Institutional Review Board
For Human Subjects Research

FORM A: APPLICATION FOR USE OF HUMAN SUBJECTS IN RESEARCH

Underline, circle, or highlight the most appropriate answer for each question. DO NOT LEAVE ANY QUESTIONS UNANSWERED. If items are unanswered, your IRB will be automatically returned to you for completion.

DATE:
INVESTIGATOR (S):
Research Faculty SPONSOR†:
ACADEMIC DEPT./DIVISION:
PROJECT TITLE:
FUNDING AGENCY:(If applicable)

Investigators MUST complete all questions below before submitting to the IRB Compliance Coordinator. Please circle, check or darkly mark answers.

  1. The investigator(s) request the following type of review:
/ EXEMPT / EXPEDITED / FULL
  1. Will human subjects be participating in:

  1. biomedical procedures?
/ YES / NO
  1. procedures to elicit information (personality tests, questionnaires, inventories, surveys, observations, etc.)?
/ YES / NO
  1. procedures specifically designed to directly modify the knowledge, thinking, attitudes, feelings, or other aspects of the behavior of subjects?
/ YES / NO
  1. If biomedical procedures are involved:

  1. are provisions for emergency medical care necessary?
    (ifYES, give details on Form B of the protocol)
/ YES / NO / N/A
  1. has a qualified MD participated in planning the project?
/ YES / NO / N/A
  1. will this study involve drugs or chemical agents (dosages), ionizing radiation, nonionizing radiation (microwaves, lasers), or high intensity sound?
/ YES / NO / N/A
  1. Does this study involve giving false or misleading information to subjects or withholding information from them such that their "informed consent" is in question?
/ YES / NO / N/A
  1. Are procedures to be used new or innovative (not established and accepted)?
/ YES / NO / N/A
  1. Will the procedures:

  1. cause any degree of discomfort, harassment, invasion of privacy, risk of physical injury, or threat to the dignity of subjects, or be otherwise potentially harmful to subjects?
/ YES / NO
  1. if answer to 6a is YES, have specific provisions been made to correct any harmful or adverse conditions that may arise? (Give details in the Form B protocol)
/ YES / NO / N/A
  1. Can the potential benefits to subjects from the conduct of this study be considered to outweigh the risks to subjects?
/ YES / NO
  1. Can the potential benefits to society from the conduct of this study be considered to outweigh the risks to subjects?
/ YES / NO
  1. Will subjects come in direct contact with any type of electrically powered equipment? (If the answer is YES, give in the Form B protocol the name and qualifications of the individual who will check for electrical safety and attach a signed letter from that person which indicates his/her level of involvement with the project.)
/ YES / NO
  1. Will subjects receive any payment for participating (money, course credit, etc.)? (If answer is YES, give details in Form B protocol.)
/ YES / NO
  1. Is the project specifically designed to involve subjects who are:

  1. minors (less than 18 years of age)?
/ YES / NO
  1. pregnant women?
/ YES / NO
  1. prisoners?
/ YES / NO
  1. mentally handicap?
/ YES / NO
  1. mentally disabled (e.g., brain-injured, psychiatric patients, etc.)?
/ YES / NO
  1. physically disabled (e.g., uses wheelchair, walker, etc.)?
/ YES / NO
  1. institutionalized?
/ YES / NO
  1. Shenandoah University students?
/ YES / NO
  1. Do procedures include obtaining parental/guardian consent and/or institutional authorization for access to subjects if minor, mentally retarded/disabled, or institutionalized subjects are involved?
/ YES / NO
  1. Are procedures for maintaining confidentiality of all subjects' data fully described?
/ YES / NO
  1. Are procedures for obtaining informed consent fully described?
/ YES / NO
  1. Will a copy of the informed consent document and explanation of the study be provided to each subject?
/ YES / NO
  1. Have copies of informed consent documentation been submitted along with the protocol (i.e., signature document with explanation of study, transmittal letter, debriefing statement, or other)?
/ YES / NO
  1. Will any non-Shenandoah University site(s) be included in data collection?
/ YES / NO
  1. Fill in the estimates:

  1. Average amount of time required for each subject's participation
    (in hours or minutes):

  1. If questionnaires or tests are involved, the total number of items/questions involved:

  1. Number of volunteers (subjects) to be involved in this study:

  1. Human research time frame:

  1. Beginning date of research involvement (pending IRB approval):

  1. Ending date of research involvement:

*******************************************************************************************

We certify that the project or activity described in the attached information was planned to adhere to the University's policies and the institutional assurance with the US Department of HHS regarding the use of human subjects. University review and approval is requested. Major additions to or changes in procedures involving human subjects that occur after review of the application will be brought to the attention of the review committee by the investigator. In addition, the committee will be notified of any unanticipated events that do or could affect the safety and well being of subjects.

Principal Investigator's Name / †SU Faculty Sponsor's Name / SU Division/Unit Chair's Name
Address / Address / Address
Phone / Phone / Phone
Email / Email / Email
Signature / Signature / Signature

†Student projects must be supervised/sponsored by a Shenandoah University faculty member. Although non-Shenandoah University investigators may be involved in a project in any capacity, all projects must be sponsored by a Shenandoah faculty member who is ultimately responsible for the safe conduct of the study.

To avoid delays, do not leave any items blank on forms and make sure to provide all copies of information needed to complete the review process, as well as ALL requested signatures.

Submit completed electronic forms to . Paper (hard) copies of requested items should be sent to the SU Compliance Coordinator, c/o Office of Academic Affairs, 1460 University Drive, Winchester, VA 22601.

Shenandoah University IRBPage 1 of 3

Revised: July 2013