When Completing this Application
Frequently, the IRB experiences delays in the review and approval process due primarily to the submission of incomplete
or unclear applications. It is always in the best interest of the investigator to submit a complete application that contains
all parts in detail. Any missing items or lack of clarification of important information in the proposal can cause delays.
Below are a few pointers to help your application move smoothly through the review process:
 The importance of proofing your application prior to submitting cannot be stressed enough. Reviewers pay very close
attention to consistency. Compare what is stated in the application to what is stated in the information sheet, consent forms,
or any other documents. All documents must be consistent with each other. Check to see if the number of subjects and the
type of subjects are consistent through all documents. Are all procedures described in the application also described in the
consent form? Is the list of investigators at the beginning of the application complete? Does it include all personnel
mentioned in the body of the application, etc?
 Please remember you are completing an IRB application, not a grant proposal or journal article. Do not cut and paste text
from these sources into your IRB application. Answer each question on the IRB application as to how it pertains to the
human subjects research component of your project. Focus your application on the human subjects interaction.
 Check to see if your application is signed and dated. Numerous applications are returned because the PI did not sign the
application prior to forwarding to ORSP.
 If a question on the application doesn’t pertain to your type of study, write “N/A”. This indicates you have read and haven’t
accidently skipped the question.
 Make sure the project start date you list falls after the IRB has reviewed and approved the project. IRB approval must be
given prior to the start of the research project and cannot be retrospective.
 Reviewers of your IRB application focus mainly on the recruitment process, consent process and potential risks to subjects.
Additional questions will arise and approval delayed if the application does not convey the following:
- Exactly who will be studied (age, gender, special class, etc.) Will anyone be excluded from participation?
How many people do you plan to enroll and details of how will you recruit and enroll them?
- Exactly what data will be collected from the subjects? Are all data collection instruments attached?
- Who will collect the data?
- Details of exactly what study subjects are asked to do. How many surveys? How many visits and what procedures?
How much time will be involved?
 Understand the difference between “anonymous data” and “confidential data” and use these terms correctly in your IRB
-
application. Simply not collecting a person’s name on a survey does not automatically make data anonymous. Take into
consideration if other combined data could possibly point to a specific person. For example, a person’s title and department
can be combined to identify a person even without a name (i.e. Director, ORSP). Data collected when a subject’s identity
could possibly be revealed is “confidential data” not “anonymous data.”

If you would like to complete a self-assessment of your application prior to submission, you may complete the “IRB
Reviewers Worksheet”. This sheet is completed by reviewers for each application received and highlights the most
important review criteria that must be contained in your application.
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Northeast Ohio Medical University
Institutional Review Board (IRB)
FOR USE WITH PROJECTS INVOLVING SURVEYS OR BEHAVIORAL RESEARCH
Office of Research and Sponsored Programs
Directions: Your application must include a completed, signed, printout of this form, together with your proposed
consent form, protocol, questionnaires, and any appendices that might be helpful to the IRB’s consideration. Answer ALL
questions in the application form; do NOT say, “See attached.” Failure to properly complete this application will delay final
approval. Refer to Guidelines for Protection of Human Subjects in Research for directions in completing this form and
submitting your application. Please submit 1 hardcopy to: Trish Wilson, Research Administrator, IRB Office, Room G-235,
NEOMED Rootstown Campus or electronically to paw@NEOMED.edu. If you are sending this application electronically, you
must scan the application so that the PI’s signature is displayed. Type signatures will not be accepted. Applications requiring
full board review must be received 14 days prior to the scheduled full board meeting. The time required for exempt or
expedited review depends on the availability of the IRB reviewers and the availability of the investigator to make any
necessary corrections. We cannot guarantee an exemption or an expedited review in less than two weeks. Please
plan accordingly. If you are using existing institutional data or your project requires a change in the curriculum, you must first
contact Elizabeth Young, M.D., for permission at ext. 6338.
First person listed below must be a NEOMED faculty member who will serve as the Principal Investigator for this study. Only 1
person may be named as a principal investigator.
1. Study Personnel (names, degrees)
Dept./Section/Location
Telephone
Email
Status
Principal
Investigator
Person to Contact Regarding this Application:
Telephone
FAX
Location and Room #
2. TITLE OF PROTOCOL
3. PROJECT PERIOD:
Start:
End:
(Start date must be after IRB approval.)
4. FUNDING SOURCE (name of sponsor or funding agency) :
A. Is the sponsor a for-profit corporation? (double click on the appropriate box)
No
Yes: Provide an indemnity agreement.
_______________________________________________________________________________________________________________
5. PRINCIPAL INVESTIGATOR ASSURANCE:
“I have read NEOMED’s Guidelines for Protection of Human Subjects in Research. In addition, all key personnel
have completed the required on-line training in human subjects research. I understand it is my responsibility, as
Principal Investigator, to assure the accuracy of the description of research in this application. Upon approval, I
assure all research will be conducted as approved in my application unless I request an amendment to change the
studies procedures.”
Principal Investigator: _________________________________________
Date:___________________
Student’s Signature if a student project: ___________________________
(All student projects must have a faculty member as PI)
Date: __________________
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A.
Will personnel and resources from another department be involved in this study?
No
Yes: Letter of agreement must be attached if not listed as co-investigator.
B. Are non-NEOMED Consortium institutions involved?
No
Yes: Letter of agreement must be attached. Please attach Co-Investigator’s memo “Intent to Collaborate”.
Will part or all of the study be conducted at that site?
No
Yes
C
Do any of the investigators have a potential conflict of interest in the performance of this study?
No
Yes: Attach explanatory statement.
D
Will subjects be recruited using advertising material or form letters?
No
Yes: Attach sample copy.
E
Is the study being submitted to any Federally Funded Institute or Agency for sponsorship?
No
Yes: PHS policy requires assurance that the composition of the proposed study population benefits all persons
at risk of the condition under study. The gender and racial/ethnic composition, together with a rationale for
inclusion/exclusion, should be described in the funding proposal and in Section VII, which follows.
F.
Have all Investigators and Co-Investigators completed a training course for conducting Human Subjects Research within the
last 3 years? If not, please complete the on-line training course located at http://citiprogram.org. Please list below the date of
certification. If a certificate is currently not on file with the IRB, please attach to this application.
Principal Investigator:
Co-Investigators:
Co-Investigators:
Date of certification:
Date of certification:
Date of certification:
Co-Investigators:
Date of certification:
6. Type of Review- Exempt, Expedited, or Full Board
Depending on the level of risk of the research proposed and the participant population, the IRB may conduct either an
exempt status, expedited, or full board review. Exempt and expedited research much not be greater than minimal
risk to subjects involved. Research determined to be greater than minimal risk must be review at a convened full
board meeting. Expedited and exempt status review will be conducted by the IRB Chair in conjunction with the Human
Protections Administrator.
Determine which type of review your protocol may require by checking the boxes below:
Check the category below that qualifies this study as an exempt research activity:
(1) 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.
(2) 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 could
reasonably place the subjects at risk of criminal or civil liability or be damaging to the subjects' financial standing,
employability, or reputation.
(3) Research involving the use of educational tests (cognitive, diagnostic, aptitude, achievement), survey
procedures, interview procedures, or observation of public behavior that is not exempt under 2 above, 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 thereafter.
(4) 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.
(5) 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:
Revised April 2012
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(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.
(6) 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.
Check the category below that qualifies this study as expedited research:
(1) Research on individual or group characteristics or behavior (including, but not limited to, research on
perception, cognition, motivation, identity, language, communication, cultural beliefs or practices, and social
behavior) or research employing survey, interview, oral history, focus group, program evaluation, human factors
evaluation, or quality assurance methodologies. (Note: Some research in this category may be exempt from the HHS
regulations for the protection of human subjects 45 CFR 46.101 (b)(2) and (b)(3). This listing refers only to research
that is not exempt.)
(2) Collection of data from voice, video, digital, or image recordings made for research purposes.
(3) Research involving materials (data, documents, records, or specimens) that have been collected or will be
collected solely for nonresearch purposes (such as medical treatment or diagnosis). (Note: Some research in this
category may be exempt from the HHS regulations for the protection of human subjects. 45 CFR 46.101(b)(4). This
listing refers only to research that is not exempt.)
(4) Collection of blood samples by finger stick, heel stick, ear stick, or venipuncture as follows:
From healthy, nonpregnant adults who weigh at least 110 pounds. For these subjects, the amounts drawn may not
exceed 550 ml in an 8 week period and collection may not occur more frequently than 2 times per week; or
From other adults and children1 considering the age, weight, and health of the subjects, the collection procedure, the
amount of blood to be collected, and the frequency with which it will be collected. For these subjects, the amount
drawn may not exceed the lesser of 50 ml or 3 ml per kg in an 8 week period and collection may not occur more
frequently than 2 times per week.
(5) Prospective collection of biological specimens for research purposes by noninvasive means. Examples: (a) Hair
and nail clippings in a nondisfiguring manner; (b) deciduous teeth at time of exfoliation or if routine patient care
indicates a need for extraction; (c) permanent teeth if routine patient care indicates a need for extraction; (d) excreta
and external secretions (including sweat); (e) uncannulated saliva collected either in an unstimulated fashion or
stimulated by chewing gumbase or wax or by applying a dilute citric solution to the tongue; (f) placenta removed at
delivery; (g) amniotic fluid obtained at the time of rupture of the membrane prior to or during labor; (h) supra- and
subgingival dental plaque and calculus, provided the collection procedure is not more invasive than routine
prophylactic scaling of the teeth and the process is accomplished in accordance with accepted prophylactic
techniques; (i) mucosal and skin cells collected by buccal scraping or swab, skin swab, or mouth washings; (j) sputum
collected after saline mist nebulization.
(6) Collection of data through noninvasive procedures (not involving general anesthesia or sedation) routinely
employed in clinical practice, excluding procedures involving x-rays or microwaves. Where medical devices are
employed, they must be cleared/approved for marketing. (Studies intended to evaluate the safety and effectiveness
of the medical device are not generally eligible for expedited review, including studies of cleared medical devices for
new indications.) Examples: (a) Physical sensors that are applied either to the surface of the body or at a distance
and do not involve input of significant amounts of energy into the subject or an invasion of the subject’s privacy; (b)
weighing or testing sensory acuity; (c) magnetic resonance imaging; (d) electrocardiography,
electroencephalography, thermography, detection of naturally occurring radioactivity, electroretinography, ultrasound,
diagnostic infrared imaging, doppler blood flow, and echocardiography; (e) moderate exercise, muscular strength
testing, body composition assessment, and flexibility testing where appropriate given the age, weight, and health of
the individual.
Research that can not be classified as exempt or expedited above will require review by a full IRB at a convened
meeting.
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8. USE OF HEALTH INFORMATION:
Does the study involve the use of health information? Health information is defined as:
* any information pertaining to the past, present, or future physical or mental health or condition
of an individual;
* any information pertaining to the provision of health care to an individual; or
* any information pertaining to the past, present, or future payment for the provision of health care to an
individual.
No
Yes: You are required to complete a HIPAA Application for the use of health information along with this IRB
Application. HIPAA applications can be found at http://www.neomed.edu/research/orsp/researchcompliance/irb-folder/irbforms/HIPAA Application.doc
SECTION I - SUMMARY INFORMATION
THIS SECTION MUST BE COMPLETED
1.
Will you perform medical procedures as part of this research proposal?
2.
SUBJECT POPULATION: (Check all appropriate boxes.)
Adults
Children
Comatose
BioMed Academy students
Institutional residents
Fetuses
Male Only
NEOMED/COP students/employees
Patients
Pregnant women
Terminally ill
Traumatized (Emotional)
3.
No
Cancer patients
Cognitively or psychologically impaired
Elderly
Female Only
Human in vitro fertilization
Exclusion of minorities
Non-English speaking
Physically Handicapped
Prisoners or parolees
Traumatized (Physical)
Other
If the research involves any of the following, check the appropriate boxes:
Interviews
Survey/questionnaire (must attached survey or
questionnaire to this application)
Deception
Study of existing data (medical records)
Study of human biological specimens
Venipuncture (<450cc)
Genetic research
4.
Yes
HIV/AIDS
Behavioral observation
Waiver of written consent
Controlled substances (see Guidelines #6)
Microorganisms or recombinant DNA (see Guidelines #7)
Potential development of commercial product from human
biological materials (see Guidelines #8)
PI or Co-PI is the treating physician
Location(S) Of Research To Be Conducted At:
NEOMED campus
BioMed Academy
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Teaching hospital or university (s), please list:
Other locations, specify:
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SECTION II - PROTOCOL SUMMARY
THIS SECTION MUST BE COMPLETED
INSTRUCTIONS: In order to review your proposal, the Institutional Review Board must have all of the following
information. Each topic must be titled using the boldface subheadings listed below. State “Not Applicable” for
topics that are not applicable to your application. Address each topic independently in the sequence listed without
reliance on information covered under other subparts. Attaching sections of a grant application is not an acceptable
substitute. Provide sufficient information for effective review by all members of the IRB, including non-specialists.
Define all abbreviations and terms not part of common language and use simple words and sentence structure as
much as possible.
PURPOSE OF THE STUDY, THE BACKGROUND AND THE LITERATURE REVIEW (1-3)
1.
LAY LANGUAGE SUMMARY: (Please use non-technical language that is understood by nonscientific
members to summarize the proposed research project. The information must include: (1) a brief statement of the
problem and related theory supporting the intent of the study, and (2) a brief but specific description of the
procedure(s) involving the human subjects. Attach an additional page as necessary. However, please do not
exceed one single-spaced, type-written page.)
2.
Purpose of the Study: What are the specific scientific objectives (aims) of the research?
3.
Background: State the background of the study. Include a critical evaluation of existing knowledge, and
specifically identify the information gaps which the project is intended to fill. Describe previous work in animal
and/or human studies that provide a basis for the proposed research and that support the expectation of obtaining
useful results without undue risk to human subjects.
Note: Include appropriate citations to the scientific literature or attach a copy of literature review.
CHARACTERISTICS OF THE SUBJECT POPULATION (4-6)
4.
Number of Subjects: What is the anticipated number of subjects to be enrolled and, in the case of multi-center
research, the total number of subjects for the entire project?
5.
Inclusion/Exclusion Criteria:
a) What are the criteria for inclusion and exclusion?
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b) How will eligibility be determined, and by whom?
c)
Are any inclusion or exclusion criteria based on age, gender, pregnancy or childbearing potential, or
racial/ethnic origin? If so, explain and justify.
Note: Equitable inclusion of both men and women of all ages, and individuals from diverse racial/ethnic
backgrounds, is important to assure that they receive an equal share of the benefits of research and that they do
not bear a disproportionate share of its burdens. Participation of adult subjects of both genders and diverse
INFORMED CONSENT (19-26)
racial/ethnic backgrounds should not be restricted without medical or scientific justification.
6.
7.
Vulnerable Subjects: Will any vulnerable subjects be included? If so, identify the subject groups and justify
their involvement.
Examples of vulnerable subjects: children, elderly, pregnant women, fetuses, cognitively impaired individuals,
persons with severe psychological disorders, terminally ill patients, emergency patients, institutional residents,
prisoners, parolees, non-English speaking subjects, and NEOMED/COP students/staff.
SUBJECT IDENTIFICATION AND RECRUITMENT (7)
Method of Subject Identification and Recruitment: What method(s) will be used to identify and recruit
prospective subjects? Attach a copy of any planned advertisements/notices and letters to potential subjects.
Note: The identification and recruitment of subjects must be ethically and legally acceptable and free of
coercion. Procedures used to recruit subjects should be designed to reach diverse populations. Vulnerable
subjects, such as persons in nursing homes or institutions, should not be recruited merely for the sake of
convenience.
8.
METHODS AND PROCEDURES (8-10)
Methods and Procedures Applied to Human Subjects: Describe the study design and all procedures
(sequentially) to which human participants will be subjected. Identify all procedures that are considered
experimental and/or procedures performed exclusively for research purposes.
9. For Research Involving Survey, Questionnaires, etc.: Describe the setting and mode of administering the
instrument (e.g., by telephone, one-on-one, e-mail or group) and the provisions for maintaining privacy and
confidentiality. Include the duration, intervals of administration, and overall length of participation.
Note: If the protocols for the interviews or the questionnaires are not yet designed, provide a sample of the
questions or describe the subject matter to be covered. (If the instrument has been prepared even in draft form,
submit a copy.) The final survey instruments or questionnaires must be reviewed and approved by the IRB
before they may be used.
10. Data Collection, Storage and Confidentiality:
a) How will data be collected and recorded? Will it be associated with personal identifiers or coded to
protect personal privacy?
b) Where will the data be stored during the study and how will it be secured?
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c)
Who will have access to the data and/or to the codes? If data with subject identifiers will be released,
specify the person(s) or agency to whom this information will be released.
d) What will happen to the data when the research has been completed?
Note: The principal investigator is responsible for taking all necessary steps to maintain confidentiality of data.
This includes coding data and choosing an appropriate and secure data storage mechanism that will prevent
unauthorized access to the data. Where appropriate, the principal investigator should seek a certificate of
confidentiality from the federal government.
RISK/BENEFIT ASSESSMENT (11-15)
11. Potential Risks and Discomforts: What are the potential risks/discomforts associated with each intervention or
research procedure? If data are available, estimate (a) the probability that a given harm may occur, (b) its
severity, and (c) its potential reversibility.
Note: A risk/discomfort is a potential harm associated with the research that a reasonable person would
consider important in deciding whether to participate in the research. Risks can be generally categorized as
physical, psychological, sociological, economic and legal.
12. Risk Classification: What is the overall risk classification of the research: minimal, greater than minimal,
significant, or unknown?
Note: According to HHS/FDA Regulations minimal risk means "The probability and magnitude of harm or
discomfort anticipated in the research are not greater in and of themselves than those ordinarily encountered in
daily life or during the performance of routine physical or psychological examinations or tests." When the risks
associated with a new procedure or product is unknown, they cannot be classified as “minimal.” Your
estimation of risk determines the Emergency Care and Compensation for research-related Injury clause in the
informed consent form.
13. Minimizing Risks: What procedure(s) will be utilized to prevent/minimize any potential risks or discomfort?
Note: All potential risks and discomfort must be minimized to the greatest extent possible by using procedures
such as appropriate monitoring and withdrawal of the subject upon evidence of a specific adverse event or
clinical sign(s). This section should reflect that all appropriate steps will be taken to protect subjects from
harm.
14.
Potential Benefits:
a) What potential benefits may subjects receive as a result of their participation in the research?
b) What potential benefits to society may be expected from this research?
Note: Societal benefits generally refer to the advancement of medical knowledge and/or possible benefit to
future patients
15. Risk/Benefit Ratio: What is the risk/benefit ratio of the research, compared with that of the available
alternatives?
Note: The potential benefits of research must justify the risks to human subjects. Some risks may not be
reasonable, no matter how important the potential benefits. The risk/benefit ratio of the research must be at
least as favorable for the subjects as that presented by standard treatments for their condition. When
comparing the risk/benefit ratio of research with that of available alternatives, the alternative of doing nothing,
or “watchful waiting,” should be included in the analysis.
FINANCIAL CONSIDERATIONS (16-18)
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16. Payment for Participation: Describe all plans to pay subjects, in cash or in kind. If no payment is planned,
that should be stated. Information regarding payment consideration should include: Will they receive services
or other benefits instead of cash? Will they be reimbursed for travel and other expenses? What conditions must
be fulfilled by subjects to receive either full or partial payment?
Note: The amount of payment must be justified and not constitute undue inducement of the subject to
participate in the research.
17. Financial Obligations of the Subjects: What financial obligations will subjects incur as a result of
participating in the study? Will subjects have to pay for any of the treatment(s) they receive or tests performed
in the research?
Note: This section should clarify who will pay for procedures associated with the study as well as financial
responsibility for routine clinical care (e.g., Diagnostic tests, hospitalization, follow-up). Insurance and other
third party payers may not cover procedures associated with participation in research (even if they might have
paid for some of the procedures in connection with standard therapy). Consequently, subjects’ costs may be
increased as a result of additional follow-up examinations and/or tests required by the research.
18. Emergency Care and Compensation for Research-Related Injury: If the research presents greater than
minimal risk, what emergency care is available in case of research-related injury? Who will be responsible for
the cost of such care? Will subjects be compensated for out-of-pocket expenses or lost wages if they suffer a
research-related injury?
19.
Are you requesting a waiver of documented, written consent? (IRB’s can choose to waive written consent but are not
required to)
Yes
No
An IRB may waive the requirement for the investigator to obtain a signed consent form for some or all subjects if it
finds either: (Please circle the correct reason for waiver.)
(1) That the only record linking the subject and the research would be the consent document and the principal
risk would be potential harm resulting from a breach of confidentiality. Each subject will be asked whether the
subject wants documentation linking the subject with the research, and the subject's wishes will govern; or
or
(2) That the research presents no more than minimal risk of harm to subjects and involves no
procedures for which written consent is normally required outside of the research context.
20. Capacity to Consent: Will all adult subjects have the capacity to give informed consent? If not, describe the
likely range of impairment and explain how, and by whom, their capacity to consent will be determined.
Note: In research involving more than minimal risk, capacity to consent should be determined by a psychiatrist,
clinical psychologist, or other qualified professional not otherwise involved in the research. Individuals who
lack the capacity to consent may participate in research only if consent is given on their behalf by a legally
authorized representative.
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21. Personnel Inviting Participants: Who will be inviting subjects to participate and what will they say? Identify
by name and training the individual(s) authorized to describe the research to subjects/representatives and to
invite their participation.
Note: Only those individuals authorized to solicit consent may sign the consent form confirming that the
prospective subject was provided the necessary information and that any questions asked were answered.
22. Process of Consent: How and where will the consent process take place? How will it be structured to enhance
independent and thoughtful decision-making? What steps will be taken to avoid coercion or undue influence?
Note: Consider: a) the environment and location where informed consent will be solicited; b) the timing of the
process (e.g., in relation to hospital admission, surgery, medication, stressful events); c) the involvement of
someone other than the investigators to help explain the research; and d) opportunity for the prospective
subjects/representatives to discuss participation in the research with family, friends, or their advisors before
signing the consent form.
23. Comprehension of the Information Provided: How--and by whom--will it be determined whether the
subjects or their legally authorized representatives understand the information provided?
Note: This section should clearly document that the investigator has an adequate plan in place to assure
existence of an acceptable level of comprehension before consent is documented. The principal investigator (or
approved designee) is responsible for assuring that prospective subjects or their representatives have sufficient
understanding of the research to make an informed decision about participation. It is important that they
understand the purpose of the research, the nature and duration of the procedures, any risks and discomforts
involved, the possible benefits to the subjects and others, and their right to withdraw consent at any time
without penalty. Willingness to sign the consent form is not an adequate demonstration of their understanding.
Some investigators try to determine the level of prospective subjects’ comprehension by questioning them about
the research. (This approach is useful with children and adolescents, as well as with adults of uncertain
capacity to consent.)
24. Information Withheld From Subjects: Will any information about the research purpose and design be
withheld from potential or participating subjects? If so, explain and justify the non-disclosure and describe
plans for post-study debriefing.
Note: Any non-disclosure must be approved by the IRB and may not exclude information that a reasonable
person would want to know in deciding whether to participate in the research. In addition, the alteration in the
consent procedure must be approvable under 45 CFR 46.116(d): (1) the research involves no more than
minimal risk to the subjects; (2) the waiver or alteration will not adversely affect the rights and welfare of the
subjects; (3) the research could not practicably be carried out without the waiver or alternation; and (4)
whenever appropriate, the subjects will be provided with additional pertinent information after participation.
25. Consent/Assent Forms: Specify the form(s) that will be used among the following: adult consent form,
parental consent form and/or child assent form (age 7-12).
26. Informed Consent:
a) If personal identifiers may be recorded, will the subjects be consented for the involvement of their data in the
research?
(If yes, attach a copy of an informed consent. If no, please answer.b)
b) Provide justifications to the following questions for requesting a waiver of informed consent:
i) Why does the proposed use of data present no more than minimal risk to the subjects?
ii) Why could the research not practicably be carried out without the waiver of informed consent?
iii) Why will a waiver of informed consent not adversely affect the rights and welfare of the subjects?
iv) How will pertinent information be provided to the subjects, if appropriate at a later date?
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