Policies and Procedures

Developing your application

Please allow adequate time for the preparation and submission of your proposal. Present all information clearly and concisely keeping in mind that members of the review committee may not be familiar with your field. Avoid or explain technical terms whenever possible. Answer all questions completely, provide any requested documentation, and sign or type your name on the certification page.

How will my application be reviewed?

Your application may receive full or expedited review. You may also determine that your research meets one or more of the following criteria and is therefore considered EXEMPT from committee review.

Full Review:

Research involves more than minimal risk such as:

Deception that may result in greater than minimal risk (see definition of minimal risk under Expedited Review).
New or experimental drug research.
Activities that induce stress at greater levels than that of daily life.
Research with vulnerable (children, pregnant women, homeless, prisoners, etc.) populations.
Data collection that includes highly sensitive information.

The application must be submitted to the committee chairperson two (2) weeks prior to the meeting.
The full committee meets on the 2nd and 4th Wednesdays of the month when school is in session to review these proposals.

If you believe your research meets the criteria for full review, complete IRB form 1. A copy will be automatically forwarded to the IRB chairperson. Please make a copy for your records.

Expedited Review:

Research that involves no more than minimal risk defined as “the probability and magnitude of harm or discomfort anticipated in the research are not greater in and of themselves than those ordinarily encountered in daily life or during the performance of routine physical or psychological examinations” [CFR, vol 56, no. 117, sec 102 (i), pp. 28013-28014). A summary of categories of minimal risk may include:

Collection of: hair and nail clippings, in a nondisfiguring manner; deciduous teeth; and permanent teeth if patient care indicates a need for extraction.
Collection of excreta and external secretions including sweat, and uncannulated saliva.
Recording of data from subjects 18 years of age or older using noninvasive procedures routinely employed in clinical practice. It does not include exposure to electromagnetic radiation outside the visible range (for example, x-rays, microwaves).
Collection of blood samples by finger stick or venipuncture by trained personnel, in amounts not exceeding 450 milliliters in an eight-week period and no more often than two times per week, from subjects 18 years or older and who are in good health and not pregnant.
Voice recording made for research purposes such as investigations of speech defect.
Moderate exercise by healthy volunteers or vigorous activity by physically trained individuals if appropriately screened by a physician or nurse practitioner prior to participation in said activity.
The study of existing data, documents, records, pathological specimens or diagnostic specimens. [Note: ALL of the data, documents, records, or specimens must be in existence before the project begins.]
Research on individual or group behavior or characteristics of individuals, such as studies of perception, cognition, game theory, or test development, where the investigator does not manipulate subjects’ behavior and the research will not involve stress to subjects.
Deception that is designed to distract but does not significantly misrepresent the research and is anticipated to result in no more than minimal discomfort to the participant at the time of debriefing.
Research on drugs or devices for which an investigational new drug exemption or an investigational device exemption is not required.

A subcommittee reviews the application within two weeks of submission.

If you believe your research meets the criteria for expedited review, complete IRB form 1. A copy will be automatically forwarded to the IRB chairperson. Please make a copy for your records.

Exempt from Review:

Many research protocols may meet the definition of research, yet may be exempt from review by the IRB. Research with children, prisoners, and other “vulnerable” populations do NOT qualify for exemption. Research that may be considered exempt includes:

surveys that are done in a completely anonymous manner.
institutional program evaluation that is not publicly disseminated.
research that has been already approved by another institutional review board (documentation of this approval is required by the IRB-submit to the committee chair)

If you believe your research meets the criteria for exemption, complete IRB form 2. A copy will be automatically forwarded to the IRB chairperson. Please make a copy for your records.

The chair of the IRB reviews these proposals within 1 week and consults with other committee members as needed to verify the exempt status of the proposal.

A more comprehensive checklist is provided within IRB form 2. The researcher must identify which criterion promotes eligibility for exemption.

Research That Occurs within the Context of a Class

Classroom activities that are solely instructional do not need to be reviewed as long as the work fits ALL of the following:

Is a normal part of the student’s course work;
Is supervised by a faculty member;
Has as its primary purpose the development of the student’s research skills;
Does not deal with issues of a sensitive nature;
Is not research that is expected to result in publication or some other form of public dissemination.

Please note: The vast majority of research will not fit this category and must be reviewed.

The Informed Consent Form

The informed consent document represents a process of communicating the research project to potential participants and obtaining agreement to participate. Written informed consent is most often required. A legal representative (guardian) must provide informed consent for those who are unable to provide consent, such as children and the mentally disabled. A copy of the consent form should be given to the person signing the form. Where informed consent is needed, the IRB must approve the actual document used in the research. Please use the template provided, which contains the essential elements for informed consent. Consent forms are secured and retained for 3-5 years unless otherwise designated by the researcher or committee.

Informed consent is required for data collected with identifiers, including code numbers that are connected to a person’s identity. Essential elements of informed consent are present and include:

Readability for the target audience (a 6^th to 8^th grade reading level is often recommended for adult subjects). In Microsoft Word, readability statistics can be determined by going to tools, options, spelling/grammar, and checking the box marked readability statistics after highlighting the passage in question. An article abstract about readability can be found at <http://content.nejm.org/cgi/content/abstract/348/8/721>
Avoidance of technical jargon.
An explanation of all elements of the research (what is expected of the subject).
Full disclosure of research aims and methods (including videotaping or audio taping) whenever feasible; minimizing level of deception and debriefing is required if deception is implemented.
Full disclosure of anticipated risks and benefits.
Full disclosure of access to information including who will see and maintain the data and the potential for loss of anonymity or confidentiality.
Full disclosure of the voluntary nature of the research including a statement that the participant may decline participation or may withdraw from the research without affecting the relationship between the researcher, institutions, and participant.
Full disclosure of the specific responsibilities of the participant and the researcher.

Informed consent is not required if data is drawn from public or observed behavior or if data does not contain identifying information or if the identifying information is removed and destroyed. In some cases, informed consent can be waived, such as when (1) the research involves no more than minimal risk to participants; (2) the waiver or alteration of consent procedures will not adversely affect the rights and welfare of the participants; (3) the research could not practicably be carried out without the waiver or alteration; and (4) whenever appropriate, the participants will be provided with additional pertinent information after participation.

Ethical Conduct of Research

Adhering to the principles of ethical conduct of research is required of all projects involving human subjects:

1. Evaluation of Ethical Acceptability of Research. The researcher is responsible for determining the ethical acceptability of the research and must incorporate any safeguards necessary to protect human subjects.

2. Ethical Practice. The research establishes and maintains responsibility for ethical conduct of research including protections for human subjects and others involved in the project. This includes reporting any adverse events immediately to the IRB, informing the IRB of any changes in the study protocol prior to implementation, and maintaining documents (informed consent) for a period of three (3) years after completion of the research.

3. Freedom from Coercion. Participants must be free to decide whether or not to participate in the research without this impacting the relationship of the participant with others involved directly or indirectly (including the College/University) with the research.

4. Debriefing. Any research that methodologically requires deception must include a statement of debriefing at the conclusion of the research. The debriefing must include the rationale for the need for deception, full clarification of the study purpose, and removal of any misconceptions. The researcher is responsible for taking measures to assure that no damaging consequences occur as a result of deception and that appropriate support is provided to research participants.

5. Freedom from Harm. The researcher is responsible for protecting participants from harm that may result from the research protocol whenever possible. This includes any related physical and emotional discomforts and harm that may occur prior to, during, or after the research. A research procedure that is likely to result in serious or long-term harm will not be approved. The researcher is responsible for correcting undesired consequence of the research and notifying appropriate authorities, including the IRB chair.

6. Confidentiality. Guaranteeing anonymity is a process of collecting data without any identifying information. Confidentiality guarantees that although the data may contain identifiers, that the identifying information will not be disclosed to others. Privacy of the participant identity and data is of utmost importance and must be respected.

Research with Vulnerable Populations

According to the Federal Register, populations such as children, prisoners, pregnant women, mentally disabled persons, or economically disadvantaged persons are “vulnerable.” Research involving these populations is required to have additional safeguards to protect the rights and welfare of these subjects. Studies involving prisoners will not be reviewed and approved by the IRB; these will be referred to the appropriate state or federal agency that oversees that prison system.

Children are defined as individuals under the age of eighteen (18) years. Research with children will be reviewed only if (1) the procedures do not present greater than minimal risk, (2) a plan is developed for obtaining informed consent from at least one legal representative (guardian), and (3) a plan is developed for obtaining assent from children ages seven (7) and older.

Research Using Web-Based Surveys

Web-based surveys require careful scrutiny in order to protect the anonymity or confidentiality of subjects. These surveys need to have a provision for excluding research subjects who are under the age of 18. The researcher must provide specific, detailed information about the type of information that is collected AND the underlying technology being used to collect the data. For example, does the program/software/survey technology collect any electronic identifying information? Does the survey involve collecting any information that is regarded as private or could be harmful to the participant if revealed? How does the program/software/survey technology provide a means for preventing multiple survey completions by subjects? How does the program/software/survey technology prevent “hacking” into the data base?

Committee Meetings

Committee meetings for proposals requiring full review are held on the 2nd and 4th Wednesdays of each month during the academic year from 4:45-6:30pm. Any proposal that is submitted for full committee review must be received by committee members 1 week prior to the IRB meeting. The IRB will review proposed research where a majority of the members are present including at least one member whose background is primarily scientific and one member who is primarily nonscientific. Scientific background is defined as those teaching, practicing or performing research within a biological, physical, or psychological discipline. Researchers are asked to attend full committee meetings if a full review is requested. At the conclusion of discussion, the committee will vote on the application approval followed by a summary of any recommendations.

Committee meetings for proposals requiring expedited review are scheduled by the expedited review subcommittee as needed. Expedited review proposals require 1 week for review. The expedited review subcommittee submits results to the IRB chair and these are then forwarded to the researcher(s).

Approval of your application

In order for the research requesting full or expedited committee review to be approved, it shall receive the approval of a majority of those members present at the meeting. Criteria for approval are the following:

The risks to participants are minimized and are reasonable in relation to benefits.
The study is well designed.
Select procedures are in common use for diagnostic or treatment purposes whenever feasible.
Selection of participants is equitable.
The research is cognizant of the special considerations of vulnerable populations, such as children, pregnant women, and the economically disadvantaged.
Informed consent follows guidelines, is obtained and appropriately documented.
When appropriate, the researchers monitor the collected data to ensure the safety of the participants.
The privacy of participants is protected and the data are kept confidential.
The rights of participants, including freedom from coercion, are protected.

Receipt of an official letter of approval indicates the investigator(s) may proceed with the study. There are three levels of approval:

Approved without modification. The researcher may proceed upon receiving the official letter.
Approved with minor modification(s). Some proposals require minor modifications to the protocol or consent form but the study is essentially considered “approvable”. The research must address the concerns identified by the committee, the researchers will submit the modifications, and can begin the research upon receiving the official letter.
Not approved. The research must address the substantial concerns identified by the committee and resubmit the proposal if desired.

Changes in your study protocol after approval

ANY changes in your study protocol that occur after the final approval is received must be communicated to the IRB chair prior to implementing the change. Significant changes in protocol that impact the protection of human subjects will require re-evaluation by the committee.

Continuation of your research

Approval of the research extends for one year from the date of initial approval letter. Continuation of the protocol requires notification of the IRB chair. Submit one (1) electronic copy of form IRB-3 for extension of the approval to the IRB chair.

Committee retention of records

The committee chair shall retain research records including, but not limited to, the final approval letter, a copy of the proposal and consent/assent form, statements of significant new findings or injuries to subjects, for a period no less than three (3) years after the research has been completed after which these records will be destroyed.

Appeals Process

The decision to approve an IRB application lies with the chair, expedited review team, or full committee to which it has been assigned, and is based upon application of the federal regulations cited above. Because the IRB is dedicated to maintaining the overall high quality of its peer review system and of the review of individual applications, it has established appeal procedures for investigators to address such concerns.

An investigator who is concerned about the review of his or her application should first contact the IRB chairperson. This is the key person for clarifying points in the summary statement or about the review
process, and may be able to provide additional information beyond that which appears in the summary statement. Often, the chairperson will recommend revising the application, addressing the points raised in the review, and resubmitting a new application.

However, if after discussion with the chairperson, the investigator still has serious concerns about the committee's procedures, he or she should submit a formal letter of appeal to the chairperson specifying the disputed policy or procedures encountered in the review. It is the chairperson's responsibility to handle the appeal and to do so according to specific appeal procedures.

The chairperson will consult with the IRB committee that administered the review of the application, and this consultation could result in a decision to re-review the application. A re-review consists of a review of the same application, not a revised version, by the full IRB committee. If possible, this review should occur without access to the summary statement of the disputed review. The re-review decision is made by formal majority vote of the IRB committee and is presented to the chairperson. The chairperson communicates the outcome to the investigator.

If the investigator continues to dispute the procedures or outcome of the application, then the appeal case will be reviewed by the Assistant Dean and Academic Dean/Associate Provost in conjuction with the full IRB committee. The IRB Chair will provide the Assistant Dean and Academic Dean/Associate Provost and all IRB members with all documentation related to the researchers’ proposal. After all parties have had an opportunity to review the relevant documents, the IRB Chair will convene a full review of the disputed proposal attended by the researcher(s), Assistant Dean and Academic Dean/Associate Provost, and at least five members of the IRB including the “outside” member from the community. After the proposal has been discussed by all present at the meeting, the IRB chair will then use a secret ballot to conduct a vote for approval or disapproval of the disputed proposal by the IRB committee. This vote becomes the final decision of the IRB and the only remaining recourse for the researcher(s) is to submit a revised proposal for review by the IRB using its established procedures. Written documentation of the outcome (appeal rejection or re-review and approval of the study) of the Assistant Dean and Academic Dean/Associate Provost, and IRB committee deliberations will be sent to the investigator, and the appeal letter and associated correspondence will be retained in the official file for the application.