Application Checklist

Social Behavioral Application Instructions and Checklist

Regulations: Title 45 Code of Federal Regulations Part 46 (45 CFR 46) Protection of Human Subjects specifies federal regulations for the conduct of research involving human subjects. All human subjects research at Arizona State University must be conducted in accordance with 45CFR46. The regulations are available at http: //www. hhs. gov/ohrp/humansubjects/guidance/45cfr46. htm Completing the Application: Applications that require Full Board review must be submitted at least 12 business days (2. 5 weeks) prior to the next IRB meeting. All applications should be in type-written form and written in non-technical terms. It is the investigator's responsibility to provide information about research procedures so that the IRB has a clear understanding of what the research entails. Researchers should keep in mind that the individuals reviewing the application may be unfamiliar with the field of study involved. If possible, please place your typewritten response directly under each question. This is preferable to using a separate sheet during the review process. It is important that you answer every question to ensure that all of the necessary information is included in your application. Do not leave items blank in the application, or fail to provide to the IRB any poster, document, or other written communication to subjects. In addition to submitting an IRB application, researchers should submit any supporting material that will assist the IRB's review. Approval: Data collection may not begin until researchers have received approval to conduct the research. At the same time, research shall not continue beyond the date stated on the approval letter. Research projects involving human subjects can be approved for up to one year in accordance with Federal Regulations. A study is considered complete when data collection and data analysis are complete.

Application Checklist

This page is provided to assist you with completion of your application. Do not include this page with your application. This page is to be used as a guide for researchers. Be sure your completed application includes the following:

	Title page with the contact information for all investigators. This information will serve as the official roster of investigators for your protocol.
	Complete application form.
	A brief description of the purpose, background, and methodological design of the study.
	A description of the setting or location(s) of where the research will be conducted. If applicable, attach letters of support or agreement showing permission to conduct research at this location.
	An estimate of how the amount of time that will be requested of each participant.
	A description of any potential financial or professional interest by a funding source in the outcome of the research.
	A description of any potential benefits to participants for participating in this research (including incentives of any type).
	A description of inclusion and exclusion criteria in selecting participants.
	A description of steps that will be taken should a participant become upset or distressed as a result of their participation in this study, if applicable. Provide a list of community agencies or counseling services that will be used as referral sources, if applicable.
	A description of instances in which participant confidentiality would be broken.
	Grant proposal, research proposal, or prospectus. The entire proposal should be included when you are seeking or have obtained funding from an external sponsor.
	Copies of advertisements, recruitment letter(s), telephone scripts, instructions to participants. Recruitment cannot begin until the study has been reviewed and approved by the IRB.
	Forms that will be used to document informed consent and assent (e. g., written consent form, written assent, cover letter). Required unless a waiver of written consent is being requested.
	Debriefing script when applicable. Required when deception is used.
	Copies of surveys, instruments or measures, questionnaires, interview schedules, focus group questions, screening instruments, and/or other materials used to collect data.
	Certification of backtranslation for any materials that were translated into a language other than English as well as copies of materials in that language. (
	CV/Biosketch for PI
	Copy of Human subjects training for all investigators and co-investigators (http: //researchintegrity. asu. edu/irb/training/)

Please submit one complete application packet to the address below. You can submit your application via hard copy (drop-off or mailed). See the checklist above for a list of materials that should be included in your application. Office of Research Integrity and Assurance Arizona State University PO Box 871103 (campus mail code 1103) Tempe, Arizona 85287-1103 Fax: 480-965-7772