North Carolina Agricultural and Technical State UniversityProtocol Number:

Institutional Review Board Protocol ApplicationApproval Date:

Completing the Application Packet for an IRB Protocol

IRB Application/Protocol:

Save and upload the application and supporting forms for processing.

1.Provide accurate contact information in case clarifications are needed.

2.Contact the Office of Research Compliance and Ethics at for a username and password to the uploading website. Provide your department and email address.

3.Upload your IRB application and supporting materials in original format (no PDFs, please). Go to and upload your application, consent forms, recruitment scripts, email text, surveys, flyers, etc. Instructions on how to upload are included at the end of this document.

4. Sign the signature page and obtain department chair or director’s signature. If applicable, obtain advisor’s signature.

5. Submit the signature pageseither by scanning and uploading to the IRB Uploads site or by mailing them via campus mail to Fort IRC Room 420.

6. Problems uploading? Contact IRB staff at 336-285-2961.

Informed Consent:

You must provide informed consent.

1.Use one of the informed consent templates found on our website. Choose the one most appropriate for your study (survey, focus group, etc).If your study is anonymous and does not involve children,you may use theconsent information sheet. If you are audio or video recording your participants, you must use thestandard consent form templateand obtain signatures.

2.If children will be involved, you must obtain parental permission. If your research involves children ages 7 and up, you must also obtain child assent. There are templates for both of these on our website.

3.All consent forms must be written at the reading level of the potential participants.

Human Subjects Research Training:

The IRB will verify completion of this required training before releasing approval.

  1. The Principal Investigator and all research staff having direct contact with human subjects or their identifiable data must have human subject protections certification. Register as a new user if you have never used this site for IRB testing.
  2. Forthe learner group, choose social behavioral researcher investigators and key personnel.
  3. When asked if you have taken the basic course, choose N/A.

Project Materials (Surveys, Flyers, Letters of Approval):

  1. Advertisements/ Flyers must be approved by the IRB (see Forms section on website).
  2. Provide copies of IRB approval for projects that involve collaboration with off-campus researchers (from other universities, local school systems, etc).

Advisors

  1. There must be a biosketch for advisors on file in the Compliance Office.
  2. Advisors must complete and submit CITI training with student applications.

Questions? Contact us!

Office of Research Compliance and Ethics

Fort IRC Building,Room 427

336 285-2961
Please answer all questions.

Research Study Title:
Principal Investigator:
Status: / Undergraduate Student
Masters Student / Faculty/Staff
Ph.D. Candidate
Affiliated with NC A&T? / Yes
No (N.C. A&T Sponsor Required)
Banner ID #
(students only)
Home or Mobile Telephone:
Email Address:
Academic Department:
Faculty Advisor(s):
Campus Mailing Address:
Work Telephone:
Email Address:
Faculty Advisor’s
Academic Department:
Study Sponsor: / Internal
External Other
External Commercial / Federal
None
Current or Planned Funding Sources:
P.I. of Grant:
Name of Funding Source:
Grant Proposal Number:
Grant or Project Title:
Other:
Research Summary
  1. Application for:
/ Thesis/ Dissertation
Classroom Project
Faculty Research
  1. Study Beginning and Ending Date:
(Beginning date must be after IRB approval.)
  1. Purpose of Your Research:

  1. Background Information:
(Problem statement, significance of problem)
  1. Research Questions/Hypotheses:

  1. Research Design and Methods:(Study procedures; sequential description of study procedures; include how data will be analyzed)

  1. Research Content Area:
/ Biological Sciences
Behavioral Science
Medical
Physiology
Other: / Education
English
History
Journalism
  1. Does your proposed study involve deception of any kind?
If yes, please explain the following:
A. The nature of the deception,
B. Your rationale for using it, and
C. How you will debrief participants. / No
Yes
A.
B.
C.
  1. Data Collection will involve the use of which of the following?
(Select all that apply.) / Educational Test (cognitive, diagnostic, aptitude)
Surveys / Questionnaires
Private Records / Files
Interview Observation
Online Database
Audio Recording Video Recording
Physical/ Physiologic Measurements or Specimens
Instrument(s)
Submit a copy of instruments separately.
Do not add actual questions to this section.
Note: “See Attached” will not be accepted. You must list each instrument.
Number of Instruments
for This Study:
  1. Instrument Title:

  1. Source of the Instrument:
/ PI Developed
Publicly Available
Purchased (Proof of Purchase Attached)
By Permission (Letter or Email Attached)
  1. Description of the Instrument:
(type of questions, likert scale, etc)
  1. Instrument Title:

  1. Source ofthe Instrument:
/ PI Developed
Publicly Available
Purchased (Proof of Purchase Attached)
By Permission (Letter or Email Attached)
  1. Description of the Instrument:
(type of questions, likert scale, etc)
  1. Instrument Title:

  1. Source of the Instrument:
/ PI Developed
Publicly Available
Purchased (Proof of Purchase Attached)
By Permission (Letter or Email Attached)
  1. Description of the Instrument:
(type of questions, likert scale, etc)

If you have more than three instruments, please see our website for an additional page.

Page 1 of 18

North Carolina Agricultural and Technical State UniversityProtocol Number:

Institutional Review Board Protocol ApplicationApproval Date:

Participant Characteristics and Sampling Techniques
  1. Number of Participants
/ Male / Female / Both
  1. Age Range

  1. Location and Relationship
/ Number of Sites / Does the researcher have a relationship to participants?
If yes, click the appropriate box/boxes below and explain the relationship in the space provided.
Location
List all areas where data collection will take place.
Business/Organization
Daycare/Preschool
Elementary/secondaryschool
In-patient hospital or clinic
Internet-based
Jail/Prison
Laboratory/biomedical
Researcher’s Workplace
Military Facility or Unit
Outpatient facility
Records-based
University/college
Urban/community
Veteran’s Administration
Other(specify)
  1. Targeted Population
(Select all that apply)
Adults - healthy with no special characteristics
Children/minors (under 18 years of age)
Culturally or medically vulnerable groups
FDA-regulated research
Outpatients/in-patients
Pregnant women may or may not participate
Fetuses
Prisoners
Research involving animals
Soldiers or military personnel
Veterans
Elderly
Workers/employees
North Carolina A&T State University students
North Carolina A&T State University faculty and staff
Other (specify on page 7, section VI and/or VII)
Participant Characteristics and Sampling Techniques (continued)
  1. Describe how participants will be identified and selected for recruitment. Include all comparison groups (treatment and control).

  1. Inclusion Criteria for Participants

  1. Exclusion Criteria for Participants

  1. Describe the specific process by which you will obtain the participants’ informed consent/assent.
(Attach all materials – forms, scripts, etc.) / Written, withsignature
Information sheet
Internet / Email
Telephone
Oral consent w/info.sheet
  1. Do you request an alteration or waiver of consent or elements of consent?
(Please refer to the IRB Handbook for the requirements that must be met in order to be granted a waiver of these elements.) / Waive documentation by signature
Waive child assent
Waive parental consent
Waive other elements:
Total waiver (Research must meet all of the boxes below in order to qualify for a total waiver.)
  1. If you are requesting a total waiver, certify that all of the requirements for IRB approval of a waiver exist for this study by checking the following.
/ The research involves no more than minimal risk to the subjects;
The waiver or alteration will not adversely affect the rights and welfare of the subjects;
The research could not practicably be carried out without the waiver or alteration; and
Whenever appropriate, the subjects will be provided with additional pertinent information after participation.
  1. Explain who will make the initial contact with participants and how the participants will be contacted.(Submit any email text, flyers, announcement scripts, etc., with your application.)
/ PI Co-PI Staff
  1. Will participants receive inducements for participating in the study?
If yes, describe the specific type, amount, and method to be used (gift card, extra credit, cash, etc). / No
Yes
Risk and Benefit Analysis
  1. Describe the activities participants will be asked to do and how long participation will last.

  1. If some of the participants are in a control group, describe in detail the activity planned for that group.
/ N/A
  1. Please identify all risks that may reasonably be expected as result of participating in this research.
/ Breach of Confidentiality
Deception
Psychological
Coercion / Physical
Social
None
  1. Describe any reasonably foreseeable risks or discomforts to the participants.

  1. Describe how foreseeable risk will be minimized.

  1. Explain any benefits to the participants. If participants will not directly benefit, describe the benefit to society or the scientific knowledge gained.(Inducements such as money or extra credit are considered compensation, not benefits.)

  1. During the course of data collection, what provisions will you make to ensure the safety of participants?
(e.g., how often will you review data to monitor participants’ safety) / N/A
  1. If the research involves more than minimal risk, what compensation and/or medical treatments will be available to the participants?
/ N/A
  1. If offering students extra credit, describethe alternative assignment plan for extra credit.(Provide attachments as necessary.)
/ N/A
Confidentiality, Privacy, Anonymity, and Protection of Data
  1. Protection of Data
/ Will data be collected anonymously / Yes No
If NOT collected anonymously, will it be collected confidentially? / Yes No
  1. For confidential data collection, justify your need to code participants’ data and link it to identifying information.
/ N/A
  1. How will confidential data be coded and linked to identifying information?
/ Will it be recorded and analyzedanonymously?
N/A Yes No Explain:
  1. Where will code lists (the key) be stored?
/ N/A
  1. Where will the data be stored?
/ In a locked file cabinet
On a password-protected office computer
On a password-protected network drive
Portable media (laptop, flash drive, CD, etc.)
Other:
  1. How long will data be kept?
(Must be at least 3 years after study ends.)
  1. Will the coding list be destroyed? If so, state the plan for this.
/ N/A
No
Yes Explain:
  1. Who will have access to media used to record the data?(paper, recordings, computer files, etc.)

  1. If audio/video recordings are made, please describe whether they will be transcribed, and, if so, describe at what point transcription will occur and whether recordings will be destroyed.
/ N/A
  1. How long will the media be retained?
(It is required that data be stored for a minimum of three years after study ends.)
  1. If data will be destroyed, describe the secure method for destroying the materials while maintaining confidentiality.

Attach the following documents, as applicable:
  • A copy of the consent form
  • A copy of the survey or interview/focus group questions
  • For conducting research at another institution: documentation of approval from institution’s IRB.
  • Recruitment materials (flyers, advertisements, recruitment scripts, email text)
  • For research conducted at an external organization or agency (business, school, hospital, clinic, web-board owner, etc.), written documentation of approval.

Co-investigator(s), Research Assistants, Other Study Staff
List persons involved in assisting the principal investigator with the study. If you need additional room, please email us at or an additional form.
# 1
Name:
Title:
Telephone Number: / ( ) -
Email Address:
Address:
Institution:
Description of the work this person will be performing:
Biographical Sketch Attached: / No Yes
# 2
Name:
Title:
Telephone Number: / ( ) -
Email Address:
Address:
Institution:
Description of the work this person will be performing:
Biographical Sketch Attached: / No Yes
# 3
Name:
Title:
Telephone Number: / ( ) -
Email Address:
Address:
Institution:
Description of the work this person will be performing:
Biographical Sketch Attached: / No Yes
# 4
Name:
Title:
Telephone Number: / ( ) -
Email Address:
Address:
Institution:
Description of the work this person will be performing:
Biographical Sketch Attached: / No Yes
Certification/Signature Page
Research may begin only after the PI receives a copy of this form signed by the IRB Chair.
Principal Investigator(typed name)
Date:
Signature
As the principal investigator, my signature signifies
  • I have read, understood and agree to comply with the North Carolina A&T State University Policy and Procedures for the Use of Human Subjects in Research;
  • I will obtain IRB approval before implementing changes to the protocol, consent form, or supporting documents;
  • I will secure informed consent from subjects or their responsible representatives, using the currently approved consent form;
  • I will immediately report significant changes and unanticipated problems to the IRB;
  • I will apply for continuation of the protocol as scheduled by the IRB;
  • I will submit a final report at project completion; and
  • I will conduct all procedures under this project exactly as outlined in the proposal narrative.
Complete the Conflict of Interest Section
/ Conflict of Interest Statement:
To protect subjects from financial conflicts of interest, perceived or real, the IRB requires that such potential conflicts be disclosed. If the IRB determines that a conflict exists that could influence the research or jeopardize the well being of subjects, the IRB may require additional information about the conflict or may require that the conflict be resolved before the research is approved. In addition, it may require that the conflict be disclosed to the subject in the Informed Consent Statement.
If you or any member of your immediate family (spouse, child, parent, in-law, or sibling) has a financial interest in either a public or private company whose drug, procedure, technique, device, or software is used or tested in this study, please indicate the following:
Yes No I own equity in the company (stock ownership equal to or greater than 5%, Stock Options, Real Estate, or other ownership interest in any amount) whose drug, procedure, technique, device, or software I am testing.
Yes No I am aware that a faculty member or other employee of the institution owns equity in the company (stock ownership equal to or greater than 5%, stock options, real estate or other ownership interest in anyamount) whose drug, procedure, technique, device, or software I am testing.
Yes No The company holds patent rights to inventions created by me or a member of my immediate family or by another faculty member or otheremployee of the institution.
Yes No I or a member of my immediate family hold(s) a position of senior management officer or director of the company whose drug, procedure, technique, device, or software I am testing.
Yes No I am aware that a faculty member or other employee of the institution hold(s) a position of seniormanagement officer or director of the company whose drug, procedure, technique, device, or software Iam testing.
Yes No I am a scientific advisor or consultant to the company and I receive honoraria exceeding $5,000 annually.
Yes No I am aware that if a device, technique, software, or procedure involved in the research is marketed, I or a member of my immediate family will get royalty income or other income from the sale of the product.
Yes No I am aware that if the drug, device, technique, software, or procedure involved in the research ismarketed, another faculty member or other employee of the institution will get royalty income or otherincome from the sale of the product.
Yes No Any other financial interest that may appear to conflict with the protection of subjects or which should be disclosed to subjects in order to secure informed consent.
Please include a separate letter of explanation if there is further information that the IRB should consider.
If you did not check any of the boxes above or attached a letter of explanation for consideration by the IRB, your signature is your representation that you have no financial or other conflict of interest that could adversely affect a subject in this study.
Faculty Sponsor(typed name)
Date:
I, faculty sponsor for this research, assure the IRB committee of the funding status of the research study:
Not funded ______(faculty must initial)
Funded (provide information on page 3)
Signature
As supervisor (e.g., mentor, instructor, practicum supervisor, internship supervisor, staff supervisor), you certify the following:
  • The information provided in this application is correct and complete.
  • I have reviewed and provided prior approval to my supervisee for any substantive modification in the proposed study.
  • I will receive and forward to the IRB reports from my supervisee about any unexpected or otherwise significant adverse events in the course of the study. I will review records maintained by my supervisee until the final written document is produced and approved by you and the oversight committee.
  • I declare responsibility for ensuring that the research complies with federal and state regulations and NC A&T State University policies regarding the involvement of human subjects in research.
/ Department Chairperson(typed name)
Date:
I, the Chairperson of the investigator’s department, have reviewed the research protocol and support the study as it is described.
Signature
Co-PI Signature Page
If you need additional copies of this page, please email us at .
Research may begin only after the investigator receives a copy of this form signed by the IRB Chair.
Co-Principal Investigator (typed name)
Date:
Signature
As the Co-PI, my signature signifies
  • I have read, understood and agree to comply with the North Carolina A&T State University Policy and Procedures for the Use of Human Subjects in Research;
  • I will obtain IRB approval before implementing changes to the protocol, consent form, or supporting documents;
  • I will secure informed consent from subjects or their responsible representatives, using the currently approved consent form;
  • I will immediately report significant changes and unanticipated problems to the IRB;
  • I will apply for continuation of the protocol as scheduled by the IRB;
  • I will submit a final report at project completion; and
  • I will conduct all procedures under this project exactly as outlined in the proposal narrative.
Complete the Conflict of Interest Section
/ Conflict of Interest Statement:
To protect subjects from financial conflicts of interest, perceived or real, the IRB requires that such potential conflicts be disclosed. If the IRB determines that a conflict exists that could influence the research or jeopardize the well being of subjects, the IRB may require additional information about the conflict or may require that the conflict be resolved before the research is approved. In addition, it may require that the conflict be disclosed to the subject in the Informed Consent Statement.
If you or any member of your immediate family (spouse, child, parent, in-law, or sibling) has a financial interest in either a public or private company whose drug, procedure, technique, device, or software is used or tested in this study, please indicate the following:
Yes No I own equity in the company (stock ownership equal to or greater than 5%, Stock Options, Real Estate, or other ownership interest in any amount) whose drug, procedure, technique, device, or software I am testing.
Yes No I am aware that a faculty member or other employee of the institution owns equity in the company (stock ownership equal to or greater than 5%, stock options, real estate or other ownership interest in any amount) whose drug, procedure, technique, device, or software I am testing.
Yes No The company holds patent rights to inventions created by me or a member of my immediate family or by another faculty member or other employee of the institution.
Yes No I or a member of my immediate family hold(s) a position of senior management officer or director of the company whose drug, procedure, technique, device, or software I am testing.
Yes No I am aware that a faculty member or other employee of the institution hold(s) a position of senior management officer or director of the company whose drug, procedure, technique, device, or software I am testing.
Yes No I am a scientific advisor or consultant to the company and I receive honoraria exceeding $5,000 annually.
Yes No I am aware that if a device, technique, software, or procedure involved in the research is marketed, I or a member of my immediate family will get royalty income or other income from the sale of the product.
Yes No I am aware that if the drug, device, technique, software, or procedure involved in the research is marketed, another faculty member or other employee of the institution will get royalty income or other income from the sale of the product.
Yes No Any other financial interest that may appear to conflict with the protection of subjects or which should be disclosed to subjects in order to secure informed consent.
Please include a separate letter of explanation if there is further information that the IRB should consider.
If you did not check any of the boxes above or attached a letter of explanation for consideration by the IRB, your signature is your representation that you have no financial or other conflict of interest that could adversely affect a subject in this study.

How to Submit Your IRB Forms Online