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Frequently Asked Questions (FAQs)



Does my research require review?

If you are a faculty member, staff member, or student at HU and your research involves the use of human participants or animals (either directly or through records), your research requires human participant review.
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What about research projects that are part of HU coursework?

Because HU classroom based projects that will involve research will not usually be published, they need not go through the IRB process. Nonetheless, professors who use research projects or exercises as part of their teaching methods or those who teach research methods courses are expected to have a section on research ethics and to teach ethical research procedures before the students undertake such activities. Feel free to contact the Chair of the IRB for any questions.
Sometimes data from a classroom research project become part of a dissertation, a paper submitted to a conference or a journal. At the time that this shift from classroom project to research occurs, the use of the data has changed and the researcher is obligated to subject the research activity to IRB review

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Do studies that focus on quality improvement and quality assurance activities require IRB approval?

 
Quality Improvement and Quality Assurance activities conducted solely for the intent of maintaining or improving quality of services provided by an institution are not considered research activities. However, if the data collected are generalizable and are to be shared outside of the institution through discussion, presentation, or publication, the activity qualifies as research. In instances such as this, the research use of the data collected must be reviewed

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Do evaluation projects require IRB approval?

 
Evaluations are systematic studies of programs (or of products or personnel) to determine impact and/or for improvement purposes. If the information generated from the evaluation is being used only for program administrators or staff, and is not intended for dissemination or publication, there is no need for IRB review. If there is a possibility that a publication or presentation may emerge from an evaluation study, IRB review is necessary. Please be aware that the agency for which the evaluation is being done, may require IRB approval.

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How do I start the review process?

Once you have decided to use human participants in your research:
Complete an IRB protocol application and submit it to the office of the chairman of IRB located in the Deanship of Scientific Research and Graduate Studies at Hashemite University.
Include all relevant information (IRB protocol application, consent forms, assent forms, surveys, questionnaires, test instruments, advertisements, debriefing statements, contact letters, interview protocols, etc...)
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What levels of risk are employed for research with greater or lesser degrees of risk?

Research applications are reviewed at one of three levels, depending on the level of risk to the human participants and on the regulations that define the categories of review, which are exempt, expedited, and full board review. The determination of what level of review is required is determined by the IRB staff, NOT the researcher. Whatever the level of review, the ethical treatment of human participants is always a requirement.

Exempt: Research activities that fall into this category fit one of six categories:

Research conducted in established or commonly accepted educational settings, involving normal educational practices, such as:

1. Research on regular or special educational instructional strategies, or

2. 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:

1. Information is recorded in such a manner that participants can be identified, directly or through identifiers linked to the participants.

2. Any disclosure of the human participants' responses outside the research could reasonably place the participant at risk of criminal or civil liability or be damaging to the participant's 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 the is not exempt under bullet two of this section, if:

1. The human participants are elected or appointed public officials or candidates for public office; or

2. Its required without exception that the confidentiality of personally identifiable information will be maintained throughout the research and thereafter.

 
Research involving the collection or study of existing data, documents, records, pathological 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 participants.

Research and demonstration projects which are conducted by or subject to the approval of federal government department or agency heads, and which are designed to study, evaluation or otherwise examine:

1.Public benefit or service programs;
2. Procedures for obtaining benefits or services under those programs;
3. Possible changes in or alternatives to those programs or procedures; or
4. Possible changes in methods or levels of payment for benefits or services under those programs.

Taste and food quality evaluation and consumer acceptance studies,
1. If wholesome foods without additives are consumed or

2. 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.



Expedited: Research activities that fall into this category present no more than minimal risk to human participants, and involve only procedures listed in one or more categories:
Recording of data from participants 18 years or older using noninvasive procedures;
Video/Audio recording;
Study of existing data;
Research on an individual or group behavior that involves no manipulation of the participants and is not stressful.



Full Board Review: Research that involves greater than minimal risk is reviewed by the IRB board. Research that requires full board review includes but is not limited to:
Certain types of research involving children, pregnant women, fetuses, and other vulnerable populations;
Research involving prisoners;
Research that involves deception;
Survey research that involves sensitive questions or is likely to be stressful for the participants; or Collection of blood samples in minimal amounts.
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What issues does the IRB consider?

The IRB reviews the purpose, procedures, and participant populations to be used and determines if the benefits of the activity outweigh the risks to the participant. Fuller information about each of these is available on the web and in the IRB handbook. Issues considered in the analysis include:
Whether risks to participants are minimized;
How participants are approached so that they can readily refuse;
How privacy, confidentiality and informed consent will be handled;
What physical and psycho-social risks, stresses, and discomforts participants will be asked to endure;
Whether vulnerable populations (e.g. prisoners, children) are to be included;
Whether additional safeguards have been included in the study to protect the rights and welfare of any participants likely to be vulnerable to coercion or undue influence such as prisoners or children;
How sensitive the information is;
Whether risks to participants are reasonable in relation to anticipated benefits, if any, to participants, and the importance of the knowledge that may reasonably be expected to result;
Whether diverse populations are included;
How data will be handled after the completion of the study.
The scientific merit of the activity is considered only if it has an impact on the risk-benefit analysis. For example, will the number of participants proposed allow the results obtained to be statically significant? Is there a less risky way to achieve the same results?
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How do I obtain informed consent?

Since the central requirement for human participants research is that people participate voluntarily, the consent process is one of the more important parts of the research project. The process must assure that the potential participant understands the study and its risks and benefits and can certify his or her willingness to participate or decline to participate in the study. Under certain circumstance the IRB can waive or alter the informed consent process. Sample consent form is available in the IRB home page.
In the case of minors, an assent form is to be used in addition to the consent form from a parent or guardian. Sample assent form is available in the IRB website.
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Is approval ever denied?

The IRB may determine there is insufficient information to approve or disapprove an application. If this is the case, the IRB will ask the researcher to provide additional information. When the information is received by the IRB, the application is reconsidered.
The IRB may determine that the risks of the proposed activity outweigh the benefits and will withhold approval. The IRB will work with the researcher toward a compromise to reduce the risks and gain approval to carry out the research.

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How can I change my research after it has been approved?

You must notify the IRB if you wish to change any aspect of your research by submitting two copies of all change materials, along with an explanation of the changes made to your research.
Substantial changes in the focus, procedures, or participant population of the research may require submission of a new application.
Call the IRB at ( +962 5 590333- 4505) ( E-mail: irb@hu.edu.jo) if you have questions about what kinds of changes require new applications.
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How long is approval valid?

Approval is valid for one year even it is a multi-year project. If the project was initially designed to go beyond one year and was approved with that assumption, an annual renewal will be easily expedited through a renewal application. The renewal process follows the same timeline in granting approvals as an original IRB application.
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What are my responsibilities as the principal investigator?
 

The principal investigator (PI) is ultimately responsible for the conduct of research, including ensuring that an investigation is conducted according to the approved protocol and the applicable regulations. The PI is also responsible for the rights, safety, and welfare of the participants.

The Hashemite University, Tel: +962 (5) 3903333 Fax: +962 (5) 3826613 Email: irb @hu.edu.jo Copyright © 2011, All Rights Reserved.