Appendix A

ABOUT THE OFFICE

Grand Canyon University Institutional Review Board (GCU IRB) has responsibility for the review of research involving human subjects for GCU College of Doctoral Studies, College of Education, College of Nursing and Health Care, Colangelo College of Business, College of Science, Engineering and Technology, College of Theology, College of Humanities and Social Sciences, and College of Fine Arts and Production. The GCU IRB Office consists of two full-time staff under the Office of Research and Dissertations, one Institutional Official, and 19 Board Members.

What is IRB?

The Institutional Review Board (IRB) ensures that all research conducted under the purview of Grand Canyon University meets the highest ethical standards, complies with the federal regulations for the protection of human participants in research (45.CFR.46)

The IRB provides timely and efficient processing, review, monitoring, tracking, and reporting of all research protocols and IRB activities, and ensures that all research conducted by researchers within the GCU community meets the following requirements:

• Protects human participants
• Develops and sustains an ethical research environment
• Assures that researchers are qualified
• Assures that research has the potential to add value to the academic community and society

Why IRB Review?

The IRB at Grand Canyon University is registered with The Department of Health and Human Services, Office of Human Research Protections, and has gained the status of Federal-wide Assurance, which assures that the GCU community of researchers abides by the Code of Federal Regulations, Title 45, Part 46 (45.CRF.46).

• The National Research Act, passed by Congress in 1974, established the National Commission for the Protection of Human Subjects of Biomedical and Behavioral Research. The purpose of the Commission is to ensure that the rights and well-being of human subjects involved in research are protected. Therefore, any institution that engages in or supports research must establish an Institutional Review Board (IRB) for the purpose of approving and monitoring research according to Federal Policy such that human subjects are protected during all phases of the research process.
• Belmont report - On July 12, 1974, the National Research Act (Pub. L. 93-348) was signed into law, there-by creating the National Commission for the Protection of Human Subjects of Biomedical and Behavioral Research. The Belmont Report explains the unifying ethical principles that form the basis for the National Commission’s topic-specific reports and the regulations that incorporate its recommendations. The Belmont Report identifies three fundamental ethical principles for all human subject research – respect for persons, beneficence, and justice. Those principles remain the basis for the HHS human subject protection regulations.
• Ethical principles
  • Respect for persons - autonomy and protection
  • Beneficence - do no harm, maximize benefits and minimize hazards
  • Justice - equality in distribution of benefits and burdens

IRB Review Categories

There are three categories of IRB review. These categories are based on federal regulations, and relate to the degree of risk to research participants. If you have questions about the categories of review, contact the Office of Academic Research and IRB at 602-639-7804.
http://www.hhs.gov/ohrp/policy/protocol/index.html

What kind of study do I have?

Exempt Study/Review

Federal regulations limit the categories of research that qualify for exemption. The IRB is responsible for determining that the research qualifies for exempt review.

The majority of research studies that qualify for exempt review involve the use of anonymous existing data or specimens. Anonymous means the study information can never be linked to identifiers. Data that are coded and linked to name, record number, social security number or other identifiers do not qualify for exempt review status. Information regarding privacy can be found here.

Exempt Research

The Department of Health and Human Services (DHHS) regulations apply to all research involving living human subjects, but there are some categories of research that the government exempts from IRB review. The research that falls into these special categories is subject to the institutional policies of the Grand Canyon University (GCU). To qualify as an exempt study, the research must fall within one of the specific governmental categories AND satisfy the other regulatory and GCU institutional exceptions.

The GCU IRB will make the exemption determination, not the principal investigator. Any study that the GCU IRB believes is not exempt must receive either expedited or full review by the GCU IRB.

Additional FAQ’s from Office of Human Research Protection regarding Exempt Research:
For more detailed and specific information on Exempt Review Procedure please log into the DC Network. Located in the Research/Dissertation tab > Institutional Review Board (IRB) > 4. IRB Policy and Procedures > Click on Policy for Procedure for Exempt, Expedited and Full IRB Review

Expedited Study/Review

Certain types of studies that involve only minimal risk to research participants may qualify for expedited review. The majority of research studies that qualify for expedited review involve the use of confidential records, data or specimens, that exist (on the shelf) at the time of IRB approval. The IRB Chairperson and/or a designated IRB member conduct expedited reviews based on the written materials provided by the researcher. One copy of the Research Protocol Proposal Form should be submitted to Office of Research Integrity – Human Subjects Research.

Expedited Research

Research activities that (1) present no more than minimal risk to human subjects, and (2) involve only procedures listed in one or more of the following categories, may be reviewed by the IRB through the expedited review procedure authorized by 45 CFR 46.110 and 21 CFR 56.110. The activities listed should not be deemed to be of minimal risk simply because they are included on this list. Inclusion on this list merely means that the activity is eligible for review through the expedited review procedure when the specific circumstances of the proposed research involve no more than minimal risk to human subjects.

For more detailed and specific information on Expedited Review Procedure please log into the DC Network. Located in the Research/Dissertation tab > Institutional Review Board (IRB) > 4. IRB Policy and Procedures > Click on Policy for Procedure for Exempt, Expedited and Full IRB Review

Full Board Study/Review

Studies with increased levels of risk, and those studies involving vulnerable populations are reviewed via the full review board. The full review board meets monthly. Submission dates are due by the 4th Wednesday of every month, and full board review will meet on the 2nd Wednesday of every month. Submit one copy of the complete protocol package by the protocol due date. You will be contacted if additional copies are needed.

For more detailed and specific information please visit DC or IRBNet. Additional questions and information, please first contact your chair. If the chair needs additional assistance the Chair should contact the Office of Academic Research at 1-602-639-7804 or by e-mail at [email protected].

What is IRB Approval?

All doctoral students are required to obtain approval from the University’s Institutional Review Board (IRB) before recruiting research participants or collecting data. IRB approval is given only when the potential benefits of the study outweigh the risks, in accordance with the university’s ethical standards as well as U.S. federal regulations. IRB questions should be directed to [email protected].

How Long Does IRB Review Take?

Exempt Review

Applications for exempt review may be submitted electronically at any time by the Chair. Allow for at least two (2) weeks (10 -12 business days) for review. Exempt and expedited applications are evaluated by the Exempt/Expedited Review Team.

Expedited Review

Applications for expedited review may be submitted electronically at any time to the Chair. Allow for at least two (2) weeks (10 -12 business days) for review. Exempt and expedited applications are evaluated by the Exempt/Expedited Review Team.

Full Board Review

Applications for full board review are reviewed at a convened meeting of the University IRB. These must be submitted electronically to the Chair. Submission dates are due by the 4th Wednesday of every month, and full board review will meet on the 2nd Wednesday of every month (when applicable). Full IRB review times may vary depending on the nature of the study. IRB offices will be in contact with the project team regarding review.

Required Research Training

CITI Ethics Training

CITI training www.citiprogram.orginvolves web-based instruction in the ethics of research with human subjects. This instruction is free to the researchers of Grand Canyon University. Prior to applying for IRB approval, all Grand Canyon University doctoral learners must register and successfully complete the required Graduate Student CITI training modules. Time to complete all modules can range from 10-15 hours.

Upon successful completion of CITI training a notice will be sent to the College of Doctoral Studies. Training certification remains in effect for five years.

Key Supplemental materials

Informed Consent

• Recruitment scripts
• Telephone screening scripts
• Advertisements and announcements

Templates are available to:

• make it easier
• standardize some of the language
• use template language when appropriate for your study

Two Categories Involved in Informed Consents

Adults and Children
Depending on the specific details of the proposed research, informed consent/assent forms and may be required.

Adults provide consent

• For themselves
• For children or cognitively impaired subjects

Children (under age of 18) and those who are cognitively impaired provideassent

• Language must be appropriate
• Includes all the elements of consent
• May or may not involve a signature
• May include dissent procedures for behaviors that indicated a desire to not participate in a study (crying, hitting, biting kicking, screaming, etc.)

Additional FAQ’s from Office of Human Research Protection regarding Informed Consent:
Office for Human Research Protections (OHRP) Informed Consent Frequently Asked Questions : (http://www.hhs.gov/ohrp/policy/expedited98.html )

• Language must be appropriate
• Includes all the elements of consent
• May or may not involve a signature
• May include dissent procedures for behaviors that indicated a desire to not participate in a study (crying, hitting, biting kicking, screaming, etc.)

Adults and Children

• Not considered benefits of the research
• OK to use many ways to create an incentive to participate
• Payment or incentive must match effort or discomfort involved
• Payment must not become coercive
  • Large sums of money
  • Payments to parents for child’s participation
• Do what is fair as far as payment for partial participation

Adults and Children

• The purpose of the research
• The length/duration of the study
• How many additional subjects will be participating (locally/nationally)
• What risks/benefits are involved with study
• How much incentive for each part of the study
• Total possible compensation for completing the study
• Policy on payment if subject withdraws from the study

Research volunteers have a special set of rights that apply when participating in research. The Office for Human Research protections (OHRP) brochure Becoming a Research Volunteer offers important considerations and information about participating as a subject in a research study.