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OutlineOutline

1. Introduction to Research Ethics2. Requirements of Research Ethics3. Institutional Review Board (IRB)4. Systematic Review of Research Proposal5. Case reviews

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Research Ethics

Concepts of research ethics:• Support and remind researchers to protect human

subjects.• Provide us with a structure for analysis and decision-

making.• Provide workable definitions of benefits and risks,

along with guidelines for evaluating and balancing the benefits and risks of our studies.

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What is Research?What is Research?

Definition of Research:• a systematic investigation designed to develop

or contribute to general knowledge.

Definition of Human Subject:• A living individual about whom an investigator

conducting research obtainsdata through intervention or interaction with the

individual, or identifiable private information (e.g. record review)

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Why Research Ethics?

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Misconduct

Ethical Codes and Guidelines

In 2004 and 2005, Dr. Hwang Woo-Suk, published two papers in the journal Science that claimed his team had succeeded in creating human embryonic stem cells through cloning. Allegations later followed from a co-worker that these paper was based on fabricated data.

The papers were editorially retracted, Dr. Hwang lost his position at Seoul National University, and the South Korean government ended its financial and legal support of his research.

Famous Misconduct CasesStem Cell Case (2005-2006)

http://www.nytimes.com/2009/10/27/world/asia/27clone.html?_r=1&ref=hwangwoosuk

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Examples of Codes & GuidelinesExamples of Codes & Guidelines

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The Belmont Report

In 1979 the National Commission published theBelmont Report. The Belmont Report identifies three basic ethical

principles that underlie all human subject research. These principles are commonly called the Belmont Principles. The Belmont Principles are:

Respect for persons, Beneficence, and Justice.

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The Belmont Principles• Respect for persons include:

• The requirement to obtain informed consent. • The requirement to respect the privacy of research subjects.

• Beneficence Include:• The requirement to use the best possible research design to

maximize benefits and minimize harms.• The requirements to make sure the researchers are able to

perform the procedures and handle the risks.• The prohibition of research that is without a favorable risk-

benefit ratio.

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The Belmont Principles Con.

• The principle of justice include:• The requirement to select subjects equitably.• The requirement to avoid exploitation of vulnerable populations or

populations of convenience.

It was the Commission's intention that each of the three principles should have equal moral force.

Researchers required to consider each case separately and on

its own merits in light of all three principles.

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Requirements of Research Requirements of Research Ethics Ethics

1. Community Partnership (Respect of culture)2. Social value (valuable to research subject &

community)3. Scientific validity (use of accepted scientific

methods)4. Fair subject selection (inclusion & exclusion

criteria) (vulnerable groups)5. Favorable risk-benefit ratio (Risk could be physical,

psychological, social, economical or legal )6. Independent review (To avoid conflicts of

interests)7. Informed consent8. Respect for human subjects

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Levels of risksLevels of risks

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MinimalMinimal

AboveAboveminimalminimal

TooTooriskyrisky

7-Informed Consent Process 7-Informed Consent Process (cont)(cont)

Contents:1. Purpose of the research2. Procedures (duration)3. Risks4. Benefits5. Alternatives6. Confidentiality7. Withdrawal8. Compensation9. Who will contact

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Voluntary DecisionNo pressureNo undue-

encouragement

Samples

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Microsoft Word Document

Microsoft Word Document

Microsoft Word Document

Microsoft Word Document

Institutional Review Board (IRB)

• IRB is a review committee established to help protect the rights and welfare of human research subjects. Regulations require IRB review and approval for research involving human subjects.

Most research institutions, professional organizations, and scholarly journals apply the same requirements to all human research. Although federal regulations refer to IRBs, an institution may have chosen a different name for the committee (Ethics Review Committee).

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IRB protects:

1- The research subjects2- The researchers3- The institutes4-The community

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• The primary function of an Institutional Review Board (IRB) is protection of human subjects involved in research.

The Composition of the IRB

SCH regulations dictate that the IRB membership will include:

• At least five members. • Members of both sexes. • Members that come from varied professions. • At least one member whose primary concerns are in

nonscientific areas. • At least one member whose primary concerns are in scientific

areas. • At least one member who is not otherwise affiliated with the

institution.

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The Authority of the IRB

SCH regulations stipulate that an IRB can: • Approve research. • Disapprove research. • Modify research. • Conduct continuing reviews. • Observe/verify changes. • Suspend or terminate approval. • Observe the consent process and the research

procedures.

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Consequences of Not Following IRB Regulations

If IRB regulations are not followed, consequences could include:• Suspension of research project. • Suspension of all of a PI's research projects. • Inability to use data or publish results. • Notification of sponsors, regulatory agencies and funding agencies of

noncompliance. • Inability to receive funding from federal grants. • Additional monitoring and oversight by the IRB and/or third party

monitoring of research activities. • Termination of employment. • Loss of licenses. • Immediate shut-down of ALL research at an organization.

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QU-IRB(Qatar University – Institutional Review Board)

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QU-IRB

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•Qatar University’s Institutional Review Board (QU-IRB), under the directives of Supreme Council of Health (SCH) was formed as an independent committee under research compliance in September 2011. All research that is to be conducted on human subjects must be submitted to QU-IRB for ethical acceptability

General Procedures OutlinePart 1. (from Applicant)Filled in forms (Application, Checklist and other supporting documents) should be sent to QU-IRB at the email address QU-IRB@qu.edu.qa. (All forms are available in the Required Forms list)

•If both English and Arabic languages are to be used, supporting documents such as surveys, questionnaires, consents/ascents, etc…, should be provided in both languages.

•If exemption from Full Ethics Review is requested, it should be specified in the email with reasons for such request.

•Exemption criteria is stated in the Research Ethics Detailed Manual which can be accessed through QU-IRB Web Site

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General Procedures Outline Cont.

• Step 1: Application received undergo initial screening to make sure the forms are complete and filled in properly.

• Step 2: Once step 1 is complete, the proposals are reviewed by the chairperson for possible exemption or expedited. If ok, the exemption letter is issued without sending the application for a full ethics review.

• Step 3: If the application does not meet the exemption requirements, it undergoes a full ethics review. Once approval is granted, approval letter is issued.

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Forms Required for QU-IRB:

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1.Application 2. Checklist

3. Surveys / Questionnaires

4. Consents / Ascents (if applicable)

5. Supervisor Letter for student graduate projects

6. QU-IBC approval (if applicable)

6. Collaborating Institute’s IRB Approval (if applicable)

7. Any other relevant supporting documents (Dept. Approval)

In case of a renewal request, only a renewal request is needed.

Microsoft Word 97 - 2003 Document Adobe Acrobat

Document

•If you are seeking an exemption from the full ethical review (expedited review), please state that in your email with a justification for such request. •Please note that for student UG projects, all communication to IRB should be done by the Supervisor. •Sample documents can be accessed throughhttp://www.qu.edu.qa/offices/research/quirb/sample_documents.php•We recommend to check the IRB website for querieshttp://www.qu.edu.qa/offices/research/quirb/index.php

•Please send all documents to "QU-IRB@qu.edu.qa". Once received, these documents will undergo an initial screening and thereafter the routine process for IRB review. The committee may ask further clarifications/information during the course of the review. Once the review is complete, IRB decision letter will be issued accordingly.

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Systematic Review of Research Proposal

What Qualifies as Research Involving Human Subjects?

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First Questions to Ask:

Is the project considered research?

Does the study involveHuman Subjects? Q

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Human Subject Research

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A research Involving living individuals about whom the

researcher obtains:

Data through

intervention or

interaction

Identifiable private

information

OR

Non-human subjects Exempt research

Types of IRB Review

• Review by IRB chair or his/her designee• Is it considered research?• Does not involve human subjects?• Can be exempt from Review?

• Full Board Review

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Exempt Research

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Research is exempt from full board review and future review by the

IRB

The decision may be made ONLY by the

chair or designee

The decision must be done in

advance of the

research

There must be clear determinants of what qualifies

for exempt research

Limitations for Exempt Research

• Not involving vulnerable subjects• Prisoners• Children • Pregnant women

• Not more than minimal risk QU

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Categories of Exemption #1• Research conducted in commonly accepted educational

settings, involving normal educational practices, such as:• Research on special education instructional strategies,

(Lectures ,Seminars, etc..).

• Research on the effectiveness of or the comparison among instructional techniques, curricula, or classroom management methods.

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Categories of Exemption #2

• Research involving the use of Survey Procedures, Interview procedures or Observation of public behavior

UNLESS

• information is obtained and recorded by the investigator

in such a way that the subject can be identified, AND

• disclosure could reasonably place the subject at risk of

criminal or civil liability or be damaging to the subject’s

financial standing, employability, or reputation.

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Categories of Exemption #3

• Research involving the collection or study of existing data, documents, records, pathological specimens, or diagnostic specimens• If these sources are publicly available OR

• The information is recorded in a way that the subject can not be identified directly Or through identifiers linked to the subject

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Involves Human Subject?

Qualify for Exempt Status?

IRB Review

No need for IRB review

Research Activity?

Yes

No

No

Yes

Yes

Decision Chart for Review

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5Thank You