Institutional Review Board Office

Office of Doctoral Studies

IMPORTANT NOTE FOR STUDENT RESEARCHERS
It is the researcher’s responsibility to make sure that the IRB application and all supporting materials are submitted to [email protected]. The IRB staff always confirms receipt of IRB materials. Data collection should not commence prior to receiving explicit IRB approval from [email protected]

WHAT IS IRB APPROVAL?
The Institutional Review Board (IRB) consists of faculty, terminally qualified and experienced in conducting research and/or leading academic research studies. The IRB is responsible for ensuring that all University of the Potomac research complies with the university’s ethical standards and meets U.S. federal regulations and any applicable international guidelines. IRB approval indicates the institution’s official assessment is that the potential risks of the study are outweighed by the potential benefits.
Outside of the explicit dates and terms of IRB approval, researchers are not entitled to any protections, recognition, funding, or other support provided by University of the Potomac

Institutional Review Board

WHO SHOULD USE THIS IRB APPLICATION FORM?

This application should be completed by all students and faculty who are conducting research projects of any scope involving the collection or analysis of data from living persons (whether from surveys, interviews, observation, student work, or records of any type). The only categories of research that do not need to be submitted for IRB approval are literature reviews, hypothetical research designs, and faculty projects that are completely independent of University of the Potomac. Research projects conducted by full-time employees of UOTP are also under the purview of the UOTP IRB. Instead of completing this form, staff researchers should send an email inquiry to [email protected] to initiate the IRB approval process for staff research.

WHEN SHOULD I WORK ON AND SUBMIT MY IRB APPLICATION?

Questions about the IRB application and related materials may be submitted to [email protected] at any time.

It is expected that doctoral students will review IRB requirements as they are writing the proposal and to that end, this IRB application can be used as a worksheet to help think through the ethical issues of data collection. However, the student would need to complete the IRB application after proposal approval in order to address the details of the final, approved research design.

HOW LONG DOES IRB REVIEW TAKE?

Researchers should allow a minimum of 4-6 weeks for IRB review (4 weeks for minimal risk studies and 6 weeks for studies involving vulnerable populations). This form takes 1-2 hours to complete, depending on the complexity of the study. Once the IRB staff confirms that the IRB application is complete, the IRB application will be scheduled for review at the next available IRB meeting (typically within 10 business days). Feedback from the board will be returned within 5 business days (amounting to a total of 15 business days for the initial review). Note that when a study is “approved with revisions,” the researcher should allow an additional 10-15 business days for those revisions to be reviewed and approved.  If the revisions do not adequately address the ethical concerns, then an additional round of revisions and review might be necessary.  The IRB members make every effort to make the revision requirements as clear as possible.

WHEN SHOULD I WORK ON AND SUBMIT MY IRB APPLICATION?

Questions about the IRB application and related materials may be submitted to [email protected] at any time.

It is expected that doctoral students will review IRB requirements as they are writing the proposal and to that end, this IRB application can be used as a worksheet to help think through the ethical issues of data collection. However, the student would need to complete the IRB application after proposal approval in order to address the details of the final, approved research design.

HOW LONG DOES IRB REVIEW TAKE?

Researchers should allow a minimum of 4-6 weeks for IRB review (4 weeks for minimal risk studies and 6 weeks for studies involving vulnerable populations). This form takes 1-2 hours to complete, depending on the complexity of the study. Once the IRB staff confirms that the IRB application is complete, the IRB application will be scheduled for review at the next available IRB meeting (typically within 10 business days). Feedback from the board will be returned within 5 business days (amounting to a total of 15 business days for the initial review). Note that when a study is “approved with revisions,” the researcher should allow an additional 10-15 business days for those revisions to be reviewed and approved.  If the revisions do not adequately address the ethical concerns, then an additional round of revisions and review might be necessary.  The IRB members make every effort to make the revision requirements as clear as possible.

CAN I CONTACT MY RESEARCH PARTICIPANTS BEFORE IRB APPROVAL?

Note that researchers may NOT begin recruiting participants (i.e., obtaining consent form signatures) prior to IRB approval.

WHAT IF I NEED TO CHANGE MY RESEARCH PROCEDURES AFTER IRB APPROVAL?

Researchers must reapply for IRB approval if changes are made to the research procedures after IRB approval.

WHAT ARE THE CRITERIA FOR IRB APPROVAL?

The purpose of this IRB application is to collect enough specific information to document that the study’s benefits outweigh the costs and that the procedures are in compliance with federal regulations and university policies. To those ends, the board will evaluate the IRB application based on how well the following ethical principles are upheld:

Beneficence = maximize possible benefits and minimize possible harms
Justice = fairly distribute benefits and burdens of research
Respect for Persons = acknowledge participants’ autonomy and protect those with diminished autonomy

General Description of the Proposed Research
– Demonstrate the ethical rationale for each component of data collection by describing how each will be analyzed to address the research question(s).
– Provide specific descriptions of the tasks the participants will be asked to complete.

Potential Risks and Benefits
– Describe anticipated risks and benefits of study participation.
– Make provisions to minimize risks to research participants and document those procedures.

Data Integrity and Confidentiality
– Describe procedures to maintain data confidentiality and integrity.
– If data includes personal identifiers, submit signed certificates of confidentiality for everyone who has access to the data (except faculty members).
– If applicable, complete extra sections relevant to protected health information.

Potential Conflicts of Interest
– Disclose and manage potential conflicts of interest.

Data Collection Tools
– Describe all tools (surveys, interview questions, etc.) and authorizations related to data collection including evidence of compliance with copyright holder’s terms of usage, permission to reproduce the instrument in the dissertation, or confirmation that the tool is public domain (as applicable).

Description of the Research Participants
– Describe the study population, particularly inclusion and exclusion criteria, to demonstrate that those who shoulder the burden of the research will actually benefit from it.
– Describe how any vulnerable populations will be protected from safety/privacy risks and pressure to participate.

Informed Consent
– Make provisions to obtain and document informed consent from all study participants and the appropriate parents, guardians, or caregivers.
-Submit unsigned copies of any relevant consent documents.

Final Checklist and Electronic Signatures
-Students must obtain faculty approval before submitting this form to [email protected]

This form must be completed and submitted via email. If you have questions as you are completing the form, please contact [email protected]

INSTITUTIONAL REVIEW BOARD POLICY

BACKGROUND An Institutional Review Board (IRB) is a specialized committee, officially established to review and approve research proposals, required by the Health and Human Services (HHS) regulations that safeguard the rights and welfare of human subjects. IRB determines “the acceptability of proposed research in terms of institutional commitments and regulations, applicable law, and standards of professional conduct and practice” (45 CFR 46). An essential aim of the IRB is to safeguard human subjects from physical or psychological harm by evaluating the ethics of the proposed research and its methodologies in order to endorse informed harmless and voluntary participation by potential subjects. University of the Potomac (UOTP) policy is to apply the guidance and regulations applicable under (45 CFR 46.107) to all human research conducted at the university. The mission of UOTP’s IRB is to safeguard the rights and safety of participating subjects in research conducted by UOTP’s students and faculty. The IRB will provide support and guidance to the university’s research community to ensure that:
  • The risks to human subjects are reduced by applying procedures consistent with sound research design and that do not needlessly expose the research participants to risk.
  • The benefits- the desired outcomes- of the research outweigh the risks- the probability of harm or injury (physical, psychological, social, or economic) occurring as a result of participation in a research study.
  • The selection of human subjects for research participation is impartial.
  • Full disclosure of the risks and benefits of research participation is made to the participants prior to their participation.
  • Sufficient provisions are in place for the protection of the privacy of human research subjects and confidentiality of data.
  • Suitable protections are in place for subjects that may be vulnerable to coercion or undue influence.
POLICY University policy requires the creation of an IRB oversight committee to assure compliance. The HHS regulations 46 CFR 46.107 require that IRBs have at least 5 members from a variety of backgrounds including, at least, one member who is not affiliated with the University. The experience, expertise and diversity of the IRB members should allow the IRB to provide a complete and adequate review of the research activities conducted at the institution. The Provost & Chief Academic Officer appoints the Chair of the IRB. The Chair of the IRB will work with the Academic Affairs Committee to appoint the members of the IRB in accordance HHS regulations. Research may involve issues about which IRB members lack specific expertise. In these situations, IRBs should identify and invite individuals with specialized knowledge to assist in the review of applications and protocols where the expertise is required. An essential aim of the IRB is to safeguard human subjects from physical or psychological harm by evaluating the ethics of the proposed research and its methodologies in order to endorse informed harmless and voluntary participation by potential subjects. The major roles of IRBs in the oversight of research are:
  1. Determine that research conducted using human subjects is subject to regulation (45 CFR 46.107)
  2. Initial review and approval or disapproval of the proposed research activity
  3. Ensuring that the proposed informed consent process meets all of the requirements of 45 CFR 46.116
  4. Providing continuing oversight for progress reports and protocols for ongoing research studies

Procedures

It is the principal investigator’s responsibility to make sure that the IRB application and all supporting materials are submitted to ([email protected]). UOTP’s IRB always confirms receipt of IRB materials. Human subject research cannot commence prior to receiving explicit IRB approval from [email protected]