INSTITUTIONAL REVIEW BOARD

Technology is changing the way we live and think and it is growing faster than our capacity to maintain pace. The future success and competitiveness of any organization will depend on its ability to keep abreast with the technological advancements. Parallel and equally important to technology advancements is the future of education; educational institutions will be largely virtual and based on the artificial intelligence technology. There will be an outburst of the Internet of Things, which will enable us to talk to our belongings, walls and appliances that will be intelligent enough to learn from their experiences.

INSTITUTIONAL REVIEW BOARD

An Institutional Review Board (IRB) is a specialized committee, officially established to review and approve research proposals, required by the Health and Human Services (HHS) regulations that safeguards the rights and welfare of human subjects. IRB determines “the acceptability of proposed research in terms of institutional commitments and regulations, applicable Federal law, and standards of professional conduct and practice” (45 CFR 46).

An essential aim of the IRB is to safeguard human subjects from physical or psychological harm by evaluating the ethics of the proposed research and its methodologies in order to endorse informed harmless and voluntary participation by potential subjects.

Stratford university policy is to apply the guidance and regulations applicable under (45 CFR 46.107) to all human research conducted at the university.

The mission of Stratford’s IRB is to safeguard the rights and safety of participating subjects in research conducted by Stratford’s students and faculty.

The IRB will provide support and guidance to the university’s research community to ensure that:

• The risks to human subjects are reduced by applying procedures consistent with sound research design and that do not needlessly expose the research participants to risk.

• The benefits- the desired outcomes- of the research overweighs the risks- the probability of harm or injury (physical, psychological, social, or economic) occurring as a result of participation in a research study.

• The selection of human subjects for research participation is impartial.

• Full disclosure of the risks and benefits of research participation is made to the participants prior to their participation.

• Sufficient provisions are in place for the protection of the privacy of human research subjects and confidentiality of data.

IMPORTANT NOTE FOR STUDENT RESEARCHERS

It is the researcher’s responsibility to make sure that the IRB application and all supporting materials are submitted to IRB@stratford.edu. The IRB staff always confirms receipt of IRB materials. Human subject research data collection should not commence prior to receiving explicit IRB approval from IRB@stratford.edu.

INSTITUTIONAL REVIEW BOARD FAQ’S

WHAT IS IRB APPROVAL?

Stratford’s IRB consists of members from varying backgrouds who are qualified and experienced in conducting research and/or leading academic research studies. The IRB is responsible for ensuring that all Stratford University research complies with the university’s ethical standards and meets U.S. federal regulations and any applicable international guidelines. IRB approval indicates the institution’s official assessment that the potential risks of the study are outweighed by the potential benefits.

Outside of the explicit dates and terms of IRB approval, researchers are not entitled to any protections, recognition, funding, or other support provided by Stratford University.

WHO SHOULD USE THIS IRB APPLICATION FORM?

This application should be completed by all students and faculty who are conducting research projects of any scope involving collection or analysis of data from living persons (whether from surveys, interviews, observation, student work, or records of any type). The only categories of research that do not need to be submitted for IRB approval are literature reviews, hypothetical research designs, and faculty projects that are completely independent of Stratford University. Research projects conducted by full-time employees of Stratford are also under the purview of the Stratford IRB. Instead of completing this form, staff researchers should send an email inquiry to IRB@stratford.edu to initiate the IRB approval process for staff research.

WHEN SHOULD I WORK ON & SUMBIT MY IRB APPLICATION?

Questions about the IRB application and related materials may be submitted to IRB@stratford.edu at any time.

HOW LONG DOES IRB REVIEW TAKE?

Researchers should allow a minimum of 4-6 weeks for IRB review (4 weeks for minimal risk studies and 6 weeks for studies involving vulnerable populations). This form takes 1-2 hours to complete, depending on the complexity of the study. Once the IRB staff confirms that the IRB application is complete, the IRB application will be scheduled for review at the next available IRB meeting (typically within 10 business days). Feedback from the board will be returned within 5 business days (amounting to a total of 15 business days for the initial review). Note that when a study is “approved with revisions,” the researcher should allow an additional 10-15 business days for those revisions to be reviewed and approved. If the revisions do not adequately address the ethical concerns, then an additional round of revisions and review might be necessary. The IRB members make every effort to make the revision requirements as clear as possible.

CAN I CONTACT MY RESEARCH PARTICIPANTS BEFORE IRB APPROVAL?

No. Researchers may NOT begin recruiting participants (i.e., obtaining consent form signatures) prior to IRB approval.

WHAT IF I NEED TO CHANGE MY RESEARCH PROCEDURES AFTER IRB APPROVAL?

Researchers must reapply for IRB approval if changes are made to the research procedures after IRB approval.

WHAT ARE THE CRITERIA FOR IRB EXEMPT CATEGORIES?

Some research categories are exempt from IRB review, but the researcher still has to be submitted to the IRB. If it falls under the exempt categories, the IRB coordinator will grant a desk approval without sending it to the board for review. Unless otherwise required by department or agency heads, research activities in which the only involvement of human subjects will be in one or more of the following categories are exempt from this policy:

• Research conducted in established or commonly accepted educational settings, involving normal educational practices, such as
• research on regular and special education instructional strategies, or
• research on the effectiveness of or the comparison among instructional techniques, curricula, or classroom management
methods.
• Research involving the use of educational tests (cognitive, diagnostic, aptitude, achievement), survey procedures, interview
procedures or observation of public behavior, unless:
information obtained is recorded in such a manner that human subjects can be identified, directly or through identifiers linked
to the subjects; and
• 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.
• 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 paragraph (b)(2) of this section, if:
• the human subjects 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 throughout the research and thereafter.
• 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.
• 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:
• Public benefit or service programs;
• procedures for obtaining benefits or services under those programs;
• possible changes in or alternatives to those programs or procedures; or
• possible changes in methods or levels of payment for benefits or services under those programs
• Taste and food quality evaluation and consumer acceptance studies,
• if wholesome foods without additives are consumed or
• 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

DO I NEED TRAINING FOR IRB APPROVAL?

Applicants are required to complete the NIH Web-based training course “Protecting Human Research Participants”. This is an online training consisting of seven modules; each addressing the principles used to define ethical research using humans and the regulations, policies, and guidance that describe the implementation of those principles. The entire course will take approximately 3 hours to complete. Applicants are required to complete the course before completing IRB application form.

The course completion certificate should be attached with the application form.