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Online Training Module and Quiz

All applicants submitting research proposals for approval are required to successfully complete an online quiz (attaining a score of 70% or higher) before the participant's application will be reviewed by Oakland City University's Institutional Review Board (IRB).

The quiz is designed to insure that all participants fully understand the ethical issues pertaining to research involving human and/or animal subjects.

Review of the online training module is recommended before completing the online quiz.

Online Training Module

OVERVIEW

This online training module is designed to provide a general overview of the policies and procedures for applying for the necessary IRB approval for all research activities involving human subjects and animals. In addition to a general overview of the policies and procedures, this training module will provide the online researcher with an understanding of these policies and procedures.

PURPOSE OF THE IRB

The Oakland City University Institutional Review Board (IRB) is an administrative body required by the federal government to protect the rights and welfare of anyone who is recruited to participate in research.

The Oakland City University IRB reviews all research by Oakland City University students, faculty, and staff.

There are many different rules and regulations that govern how research involving human subjects is conducted at federally funded research institutions. Pursuant to federal law and Oakland City University policy, all research (funded or unfunded) involving human and/or animal subjects, conducted by faculty and/or student investigators, must be reviewed and approved by the Oakland City IRB prior to the commencement or recruitment of subjects and data collection.

Please note that if you are conducting research at another institution, such as a school, college or university, or health care organization (hospital, clinic, etc.), you must submit your research proposal to that institution's IRB, as well. Research will not be approved until the Oakland City University IRB receives approval from the reciprocal institution. However, research proposals can be reviewed while under review from another institution.

HISTORY

Nuremberg Code (1946): A U.S. military tribunal of German physicians conducted experiments on captives during WWII. Because of this, we created requirements for voluntary participation, documented consent, and proof that benefits outweigh risks to subjects.

Thalidomide Tragedy (1950s): An unapproved drug taken by pregnant women to help with nausea and sleep led to deformed babies. This led to strict FDA regulations on drugs and testing on humans that are still in place today.

Declaration of Helsinki (1964): International standards were set to protect human subjects so that the risks did not exceed "the benefits to humanity." These standards led to the requirement of an independent review board for research, which became the IRB.

Tuskegee Experiment (1932-72): Low-income African-American males infected with syphilis were observed by the U.S. Public Health Service in a longitudinal study to document the progression of the disease. Subjects were not given the known cure for the disease (penicillin) even after it became available in the 1950s. Risks were increased and vulnerable publics were used for research that benefits a larger general population.

Development of the Law: Lessons learned from the tragic case in Tuskegee (and other cases) led to some of our distinctions and protections of special populations as outlined in the Belmont Report and in the National Research Act (1974).

The Belmont Report established three basic ethical principles: respect for persons, beneficence and justice. These principles serve as the foundation for regulations involving human subjects.

Source: DHHS and http://researchadmin.iu.edu/HumanSubjects/IUPUI/hs_home.html

KEY CONCEPTS, PRINCIPLES, AND APPLICATIONS

Respect for Persons
Individuals should be treated as autonomous agents, and persons with diminished autonomy are entitled to protection.

Informed Consent
Subjects, to the degree that they are capable, must be given the opportunity to choose what shall or shall not happen to them.

Elements of Informed Consent

  • Information
  • Comprehension
  • Voluntariness

Beneficence
Human subjects should not be harmed. Research should maximize possible benefits and minimize possible harms.

Assessment of Risks and Benefits
The nature and scope of risks and benefits must be assessed in a systematic manner. 

Justice
The benefits and risks of research must be distributed fairly.

Selection of Subjects
There must be fair procedures and outcomes in the selection of research subjects.

TYPICAL TYPES OF RESEARCH REVIEWED BY AN IRB

Psychology Experiments – (Example: Testing the effects of empathy versus informational appeals on message recall)

Biomedical Research – (Example: Comparing finger prick versus forearm prick for tests or for administering drugs)

Surveys – (Examples: Interviewing pharmacy patients, interviewing newspaper subscribers)

Observation – (Example: Watching children in a classroom respond to different teaching methods)

Depth interviews – (Example: Interviewing foreign exchange students at the university)

Retrospective Chart Review – (Example: Examining diabetic patients' charts to identify the prevalence of drugs prescribed for illnesses other than diabetes—using existing data)

Prospective Chart Review – (Example: Using a set of patient characteristics to identify a sample for reviewing charts of future patients to a clinic)

Video Documentary – (Example: Chronicling the lives of homeless people on video)

Educational, Psychological, or Cognitive Tests Comparison of Educational Techniques – (Examples: Dance instruction, multi-cultural music education program)

KEY RESEARCH TERMS AND DEFINITIONS

Anonymity: Assurance that no one, not even the researcher, knows whose responses have been recorded in a study

Confidentiality: Assurance that only the researcher knows who belongs to the data; that a third party who somehow gained access to the data would not be able to make a link between the subject and the data recorded from that subject.

The IRB is particularly interested in knowing if you plan to keep subject identifiers (name, telephone number, student ID, patient chart number, etc.) on data collection forms (such as the survey instrument), and if so, why it is necessary. If identifiers are maintained and links to the subject can be made, then the IRB is interested in knowing how you plan to store the data to ensure that a third party could not have access to the data.

Data: Anything that is observed and recorded in a study (e.g., blood, pictures, responses to questions, HIV status, emotional reactions to a stimulus, etc.)

Informed consent: Research participants should be fully informed of the procedures to which they will be exposed (or debriefed at the end, if some deception is necessary in the execution of the study) and the potential risk (if any) of their participation. Documentation of informed consent is required in most experimental research, biomedical research, and survey research. In cases in which documented informed consent (subject signing a form) is not possible, a request to waive that requirement may be filed with the IRB. If you wish to recruit children in your research, you will also need parental consent for each child participant, as well as the children's consent if of age of assent.

If your study requires informed consent, then enclose a consent form with your proposal.

Maintenance of records: The University, the IRB, and the Researcher must maintain appropriate records for three years after the termination of the study. The IRB is also interested in how data will be stored to protect subjects' identity.

Principal Investigator (PI): The PI is the lead researcher. Students cannot be PIs. A staff or faculty member employed by Oakland City University must be the PI and is ultimately responsible for ensuring the approved protocol is followed and for complying with all IRB policies. Students or researchers sign IRB proposals, but the faculty adviser is the PI. The PI must also report to the IRB any unexpected adverse effects as a result of the research.

If applying to another institution for IRB approval, the PI must be a staff member of that institution. The PI for the Oakland City University application may differ from the PI for your outside institution IRB application, for example.

Research instrument: The research instrument is the form used to collect data, such as a code sheet or a questionnaire. These must be completed and included with your IRB proposal.

Research protocol: A written description of the involvement of humans in the research project and the measures to be taken to protect them from risk

Risk: Refers to potential harm to subjects as a result of the study procedures; such harm could be physical, emotional, legal, financial, or harm to reputation

Sample: The group of individuals you will study (via survey, experiment, observation, medical chart review, etc.) that is a subgroup of a specific population (or universe)

Vulnerable publics: These individuals who may be easily coerced without protections, who may not be able to provide fully informed consent, or who may be unusually affected by some research interventions (prisoners, children, pregnant women, cognitively impaired people, and fetuses, as defined by the Department of Health and Human Services)

TYPES OF IRB REVIEW

Exempt

Exempt review requires one reviewer; expect the review to take 10 working days from first business day after receipt of proposal.

Qualifying for Exempt review does NOT mean you do not have to submit a proposal. If the IRB grants Exempt review status for your proposal, it means you do not have reporting and follow-up requirements, as do the Expedited and Full Review categories.

The IRB makes the final determination about the status of a research proposal, whether it be Exempt, Expedited, or Full.

Research involving human subjects qualifies for EXEMPT REVIEW if it satisfies one or more of the conditions listed below:

  • Research conducted in established or commonly accepted educational settings, involving normal education practices
  • Research on regular and special educational instructional strategies
  • Research on the effectiveness of or the comparison among, instructional techniques, curricula, or classroom management methods
  • Research involving the observation (including observation by participants) of public behavior
  • 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 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 a variety of approved programs
  • Research involving use of educational tests (cognitive, diagnostic, aptitude, achievement) unless...
    • Information obtained is recorded in such a manner that human subjects can be identified, directly or through identifiers linked to the subjects
    • Any disclosure of the human subjects' responses outside of the research could reasonably place the subjects at risk of criminal or civil liability or be damaging to the subjects' financial standing, employability, or reputations.
  • Research involving survey, observational, or interview procedures is usually Exempt, except where ALL THREE of the following conditions exist:
    • Responses are recorded in such a manner that the human subjects can be identified, directly or through identifiers linked to the subjects.
    • Responses, if known outside the research, could reasonably place the subject or respondent at risk of criminal or civil liability or be damaging to the subjects' financial standing or employability.
    • The research deals with sensitive aspects of the subject's own behavior, such as illegal conduct, drug use, sexual behavior, or use of alcohol.

NOTE: All research involving survey or interview procedures is considered Exempt when the respondents are elected or appointed public officials or candidates for public office.

Expedited

Expedited review requires two reviewers; expect the review to take 10 working days from the business day after receipt of the proposal.

The IRB chair and at least two members of the IRB may conduct expedited reviews.

Expedited review may be appropriate for requests of minor changes in previously approved research during the period for which approval is authorized.

The IRB may use an expedited review procedure for research that involves no more than minimal risk to the subjects and in which the only involvement of human subjects will be in one or more of the categories listed below.

  • Video/audio recordings made for research purposes, such as investigations of speech defects
  • The study of existing data, documents, records, pathological specimens, or diagnostic specimens
  • Research on individual or group behavior or characteristics of individuals, such as studies of perception, cognition, game theory, or test development, in which the research investigator does not manipulate subjects' behavior and the research will not involve stress to subjects
  • Survey or observational research, educational tests, and reviews of existing data that do not qualify for Exempt Review (see previous section on Exempt review)
  • Any other category specifically added to this list by the Department of Health and Human Services and published in the Federal Register

The PI must maintain the research records for a minimum of three years.

The PI must inform the IRB when the data collection is complete.

Full

Full review requires the review of the full IRB committee; expect review to take 20 days from the first business day after receipt of the proposal.

In any Full Review case involving research that places human subjects at more than minimal risk, a series of safeguards must be in place to ensure that research participants will have full understanding of the procedures prior to giving consent.

The IRB will want to ensure that risks to human subjects are minimized.

Also, risks to subjects should be deemed reasonable in relation to anticipated benefits, if any, to subjects, and to the importance of knowledge that may reasonably be expected to result from the research.

IRB APPLICATION REQUIREMENTS

Before applying to the IRB, applicants must complete this training module, and take the Online Training Quiz.

Identify and download the appropriate form for review category.

Complete the form and obtain the proper signatures.

Attach all completed instruments (such as questionnaires or data collection sheets) that you will be employing in your study.

Attach completed consent forms required for your study.

Submit materials electronically to Morris Pelzel, Director of Internal Review Board, mpelzel@oak.edu.

You may not begin collecting data until you have received approval from the IRB at Oakland City University, and any other IRB to which you have applied. Upon receipt of IRB approval, you may begin data collection.

Report to the IRB when data collection is completed (if Expedited or Full review status).

NOTE: If you have a tight timeframe for collecting data, make sure you allow enough time (and not just the minimum required) for IRB review. For example, it may take five days for review of your proposal, but the IRB may request more explanation or a revised consent form, which will add more time to the review period.

If you have questions about your application, email irb@oak.edu.

FREQUENTLY ASKED QUESTIONS (FAQ)

Q: What does Oakland City University's IRB do?

A: Oakland City University's Institutional Review Board (IRB) has as its mission and function to review and approve all proposed research involving human subjects and animals that is conducted under the University's auspices through its Schools. Approval is required, regardless of whether the research is funded status or sponsored status. The code of federal regulations guiding IRB policy can be found here: 45 CFR 46.

Further, Oakland City University's IRB fully intends to follow the intent and purpose of the law. The IRB believes that the law is designed to protect the rights and safeguard the welfare of human research subjects and/or animals utilized in research activities. Since the law provides guidelines for establishing a local peer-review process, the IRB believes that this review process will help students or researchers better understand the nature of research and the importance of ethical approaches in conducting research.

Q: What forms of research need to be reviewed?

A: The IRB must review any and all research that will be conducted by students or faculty that involves human subjects or animals. For the purposes of this review, the term research is defined by federal law 45 CFR §46.102 as "a systematic investigation, including research development, testing and evaluation, designed to develop or contribute to generalizable knowledge." All activities that meet the foregoing definition of research need to be reviewed by the IRB, including activities that may or may not be conducted or supported under a program which is considered research for other purposes. (Please note that some demonstration and/or service programs may include research activities.) For the purposes of this policy, a systematic investigation is any data collection method. This includes interviews, surveys, tests, observations, or other experiments, regardless of content area, including pilot studies.

As additional criteria, the IRB further defines research as a project designed to "contribute to generalizable knowledge," when it adds to a field of knowledge (e.g., the field of education, the field of religion, the field of management), and when the research results become publicly available, either through a presentation or publication.

For the purposes of this policy, the IRB considers a research project to involve human subjects if the research activity involves "a living individual about whom an investigator . . . obtains data through intervention or interaction with the individual or identifiable private information," as defined by 45 CFR §46.102. This definition is interpreted broadly, therefore, even if a student or researcher is just interviewing people or conducting a survey, human subjects are involved in the research and the research must be reviewed by the IRB in accordance with this policy.

The following research projects/activities are subject to prior review and approval by Oakland City University's IRB: any documentation of information from an identifiable person or any collection of information about an identifiable person that is not publicly available, when the results of the research activity will be made public (for example, through oral presentations or written articles for publication). Such research projects include any qualitative and quantitative research that involves human participants. If there is any doubt as to whether a proposed project should be reviewed by the IRB, a member of the IRB board should be contacted for assistance.

Q: Which application form should the student or researcher use to have his or her research proposal reviewed?

A: In order for a student or researcher to conduct any type of research activity involving human subjects and/or animals, the student or researcher must fill out the appropriate sections of the Universal Research Application. The sections of the Universal Research Application that will be required to be completed and the documentation that will need to be included with the application depend on the applicable review level for the application. There are three tiers of IRB review into which research activities involving human subjects and/or animals could fall. The three tiers are:

  • Exempt status
  • Expedited review status
  • Full review

The student or researcher is to initially determine the type of IRB review for which his or her project would qualify. (The IRB will make the final determination.) The student or researcher needs to understand that irrespective of the level of review that he or she determines is appropriate for his or her research activity, any research project may be submitted to the IRB for full review at a regularly convened meeting upon the election of the IRB. If the student or researcher has questions about the type of review for which the research activity will qualify, he or she should call the Chair of the IRB or any one of its members.

Q: What if the student or researcher plans to use animals?

A: If a student or researcher desires to conduct research activities that involve animals, then, in addition to the policies and procedures outlined in this policy, the student or researcher should be familiar with and prepared to follow the Oakland City University polices and guidelines and the Federal regulations with regard to care and use of animals. The Animal Welfare Act of 1966 (P.L. 89-544, as amended) and the Health Research Extension Act of 1985 (P.L. 99-158) provide guidelines and requirements for the care and husbandry of animals utilized in research activities. In addition to the Universal Research Application (completed for Full Review Status) required for research activities involving human subjects and animals, the student or researcher will be required to complete an Animal Care and Use Application. The Animal Care and Use Application must be submitted at the same time as the Universal Research Application, so that the IRB can conduct a Full Review of both applications.

Q: Where does the student or researcher send the application form?

A: The appropriately completed Universal Research Application and the necessary supporting documentation, must be submitted electronically to irb@oak.edu as an attachment, along with any necessary other attachments. After the Universal Research Application form has been reviewed and approved by the appropriate level of the IRB, the student or researcher must submit an original, signed copy of all signature pages in the Universal Research Application to the Oakland City University IRB in Murray Administration Center prior to commencing any activities.

A current copy of the curriculum vita of the Primary Investigator (PI) (faculty member) must be on file in the Academic Affairs office. If the PI has submitted a current vita during the current academic year, he or she will not need to include it with his or her research application.

Q: How long will the IRB process take?

A: An Exempt Status Universal Research Application may be submitted at any time. Only one (1) member of the IRB needs and/or will be assigned to review this level/type of application. In the event the IRB member assigned to review the Exempt Status Universal Research Application has questions about the Universal Research Application that need to be answered prior to approving or disapproving the research activity, the student or researcher will be contacted for clarification. A response by the IRB will generally be given within ten (10) working days. (For the purposes of this policy, holidays and weekend dates are not considered working days.)

An Expedited Review Status Universal Research Application may be submitted at any time. Only one (1) member of the IRB needs and/or will be assigned to review this level/type of application. In the event that the IRB member assigned to review the Expedited Review Status Universal Research Application has questions about the Universal Research Application that need to be answered prior to approving or disapproving the research activity, the student or researcher will be contacted for clarification. A response by the IRB will generally be given within ten (10) working days. (For the purposes of this policy, holidays and weekend dates are not considered working days.)

A Full Review Status Universal Research Application may be submitted any time. The entire IRB must review a Full Review Status Universal Research Application. The IRB will generally meet within ten (10) working days after the Full Review Status Universal Research Application has been submitted. (For the purposes of this policy, holidays and weekend dates are not considered working days.) In the event that the IRB has questions about the Universal Research Application that need to be answered prior to approving or disapproving the research activity, the student or researcher will be contacted for clarification. A response by the IRB will generally be given within ten (10) working days after the IRB meets to discuss the Full Review Status Application. Please note that the IRB may require that a student or researcher provide written clarifications to questions the IRB may have with regard to the Full Review Status Universal Research Application prior to approving or disapproving a research activity.

In addition to the forgoing outline of the application process, Federal Certification forms will need to be provided if the research proposal is being submitted for federal or state funding that requires such forms. Please note that while Oakland City University and the IRB are committed to expediting the application process for all research involving human or animal subjects, the foregoing outline and timeline is an estimate only and particular circumstances may require more or less time to render a decision on whether research activities are approved or disapproved.

Q: When can the student or researcher start collecting data?

A: No data or research on or with human subjects or animals may be collected or commenced until approval is received from the IRB.

Q: What are the main ethical considerations used in reviewing research?

A: Federal law requires that the IRB make certain that the student or researcher understands each of these ethical issues:

  • Potential research-related risks to human subjects are minimized in the areas of physical, psychological, social, legal, and economic status.
  • The risks to human subjects are reasonable in relationship to the anticipated benefits to the subject.
  • The selection of human subjects is equitable and no group is excluded without justifiable reason based on gender, race, religion, or economic status.
  • Confidentiality of human subjects is protected as required by law.
  • Informed consent of human subjects in the research study is demonstrable.
  • Evidence of understanding of any special problems that may potentially exist in the research is explored.
  • Treatment and care of animals is appropriate.

The IRB acknowledges that the above list is not complete and that it is to serve as a basis for the student or researcher to understand the ethical issues involved in research that must be addressed, and the importance of those issues.


ONLINE QUIZ

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Your project involves research conducted in established or commonly accepted educational settings, involving normal education practices. What kind of review will your research require?

You are requesting minor changes in previously approved research during the period for which approval is authorized. What type of review does your research require?

All research involving survey or interview procedures is considered Exempt when the respondents are elected or appointed public officials or candidates for public office.

In research that places human subjects at more than minimal risk, a series of safeguards must be in place to ensure research participants will have full understanding of the procedures prior to giving consent. What review is necessary for this type of research?

In what document were the international standards set to protect human subjects so that the risks did not exceed "the benefits to humanity."

The Principal Investigator (PI) is the lead researcher. At Oakland City University, who is allowed to be a PI?

The assurance that only the researcher knows who belongs to the data; and that a third party who somehow gained access to the data would not be able to make a link between the subject and the data recorded from that subject is known as what?

Research methods such as interviewing pharmacy patients or newspaper subscribers are known as what?

Respect for persons, beneficence and justice are the three ethical principles established by what document?

The form used to collect data, such as a code sheet, a questionnaire, etc., is known as what?

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