INSTITUTIONAL REVIEW BOARD

APPLICATION FOR APPROVAL OF INVESTIGATION

INVOLVING THE USE OF HUMAN PARTICIPANTS

(Please submit 2 copies to the Chairperson of the IRB)

MUST BE TYPED

PART I

  1. Principal Investigator’s Name:

Department/Campus Address:

Campus Phone: Home or Cell Phone:

University email: ______

2. If you are a student, provide the following:

Faculty Sponsor: Extension:

3. Title of Project:

4. Total project period: From: to:

  1. This is: ( ) a new project ( ) an annual renewal
  2. Has this project been previously considered by the Institutional Review Board?

Yes No

If yes, give approximate date of review:

  1. Check all that apply:

( ) a specific project ( ) a grant proposal ( ) a protocol change

( ) administration ( ) faculty ( ) staff

( ) graduate student ( ) undergraduate ( ) for educational purposes only*

  1. Has the principal investigator (and faculty sponsor, if the PI is a student researcher) completed the Collaborative Institutional Training Initiative (CITI) online training program for social and behavioral researchers or for biomedical researchers? Yes No
  1. Is a proposal for external support being submitted? Yes No

If yes, you must submit one complete copy of that proposal as soon as it is available and complete the following:

a. Is notification of IRB approval required? Yes No

b. Is this a renewal application? ______Yes ______No

  1. Funding source (if applicable)
  2. Type of review requested –

There are three types of review: Exempt, Expedited, and Full Board. If research does not meet the criteria for Exempt or Expedited Review, then the investigation must undergo Full Board review. The criteria for Exempt and Expedited review are listed in the appendix of this document. Description of research types that qualify for either Exempt or Expedited review are described below. You must list the appropriate research category from the list.Any research that is not exempt or expedited requires Full Board review, unless the research is conducted for educational purposes only.

Investigator’s recommendation:(Indicate 1 review type only)

( ) Exempt Exempt category number from Appendix ______

( ) Expedited Expedited category number from Appendix ______

( ) Full Board

( ) Study Conducted for Educational Purposes Only*

*Students involved in research primarily for educational or instructional purposes (and not designed to contribute to generalized knowledge) should submit their responses and supporting documentation to their class instructor rather than the IRB chair. If the instructor assumes ethical and professional responsibility for the research projects in the class, IRB review is not necessary. If the instructor does not assume ethical and professional responsibilities, then each student must submit the APPLICATION and supporting documentation to the chairperson of the IRB.

PART II

Description of Research Study

Instructions: Faculty and student researchers using human participants must respond to all of the items below. Faculty involved in research should submit their responses to the chairperson of the Institutional Review Board. In addition, attach copies of instructions to participants, informed consent forms, questionnaires, measures, scoring criteria, and other supporting documentationto this application.

NO RESEARCH USING HUMAN PARTICIPANTS MAY BE CONDUCTED UNTIL THE APPLICATION IS APPROVED.

  1. PURPOSE OF RESEARCH: Please describe the purpose of the proposed research.
  1. What is the goal of the research? What research questions are you trying to answer?
  1. How will you use the results of the research?
  1. Briefly describe the proposed research (include major hypotheses and research design):
  1. IDENTIFICATION AND RECRUITMENT OF PARTICIPANTS: Describe the participants in the proposed research.
  1. Describe how you will obtain or recruit participants in the research.
  2. Who will recruit participants?
  3. Where will your participants come from?
  4. How will you solicit or contact potential participants? (e.g., face-to-face, flyers, emails, in-class recruitment, advertisements)
  1. What selection criteria will you use to select specific participants? Please describe the expected number of participants and their personal characteristics, such as gender, age ranges, ethnicities, and any other characteristics relevant to the purposes of the study.
  1. Will the participants be minors or from “vulnerable populations” (e.g., children, prisoners, mentally or physically infirm, pregnant women)? If so, what special protective procedures will be employed?
  1. What inducements will be given to participants to participate?
  1. RESEARCH PROCEDURES:
  1. Provide a step-by-step description of what your participant will do. Describe each procedure in sequence, including the frequency, duration and location of each procedure.
  1. INSTRUCTIONS: What instructions will be given to the participants?Attach a copy of your instructions and scripts).
  1. DATA COLLECTION:
  1. What data collection methods or tools will you use? For example, will you use questionnaires/surveys (Attach a copy), observations, interviews (Attach instructions and scripts), focus groups (Attach instructions and scripts), reviewing educational or medical records, recording video and/or audio, photographing, using biomedical procedures?
  1. Are the data to be collected related to illegal activities? If yes, explain.
  1. Is deception involved? If yes, did you consider other, non-deceptive methods of data collection? Explain why the research requires use of deception.
  1. Will all parties involved in the data collection complete CITI training prior to collecting data?
  1. INFORMED CONSENT: Explain in detail how informed consent will be obtained.
  1. How will informed consent be obtained?
  2. Attach a copy of your informed consent form.
  1. COMPENSATION: Describe any compensation (e.g., gift certificates, monetary payments, raffle entry, class credit) that will be provided to participants.
  2. PARTICIPANT PRIVACY: Describe how you will protect the participants’ privacy during data collection.
  1. CONFIDENTIALITY OF DATA: Describe how you will protect the confidentiality of the participants’ data after data collection.
  1. How will you protect the identities of participants?
  1. In what format will data be stored (e.g., paper or electronic format?)
  1. Where will the data be stored? (e.g., on a password-protected computer, in a locked file cabinet, data is de-identified or identities coded,)
  1. Who will have access to the data?
  1. RISKS AND BENEFITS: Please explain any possible risks of mental, legal, physical, or social harm or inconveniences to the participants.
  1. What are the risks or inconveniences to the participants? Examples include physical or emotional stress or discomfort, loss of privacy or confidentiality, loss of time,
  1. Do the risks exceed what would occur in everyday life?
  1. Howprobable are these risks?
  1. What steps will be taken to minimize or ameliorate the impact of these risks for participants?
  1. How will you identify and handle the risks?
  1. Describe your plans for an emergency, even if you believe that it is unlikely to occur. (e.g., cell phone access, notifying campus security, refer to Wellness Center)
  1. What provisions have beenmade to insure that appropriate facilities and professional attention necessary for the health and safety of theparticipants are available and will be utilized?
  1. What are the potential direct benefits of this research to the participants?
  1. What are the other potential indirect or broader benefits of this research? (i.e., To the body of research? To the researchers? To Stevenson University? Tothe community?)
  1. Please justify why you think the potential benefits of this research activity, in general, outweigh any possible or probable risks.

Additions to or changes in procedures involving human subjects as well as any problems connected with the use of human subjects once the project has begun must be brought to the attention of the Institutional Review Board.

I understand that it is my responsibility to ensure that the rights and welfare of the human subjects are properly protected. I understand that I cannot initiate any contact with human subjects before I have received approval and/or complied with all contingencies made in connection with that approval. I agreeto make myself familiar with and to abide by 45 CFR 46.116. I have read the Stevenson University Institutional Review Board’s policy on use of human participant and agree to abide by it.

I affirm the accuracy of this application, and I accept the responsibility for the conduct of this research and the protection of human subjects as required by law.

Date

Signature of Principal Investigator (PI)

Date

IF PI is student, Signature of Faculty Advisor

Other Investigators:

Checklist of attachments (Select all that apply):

( ) Informed Consent Document

( ) Instructions

( ) Questionnaire/Surveys

( ) Scripts

( ) Experimental Stimuli

( ) Other: ______

Please submit the completed application, together with copies of all pertinent attachments to the chairperson of the Institutional Review Board.

IRB Chair recommendation:

( ) Exempt from IRB Review ( ) Expedited Review ( ) Full Board Review

Final recommendation:

( ) Exempt* ( ) Approved with conditions ( ) Approved ( ) Not approved

*indicate the number of the exemption category:

Federal-Wide Assurance Number______Expiration Date: ______

Date

Signature of Chairperson (or Designee) Stevenson University IRB

IRB Application Appendix

Exempt research categories:

  1. Research conducted in established or commonly accepted educational settings, involving normal educational practices, such as
  2. research on regular and special education instructional strategies, or
  3. research on the effectiveness of or the comparison among instructional techniques, curricula, or classroom management methods.
  4. Research involving the use of educational tests (cognitive, diagnostic, aptitude, achievement), survey procedures, interview procedures or observation of public behavior, unless:
  5. information obtained is recorded in such a manner that human subjects can be identified, directly or through identifiers linked to the subjects; and
  6. 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.
  7. 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)(2) of this section, if: (i) the human subjects are elected or appointed public officials or candidates for public office; or (ii) federal statute(s) require(s) without exception that the confidentiality of the personally identifiable information will be maintained throughout the research and thereafter.
  8. 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.
  9. Research and demonstration projects which are conducted by or subject to the approval of department or agency heads, and which are designed to study, evaluate, or otherwise examine:
  10. Public benefit or service programs;
  11. procedures for obtaining benefits or services under those programs;
  12. possible changes in or alternatives to those programs or procedures; or
  13. possible changes in methods or levels of payment for benefits or services under those programs.
  14. Taste and food quality evaluation and consumer acceptance studies,
  15. if wholesome foods without additives are consumed or
  16. 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.

Expedited research categories:

  1. Clinical studies of drugs and medical devices only when condition (a) or (b) is met.
  2. (a) Research on drugs for which an investigational new drug application (21 CFR Part 312) is not required. (Note: Research on marketed drugs that significantly increases the risks or decreases the acceptability of the risks associated with the use of the product is not eligible for expedited review.)
  3. Research on medical devices for which (i) an investigational device exemption application (21 CFR Part 812) is not required; or (ii) the medical device is cleared/approved for marketing and the medical device is being used in accordance with its cleared/approved labeling.
  4. Collection of blood samples by finger stick, heel stick, ear stick, or venipuncture as follows:
  5. (a) from healthy, non-pregnant adults who weigh at least 110 pounds. For these subjects, the amounts drawn may not exceed 550 ml in an 8 week period and collection may not occur more frequently than 2 times per week; or
  6. from other adults and children2, considering the age, weight, and health of the subjects, the collection procedure, the amount of blood to be collected, and the frequency with which it will be collected. For these subjects, the amount drawn may not exceed the lesser of 50 ml or 3 ml per kg in an 8 week period and collection may not occur more frequently than 2 times per week.
  7. Prospective collection of biological specimens for research purposes by noninvasive means.
    Examples: (a) hair and nail clippings in a non-disfiguring manner; (b) deciduous teeth at time of exfoliation or if routine patient care indicates a need for extraction; (c)permanent teeth if routine patient care indicates a need for extraction; (d) excreta and external secretions (including sweat); (e) uncannulated saliva collected either in an unstimulated fashion or stimulated by chewing gumbase or wax or by applying a dilute citric solution to the tongue; (f) placenta removed at delivery; (g) amniotic fluid obtained at the time of rupture of the membrane prior to or during labor; (h) supra- and subgingival dental plaque and calculus, provided the collection procedure is not more invasive than routine prophylactic scaling of the teeth and the process is accomplished in accordance with accepted prophylactic techniques; (i) mucosal and skin cells collected by buccal scraping or swab, skin swab, or mouth washings; (j) sputum collected after saline mist nebulization.
  8. Collection of data through noninvasive procedures (not involving general anesthesia or sedation) routinely employed in clinical practice, excluding procedures involving x-rays or microwaves. Where medical devices are employed, they must be cleared/approved for marketing. (Studies intended to evaluate the safety and effectiveness of the medical device are not generally eligible for expedited review, including studies of cleared medical devices for new indications.)
    Examples: (a) physical sensors that are applied either to the surface of the body or at a distance and do not involve input of significant amounts of energy into the subject or an invasion of the subject=s privacy; (b) weighing or testing sensory acuity; (c) magnetic resonance imaging; (d) electrocardiography, electroencephalography, thermography, detection of naturally occurring radioactivity, electroretinography, ultrasound, diagnostic infrared imaging, doppler blood flow, and echocardiography; (e) moderate exercise, muscular strength testing, body composition assessment, and flexibility testing where appropriate given the age, weight, and health of the individual.
  9. Research involving materials (data, documents, records, or specimens) that have been collected, or will be collected solely for nonresearch purposes (such as medical treatment or diagnosis). (NOTE: Some research in this category may be exempt from the HHS regulations for the protection of human subjects. 45 CFR 46.101(b)(4). This listing refers only to research that is not exempt.)
  10. Collection of data from voice, video, digital, or image recordings made for research purposes.
  11. Research on individual or group characteristics or behavior (including, but not limited to, research on perception, cognition, motivation, identity, language, communication, cultural beliefs or practices, and social behavior) or research employing survey, interview, oral history, focus group, program evaluation, human factors evaluation, or quality assurance methodologies. (NOTE: Some research in this category may be exempt from the HHS regulations for the protection of human subjects. 45 CFR 46.101(b)(2) and (b)(3). This listing refers only to research that is not exempt.)
  12. Continuing review of research previously approved by the convened IRB as follows:
  13. where (i) the research is permanently closed to the enrollment of new subjects; (ii) all subjects have completed all research-related interventions; and (iii) the research remains active only for long-term follow-up of subjects; or
  14. where no subjects have been enrolled and no additional risks have been identified; or
  15. where the remaining research activities are limited to data analysis.

9. Continuing review of research, not conducted under an investigational new drug application or investigational device exemption where

categories two (2) through eight (8) do not apply but the IRB has determined and documented at a convened meeting that the research involves

no greater than minimal risk and no additional risks have been identified.

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Rev. 5/19/2014