STATE UNIVERSITY OF NEW YORK AT POTSDAM INSTITUTIONAL REVIEW BOARD Appendix A – Level of Review Request Project # Full Board Review - Research involving more than minimal risk to the participant requires review by the full IRB in a convened meeting. Full-board review covers all research that does not qualify for expedited review or review for certification of exemption. For example, a proposal MUST go through full-board review if any one of the following is true: Identification of the subjects and/or their responses would reasonably place them at risk of criminal or civil liability or be damaging to the subject’s financial standing, employability, insurability, reputation, or be stigmatizing, unless reasonable and appropriate protections will be implemented so that risks related to invasion of privacy and breach of confidentiality are greater than minimal. There is more than minimal risk of emotional distress or physical harm to subjects Subjects are deceived in the research The research is taking place in another country Subjects are members of protected populations such as children (under 18 years of age) or individuals with cognitive impairments Subjects are offered remuneration for participation To submit an application for full-board review, use the application entitled “Application for Permission to Involve Humans Subjects in Research - Expedited or Full Board Review”. Expedited Review – Research that involves no more than minimal risk to the participant AND falls into one of the categories below MAY qualify for expedited review UNLESS participants are deceived, the research takes place in another country, participants are offered remuneration for their participation or participants are members of protected populations, such as children (under 18 years of age). Expedited review categories are outlined in detail in Part IIB – 11(c) of the SUNY Potsdam Policy on the Use of Human Subjects in Research (available on the IRB website). Please check the appropriate box to indicate the category of research into which this project falls. Collection of blood samples by finger stick, heel stick, ear stick or venipuncture (see the SUNY Potsdam Policy on the Use of Human Subjects in Research – Part IIB-11(c)-1 for further guidance). Johanne Sullivan, Chair Raymond Hall 204 Phone 267-2688 SUNYPotsdamIRB@potsdam.edu Rev 1.24.14 STATE UNIVERSITY OF NEW YORK AT POTSDAM INSTITUTIONAL REVIEW BOARD Prospective collection of biological specimens for research purposes by noninvasive means (see the SUNY Potsdam Policy on the Use of Human Subjects in Research – Part IIB-11(c)-2 for further guidance). Collection of data through noninvasive procedures (not involving general anesthesia or sedation) routinely employed in clinical practice, excluding procedures involving x-rays or microwaves. (see the SUNY Potsdam Policy on the Use of Human Subjects in Research – Part IIB-11(c)-3 for further guidance) Research involving materials (data, documents, records, or specimens) that have been collected or will be collected solely for non-research purposes (such as medical treatment or diagnosis). Collection of data from voice, video, digital, or image recordings made for research purposes. Research on individual or group characteristics or behavior or research employing survey, interview, oral history, focus groups, program evaluation, human factors evaluation, or quality assurance methodologies. To submit an application for expedited review, use the application entitled “Application for Permission to Involve Humans Subjects in Research - Expedited or Full Board Review”. Review for Certification of Exemption - Specific categories of research involving no more than minimal risk may be granted exempt status. The eligibility criteria for exemption are outlined in detail in Part III C – 8 of the SUNY Potsdam Policy on the Use of Human Subjects in Research (available on the IRB website). Please check the appropriate box to indicate the category of research eligible for exemption into which this project falls. Research conducted in established or commonly accepted educational settings, involving normal educational practices, such as: (i) research on regular and special education instructional strategies, or (ii) research on the effectiveness of or the comparison among instructional techniques, curricula, or classroom management methods. (Please note that research on classroom management methods in special education will not qualify for exempt certification.) Research involving the use of educational tests (cognitive, diagnostic, aptitude, achievement), survey procedures, interview procedures or observation of public behavior unless: (i) information obtained is recorded in such a manner that human subjects can be identified, directly or through identifiers linked to the subjects; and (ii) any disclosure of the human subjects' responses outside the research could reasonably place the subjects at risk of criminal or civil liability or be damaging to the subjects' financial standing, employability, or reputation. Please note that research using survey, interview or observational procedures with vulnerable populations (including children) is not exempt. Johanne Sullivan, Chair Raymond Hall 204 Phone 267-2688 SUNYPotsdamIRB@potsdam.edu Rev 1.24.14 STATE UNIVERSITY OF NEW YORK AT POTSDAM INSTITUTIONAL REVIEW BOARD Research involving the use of educational tests (cognitive, diagnostic, aptitude, achievement), survey procedures, interview procedures or observation of public behavior that is not exempt under paragraph b above if: (i) the human subjects are elected or appointed public officials or candidates for public office; or (ii) federal statute requires without exception that the confidentiality of the personally identifiable information will be maintained throughout the research and thereafter. Research involving the collection or study of existing data, documents, records, pathological specimens, or diagnostic specimens, if these sources are publicly available or if the information is recorded by the investigator in such a manner that subjects cannot be identified directly or through identifiers linked to the subjects. Research or demonstration projects which are conducted by or subject to the approval of federal department or agency heads and which are designed to study, evaluate, or otherwise examine: (i) public benefit or service programs, (ii) procedures for obtaining services or benefits under those programs; (iii) possible changes in or alternatives to those programs or procedures; or (iv) possible changes in methods or levels of payment for benefits or services under those programs. Taste and food quality evaluation and consumer acceptance studies, (i) if wholesome foods without additives are consumed or (ii) if a food is consumed that contains a food ingredient at or below the level and for a use found to be safe, or agricultural chemical or environmental contaminant at or below the level found to be safe, by the Food and Drug Administration or approved by the Environmental Protection Agency or the Food Safety and Inspection Service of the U.S. Department of Agriculture. Some research falling into these categories may not be eligible for exemption. For a list of factors that make a study ineligible for exemption see Part IIIC of the SUNY Potsdam Policy on the Use of Human Subjects in Research (available on the IRB website) To submit an application for certification of exemption, use the application entitled - “Application for Permission to Involve Human Subjects in Research – Exempt”. Johanne Sullivan, Chair Raymond Hall 204 Phone 267-2688 SUNYPotsdamIRB@potsdam.edu Rev 1.24.14