Resurrection University IRB Form

NEW RESEARCH PROJECT

APPLICATION FOR IRB REVIEW

ALL FORMS MUST BE TYPEWRITTEN AND FULLY COMPLETED!

Submit the required number of copies of this form, the consent form, and the complete protocol for distribution to the IRB no fewer than three weeks prior to the IRB meeting. Materials received fewer than three weeks prior to the meeting will not be reviewed until the next IRB meeting. Incomplete forms will be returned.

PROJECT NUMBER:
PROJECT TITLE:
INVESTIGATOR(S):
PROJECT COORDINATOR:
MAILING ADDRESS:
E-MAIL ADDRESS:
PHONE NUMBER:
FUNDING SOURCE:

I understand that if this project is approved by the Institutional Review Board, I will be required to submit periodic reports.

Principal Investigator: ______

Signature Date

Printed Name of Principal Investigator:

Dean of College: ______

Signature Date

Printed Name of Dean of College:

External Agency Supervisor/Director (if appropriate): ______

SignatureDate

Printed Name of External Agency Supervisor/Director:
PROJECT TITLE:
  1. PROJECT DESCRIPTION:
  1.  NEW PROJECT qualifying for EXEMPTION FROM REVIEW

(Complete the Claim of Exemption Form in addition to this application)

  1. Project will be conducted at the following site(s):
  1. This project involves the use of an INVESTIGATIONAL NEW DRUG (IND) or an APPROVED DRUG FOR AN UNAPPROVED USE.  YES  NO
  1. This project involves the use of an INVESTIGATIONAL MEDICAL DEVICE or an APPROVED MEDICAL DEVICE FOR AN UNAPPROVED USE.  YES  NO
  1. This project involves the use or RADIATION or RADIOISOTOPES.

 YES  NO

  1. HUMAN SUBJECTS from the following population(s) would be involved in this project

 MINORS  PRISONERS COGNITIVELY IMPAIRED

 FETUSES PREGNANT WOMEN NONE OF THE ABOVE

  1. HUMAN SUBJECTS with whom the researcher has another relationship would be involved in this project

 STUDENT PSYCHOTHERAPIST/CLIENT

 PATIENT  PROFESSIONAL/CLIENT

 EMPLOYEE NONE OF THE ABOVE

  1. BIOLOGICAL SAMPLES:
  2. Is a biopsy involved?YES  NO
  3. Is a blood sample involved?YES  NO
  4. If yes, how much? How often?
  5. For what purpose is the above procedure being done?
    DIAGNOSTIC THERAPEUTIC RESEARCH
  6. Are other body fluids or tissues involved?YES  NO
  7. For what purpose is the above procedure being done?

DIAGNOSTIC THERAPEUTIC RESEARCH

PROJECT TITLE:
  1. TOTAL NUMBER OF SUBJECTS TO BE STUDIED:
  1. PROJECT TIMELINE:(Note: Study may not begin prior to receiving IRB approval)
  1. PROJECT ABSTRACT: (Briefly describe (200 words or less) the scientific or investigational focus of the Project)
  1. RISKS: (Describe the risks to subjects and the precautions that will be taken to minimize them. The concept of risk goes beyond physical risk and includes psychological and social risks)
  1. BENEFITS: (Describe the benefits to the subjects or to mankind in general that make the risks acceptable)
  1. ALTERNATE PROCEDURES: (Describe any alternate procedures available to the subject)
  1. FINANCIAL REMUNERATION TO SUBJECTS:
  1. PROTOCOL – Attach the complete proposal and methodology.
  1. CONSENT – Attach one copy of the CONSENT FORM(S) to be signed by the subject, any STATEMENT(S) to be read to the subject, and any INFORMATIONAL LETTER(S) to be directed to the subject.
  1. ATTACHMENTS
  2. Data collection tools and permission to use them (as appropriate)
  3. Principal Investigator and Co-Investigator(s) Certificates of Completion of Computer Based Training offered by the Office of Human Studies Research, NIH.
  4. Principal Investigator and Co-Investigator(s) Conflict of Interest Forms.
  5. Proposal
  6. Consent forms

INSTITUTIONAL REVIEW BOARD

CLAIM OF EXEMPTION FORM

FORM MUST BE TYPEWRITTEN AND FULLY COMPLETED

Note: Survey Research involving vulnerable subjects is not exempt.

PROJECT NUMBER:
PROJECT TITLE:
PRINCIPAL INVESTIGATOR(S):
INVESTIGATOR(S):
PROJECT COORDINATOR:

PROJECT ABSTRACT: (Briefly describe (200 words or less) the scientific or investigational focus of the Project).

Principal Investigator: ______

Signature Date

Printed Principal Investigator’s Name:
PROJECT TITLE:
  1. Will data be collected from individuals through intervention or interaction with individuals?

Yes No 

Will identifiable private information be collected from other sources (e.g. medical records)?

Yes  No 

  1. The exemption categories listed in item “3” do not apply when the research activities include any of the following:

a)prisoners, fetuses, or human in vitro fertilization;

b)the review of medical records if the information is recorded in such a way that subjects can be identified, directly or through identifiers linked to the subjects;

c)survey or interview techniques which include minors as subjects;

d)research involving the observation of the public behavior of minors;

e)techniques which expose the subject to discomfort or harassment beyond levels encountered in daily life;

f)the deception of the subjects.

  1. Research activities are exempt from the federal policy for the Protection of Human Subjects when the ONLY involvement of human subjects falls within one or more of the categories below. Check all of the appropriate categories that apply to your research project:

EXEMPTION #1 of the 45 CFR 46.101.(b):

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.

EXEMPTION #2 of the 45 CFR 46.101.(b):

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 that could reasonably place the subjects at risk of criminal or civil liability or be damaging to the subjects financial standing, employability, or reputation.

PROJECT TITLE:

EXEMPTION #3 of the 45 CFR 46.101.(b):

Research involving the use of educational tests (cognitive, diagnostic, aptitude, achievement), survey procedures, or observation of public behavior that is not exempt under paragraph (b) 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 hereafter.

EXEMPTION #4 of the 45 CFR 46.101.(b):

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.

EXEMPTION #5 of the 45 CFR 46.101.(b):

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: (i) Public benefit or service programs; (ii) procedures for obtaining benefits or services 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.

EXEMPTION #6 of the 45 CFR 46.101.(b):

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.

Investigator: ______

Signature Date

Printed Investigator’s Name:

Principal Investigator: ______

Signature Date

Printed Principal Investigator’s Name:

Revised 5-17-2012; 01-27-17page 1