 
Institutional Review Board Handbook // 4  
     
    TABLE OF CONTENTS 
 
Section I: Principles of Research Involving Human Participants .......................................................................6 
Statement of Ethical Principles .......................................................................................................................6 
Section II: Institutional Review Board General Information ..............................................................................7 
Membership ....................................................................................................................................................7 
Terms of Service .............................................................................................................................................7 
Training in Human Participants’ Protection ...................................................................................................7 
Responsibilities of IRB Chair .........................................................................................................................8 
Meeting Dates and Times ...............................................................................................................................8 
Meeting Procedures ........................................................................................................................................8 
Evaluation Quorum .............................................................................................................................8 
Order of Business ................................................................................................................................8 
Actions.................................................................................................................................................9 
Closed Meetings ..................................................................................................................................9 
Voting ..................................................................................................................................................9 
Conflict of Interest ..............................................................................................................................9 
Minutes ................................................................................................................................................9 
Meeting with the IRB ..........................................................................................................................9 
Actions by the IRB..........................................................................................................................................9 
IRB Records ..................................................................................................................................................10 
  Section III: Submission Procedures ..............................................................................................................11 
Global Campus Full-Time Faculty and Staff ................................................................................................11 
Global Campus Doctoral Students ................................................................................................................11 
Criteria for Review (HHS §46.102 Definitions) ...........................................................................................12 
1-No Risk ...........................................................................................................................................12 
2-Minimal Risk ..................................................................................................................................12 
3-Moderate Risk ................................................................................................................................12 
4-High Risk .......................................................................................................................................12 
Levels of IRB Review ...................................................................................................................................12 
Exempt Research ...............................................................................................................................12 
Expedited Research ...........................................................................................................................14 
Full Board Research .........................................................................................................................14 
Continuing Review .......................................................................................................................................15 
Changes to Approved Research ....................................................................................................................15 

 
Institutional Review Board Handbook // 5  
     
Regulations and References ..........................................................................................................................15 
Documentation Required for IRB Review ....................................................................................................16 
Section IV: Data Collection ..............................................................................................................................17 
Informed Consent..........................................................................................................................................17 
Subject Recruitment ......................................................................................................................................21 
Cultural Considerations ................................................................................................................................22 

Institutional Review Board Handbook // 6

SECTION I: PRINCIPLES OF RESEARCH INVOLVING HUMAN

PARTICIPANTS

The University of Arizona Global Campus is committed to the highest ethical standards in the conduct of research.

For projects involving humans as participants, Global Campus is guided by the ethical principles set forth in the

Declaration of Helsinki, the National Commission for the Protection of Human Participants of Biomedical and

Behavioral Research’s Ethical Principles, and Guidelines for the Protection of Human Participants of Research:

The Belmont Report. In addition, Global Campus is committed to ensuring that all human participant research,

regardless of funding source, follows the requirements set forth in Title 45, Part 46 of the Code of Federal

Regulations.

The IRB Policies and Procedures apply to all research involving human and vertebrate participants (including but

not limited to all mammals, reptiles, birds, fish, etc.), funded or non-funded, sponsored or not sponsored, and

carried out by UAGC students, faculty, and staff, on or off campus.

STATEMENT OF ETHICAL PRINCIPLES

The following broad principles are the basis for the University of Arizona Global Campus policy concerning

review of research involving humans:

• Whereas the participation of humans in research projects may raise fundamental ethical and civil rights

questions, all such research, funded and unfunded projects, sponsored and not sponsored, which is

carried out by Global Campus students, faculty, and staff, on or off campus, shall be covered by the

University of Arizona Global Campus Institutional Review Board (hereinafter referred to as IRB) for the

Protection of Human Participants in Research Policies and Procedures covered by this document.

• All activities involving human participants must provide for the rights, safety, health, and welfare of

each individual participant.

• The direct or potential benefit to the participant and the importance of the knowledge gained must

outweigh any inherent risk to the individual.

• Participation in research must be voluntary and informed consent procedures must conform to the IRB

Policies and Procedures.

• An individual does not abdicate any rights by consenting to be a research participant. A participant has

the right to refuse to participate or may withdraw from research at any time without penalty or loss of

benefits to which the participant would otherwise be entitled.

• Safeguarding information about an individual that has been obtained in the course of an investigation is

a primary obligation of the principal investigator.

• The primary responsibility for protection of human participants rests with the principal investigator and

with support, approval, and monitoring by Global Campus as set forth in the IRB Policies and

Procedures.

Institutional Review Board Handbook // 7

SECTION II: INSTITUTIONAL REVIEW BOARD GENERAL

INFORMATION

The purpose of the University of Arizona Global Campus IRB is to ensure ethical research practices among its

students, faculty, and staff. Individuals affiliated with Global Campus who are conducting research projects must

receive approval from IRB before commencing the study.

MEMBERSHIP

The IRB shall have one chair and at least twelve members one of which is unaffiliated with Global Campus, of

the remaining members representatives from each of the two colleges (Forbes School of Business and

Technology™ and College of Arts and Sciences), with varying backgrounds, to promote complete and adequate

review of research activities. The Senior Vice President of Academic Affairs (SVPAA) in conjunction with the

chair shall appoint members of the IRB. The chair is a voting member of the IRB and will be appointed by the

SVPAA. The IRB shall be sufficiently qualified through the experience and expertise of its members; their

diversity, including consideration of race, gender, and cultural backgrounds; sensitivity to issues such as

community attitudes; and promoting respect for its advice and counsel in safeguarding the rights and welfare of

human participants. Members must also possess the necessary professional competence to review specific

institutional commitments and regulations, applicable law, and standards of professional conduct and practice.

IRB members shall be full-time faculty and identified consultants with expertise in the field. Every effort will be

made to ensure that the members of the IRB represent diverse backgrounds. The IRB shall not consist of members

of a single profession or discipline. In order to comply with requirements for National Institute of Health or other

funded proposals, the IRB may agree to add additional permanent or temporary members or consultants to review

funded proposals. All IRB members maintain active Human Subjects and IRB Member training certificates

supported by the NIH and OHRP.

The IRB chair shall be appointed by the SVPAA, and is a voting member of the IRB. Members of the IRB shall

be appointed by a joint effort between the chair and the SVPAA for terms of service of two years. Members may

serve consecutive terms as determined by the SVPAA and IRB chair. Terms start the first of appointment and end

two years later.

TRAINING IN HUMAN PARTICIPANTS’ PROTECTION

All IRB members, faculty, sponsors, principal investigators, and supporting investigators planning to submit or

sponsor a proposal to the IRB are required to complete the NIH CITI online training in human participant’s

protection, which can be accessed electronically at: https://about.citiprogram.org/en/homepage/. Once registered

select ‘Social Behavioral Educational Research Investigators’ or SBER. A Completion Certificate, obtained at

the conclusion of this training, must be included in the Request for IRB Review and must remain active through

the entirety of the IRB review and approval, otherwise recertification will be required. More information on the

process can be obtained by contacting the IRB at [email protected].

For students submitting applications to the UAGC IRB the following certifications are required:

Institutional Review Board Handbook // 8

1. Copy of the CITI Completion Report for the two required CITI certifications (Student [HSR SBE];

Student [IPS]), with:

a. Overall passing score of at least 90% for each required set of modules, and

b. The expiration date for each module does not expire prior to the end of the 12-month IRB

approval period.

RESPONSIBILITIES OF IRB CHAIR

The chair shall:

• Schedule and lead all meetings of the IRB;

• Notify members of meetings;

• Assign cases for review as appropriate;

• Arrange for subject matter experts as needed;

• Ensure the timely disposition of all requests; and

• Appoint a secretary who will be responsible for meeting minutes and maintaining records.

MEETING DATES AND TIMES

The IRB meetings are held when deemed necessary by the chair. Contact the IRB chair for a current schedule.

The IRB chair may convene additional meetings as necessary to handle business. Members must be notified at

least 72 hours in advance of any such meetings and attendance should be seen as mandatory.

MEETING PROCEDURES

Evaluation Quorum

No risk or minimal risk proposals may be evaluated by a majority of the IRB, the IRB chair, or a committee

member appointed by the chair. Whenever possible, the appointed committee member will have competence in

the research area of the proposal. When moderate or higher risk proposals are considered, an IRB meeting will

be scheduled and a majority of IRB members must evaluate the proposal prior to obtaining approval. The chair

may appoint outside reviewers to evaluate a proposal as needed. Outside reviewers, except in legal matters, must

have a doctorate from an accredited institution in a field related to the proposal, and submit a curriculum vitae

(CV) and supporting documents to the chair. For a vote to pass, a quorum must be achieved (at least 7 IRB

Committee Members) and a majority ’aye’ vote must occur.

Order of Business

The agenda for IRB meetings shall be determined by the chair, and may include the following:

• Review of and action on minutes of previous meetings.

• Old and new business related to IRB functioning.

• Review and discussion of, and action, on (a) new proposals (in order of submission), (b) continuing

proposals, and (c) substantive changes to previously approved proposals.

• Other business.

Actions

Institutional Review Board Handbook // 9

Proposals shall be approved, approved with conditions, disapproved, or tabled until a specified future date by

majority vote of those members present.

Closed Meetings

To preserve the autonomy of the IRB and its decisions, IRB meetings are typically closed, as long as such closure

is not in conflict with 45 CFR Part 46 or other applicable Federal, State, or local law and regulations.

• Anyone may speak for or against a proposal, but remarks must be based only on the Criteria for

Approval as stated for each criterion of the IRB paperwork.

o The chair may limit the duration of comments or the number of speakers for and against a

proposal to serve the best interest of committee functioning.

o Written comments received by the chair prior to the meeting will be read into the minutes or

distributed and appended to the minutes, insofar as they address the Criteria for Approval.

• The IRB chair may invite individuals with competence in special areas to assist in the review of issues

that require expertise beyond or in addition to that represented by the regular IRB members.

Voting

Only IRB members may vote.

Conflict of Interest

IRB members, and persons speaking or submitting written comments, must declare any potential conflict(s) of

interest in advance. Members may speak for, but may not vote on their own proposals, proposals of students they

are sponsoring, or any proposal in which an IRB member is or is likely to be a participant. Written comments

shall explicitly address any conflict of interest or its absence (in the event of a perceived conflict of interest that

could be addressed for clarity).

Minutes

The secretary of the IRB will keep minutes of the proceedings. The minutes must show attendance; actions taken

by IRB; the vote on these actions including the number of members voting for, against, and abstaining; the basis

for requiring changes in or disapproving research; and a written summary of the discussion of controversial issues

and their resolution.

Meeting with the IRB

A meeting between the IRB and the faculty, staff, or student proposing a dissertation/ADP may be required only

in cases of a Full Board Review, at the discretion of the IRB. The meeting, if required, will take place via

teleconference. Exempt and Expedited Reviews do not necessitate that the PI meet with the Board. In cases of an

Exempt or Expedited Review, the PI may proceed with solicitation of participants and data collection after

receiving the formal IRB Approval Letter from the IRB Chair. Following a Full Board Review, the IRB will take

one of the following actions regarding the proposal: “approved,” “approved with conditions,” “deferred,” or

“disapproved.” Details regarding the possible actions are found below.

ACTIONS BY THE IRB

The following are the possible actions the IRB can take following a review of an IRB proposal.

Approved. The IRB will provide the principal investigator a letter indicating the start date and end date of the

Institutional Review Board Handbook // 10

approval. If the researcher anticipates that the research will not be completed by the expiration date, the researcher

should submit a Request for Renewal form, see the University of Arizona Global Campus IRB Forms page.

Approved with Conditions. IRB requests that are approved with conditions necessitate that revisions,

clarifications, or additional documents that address the issues raised by the IRB be submitted to the IRB. The IRB

will also provide a list of documents required for resubmission. The IRB Chair may act on revisions, depending

on the extent of them. The investigator must wait for written notification of approval after revisions are

made before proceeding with solicitation of participants and data collection.

Deferred. A deferred decision is rendered when insufficient information is provided or the meeting fails to meet

a quorum.

Disapproved. Applications are disapproved if the research does not meet the criteria for protecting participants

and substantial changes would be required. No IRB request will be disapproved until it has been reviewed in

accordance with the full review procedures set forth in this document. If the IRB disapproves a request for review

of a research study, a written statement of the reasons for its decision will be given to the principal investigator.

The principal investigator will have an opportunity to respond in person or in writing. Review of a previously

disapproved protocol requires a Full IRB review.

Parallel IRB and Organization Permission. If approval of another IRB is required for a study to proceed, this

University’s IRB will generally review the proposal first and, when satisfied with the proposal, will “approve

with conditions” the study with the only condition being that the researcher secures the necessary permission(s)

from the other IRB(s). Once permission from the other IRB(s) has been obtained and submitted to this

University’s IRB, a full Approval Letter will be issued. The researcher can share that full approval with the other

IRB if the other IRB(s) desires to have a copy it.

IRB RECORDS

The secretary of the IRB shall keep the following documentation of IRB activities on file for at least three years:

• Written procedures for the IRB.

• A list of IRB members including name, earned degrees, representative capacity, indications of

experience such as board certifications, licenses, etc., sufficient to describe each member’s chief

anticipated contributions to IRB deliberations, CITI certifications, and employment or other relationship

between each member and the institution.

• Minutes of IRB meetings.

• Copies of all proposals received, scientific evaluations (if any) that accompany the proposals, copies of

all internal and external correspondence related to each submitted proposal, approved sample consent

documents, progress reports submitted by investigators, and reports of injuries to participants (if any).

• Copies of all correspondence between the IRB and the principal investigator for any study.

• Records of continuing review activities.

• Updating and maintaining the IRB repository.

• Statements of significant new findings provided to participants as required by the consent documents.

Institutional Review Board Handbook // 11

SECTION III: SUBMISSION PROCEDURES

GLOBAL CAMPUS FULL-TIME FACULTY AND STAFF

All faculty and staff proposals to conduct research must be submitted to Global Campus IRB. If the research

involves Global Campus students, faculty, or staff, approval from the college dean(s) impacted as well as the

Office of Research and Creative Scholarship (ORCS) may be required. The investigator must obtain IRB

approval before undertaking the research and beginning data collection, to do so without approval would

constitute research misconduct. Following successful completion of CITI training, proposals must be submitted

to the chair, or to a person appointed by the chair to receive proposals. As noted previously, all principal

investigators submitting proposals must undergo training as outlined above and submit the following

documentation: Request for IRB Review for Faculty (cover sheet), Research Summary, CITI Certificate, and all

supporting documents (surveys, questionnaires, interview questions, College Dean approval (if appropriate),

ORCS approval (if appropriate), and an Informed Consent form).

• Proposals should be submitted electronically in PDF format (Word files can be easily ‘Saved As’ a PDF

file) and sent to [email protected].

• All files must be saved using the same format for each file (Last Name, First Name, Name of

Document).

o Smith John Research Summary

• File names should not include any special characters (e.g. & #).

GLOBAL CAMPUS DOCTORAL STUDENTS

All student investigators must submit a Request for IRB Review for Students cover sheet regardless of whether

human participants are used in the study. Students who have passed their Preliminary Oral Defense should

submit the Request for IRB Review for Students form with supporting documentation to the IRB Chair. Please

note, students are not permitted to submit any research proposals that require Global Campus or former

University of the Rockies student or faculty data.

• Proposals should be submitted electronically in PDF format (Word files can be easily ‘Saved As’ a PDF

file) and sent to [email protected].

• All files must be saved using the same format for each file (Last Name, First Name, Name of

Document).

o Smith John Research Summary

• File names should not include any special characters (e.g. & #).

Supporting documentation included with the Request for IRB Review for Students (cover sheet) should always

include a Research Summary that follows the prescribed outline, see the University of Arizona Global Campus

IRB Forms page for exemplar and template, and a copy of the principal investigator’s CITI completion report

(see above). Other supporting documentation may include: a signed Organizational Permission form for

permission to access participants or data or use the premises; an unsigned sample Informed Consent Form; an

Institutional Review Board Handbook // 12

unsigned sample Assent Form; all data collecting instruments (such as a survey or an interview script). The

format for submission of these documents is specified in Instructions for IRB Application.

The investigator must obtain IRB approval before undertaking the research and beginning data collection.

Absolutely no solicitation of human participants or data access or collection may occur prior to IRB approval.

CRITERIA FOR REVIEW (HHS §46.102 DEFINITIONS)

Research proposals submitted to the IRB are evaluated with respect to the safety and protection of subjects

according to the following levels of risk or danger to study participants. The primary task of the IRB is to weigh

the actual or potential risks posed to participants against the possible benefits of the proposed research to the

scientific community.

1-No Risk

Research participants face no physical or psychological stressors. An example of a no risk study would be a

proposal to collect and analyze existing data sources with no human subject interaction.

2-Minimal Risk

Minimal risk (most common) means that 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.

3-Moderate Risk

Research participants face moderate physical or psychological stressors beyond those encountered in daily

life. The potential benefits of the research must outweigh potential risks to study participants.

4-High Risk

Research participants face severe physical or psychological stressors beyond those encountered in daily life,

which may have sustained, lasting effects. The potential benefits of the research must outweigh potential risks

to study participants.

LEVELS OF IRB REVIEW

Exempt Research

Research in this category involves risks or stressors that are not greater than those ordinarily encountered in

daily life or during the performance of routine physical or psychological examinations. The IRB Chair must

determine that a research study qualifies for an exempt review. Researchers must not proceed with the

research until written IRB approval has been received. Absolutely no solicitation of human participants

or data collection is allowed prior to receipt of IRB approval, including pilot studies.

Action on Exempt Research is generally taken within 5-7 working days of receipt by the IRB Chair or a

Committee Member at their direction. Incomplete requests will be returned.

Research qualifies as Exempt if it falls in one of the following six (6) categories (note that not all types of

research described below are, or are permitted to be, conducted at UAGC):

1. Research conducted in established or commonly accepted educational settings, involving normal education

Institutional Review Board Handbook // 13

practices.

a) Special note for research in schools: In order for a study involving educational research (research

conducted in classrooms) to be reviewed under the Exempt category, the investigator must supply a

letter from the appropriate school district official that certifies that the study meets the following

conditions. The research activities will:

i. Not differ in any significant way from the normal range of activities of the classroom, school,

or district;

ii. Involve only customary and non-controversial instructional goals;

iii. Not deny any students’ educational benefits they would otherwise receive;

iv. Promise direct benefits (at least in the form of evaluative information) to the classroom,

school, or district;

v. Incorporate adequate safeguards to protect the privacy (e.g., anonymity or confidentiality) of

all individuals who might be participants of the research; or

vi. Involve only existing data on students which are not identity-specific.

2. Research involving the use of educational tests (e.g., cognitive, diagnostic, aptitude, and achievement tests),

survey procedures, interview procedures, or observation of public behavior, unless specific individual human

participants can be identified, directly by or through identifiers linked to the participants, and disclosure of their

identity could reasonably place the participants at risk of criminal or civil liability or be damaging to the

participants’ financial standing, employability, or reputation.

3. Research involving the use of educational tests (e.g., cognitive, diagnostic, aptitude, and achievement tests),

survey procedures, interview procedures, or observation of public behavior that is not exempt under category 2

of this section, if the human participants are elected or appointed public officials or candidates for public office,

or federal statute(s) require(s), without exception, that the confidentiality of the personally identifiable

information will be maintained through 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 participants cannot be identified directly or through identifiers linked to the participant.

5. Research and demonstration studies that are conducted by or subjected to the approval of department or

agency heads, and that are designed to study, evaluate, or otherwise examine: a) Public benefit or service

programs; b) Procedures for obtaining benefits or services under those programs; c) Possible changes in or

alternatives to those programs or procedures; or d) Possible changes in methods or levels of services under

those programs.

6. Taste and food quality evaluation and consumer acceptance studies, if wholesome foods without additives are

consumed or if a food is consumed that contains an ingredient at or below the level and for a use 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.

Institutional Review Board Handbook // 14

Expedited Research

To qualify for an expedited review, research must be no more than minimal risk and fall into nine federally-

defined expedited categories. These categories involve collection of samples and data in a manner that is not

anonymous and that involves no more than minimal risk to subjects. Actions on Expedited Research typically

take between 10-14 working days to review. Incomplete applications will be returned. Examples of Expedited

Research include the following:

• Surveys and interviews with collection of identifiers.

• Collection of biological specimens (e.g., hair, saliva) for research by noninvasive means.

• Collection of blood samples from healthy volunteers.

• Studies of existing pathological specimens with identifiers.

Full Board Research

Proposed human subject research that does not fall into either the exempt or expedited review categories must

be submitted for Full Board Review. This is the most rigorous level of review and, accordingly, is used for

research projects that present greater than minimal risk to subjects. The majority of biomedical and protected

population research submitted to the IRB will require Full Board Review. Examples include the following:

• Clinical investigations of drugs and devices.

• Studies involving invasive medical procedures or diagnostics.

• Longitudinal interviews about illegal behavior or drug abuse.

• Treatment interventions for suicidal ideation and behavior.

• Depending upon the research, protected populations can include (Note, those in bold are the most

protected and require additional IRB protections):

o Pregnant women

o Prisoners

o Children

o Individuals with physical disabilities

o Individuals with mental disabilities or cognitive impairments

o Economically disadvantaged

o Socially disadvantaged

o Terminally ill or very sick

o Racial or ethnic minorities

o Institutionalized persons (for example, persons in correctional facilities, nursing homes, or

mental health facilities)

Institutional Review Board Handbook // 15

Incomplete requests will be halted and returned. Action on Full Board Research requires a meeting of the IRB

and generally takes 15 to 25 working days. This level of research is discouraged for Doctoral Students. For

most efficient consideration of the Request for Full Review, all forms and materials must be submitted by the

15th of the preceding month. The IRB will review the submission and provide the researcher a list of concerns

one (1) week prior to the meeting. At the IRB meeting the IRB Chair will facilitate the review of the issues and

the researcher should be prepared to address each one in front of the IRB Committee. The IRB reserves the right

to explore other issues besides those provided to the researcher. Researchers must not proceed with the

research until written IRB approval has been received. Absolutely no solicitation of human participants

or data collection is allowed prior to receipt of IRB approval, including pilot studies.

CONTINUING REVIEW

Federal regulations require re-evaluation of approved research at intervals that are appropriate to the degree of

risk. At the time of its initial review, the IRB will determine the renewal date of the IRB approval. If the

research study is going to continue past the expiration date, then the investigator must submit a Request for

Renewal form. The principal investigator must submit the request for renewal in time for review and approval

by the one-year anniversary date of the previous approval. The researcher should provide all information

requested on the form; incomplete requests will be halted. If a researcher fails to provide continuing review

information to the IRB or the IRB has not reviewed and approved a request for renewal by the continuing

review date specified by the IRB, then the research study may not continue. No enrollment of new participants

or data collection is allowed after the expiration of IRB approval.

The IRB may require continuing review of any research at more frequent intervals than 12 months whenever the

degree of risk justifies such review. Additionally, the IRB has the authority to observe or have a third-party

observe the consent process and the research process for a given study. These third-party observers are required

to comply with confidentiality standards governing the ongoing research.

CHANGES TO APPROVED RESEARCH

Any changes to previously approved research, including, but not limited to, those that may change the

risk/benefit ratio, must be approved by IRB prior to implementing the changes. In addition, the IRB must be

notified of any changes in principal investigator(s) or faculty sponsorship. Principal Investigators must submit

changes in writing to the IRB Chair via the Report of Change form found on the University of Arizona Global

Campus IRB Forms page. Incomplete requests will be halted.

REGULATIONS AND REFERENCES

• Expedited review procedures for certain kinds of research involving no more than minimal risk, and for

minor changes in approved research: DHHS 45 CFR 46.110

• Criteria for IRB approval of research: DHHS 45 CFR 46.111(a)(1-2)

• Code of Federal Regulations Title 21, Section 56.110: FDA 21 CFR 56.110

• Code of Federal Regulations Title 21, Section 56.111: FDA 21 CFR 56.111(a)(1-2)

Institutional Review Board Handbook // 16

DOCUMENTATION REQUIRED FOR IRB REVIEW

IRB Forms and sample documents are available on the University of Arizona Global Campus IRB Forms page.

Submit electronic copies of the following to the IRB chair or appointed IRB representative:

• ORCS approval sheet/email (if using any UAGC data)

• Dean approval email (If using UAGC student data)

• If requesting exempt status (Appendix G)

• A Completed Request for IRB Review (Cover sheet in Appendix

B or Appendix C depending upon status)

• A Research Summary (Appendix F)

• Consent document (sample in Appendix K) and if minors are

participants, assent document (sample in Appendix M).

• If applying for “No Risk” (sample in Appendix I)

• Copies of any and all data collection surveys or instruments

• Copies of approvals from any other IRB or proposed data

collection site, such as a school or business

• All other relevant material

Institutional Review Board Handbook // 17

SECTION IV: DATA COLLECTION

This section is only applicable to those studies in which data is being collected. Data for any study may only

commence after the principal investigator has received an IRB Approval Letter. When conducting research, the

participants must agree to be a part of the research and the privacy and security of their information must be

ensured. If data is being collected a non-disclosure form is required and can be found on the University of

Arizona Global Campus IRB Forms page.

Researchers may not collect data or proceed with their research until they have received written IRB

approval. Collecting data without IRB approval is research misconduct and may result in dismissal from the

institution for faculty, staff, and/or students.

INFORMED CONSENT

An Informed Consent Form signed by each participant (sample provided in Appendix K), or the parent/guardian

of each participant, is normally required for protocols submitted for either expedited or full reviews. It is also

required when participants include vulnerable populations.

For any study in which children up to 17 years (unless emancipated) will be participating, informed consent

must be obtained from their parents/legal guardians (sample provided in Appendix L). Informed assent must be

obtained from minor participants if they are between ages 7 to 17 (see sample provided in Appendix M). An

assent form is a written document used to inform the child of the study using age-appropriate language so

he/she can determine whether or not to participate in the research. An assent form is generally presented to

children over six years of age. If the child is not yet able to read, procedures may be used to present the

information verbally to obtain verbal assent. Certain studies may be exempt from the permission requirement

(e.g., if the research is designed for conditions or for a participant population for which parental or guardian

permission is not a reasonable requirement to protect the participants (e.g., neglected or abused children; Source

45 CFR 46.408). Proposals of research to be conducted in an educational or other institution must include a

letter of approval from the school district, hospital, or other institution.

Informed consent or assent must be obtained before any data can be collected. The informed consent and/or

assent document must contain the following elements:

• Identification of investigator’s name, department, institution, status, mailing address, and telephone

number. If the researcher is a student, the name, address, and telephone number of the Doctoral Research

Chair must be included.

• A statement that the study involves research, an explanation of the purposes of the research and the

expected duration of the participant’s participation, a description of the procedures to be followed, and

identification of any procedures that are experimental. The informed consent form should tell the

potential participant all s/he will encounter, how long it will take, where it will take place, etc. It should

be written at a reading level appropriate for the particular participant. Consent forms should provide a

description of the types of questions to be asked (e.g., “In this study we are exploring whether some

people are ‘at their best’ at different times of the day. We will be asking you questions about your daily

Institutional Review Board Handbook // 18

activities, your personality, and some basic demographic characteristics, such as your age, gender, and

race.”)

• A description of any reasonably foreseeable risks or discomforts to the participant. The following risks,

if foreseeable, must be thoroughly explained:

o When sensitive questions are to be asked, either examples of the most sensitive questions or an

explicit description of these questions should be given (e.g., “We will be asking you questions,

the most sensitive of which might be: Have you ever considered committing suicide? Have you

ever made yourself throw up after a meal? Do you enjoy looking at people of the same sex?”)

o When research gathers information about a participant’s involvement in illegal activities and no

Certificate of Confidentiality is held by the researcher, the researcher must provide a statement

that questions regarding illegal activities will be asked as part of the research study. The

researcher must state in the consent form that the possibility exists, although it is not probable,

that the researcher’s data could be subpoenaed and used against the participant.

o Suspected child abuse/neglect: When applicable, a statement should be included in the consent

form that the researcher may report to appropriate legal authorities known or suspected child

abuse or neglect, and circumstances or conditions which might reasonably result in abuse or

neglect that become apparent as a result of a parent’s participation or their child’s participation in

a research study.

o If the participant incurs or may incur expenses as a result of participating in the project (e.g.,

medical or transportation expenses), the researcher must clearly state whether the participant will

be reimbursed for those expenses or if there will be no reimbursement for participating in the

research.

o In a situation where a participant could be injured while participating in a project, the researcher

must clearly explain any limitations of liability on the part of the researcher.

• A description of any benefits to the participant or to others that may reasonably be expected from the

research. The following benefits, if mentioned, must be accurately described:

o Possible benefits to society: Societal benefits should not be overstated. There may be no direct

benefit to the participant, other than a sense of helping the public at large.

o Payment of participants: Only include information on payment if payment is available. Any

conditions for receiving the payment must be included in the consent form (e.g., if only partial

payment will be made to a participant who withdraws from the study, the researcher must clearly

explain the formula for partial payment). If payment is given to defray the incurred expense of

participation, it must not be coercive in amount or method of distribution.

• A disclosure of appropriate alternative procedures or courses of treatment, if any, which might be

advantageous to the participant. For example, in drug studies the medication(s) may be available through

a family doctor or clinic without the need to volunteer for the research activity.

• A statement describing the extent to which confidentiality of records identifying the participant will be

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maintained. Federal Regulations stipulate that, where appropriate, proposals should include adequate

provisions to protect the privacy of participants and to maintaining the confidentiality of data. When a

proposal does not explain if and how privacy will be maintained, participants cannot know the future

status of their contributions to the study and so they cannot provide truly informed consent. The section

on privacy and confidentiality should include the following statements:

o Explaining how the participant’s participation will either be known, kept confidential, or

anonymous. Anonymity means that there is no way to identify an individual participant’s

responses. Confidentiality implies participants’ identities are known, but will be protected by the

investigator (to the best of his/her ability). For example, if participants sign a consent form and

their names are tied to their responses through a master list of names and code numbers, and in

addition the coded responses are kept in a secure location, the participants’ responses may be

considered confidential, but are not anonymous.

o How individual privacy will be maintained in publications or presentations.

o Explaining what the disposition of audio- or video-tapes will be at the conclusion of the study

(e.g., destroyed, erased, given to participants, used for other purposes, such as advertising a

product or procedure).

o Explaining what the disposition of master lists (linking participants’ names with data) will be at

the conclusion of the study.

o Within the consent form, researchers must clearly state that all research materials will be held for

a period of no more than five years and what will occur with the participant lists, data stored, etc.

It must also be noted that collected data for this research will never be shared with any other

researcher beyond what is publicly published.

• For research involving more than minimal risk, an explanation as to whether any compensation will be

given, whether medical treatments are available if injury occurs and, if so, what they consist of, or where

further information may be obtained. Note that the federal regulations (see CFR 46.102[g]) do not limit

injury to “physical injury.”

• A statement that participation is voluntary, refusal to participate will involve no penalty or loss of

benefits to which the participant is otherwise entitled, the participant may discontinue participation at

any time without penalty or loss of benefits to which the participant is otherwise entitled, and that the

participant has the right to refuse to answer questions.

• Identification of whom to contact for answers to pertinent questions about the research and research

participants’ rights, and whom to contact in the event of a research-related injury to the participant. The

name and email address of the IRB Chair ([email protected]) should be included should the potential

participant wish to contact the IRB, should he or she have questions or concerns.

• All studies funded by federal agencies which require demographic information about gender and

race/ethnicity must include the following statement: “This study is being funded by a federal agency

which requires that data be collected in a form that may be analyzed for differences between men and

women and races or ethnic groups.”

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When appropriate, one or more of the following elements of information shall also be provided to each

participant:

• A statement that the particular treatment or procedure may involve risks to the participant (or to the

embryo or fetus, if the participant is or may become pregnant) which are currently unforeseeable;

• Anticipated circumstances under which the participant’s participation may be terminated by the

investigator without regard to the participant’s consent;

• Any additional costs to the participant that may result from participation in the research;

• The consequences of a participant’s decision to withdraw from the research and procedures for orderly

termination of participation;

• A statement that significant new findings developed during the course of the research which may relate

to the participant’s willingness to continue participation will be provided to the participant; and

• The approximate number of participants involved in the study.

An investigator shall seek such consent only under circumstances that provide the prospective participant or the

representative sufficient opportunity to consider whether or not to participate and that minimize the possibility

of coercion or undue influence. The information that is given to the participant or the representative shall be in

language understandable to the participant or the participant’s representative.

No informed consent, whether oral or written, may include any exculpatory language through which the

participant or the representative is made to waive or appear to waive any of the participant’s legal rights, or

releases or appears to release the investigator, the sponsor, the institution or its agent from liability for

negligence.

The IRB may approve waiver of the requirement of a signed consent form in the following cases:

• The only record that links the participant to the research is the signed consent form, and the principal

risk to the participant would be a breach of confidentiality. In this case, participants must be asked if

they want to sign a consent form that links them to the research.

• The research presents no more than minimal risk of harm to the participants and the research involves no

procedures for which written consent would be required outside of the research context. If the research

involves more than “minimal risk,” then no waiver or alteration of informed consent is allowed.

• The research could not practicably be carried out with the waiver or alteration.

In these cases, the IRB may require the investigator to provide participants with information sheets to retain

(e.g., an information letter that contains the information normally included in a consent form, but with no

signature line).

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SUBJECT RECRUITMENT

Use of University Imagery and Logos

The University of Arizona Global Campus and its IRB do not permit the use of its imagery or logo in any

recruitment materials. If the researcher has received an IRB Approval Letter, then the use of the University logo

is permitted on the consent form and data collection materials.

Recruitment of Students, Employees, Friends, and Family

The federal regulations do not specifically mention the inclusion of students, employees, friends, and family

members in research, but their designation as a special population stems from 45 CFR 46.111(b):

“When some or all of the subjects are likely to be vulnerable to coercion or undue influence, such as children,

prisoners, pregnant women, mentally disabled persons, or economically or educationally disadvantaged persons,

additional safeguards have been included in the study to protect the rights and welfare of these subjects.”

As a general rule, the IRB disapproves of recruiting employees, students, friends, or family members as a

targeted population, merely for the sake of convenience or because of their easy availability.

Research participants should be recruited through general announcements, bulletin/message board postings or

advertisements, rather than individual solicitations. Investigators seeking to target students, friends, and/or

employees, including study team members, for enrollment must describe in their IRB application how they will

avoid creating the perception that participation in the research by a student, friend, or employee will favorably

influence the participant’s professional or academic career. Investigators must stress that the student/employee’s

performance evaluations, job advancement, relationship, or grades will not be influenced by participation or

lack of participation in the research study. As appropriate, the IRB may require language to that effect in the

informed consent document.

Any investigator wishing to enroll one of the groups discussed in this policy must obtain specific IRB approval

for their inclusion. The following elements must be discussed in the research summary, for initial reviews, or in

an amendment for an ongoing study:

• Precise description of the group or individual(s) to be enrolled;

• Relationship of the group or individual(s) to the study team, including supervisory relationships;

• Importance of including this group or individual(s) in the study;

• Who will consent the group or individual(s) and how the possibility of coercion will be minimized; and

• Process for ensuring objective analysis of study results, particularly for friends and family members.

Organizational Permission Forms

Organizational Permission forms allow for permission to access participants or data or use the premises, for

recruitment, data collection, or analyses. The fastest growing area of recruitment is via social media. Given the

organizational structure of social media this is understandable, but it must be known that groups and

organizations on social media are afforded the same protections as any other private entity. If a researcher

wishes to recruit from a company, institution, organization, private server, private email list, or social media

group signed Organizational Permission forms are required and the Authorizing Person must be in a position to

Institutional Review Board Handbook // 22

grant such permissions.

CULTURAL CONSIDERATIONS

In some cultures, an investigator may enter a community to conduct research or approach prospective

participants for their individual consent only after obtaining permission from a community leader, a council of

elders, or another designated authority. Such customs must be respected. In no case, however, may the

permission of a community leader or other authority substitute for individual informed consent. In some

populations, the use of a number of local languages may complicate the communication of information to

potential participants and the ability of an investigator to ensure that they truly understand it. Investigators

should develop culturally appropriate ways to communicate information that is necessary for adherence to the

standard required in the informed consent process. They should describe and justify in the research protocol the

procedure they plan to use in communicating information to participants. When consent forms need to be

translated into different languages, the IRB will need to see copies of those translated forms, along with

evidence (through back translation) that the pertinent information has been included.