Research Involving Human Subjects

CARSON-NEWMAN UNIVERSITY

INSTITUTIONAL REVIEW BOARD COMMITTEE

 

REQUEST FOR REVIEW OF PROJECT/THESIS/DISSERTATION RESEARCH INVOLVING HUMAN SUBJECTS

 

1. IDENTIFICATION OF PROJECT/THESIS/DISSERTATION (hereafter called PROJECT)
2. Project principal investigator

Complete Name:

Telephone Number:

Street Address or C-N Box:

City, State, Zip:

Email Address:

(must be official C-N email address [[email protected]])

1. Project co-principal investigator

Complete Name:

Telephone Number:

Street Address or C-N Box            :

City, State, Zip:

Email Address:

1. Chair/Advisor of the Project Committee

Chair/Advisor Name:

Department/Discipline:

1. Committee Members (if applicable):

Committee Members:

1. Project type identification:
2. Title of project:
3. Start date:
4. Estimated completion date:
5. External funding (if any):
6. Grant/contract submission deadline:
7. Funding Agency:
8. Sponsor ID number (if known) :
9. C-N Proposal number (if known):

 

 

1. TYPE OF REVIEW REQUESTED: (select all that apply)
2. ☐Full review (more than minimal risk involved)
3. ☐Short review (minimal risk project)
4. ☐Exemption review (may qualify under federal guidelines for categories of studies exempt from coverage)
5. ☐Investigational Drug: Brochure available?  Yes ☐  No ☐
6. ☐Re-Evaluation (the study has been temporarily inactive)

 

 

 

III.           DESCRIPTION AND SOURCE OF RESEARCH PARTICIPANTS

1. Human subjects (select all that apply)

☐Inpatients     ☐Volunteers   ☐Pregnant Women

☐Outpatients  ☐Fetuses         ☐Mentally Incompetent

☐Minors         ☐Prisoners      ☐Elderly Population

1. Compensation to Human Subjects: Click here to enter text.
2. Type of Project/Procedure to be used (please select the most applicable):
3. ☐ Medical-Therapeutic (evaluation of drugs, treatment

protocol, surgical procedure, etc):

2. ☐ Medical-Non-Therapeutic (physiological studies,

Laboratory analysis of blood or body substance):

3. ☐ Investigation drug (drug study protocol):
4. ☐ Radioactive materials:

Name:

Subcommittee on radioactive materials approval date:

5. ☐ Psychosocial-Manipulative (response to stressful stimuli,

hypnosis, etc.)

6. ☐ Psychosocial-Non-Manipulative (evaluation of subject

Response to educational material, attitude, survey, etc.)

7. ☐ Study involving confidential material without human

participation (chart review, etc.)

8. ☐ Other (please specify):
9. Source of subjects/participants:
10. Number of estimated participants:
11. Relationship between researcher/participant:

 

 

1. METHODS AND PROCEDURES:

Clearly and concisely describe in non-technical language the data collection and experimental research methods used in this project.  This section should be consistent in every detail with the descriptions provided to participants in the consent form or procedure.  Include non-technical descriptions of stresses to participants, experimental manipulations, tests or measures, surveys, interviews, observations, photography, video, and audio recordings.  Clearly distinguish between control and experimental/treatment participant groups.

 

 

Click here to enter text.

 

 

1. SPECIFIC RISKS/PROTECTION MEASURES:

Specify all potential risk to participants.  Estimate the nature and amount of potential risk, stress, or discomfort and assess its seriousness.  Describe precautions you will take to reduce risk and assess the effectiveness of these protective measures.  If appropriate, include a description of the means you will use to assist or treat participants who may incur injury from one or more of the risks identified in this section.  Permit sufficient detail to permit reviewers, who may not be familiar with your area of study, to evaluate any specific risk to the participants of this research.

 

Include methods and provisions by which you will address the issue of anonymity of confidentiality of data.  Note that anonymity (protecting the identity of the subject/participant) is only possible if the investigator cannot discover the participant’s identity from data collected.  In either case, describe how you will maintain the confidentiality of the participant’s data.  Identify any security measures you have for protecting the data and identify to whom access is given.  If thesis committee members or others will review or help with analysis of data, address the steps that you will take to ensure subject’s anonymity and confidentiality.

 

 

Click here to enter text.

 

 

VI        BENEFITS:

Evaluate the reasonableness of the risk stated in section II in relation to the anticipated benefits, if any, to the participants and/or society.  If the risks are minimal, please state that the risks are minimal and include a statement of anticipated benefits.

 

Note that in most research projects, the only relevant benefits are those that contribute to generalizable knowledge in a field of research.  In these cases, participant benefits are incidental.  Please do not inflate the significance of incidental benefits in this form or in your informed consent procedures.

 

Payment for participation in research, if any, is an incentive for participation and should be included in this section.

 

 

 

 

 

VII      METHODS FOR OBTAINING “INFORMED CONSENT” FROM         PARTICIPANTS:

Please state the methods you will use to legally obtain effective informed consent, assent, or permission from participants or their legally authorized representatives.  Clearly describe how you will seek consent from participants in a manner that allows them sufficient opportunity to consider participation and that minimizes the possibility of coercion or undue influence.  Indicate that the language used in your informed consent procedure is understandable to your participants or their legally authorized representatives.  Attach a copy of your informed consent document as an appendix to the completed IRB.

 

 

 

 

 

VIII     RESPONSIBILITY OF THE PRINCIPAL/CO-PRINCIPAL

You must enter the following information verbatim in Section VIII.

 

By compliance with the policies established by the IRB Committee, the principal investigator(s) subscribe to the principles stated in “The Belmont Report” and standards of professional ethics in all research, development, and related activities involving human participants under the auspices of Carson-Newman College.  The principal investigator(s) further agree that:

 

1. Approval will be obtained from the IRB Committee prior to instituting any change in this research project.
2. Development of any unexpected risk will be immediately reported to the IRB Committee.
3. An annual review and progress report will be completed and submitted when requested by the IRB Committee.
4. Signed informed consent documents will be kept for the duration of the project and for at least three years thereafter at a location approved by the IRB Committee.

 

 

1. SIGNATURES – must be on a separate page; provide two (2) copies: one (1) electronically submitted with full request and one (1) original paper copy sent to university IRB committee chair

 

When you submit this application for review please note that all signatures must be original.  As your application moves through the review process, you should prepare two identical applications, both of which contain original signatures.  As primary investigator, you should keep one copy and submit the other application with original signatures for review.

 

Project Principal Investigator: Click here to enter text.:

 

Signature:                                                                                                                  

 (Date)

 

Project Co-Principal Investigator: Click here to enter text.:

 

Signature:                                                                                                                  

 (Date)

 

Project Committee Chair: Click here to enter text.

 

Signature:                                                                                                                  

 

 (Date)

PROGRAM/DEPARTMENTAL REVIEW AND APPROVAL

NOTE:  This is needed if the program or department requires a review.

 

I have read and reviewed this research application and recommend its approval.

 

Director/Chair/Research Committee Chair:  Click here to enter text.

 

Signature:                                                                                                                  

 

 (Date)

UNIVERSITY IRB COMMITTEE REVIEW AND APPROVAL

 

The IRB Committee has read and reviewed this application for research and approves the application.

 

IRB Committee Chair:  Gregory A. Casalenuovo, PhD

 

Signature:                                                                                                                  

 (Date)

 

Approved:  April, 2010; Revised:  August, 2015; Reviewed: August 2019

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