Common Questions that are asked about the IRB:
The Institutional Review Board (IRB) is a standing university committee established under federal regulations to protect the rights and welfare of all human subjects (participants) who volunteer to participate in research studies conducted under the auspices of Wilkes University. It oversees institutional compliance with all federal, state, and University guidelines relating to research with human subjects.
The IRB is responsible for reviewing all research involving human subjects, insuring the equitable selection of research subjects, ensuring that potential research-related risks are minimized, and that there is full disclosure so that volunteers can make an informed decision to participate.
The requirements for IRB membership are addressed in the HHS regulations at 45 CFR 46.107 [Note: 45 CFR 46.304 requires a specialized IRB composition when research involving prisoners is being reviewed, including the presence of a prisoner representative].
An IRB must:
- have at least five members with varying backgrounds to promote complete and adequate review of the research activities commonly conducted by the institution;
- make every nondiscriminatory effort to ensure that the membership is not composed of entirely men or entirely women;
- include at least one member whose primary concerns are in scientific areas and at least one member whose primary concerns are in nonscientific areas;
- include at least one member who is not otherwise affiliated with the institution and who is not part of the immediate family of a person who is affiliated with the institution; and
- not allow any member to participate in the initial or continuing review of any project in which the member has a conflicting interest, except to provide information requested by the IRB.
All research involving the collection of data from human subjects must be submitted to the IRB for review. Some research activities are exempt from full IRB review but the IRB determines when an exemption is appropriate.
You are required to submit a formal application if your project or study meets both of these conditions:
- It constitutes "research" with the intent to develop new or expandable knowledge.
- If human subjects are involved, either directly or through use of identifiable data about them.
- Does my project constitute "Research"?
According to the Code of Federal Regulations, Research means a systematic investigation, including research development, testing, and evaluation, designed to develop or contribute to generalizable knowledge [45 CFR 46.102(d)]--i.e.,"with the intent to develop new or expandable knowledge".
- Is my project considered to be research "on Human Subjects"?
- Are you planning to obtain information from or about living persons?
- Will the study involve direct interaction with individuals OR data linked to personal identifiers?
- Will you gather information that would ordinarily be private?
- Will you observe behavior in a context where persons would reasonably expect privacy (e.g., their homes)?
If you answered YES to (a) AND one or more of the other questions, your project is considered to be "on Human Subjects." If you answered NO to all the questions, then you do not need IRB approval and can begin your project.
NOTE : IRBs do not have the option of granting "retroactive" approval after research is initiated or completed. You are strongly encouraged to submit your research proposal or consult with the IRB if you are unsure whether or not you need IRB approval.
If you are doing research that is limited to secondary analysis of data, records, or specimens that are either publicly available, de-identified, or otherwise impossible to be linked to personal identities, you may still need IRB approval to do your project. Sometimes a data use agreement between the researcher and the data custodian may still be required to verify that the researcher will not have access to identifying codes. It is this “de-linking” of data from personal identifiers that allows the IRB to make this determination. Regardless, you should submit an IRB proposal so the IRB can determine whether your project needs IRB review, and if so, the type of review required.
Convened IRB review (full board)
Any study involving greater than minimal risk requires a review by the convened IRB. This includes studies with minors, vulnerable populations (e.g., developmentally or mentally disabled adults, prisoners, etc.) and sensitive questions, as well as studies with the possibility of physical risk.
- Only research involving no more than minimal risk to subjects may be considered for expedited review.
- Federal guidelines provide categories for expedited review. Examples of categories
- blood sampling in minimal amounts
- review of records collected for non-research purposes (such as chart reviews)
- survey research
- Research with very minimal risk to human subjects as determined by regulatory guidelines may be exempted from continuing review at the discretion of the IRB.
- An exemption is granted by the IRB upon review of the application.
- Since this constitutes a review, protocols that are deemed exempt are effectively
“exempt from continuing review” or institutional oversight. Examples include
- observations done in recognized educational or public settings
- research on educational strategies, curricula, or management methods
The determination of exempt status or the level of review applicable to a particular study is made by the IRB.
Informed Consent is a process by which participants become knowledgeable about the activities, risks and benefits to participating in a particular research project. This knowledge is then used in making an ‘informed’ decision about whether or not they wish to participate.
Informed consent is required for all research studies unless specifically waived by the IRB. In order to participate in a research study, participants must understand that they are part of a research project, that participation is voluntary, and that they may withdraw at any time without penalty. They must also understand the procedures involved, time commitment, benefits and risks, and the extent to which confidentiality is maintained. This information is usually provided in written form and includes the following:
- Purpose of the Research
- What is expected of the participant
- Risks and/or Discomforts
- Potential Benefits
- Alternative Procedure or Treatment
- Confidentiality Provisions
- Liability statement
- IRB Contact for Information
- Voluntary Participation and Right to Discontinue without Penalty
- Signature of Participant and Investigator
Assent is basically the same as consent yet involves minor children (under age 18) who are not authorized to give legally valid informed consent because of their age. Assent is written in child friendly language and describes the research participation, risks, benefits, and other elements of consent.
No, all studies do not need a consent form. Studies that use anonymous, archival data do not require a consent form. Some studies that include anonymous, written surveys or on-line surveys may not require consent. In such cases, voluntary completion of the survey implies consent. However, an information letter is necessary for all anonymous surveys so that participants may make an informed decision as to whether they want to complete the survey. One of the exceptions to this generalization is a survey that involves minor children. In this case, a parental permission may be needed
An investigator (researcher) is required to indicate whether or not their research protocol is subject to bias by any conflicting financial interests or other personal situations of the researcher or team members involved in the study. This is referred to as a Conflict of Interest Statement. The conflict of interest statement provides the researcher with the opportunity to describe how potential conflicts of interest are managed or prevented.
Examples of Conflicts of Interest:
- Conflict of interest in research is a situation where it reasonably appears, on an actual or potential basis, that:
- The researcher’s situation could directly and significantly compromise his or her professional commitments or allegiance to Wilkes University.
- The researcher holds a position in an enterprise (e.g. as director) that may wish to restrict (or otherwise manage) adverse research findings for commercial reasons or not wish to publish the results of the research.
- The researcher’s financial interest in the research could impact the design, conduct or reporting of research activities
- The researcher has a financial interest in the company sponsoring the research. The researcher is an inventor of patents or creator of other items whose value may be affected by the outcome of the research.
- A researcher conducts a clinical trial which is sponsored by any person or organization with a financial interest in the results of the trial.
- A student conducts research on a project that receives support from a company in which the student has a financial interest or significant position.
- A student receiving support from a company in which his/her academic supervisor has a financial interest or position.
If you have a significant financial interest in the project for which you are making application to the IRB, you must complete the Wilkes University Significant Financial Interest Disclosure Form and submit it with this application.
- Disclose of the conflict through the Informed Consent process as well as on any informational, educational, or reporting documentation or presentations related to the research.
- Have the research conducted or closely monitored by a third party with no conflict of interest. This can include all or selected portions of the research.
- Modify the research procedures to minimize or eliminate the conflict. E.g. the researcher steps down from a position they hold in an enterprise that created the potential conflict by influencing research results and dissemination.
Anonymity refers to study participants who cannot be identified by any means. No identifying demographic data exists when collecting the data from the survey or questionnaire. De-identified archival data and mailed or online surveys are potential examples.
Confidentiality suggests that the data collected will be maintained and reported without divulging any identifying information; although, the investigator or members of the research team may have access to the study participant's names, gender, and other identifying information.
A consent form is a document signed by the participant that contains specific information so that he or she may make an informed decision as to whether or not to participate in the study. A signature of the participant and the principal investigator is required.
An informational letter should contain all of the content in a consent form so that a potential participant may make an informed decision as to whether or not to participate in the study. However, a signature of the participant and the principal investigator is not required. Informational letters are often used with anonymous surveys.