IRB Human Subjects Protocol Form
Revised October 2011
University of North Carolina Wilmington
Institutional Review Board
Human Subjects Protocol Form
For IRB Use Only
Protocol #: _________________
Approval Date: _____________
Expiration Date: ____________
PART A: GENERAL PROJECT INFORMATION
1.
Title of Project (use same title as grant proposal, if applicable):
2.
Proposed Start Date*:
Proposed End Date:
*In order for research to begin on the proposed start date, ORSSP must receive the signed hard
copy of this form and all supporting documentation at least ten (10) days prior to the start date.
3.
Principal Investigator: (If student is primary researcher, PI must be faculty or staff member.)
Name:
Date of IRB Training:
Title:
Phone:
Department:
Fax:
Campus Post Box #:
E-mail:
Building OR Mailing Address (if off-campus):
4.
Student Researcher: (Leave blank unless student is primary researcher.)
Name:
Phone:
E-mail:
*Date of IRB Training:
5.
Alternate Contact: Enter the name of someone other than the PI who can report to the IRB in the
event the PI is unavailable. (If this is student research, write the student researcher name here. If PI is
sole researcher, this can be department chair or other responsible individual):
EXPIRATION DATE:
A copy of this page signed by the IRB Chair below serves as formal notice of IRB action.
Approval of this protocol (and if applicable, consent/assent forms or handout/flyers) EXPIRES on the
date specified in the upper right corner of this page. Please note: If this study will continue beyond the
expiration date, it is the responsibility of the PI to file an Annual Renewal Form prior to expiration. Any
changes to this study, no matter how small, are subject to approval by the IRB on a Protocol
Amendment Form. UNCW policy requires the submission of a Closure Report upon completion of a
study. **IRB forms are available at http://www.uncw.edu/orssp/conduct-human-forms.html.**
IRB Use ONLY:
Type of IRB Review:
Results: Approved
Full Review
Expedited #_________
Exempt
Approved Pending Revisions Deferred
Disapproved
________________________________________________
Signature of the IRB Chair or Designate
__________________
Date
If necessary, revisions/clarification received: ____________________
Results: Approved
Approved Pending Revisions
Disapproved
________________________________________________
Signature of the IRB Chair or Designate
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__________________
Date
6.
Additional Personnel: List all personnel involved in the design and/or conduct of the research.
Attach another sheet if necessary. Each individual listed below must provide documentation of
acceptable human subject protection training. Note instructions in gray box below.
Name:
Faculty
Staff
Student
E-mail:
*Date of IRB Training:
Affiliation:
UNCW
Other – Specify:
Role:
Co-PI
Researcher
Research Asst.
Other – Specify:
Name:
Faculty
Staff
Student
E-mail:
*Date of IRB Training:
Affiliation:
UNCW
Other – Specify:
Role:
Co-PI
Researcher
Research Asst.
Other – Specify:
Name:
Faculty
Staff
Student
E-mail:
*Date of IRB Training:
Affiliation:
UNCW
Other – Specify:
Role:
Co-PI
Researcher
Research Asst.
Other – Specify:
Name:
Faculty
Staff
Student
E-mail:
*Date of IRB Training:
Affiliation:
UNCW
Other – Specify:
Role:
Co-PI
Researcher
Research Asst.
Other – Specify:
Please Note
Personnel Change: A protocol amendment form is required for any change in personnel.
*Date of IRB Training – if you are unsure of a training date, but believe it is on file in ORSSP, please
contact the regulatory compliance officer (ext. 7774 or kellya@uncw.edu).
Training Requirement: As required by UNCW IRB policy, key personnel, student researchers and
research assistants who are involved in the design and/or conduct must demonstrate completion of
human subject protection training. Documentation of completion must be on file in ORSSP before the
protocol will receive IRB review. This includes faculty, staff, students or professionals from other
institutions. A link to the approved online training course and instructions are provided on the
IRB website [http://www.uncw.edu/orssp/conduct-human-training.html]. ORSSP retains record all
completed training. If documentation of training is already on file, it is not necessary to resubmit it.
It is the PI’s responsibility to ensure all research team members have been appropriately trained and
have documentation of training on file.
7.
Type of Research:
Non-sponsored Research
Student Research (research to be primarily conducted by a student)
Teaching Research - - Course Number:
Sponsored Research - - Funding Entity:
UNCW Department
*Must attach a copy of the proposal*
DOE NIH
Other
Funds Awarded
Account #
Funds Pending
Proposal #
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PART B: CHECKLIST
Please check all items that relate to this particular study. All methods and procedures must be
fully described in Part H, number 2 of this protocol.
1. Subject Identification: Must check one.
a. Information is collected in such a way that subjects CANNOT be identified directly (by
names, images or other identifiers) OR indirectly (by a chart linking responses to subjects).
Note: Subject numbers and code names are not considered identifiers unless they link
somehow to identifying information.
b. Information is collected in such a way that subjects CAN be identified. (Names or other
identifiers WILL be collected with the data collected from subjects OR data collected from
subjects will be linked somehow to identifiers.)
2. Risks: Must check one.
a. Risks (including physical, emotional, social, legal or financial) are the same as encountered
in daily life or during the performance of routine physical or psychological examinations or
tests (minimal risk).
b. Risks are more than minimal in that either: (a) the probability of the harm or discomfort
anticipated in the proposed research, OR (b) the magnitude of the harm or discomfort
anticipated in the proposed research is greater than that encountered ordinarily in daily life
or during the performance of routine physical or psychological examinations or tests.
c. Information to be collected is such that subjects may be at risk of criminal or civil liability if
their responses are disclosed outside of the research setting.
d. Information to be collected is such that it may be damaging to the subjects' financial
standing, employability, or reputation if the information is disclosed outside of the research
setting.
3. Special Populations: (Check only if applicable, i.e. if you are specifically targeting one of the
following populations.)
a. Persons under age 18
b. Prisoners (persons involuntarily confined or detained in a penal institution)
c. Mentally retarded, mentally disabled, economically disadvantaged, educationally
disadvantaged, terminally ill, or incompetent individuals.
d. HIV patients, hospitalized or psychotic psychiatric patients, pregnant women, fetuses or
abortuses, or in vitro fertilization.
4. Unusual Procedures: (Check only if applicable.)
a. Deception or Stress: Subjects will be deceived in some way or placed under psychological or
emotional stress.
b. Any other procedures as described in Part H, number 2: Methods and Procedures.
5. Non-Medical Activities: (Check any that apply.)
a. Observing public behavior without videotaping or recording
b. Observing classroom practices in established educational settings
c. Using educational tests (cognitive, diagnostic, aptitude or achievement)
d. Using questionnaires/surveys/interviews (including semi-structured or open-ended interviews or
biographical data)
e. Collecting or studying (i) existing public data; (ii) de-identified data; or (iii) documents, records or
materials that have been collected or will be collected solely for nonresearch purposes (such as
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campus photographs, stories published in newspapers or newsletters).
f. Studying, evaluating, or otherwise examining: (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.
g. Collecting data from voice, video, digital, or image recordings
j. Other non-medical activities as described in Part H, number 2: Methods and Procedures.
**IF YOUR PROJECT IS NON-MEDICAL, SKIP TO PART C: SUBJECTS** If your project
involves any health or medical activities, continue to #6.
6. Review of Health Information and Other Medical Activities: (Check any that apply.)
a. Ingestion of Food or other Substances: Subjects will be asked to ingest substances other than
wholesome foods without additives. (If you marked this statement, you must include the
following language in the consent form for females: “If you are pregnant, or think you may
be pregnant, you should not participate in this study.”)
b. Obtaining medical data from a health care provider, health plan or health care clearninghouse.
(If you marked this statement, read “Requirements for the Use of Protected Health Information
(PHI) in Research” available on the IRB website http://www.uncw.edu/orssp/conduct-humanpolicies.html for UNCW IRB HIPAA requirments.)
Data will be de-identified to HIPAA standards.
Data will be identifiable. (If you marked this statement you are required to complete a
HIPAA Appendix form available on the IRB website http://www.uncw.edu/orssp/conduct-humanforms.html .
c. Collecting or studying pathological or diagnostic specimens from publicly available sources
(specimens must be pre-existing).
d. Collecting blood samples by finger stick, heel stick, ear stick, or venipuncture.
Indicate the type of subjects from which blood will be collected:
from healthy, nonpregnant adults who weigh at least 110 pounds.
from other adults or children.
How much blood will be drawn at one time?
How much blood will be drawn in an 8-week period?
How often will the collection occur?
e. Prospective collection of biological specimens for research purposes by noninvasive means.
f. Collecting data through noninvasive procedures routinely employed in clinical practice.
g. Clinical studies of drugs or medical devices.
h. Collecting data through procedures involving general anesthesia, sedation, x-rays,
microwaves, or medical devices not cleared/approved for marketing.
i. Collecting data through invasive procedures.
j. Other medical activities as described in Part H, number 2: Methods and Procedures.
PART C: SUBJECTS
1. Number of subjects: No more than
subject will be used.
(Please submit a protocol amendment form prior to exceeding this number.)
2. Ages of subjects: Minors (under age 18) - ages
Adults (18 and over) - ages
3. Check applicable:
Males
Females
4. Choose each group below that you are specifically seeking to sample or study:
a. Regular Populations:
UNCW students
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Other adult populations (without impairments or vulnerabilities)
b. Special Populations as indicated in PART B #3 (skip if targeting regular populations).
i. State the specific population you will target (for example, elementary school children,
inmates at state penitentiary, homeless individuals, etc.): If subjects are prisoners,
you must also attach a Prisoner Participant Form.
ii. State the necessity of using this subject population:
iii. State the additional safeguards that you will take to protect these susceptible subjects
from undue influence or coercion:
5. Federal regulations have established guidelines for the equitable selection of subjects. Are
the subjects indicated in #4 above
a. an appropriate subset of the population to bear the burdens of this research?
Yes
No (if No, explain)
b. a category of the population that is most likely to receive the benefits of this research?
Yes
No (if No, explain)
6. Risk to Subjects
a. Indicate the level of potential risk to the subjects (Note: You must check one. Minimal
risk is defined as the same risks one would encounter in daily life or during the performance
of a routine physical or psychological examination or test.):
Minimal Risk – continue to b and c.
More than Minimal Risk – complete question below and continue to b and c.
What are the anticipated benefits of the project? In what respect do the
potential benefits outweigh the risks?
b.
What are the potential risks (physical, psychological/emotional, financial, social,
legal, or other) to the subjects?
c.
How are these risks minimized?
PART D: LOCATION(S)
1. List all locations where investigators and collaborators will engage in protocol activities.
N/A – online survey
UNCW campus
Off-campus location(s)
 If you are recruiting or conducting research off-campus at a facility where subjects have
a reasonable expectation of privacy (public school, day care, medical facility, etc) you
must attach a letter of support from the facility administrator of each site to document
permission to use the facility.
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List off-campus location(s):
 Medical Facilities:
If any site is a hospital, physician’s office, health care provider, health insurance agency, or
other entity that maintains or transmits health information for purposes of treatment,
payment, or health care operations, you are encouraged to review the HIPAA resources
posted on the IRB website [http://www.uncw.edu/orssp/conduct-human-materials.html].
2. Multi-center Collaborations
Check here if multiple research entities will participate in this study (this does not mean
collecting data from multiple locations).
If so, was this protocol reviewed by other IRBs?
If so, was this protocol approved or rejected?
If applicable, attach notices from other IRBs. If this protocol is rejected or the
research is halted you must notify the UNCW IRB immediately.
PART E: DURATION OF TIME
1. Time per session: state the maximum number of minutes/hours that you will ask subjects to
participate in any given session.
2. Total time: state the maximum total minutes/hours that you will ask subjects to participate
for the duration of the study.
PART F: INTERVIEWS, QUESTIONNAIRES, AND TESTS
Describe type of instrument(s). If interview questions will be unstructured, describe the avenues of
inquiry or any guidelines you use in your discipline to gather information. List which tests,
questionnaires, surveys, etc. you plan to use. *Attach copies of all tests, questionnaires, surveys, etc.*
PART G: PROJECT OBJECTIVES
What are you trying to find out? Why is it important to find this out?
PART H: METHODS
1. Recruitment Procedures (how will you find subjects?):
Student Subject Pool
Mail-out or Handout
Newspaper ads/Flyers/Postings
School children with request sent to parent
Approached by staff members (list names of staff members)
Other (Explain)
2. Research Methods and Procedures: (Fully describe activities, beginning with recruitment
procedures. Fully describe consent process, data collection and analysis methods, and debriefing
procedures if applicable.)
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3. Deceptive Techniques:
Not applicable
The following deception will take place (describe)*:
*If deception will take place, please explain how the subjects will be debriefed:
PART I: DATA PROTECTION AND RETENTION
1. Will reasonable and appropriate protections be implemented so that risks related to invasion
of privacy and breach of confidentiality are no greater than minimal?
N/A – As indicated in PART B, #1a, data will be collected so that subjects CANNOT be
identified (data will be anonymous with no way to link subjects to the data collected from
them). There are no privacy or confidentiality concerns with anonymous data.
Yes - As indicated in PART B, #1b, data will be collected so that subjects CAN be
identified. Since subjects can somehow be linked to the data collected from them, the
following protections will be implemented to protect privacy and confidentiality:
No/Other – Explain:
2. Records will be kept in:
Principal Investigator’s Files. (Building
Other (Explain)
Room
)
PART J: INFORMED CONSENT PROCESS
1. Standard Consent and/or Assent-Permission Process will be conducted (if you need to
alter some or all of the consent requirements, see #2 below to describe alterations.)
a. Documentation
All elements of informed consent will be included on the following: (Check any that apply
and attach a copy of the form[s] to be used.)
Informed consent forms signed by adult subjects
Assent-permission forms signed by minor subjects and parent/guardian. (Children
over age seven are usually able to understand and sign assent forms. If no assent form will
be used, go to #2.d. below to request approval to alter the standard process.)
Other (Explain)
 Include all required elements of informed consent on any consent form to be used.
 Submit an Informed Consent Checklist if using a format other than the Question and
Answer template to demonstrate that all required elements are included. Templates,
examples of alternate formats, and the checklist are available on the IRB website http://www.uncw.edu/orssp/conduct-human-forms.html.
 The researcher must use the consent/assent/permission form that has been stamped and
initialed by the IRB when making copies for subjects to sign.
 Federal law requires the researcher to provide an extra (unsigned) copy of the
consent/assent/permission form to the subject for his/her records.
b. Personnel
The following individual(s) will obtain consent and/or assent-permission. (Check any that
apply.)
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Principal Investigator
Student Researcher
Other (Must be listed in PART A, #6 of this protocol form and have appropriate
training documentation on file with ORSSP. See Page 2 of this form for more
information on training requirements.)
Name:
Title:
Name:
Title:
Name:
Title:
 The individual(s) indicated above must ensure each subject fully understands the form,
answer any questions from subjects, and obtain signatures from subjects.
 Any staffing changes must be reported to the IRB immediately on a Protocol
Amendment form
2. PI requests approval to alter standard consent process. The research activities involve:
a. No human subjects contact (observation of public behavior, studying existing data - public or
de-identified).
b. Anonymous paper or online surveys. In keeping with the Belmont Report, the PI must include
a statement at the beginning of the survey informing subjects that their participation is
voluntary, they can stop at any time or refuse to answer any question and will not be treated
any differently by the researcher(s). For online surveys, UNCW IRB Policy additionally
requires PIs to notify subjects that data will be kept secure once it is in the PI’s possession;
however the PI cannot guarantee security during transmission of data due to keylogging and
other spyware technology that may exist on any computer used by the subject.
c. Telephone surveys. The researcher requests a waiver of the documentation
requirement, as the research cannot practicably be carried out without the waiver. The
researcher must read basic elements of informed consent to subjects at the beginning of
the phone survey (purpose of research, who is conducting research, about how long
phone call will take, voluntary nature of the research, etc.).
d. Other activities requiring an alteration. The IRB may contact you with specific requirements
depending on the nature of the alteration.
Explain what aspect of the informed consent process will be omitted and explain why
the research cannot practicably be carried out with the alteration:
IRB Use ONLY:
Request for Alteration Approved. This is an exempt project and the requirements of the
Belmont Report have been met.
Request for Alteration Approved. The UNCW IRB finds that the requirements for
46.116(d) and/or 46.117(c)(2) have been met.
Request for Alteration Approved. The UNCW IRB finds that the requirements for
46.117(c)(1) have been met.
Request for Alteration Denied. The UNCW IRB has considered the request and
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determined the following:
Research is more than minimal risk.
Rights and welfare of subjects will be adversely affected.
Research could practicably be carried out with standard consent procedures.
___________________________
IRB Chair or Designate Initials
_______________
Date
PART K: SAFETY
How will you make adequate provisions to ensure the safety of research personnel? (Do not leave
blank. Example: Staff will conduct interviews in public buildings during normal working hours.)
PART L: CONFLICT OF INTEREST (A response for each is required. If no conflict exists to
your knowledge, write “No”, “None”, or “N/A” as appropriate.)
1. State any financial or other relationships that you, or any individuals or institutions involved
in the research, hold which could create perceived or actual conflicts of interest.
2. State whether you, or any individuals or institutions involved in the research, will receive any
compensation, other than a grant award.
3. Describe what reasonable and appropriate actions you plan to take to protect subjects from
the influence of conflicting interests.
If at any time during the project, you, or any individuals or institutions involved in the research,
develop any financial or other relationships that could create perceived or actual conflicts of interest,
they must be reported in writing to the IRB within 10 business days.
For more information on Conflicts of Interest, see the ORSSP website,
http://www.uncw.edu/orssp/conduct-conflict.html.
PART M: ETHICAL RESPONSIBILITIES OF THE INVESTIGATOR
1. I agree to accept the responsibility for protecting the rights and welfare of human research
subjects and to comply with all applicable provisions of UNCW’s Federal Wide Assurance and
applicable IRB policies (see the IRB website for more information,
http://www.uncw.edu/orssp/conduct-human-irb.html).
2. When informed consent or assent/permission forms are used, I agree to provide a copy of the
IRB-approved document to each subject at the time of consent, unless the IRB specifically
waives this requirement. I understand that all signed consent documents must be retained for
three years in the manner approved by the Chair of the IRB.
3. I agree to seek IRB review and approval prior to initiating any changes to this protocol, no matter
how small, except where necessary to eliminate apparent immediate hazards to the subjects.
4. I understand that, if approved, this protocol will expire in one year, unless a shorter term is
designated by the IRB. If the study is ongoing, I agree to renew the protocol prior to the expiration
date. I understand that all research activities must cease if I allow the protocol to expire.
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5. In accordance with UNCW IRB policies, I agree to conduct a self-review of research practices on a
form designated by the IRB and sent to me approximately six months after protocol approval.
6. Within 5 business days of any occurrence, I agree to promptly report in writing to the IRB any
injuries or other unanticipated problems involving risks to subjects and others, regardless of
causality. If I am unable to file a report due to travel or other obligations, the person named as
the Responsible Individual in PART A, number 5 will do so in my place.
7. I agree to notify the IRB immediately upon termination of this study, departure of the Principal
Investigator from this institution, and/or change in the Principal Investigator for this study.
The undersigned assumes responsibility for this study and agrees to follow and abide by the policies
and procedures of the University of North Carolina Wilmington for research involving human
subjects.
____________________________________________
Principal Investigator’s Signature
(PI must sign even when student is primary researcher.)
__________________
Date
____________________________________________
Student Researcher’s Signature
(Only required when student is primary researcher.)
__________________
Date
Submit one original signed, hard copy and any of the attachments and an electronic copy checked
below to Angela Pennell Kelly, Regulatory Compliance Officer, Hoggard Hall, Room 174, or
Campus Box 5973, electronic copy to kellya@uncw.edu. This protocol will not be reviewed until the
IRB has received documentation of IRB training for anyone involved in the design and/or conduct of
the research. It is not necessary to resubmit training documentation for each new protocol if
certificates are already on file.
PART N: ATTACHMENTS
Please check all that apply and submit these items with the signed hard copy of this protocol form.
None
Additional Key Personnel, Students, or Research Assistants
IRB Training Certificate(s) - if not already on file with the IRB
Informed Consent Form
Assent/Permission Form
Informed Consent Checklist (must be submitted unless Question and Answer template is used)
Questionnaires, Surveys, Tests
Recruitment Handout/Ads/Flyers/Postings
Site Letters of Support
Privacy Policies of any social networking sites used in research
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Notices from other IRBs
Copy of Grant Proposal (*required for funded research*)
HIPAA Appendix
HIPAA Authorization
Approved Waiver HIPAA Authorization from covered entity’s IRB or Privacy Board
Prisoner Participant Form
Other
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