First and foremost DON'T PANIC.
Read all instructions prior to completing the Form A and take your time. Try to be clear and concise. If you aren’t sure how to respond to a question please ask for help. If there are any questions about your protocol or procedures, you will have an opportunity to respond to them before the IRB makes a final decision.
Contact Information - The HSRO may contact you to obtain further information and to inform you of any questions or comments. Please include email address, phone, and fax numbers. Review of your project may be slowed if responses to comments are not received in a timely fashion.
Format - Your protocol should be written for the average reader. The reviewer may not be as familiar with your field as you are. They can make the best review possible when they understand what your research activity is about.
Abstract - Your abstract should be a thumbnail sketch of your purpose and procedures, and should be written for the layperson. Imagine that you want to explain your project to someone you have just met – you want to cover everything, but not in great detail. For example:
"This project will be a retrospective study of the long-term effects of eating disorders in adolescent girls. Adult subjects will be recruited through flyers posted in community centers, and data will primarily be gathered through questionnaires distributed at these community centers. Follow-up interviews will be conducted with interested subjects. We hope to determine if eating disorders in adolescents are related to long-term problems with weight and nutrition."
You may want to write this section after you have written the rest of your protocol. Remember, you do not have to answer the sections in the order they appear in the protocol application.
Study Procedures - Be sure to describe what data you plan to collect and how you will collect the data. Consider the following:
Are you choosing a site that protects your subjects' privacy and/or security? If you're working in an institutional setting, do you have permission from the institution?
Over how long a period of time will subjects be involved? How many times are you going to be in contact with your subjects? How much time will they be asked to spend at each session or on each survey or each interview, etc.?
What are you going to do? Interviews? Surveys? Observations? Participant observations? Experiments? Describe your procedures in as much detail as possible. If appropriate provide a script of the instructions to be given to subjects
Subject Population - Who are your subjects? How will you decide who to approach? Will you include any vulnerable populations? If so, why? Are there groups of people that could benefit from the research but that aren't included? If so, provide rationale for exclusion
RECRUITMENT - How will you make your first contact with subjects? If you'll be posting fliers, explain where fliers will be posted and provide the text of the fliers. If you'll be contacting subjects by phone, explain how you will get their contact information and provide a script for the phone call. Keep in mind that recruitment materials are considered part of the consent process, so any revisions to them need to be reviewed and approved by the IRB.
Confidentiality - Describe the means by which you are able to ensure confidentiality of data. It is not enough to state that data will remain confidential; you must indicate how you are able to keep it confidential; this includes who has access to the data, how data is transmitted and stored, and presented. Who will have access to raw data, are you sharing data with anyone? What kinds of reports or presentations will be made?
Confidentiality Vs. Anonymity - "Anonymity" means that no one, not even the researcher, will be able to connect the subject's responses to his or her identity. "Confidentiality" means that the researcher will be able to connect the subject's responses to his or her identity, but that the information will not be released to anyone else. Keep your data anonymous if you can, but be sure to use these terms accurately.
Risks - If there are potential risks involved in your study, specify them even if you believe they can and will be avoided. Describe the precautions you will take to avoid these risks, and assess their likelihood. If you have previous experience or training that you feel increases your ability to identify and respond to potential risks please describe it.
Benefits - Be realistic; benefits may relate directly to your subjects or only to society at large. Indicate if subjects are not expected to receive any benefits. Don’t feel pressured to make something up.
Copies Of Questionnaires And/Or Interview Questions - Samples should be representative of the topics you plan to cover. Copies should be provided for review even if you are using "standard" instruments. If part of your research activity is to develop instruments indicate that on the submission form.
Consent Procedures -
- Non-Exempt Research - If you are obtaining written consent from more than one population, for example, students and parents, submit the appropriate form labeled for each population. Be sure to submit invitation letters that will be used introduce the research activity, for example if you collecting data via mailed surveys to parents.
- Exempt Research - While Exempt research activities do not require a documented consent form (one with the signature of the subject), RIT does expect that researchers will provide the same kind of information to each subject. All subjects should receive a written document for their records in case they have questions or any adverse reactions to the research.
Translation Procedures - When research is being conducted where subjects may use forms of communication other than English, it is important that the consent process and the appropriate information be delivered to subjects via their preferred form of communication. Procedures for ensuring accurate accommodations should be described in detail.
Waiting for Approval - You may not begin your project until you receive notification of approval. The initial review can take between fifteen and twenty business days for a new protocol submission depending on the kind of research, especially during the busy Spring quarter. You will be contacted after the initial review if you need to provide additional information which will extend the reviewing time. Research including children or other protected groups, deception or development of devices may take longer depending on the complexity of the activity. Please budget enough time for review when designing your project.
Under no circumstances should you interpret a lack of communication from the HSRO as an approval, nor should you assume your activity will be approved and begin collecting data before receiving notification of approval.
Applications - Applications are received on a year-round basis in the HSRO; please submit as soon as you have completed the applications.
For research that will be funded from agencies outside of RIT, like NSF, DOE, etc, the HSRO and most funders employ a "just-in-time" approach which means submissions do not require review until a project officer at the agency indicates they will be funded and requests proof of human subjects review. If this is the case with your activity you may have a very short window of time between when you find out the activity will be funded and when you need to provide evidence of HSRO review. In these cases you may want to review and produce a draft of the submission paperwork so that you will be able to submit to the HSRO quickly.
DEPARTMENT CHAIR and FACULTY SPONSOR SIGNATURE - The Form A will not be accepted without department chair and faculty sponsor approval - no exceptions can be made. E-mailed pdfs, and faxed copies of the Form A cover page are acceptable.