Institutional Review Board Introduction and FAQ
What is the Institutional Review Board (IRB)?
The Adler Graduate School Institutional Review Board (IRB) oversees all proposals for Master’s Projects or other academic projects involving human participants. The IRB also monitors ongoing approved activities involving human participants to make sure that any psychological, social, or physical risk to participants is not greater than it would be normally encountered in the course of everyday life and is justified by the proposed contribution of the study into generalizable knowledge.
What It Is Not?
The IRB is not charged with assessing quality (merit) of the overall proposal or with other issues such as copyright protection, unless the merit or other qualities of the proposed research and/or copyright issues may be a factor in estimating the risks to human participants.
Why Do We Need It? What Is Its Purpose?
The purpose of the IRB is to ensure that proposed study in general or any procedure that is a part of the study are not unduly harmful to participants and that participants give voluntary and informed consent and have every opportunity to exercise such consent in an educated and uncoerced fashion. The IRB also ensures that participants’ privacy and anonymity are assured as appropriate both through advanced preparation and in the duration of the research activities.
With respect to the above goals, the AGS IRB has the authority to oversee any proposed and approved project conducted by any student, faculty or staff member during the proposal submission process, for the duration of the project execution, and any time after the completion of the project if necessary. All human participants related issues, from recruitment of participants to storage and disposal of any records containing the data about the participants, are within the jurisdiction of the AGS IRB.
Further, the IRB is charged with ongoing compliance with federal regulations concerning research with human participants and with education of and consultation for all relevant individuals on topics concerning the above.
Who Are the Members of IRB?
The IRB consists of four members. The Board members have diverse research-related experiences and professional expertise. All of them have working knowledge of applicable standards of professional conduct, knowledge of vulnerable populations, and knowledge of the field in which students are getting prepared. At least one IRB member is a public member. At least one IRB member has documented clinical expertise. At least one member of the IRB is to have primary concerns in the scientific area and at least one to have primary concerns in the non-scientific area. The IRB has representation of women, men, and minority populations.
The Adler Graduate School Academic Vice President invites and appoints members to the IRB. Members serve on the IRB for up to three years, and this term may be renewable.
When necessary, the IRB will solicit expert consultations from those individuals or entities who may possess unique expertise in the areas that this IRB is lacking or is insufficient in order to provide the best guidance necessary to those seeking IRB approval.
In response to specific demands and in an attempt to expedite the review process, the IRB Chair may form task-specific subgroups.
The AVP may be called to vote on some cases in which a tie breaker is needed.
IRB members may not participate in the review process if she or he serves as the Chair or Reader for the specific student project, has interest in any sponsoring agency, has familial ties with any members of the Research Team (a student, a Chairperson, a Reader), has any connections to a proposed participant pool (working for the agency from which participants will be recruited), or is an investigator in the proposed study.
How Does It Work?
For student research, the IRB application is submitted along with the MP Proposal after completion of 599A, 599B, and 599C. Two other courses have to be completed with a grade of “B” or higher prior to submitting the IRB application – course 500 Principles of Research and course 521 Ethics and Legalities. Faculty or staff members conducting research should have equivalent prerequisites.
The AGS IRB must approve a study before any data can be collected from human participants.
The IRB maintains a schedule for meeting and for deadlines for proposals to be submitted in order to be reviewed during the subsequent meeting. Usually, and assuming that all the forms are completed correctly, proposals for literature reviews, program evaluations, or interview of experts in the field – regardless of how the project is delivered (a 45 page long literature review or an experiential project) - do not need IRB review, and are fast-tracked by needing a required set of signatures (including the IRB Chairperson or his/her designee).
Once the application and the proposal are completed and signed by the primary investigator, the Chairperson, and the Reader, the MP Proposal and the IRB Application are sent to the Adler Graduate School Academic VP. The Academic VP forwards the paperwork to the IRB for review. The IRB decision and recommendations are communicated to the primary investigator and her or his team (the Chairperson and the Reader).
If the approved project that does not conclude within a calendar year from the date of its IRB approval, it must go through additional review process. At any time, when the original proposal changes, the changes need to be communicated to the IRB immediately, and no activities involving human participants can take place until a new approval is secured. The completion of the study should be reported to the IRB within a week in the form of a written progress report covering all the items contained in the IRB application.
The members of the full IRB meet monthly to review proposals containing the use of human participants. Smaller task groups work between monthly sessions to prepare their recommendations for the full committee. There is a fast-track option for those studies that do not plan to use human participants. Proposals documenting no intent to use human participants (typically, literature reviews and some experiential projects) and having the MP Chairperson confirming that, will have expedited consideration and approval by the IRB Chairperson and the AVP. These proposals do not require a full IRB application; however, based on information submitted in the MP proposal, a student might be asked to fill an IRB application.
In addition, monthly IRB meeting agendas include any current concerns communicated to the Board through its Board members, or any other individuals.
What Will IRB Reviewers Be Looking For in a Proposal?
In brief, the IRB will consider the following factors in every proposal, as well as interactions of single factors, as potentially impacting human participants - - for the duration of the project and in the materials presented for digitization
1. Degree of risk to participants and risk-benefit analysis – for the duration of project
2. Protection of human welfare during the recruitment and selection processes
3. Quality of the process of informed consent
4. Procedures set to protect the privacy and confidentiality of participants
5. Monitoring and observations
6. Additional Safeguards
7. Incentives for Participation
There will be additional factors under consideration in each individual proposal.
All the activities of the IRB will be governed by relevant regulatory statutes (such as CFR, FERPA, and others), AGS institutional policies, and professional ethical standards. The IRB members will interpret the above set of guidelines and, in the case of conflicting opinions, will follow the most stringent guidance – in order to ensure the strictest protection of human participants.
What Projects May be Exempt from Full IRB Review?
Expedited review is a procedure through which certain kinds of research may be reviewed and approved without convening a meeting of the IRB. The IRB may also use the expedited review procedure to review minor changes in previously approved research during the period covered by the original approval. Under an expedited review procedure, review of research may be carried out by the IRB chairperson or by one or more experienced members of the IRB designated by the chairperson. The reviewer(s) may exercise all the authorities of the IRB, except disapproval. Research may only be disapproved following review by the full committee.
Some projects may be exempt from full IRB review. The exemption must be requested. Examples of such studies may be some surveys, standard educational tests/procedures, observations of public behavior, or studies with existing data that is publically available. Please note that in any research activity, exempt or not, participants and/or their legal guardians must consent to participate in an activity that is a part of research. Research falling under a category of standard educational testing, surveys, observations of public behavior, or existing and publically available data is not exempt if human participants can be identified. A burden of proof that the proposed study is exempt is on student and his/her chairperson, or on any other individual/entity conducting research activities associated with Adler Graduate School.
How Do I Request an Expedited Review or Exempt?
In order for a study to be exempt, at least ONE of the five categories listed below must apply.
Exempt Category 1:
a) 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.
AND
b) no identifiable information on participants is collected
Exempt Category 2:
a) Research involving the use of educational tests (cognitive, diagnostic, aptitude, achievement), survey procedures, interview procedures, or observation of public behavior.
AND
b) no identifiable information on participants is collected
Note: This exemption does not apply to the following types of research; 1) research involving children that includes surveys, interviews, and observations of public behavior when the investigator is a participant in the activities being observed; and 2) research in which information is recorded in such a manner that participants can be identified and disclosure of the information could reasonably place the participants at risk.
Exempt Category 3:
Research involving the use of educational tests (cognitive, diagnostic, aptitude, achievement), survey procedures, interview procedures, or observation of public behavior, if:
a) human participants are elected or appointed public officials or candidates for public office;
OR
b) federal statute(s) require(s) without exception that the confidentiality of the personally identifiable information will be maintained throughout the research and thereafter.
Exempt Category 4:
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 participants cannot be identified, directly or through identifiers linked to the participants.
Note: All of the data or materials must exist prior to proposing the research.
Exempt Category 5:
Research and demonstration projects that are conducted by or subject to the approval of department or agency heads and that are designed to study, evaluate, or otherwise examine:
a) public benefit or service programs;
b) procedures for obtaining benefits or services under those programs;
c) possible changes in or alternatives to those programs or procedures; or
d) possible changes in methods or levels of payment for benefits or services under those programs.
Note: In order to be eligible for this exemption, all of the following must apply:
The research is conducted pursuant to specific federal statutory authority.
The research has no statutory requirements for IRB review.
The research involves no significant physical invasions or intrusions upon the privacy interests of subject.
The research has authorization or concurrence by the funding agency.
You have to request an exempt by first checking the appropriate box in the IRB application, and then adding a written request for exemption to your IRB application. In your request, you need to specify the category under which you are requesting an exemption from full IRB review. Your request for an exemption is not a guarantee of an exemption. You may not start collecting data until the Adler Graduate School Institutional Review Board has communicated to you in writing its decision about exemption.
The above is our attempt to answer a few general questions. For more information, you may want to visit the Office for Human Research Protections (OHRP) of the US Department of Health and Human Services (DHHS) general website is http://www.hhs.gov/ohrp/policy/clinicaltrials.html
For general discussion about behavioral research involving human participants go to Chapter V of the Institutions Review Board Guidebook at the Office for Human Research protection (OHRP) Archive at http://www.hhs.gov/ohrp/archive/irb/irb_chapter5.htm
To read more about IRB, please go to http://www.hhs.gov/ohrp/archive/irb/irb_chapter3.htm
For a complete Glossary of Terms Frequently Used in the process of research with human participants and in the process of review of such research, please go to http://www.hhs.gov/ohrp/archive/irb/irb_glossary.htm
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