collect electronic signatures from you and from your faculty adviser when the proposal is approved, but in the meantime, please make sure you provide name and the name of your faculty sponsor/instructor on the Part I. Researcher section of the form. When you submit the completed proposal to  HYPERLINK "mailto:hsirb@moravian.edu" hsirb@moravian.edu please make sure that you CC your faculty adviser on the email correspondence. Part III. DETAILS OF THE RESEARCH PROJECT Part III. Make sure you provide all of the required details in this section of the proposal. Student proposals are often returned and the review process delayed due to missing information in this section. Students often have trouble with points III.2 and III.3 on the proposal form. Please take a moment to review the Research Design Notes that appear here on the form. If your sampling design relies on student volunteers, there is a chance that although you are not seeking people from the identified vulnerable populations, you may end up with people who are under the age of 18, women who do not even know that they are pregnant, and/or people with mental, cognitive, intellectual or physical disabilities, identified or unidentified. Because of this uncertainty, if you are relying on a volunteer participant sample, you need to address the possibility that people from these groups might end up as participants. You then need to specifically address whether their participation in your research might result in them facing any unacceptable risks (physical or psychological). If not, you need to make a statement on the proposal form that their participation either does not pose risk, or if it might pose risk, you need to either make sure that you find a way to screen these potential participants out of the sample or find ways to protect them during their participation. Make sure you not only address the vulnerable populations listed in III.2 but other kinds of risky populations (III.3) such as people with allergies or taking certain kinds of medications. For example, if your research design involves food, you have to think carefully about people with food allergies. If you are using distracters of any form (light, sound, music, other kinds of interruptions), you have to think of the possible effects on someone with ADHD, or someone with diagnosed or undiagnosed epilepsy. Part III.5: If you intend to use some form of incentive to help recruit subjects, you need to tell the HSIRB details regarding the nature and scope of the incentive. This may be extra credit in your home department, or a candy bar, or entry in a raffle for a gift card, but we need details, such as the value of the raffle prize (or candy bar). Why? The committee needs to make sure that the incentive is not excessive and/or unethical. Excessive incentives can be considered unethical, such as an excessive monetary incentive to give blood or to ingest potentially dangerous substances, or to participate in potentially psychologically damaging experiments. So if you are offering an incentive, please be very clear about the nature and value of the incentive. Part III.6: If your research involves deception, make sure you clearly argue why deception is needed and how you will debrief subjects at the conclusion of the research. Students often forget to describe the process of debriefing. We need details including the narrative of the debriefing, whether this will be an oral debriefing or a document distributed to participants. Part III.8: Safeguarding the data: proposers often fail to provide adequate detail about safeguarding the data that they collect. You need to provide very detailed information including how the data will be stored (usually under some lock and key scenario (in a locked cabinet stored in the department office, for example) or in a password protected computer file). You also need to provide explicit details about how the data will be destroyed at the end of the study (shredded, magnetized, etc.) or for how long the data will be kept for analysis. In some cases, the data may be kept for many years (especially if the study is part of a longitudinal study). If you will be keeping the data for longer than a year, you need to argue why the data needs to be kept and how you will continue to safeguard the data. You also need to explicitly identify the individual(s) who will have access to the data. In many cases for student proposals, the only person who will have access is the student proposer. In other cases, it may be the student, the faculty adviser, other students in the class, other research assistants and/or secretarial staff. All of these details need to be provided. The committee needs to make sure that everyone who has access to the data will not necessarily be able to uncover the identity of the participants, or that the information that they might gain from the data will not potentially impact their interactions with the individual. For example, consider the scenario where you distribute a survey to a small class in which there is only one male student. On the survey, you ask participants to self-identify their gender. Your faculty adviser has access to the data and since this is the faculty member who is teaching the class, he/she immediately knows the identity of the person who completed the survey who identified as male. What if the survey asked questions about plagiarism and this individual admitted to having plagiarized during his college career. The loss of anonymity here has put the individual participant in academic peril since the faculty member may have a hard time trusting this individual even though he may have never plagiarized in that individual faculty members class. The faculty member may find it very hard to objectively assess the student in this and in all future classes. While this scenario may seem farfetched, you might be amazed at how often people can accidentally be identified by a particular subset of participant demographics and how exposure might damage the standing or reputation of that individual, especially at a small school like Moravian College. This is one of the reasons why the HSIRB carefully reviews the anonymity and confidentiality protections that proposers put in place. Other Important Considerations Avoid poor grammatical constructions and numerous grammatical errors. Some proposals are so riddled with poor grammatical constructions and errors that the committee cannot assess the ethicality of the research design since we have trouble following the logic and/or steps of the design. Recall that the benefits of any research must outweigh the risks associated with the research, and by definition an illogical or poorly argued/presented research project (even one that is innocuous) is more risky than not conducting the research in the first place, even if the risk is a significant waste of time on the part of the participants. You must be sure that your project makes sense before you submit it for review. Additionally, as part of your education in professional research design, you need to be aware that most outside professional grant organizations would outright reject poorly constructed or error-ridden proposals. They would return these proposals without review. Why? Unprofessional presentations full of errors would make many granting committees doubt the eventual professional execution of a proposed projectif you are not careful in the construction of the proposal, the outside organization would not trust that you would be careful working with actual people in a research setting. The bottom line for the Moravian College HSIRB and the IRBs of other institutions is to assure the ethical treatment of human subjects. Since the physical and psychological well-being of your participants is in your hands during a research project, assessment committees want to know that you recognize your professional and moral responsibility to the protection of these human subjects. A professionally composed and organized research proposal demonstrates your maturity and integrity and therefore is a core requirement for the HSIRB submission process. In summary, the committee will return poorly written proposals which will delay the approval process. In order to avoid this potential setback, we encourage students to: proofread their proposals, ask for a peer review from a classmate, and/or take the proposal to the Writing Center before submitting it to the HSIRB. A professionally constructed proposal is both a response to federal requirements, and part of your academic/professional training. Therefore, to reiterate, meeting the standard of a grammatically correct professionally competent proposal is part of the HSIRB committees basic requirement. Instruments Missing Instruments: Many proposal reviews are delayed because copies of all of the instruments students propose using are missing. The committee cannot assess the ethicality of the research design without the instruments. Students can either submit the instrument or provide a thick description of the experiment if it is a situation. The committee needs to see all of the following types of instruments: surveys, inventories, tests, pictures, video clips, movie clips, music clips, etc. If you have any questions about how to submit the instrument, please contact Dr. Adams OConnell at  HYPERLINK "mailto:hsirb@moravian.edu" hsirb@moravian.edu. Copyright permission: If you intend to use tests or inventories already in circulation, you may need to obtain copyright permission. For psychology students, please review the following information listed on the APA website about copyright and permissions. If copyright and/or test use regulations prohibits you sharing a copy of the instrument with your proposal, please indicate that clearly on your proposal sheet and refer the committee to your faculty coordinator for verification. APA Copyright and Permissions Information:  HYPERLINK "http://www.apa.org/about/contact/copyright/index.aspx" http://www.apa.org/about/contact/copyright/index.aspx All students can also check materials at the Copyright Clearance Center:  HYPERLINK "http://www.copyright.com/" http://www.copyright.com/. Students should always consult with their faculty adviser(s), even after exploring these links. Granting proposal permission without copyright clearance is in essence plagiarism, therefore the HSIRB cannot grant full approval for a research proposal if the committee suspects plagiarism. If your copyright request is in process (we recognize that in the name of expediency, people often have to submit their proposals for review before they may have heard back from various contacts), you can submit your proposal and the HSIRB might be able to grant you conditional approval of the proposal awaiting clearance. Complete proposals As noted above many times, proposals cannot be reviewed until they are complete, so before you submit the proposal, please make sure you have all of the following items collected: The completed and proofread proposal form. Your informed consent letter/form(s). Copies of all instruments that you will use in your study and/or links to online materials (such as movie clips, music clips). If deception is involved, a description of the debriefing process and/or a copy of the debriefing form. Submitting the proposal: You should submit your complete proposal to the following email address:  HYPERLINK "mailto:hsirb@moravian.edu" hsirb@moravian.edu Please attach each piece of your proposal as a separate document/attachment (i.e. attach the proposal, then as a separate attachment, the informed consent letter, etc.), but please make sure all attachments are sent in one email. We prefer attachments that are Word files rather than pdf files, but we understand some forms will only be available as pdfs. Please try to name the file so it is recognizable as yours. For example, use the format proposers last name.document type.docx such as oconnell.proposalform.docx, or oconnell.informedconsent.docx. Failure to follow these submission instructions will lead to a delay in the review of your proposal, so please review the instructions carefully. Thank you for your careful attention to this document. If you have any questions, please consult your faculty adviser or contact Dr. Virginia Adams OConnell, Co-Chair, HSIRB, at  HYPERLINK "mailto:hsirb@moravian.edu" hsirb@moravian.edu. 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