Tips for Filling out your Application for
Nonmedical Human Subjects Research

First and foremost DON'T PANIC. Read all instructions applicable to your research prior to writing your protocol and take your time. Try to be clear and concise. 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. Be sure to watch for...

PANEL COMMENTS - IRB staff may contact you to obtain further information or to inform you of IRB questions/comments that require a written response. List where you can be contacted by electronic mail, phone, or fax. Please check your e-mail daily for IRB comments during the month your protocol is being reviewed. Approval of your project may be deferred if responses to comments are not received by the date specified.

PROTOCOL FORMAT - Your protocol should be written for the layperson. The IRB members represent a variety of disciplines. This means that some reviewers will not be as familiar with your field as you are.

PROTOCOL SUMMARY - Your protocol summary should be a thumbnail sketch of your purpose and procedures, and should be written for the layperson. Imagine that you are at a party, and 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 can come back to a section later by saving it. 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:

• Location:
  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?
• Duration:
  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 each session?
• Procedures:
  What are you going to do? Interviews? Surveys? Observations? Participant observations? Experiments? Describe your procedures in as much detail as possible. For experiments, provide a script of the instructions to be given to subjects.
• Rationale:
  Do any of your procedures present risk to subjects? If so, explain why you need to do them.

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.

Note that when it comes to children, difficulty obtaining parental consent is not necessarily a sufficient rationale for exclusion. If you believe the project presents no more than minimal risk to children, you may wish to request a waiver of parental consent. (For more information, see CONSENT PROCEDURES below.)

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.

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. If you are conducting research overseas and you have lived there previously, have friends/relatives living there, or there are other reasons that you feel increase your knowledge of the area, please specify this.

BENEFITS - Be realistic. Do not invent things, but try to design your procedures so that there is some potential benefit for your subjects.

COPIES OF QUESTIONNAIRES AND/OR INTERVIEW QUESTIONS - Samples should be representative of the topics you plan to cover. Copies should be provided for IRB review even if you are using "standard" instruments. These can be attached in the Attachments section of the protocol application.

CONSENT PROCEDURES - If you are obtaining consent from more than one population, for example, students and parents, submit a consent form labeled for each population. Be sure to attach your consent form(s) in the consent section and you assent form(s) in the assent section of the protocol application. If you are planning to obtain consent orally, be sure to choose alteration as your consent type and to answer each of the questions for the alteration, not just respond "yes" to each. You will also need to attach your oral consent script for IRB review.

TRANSLATION PROCEDURES - When research is being conducted in a language other than English, it is important that consent forms be translated accurately. Procedures for ensuring accurate translation should be described in detail. The IRB recommends the use of back-translation:

Back-Translation:

Consent form written in English (A) -> translation to subjects' language (B) -> translation back into English (C) BY SOMEONE UNFAMILIAR WITH THE ORIGINAL (A).

Compare (C) to (A) for accuracy.

WAITING FOR APPROVAL - You may not begin your project until you have been notified of the IRB's approval. The IRB process takes a minimum of one month for a new protocol submission, so please allow time for IRB to review and approve your protocol before you begin your research. Under no circumstances should you interpret a lack of communication from the IRB as an approval. You can view the current status of your protocol in your Home Page of the eProtocol system. You can also contact the IRB Manager if you have questions, at (650) 723-2480 or at Lauri.Kanerva@Stanford.edu.

URO APPLICANTS - If fieldwork is planned for Winter or Spring break, please review the submission deadlines to ensure that the IRB will have adequate time to review your application before your departure. No late protocols will be accepted. See the schedule of meeting dates and submission deadlines.

FACULTY SPONSOR SIGNATURE - Protocols will not be accepted without faculty sponsor approval -- no exceptions can be made. Faculty sponsor approvals should be sent to the IRB Manager for nonmedical human subjects research at Lauri.Kanerva@Stanford.edu.
Faculty sponsor approvals received by fax or voicemeail are not acceptable.