1. Service Units
  2. Research Integrity & Compliance
  3. Human Subjects Research
  4. Types of Research
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Types of Research

While FDA-regulated and other biomedical studies are conducted on campus, the research conducted at UConn Storrs is primarily social/behavioral in nature.  Although federal regulations for the protection of human participants cover both biomedical and social/behavioral research, they are not specific regarding the various types of social/behavioral research.  Therefore, the IRB developed the guidance to assist in the development and review of Qualitative/Ethnographic, Focus Groups, Oral History and other types of social/behavioral research.  The guidance is available on the IRB website.

Review of Studies Conducted in Foreign Countries

Research conducted by UConn investigators in foreign countries remains under UConn purview and guidelines.  While adjustments may be made to some requirements to respect cultural differences, our standards for ethical conduct are not relaxed.

The IRB may require that research projects be approved by the local equivalent of an IRB before the IRB will grant final approval.  Where there is no equivalent board or group, investigators must rely on local experts or community leaders to provide approval.  The PI must provide the IRB with documentation of this “local approval” and documentation of the authority and expertise of the individual or group who granted approval.  There must also be detailed plans in place for local monitoring of studies that pose more than minimal risk to participants.  Researchers must describe what, if any, knowledge or experience they possess regarding the language and culture of the country in question.  If the IRB is not satisfied with the review of local experts and/or the plans for continued monitoring there is the possibility that the study will not be approved.

The IRB may seek guidance first from OHRP’s International Compilation of Human Subject Research Protections or it may contact OHRP to determine whether procedures described by a foreign institution afford protections that are at least equivalent to U.S. regulations 45 CFR 46.101(h) and may be substituted for the U.S. regulations.  Under this provision, OHRP investigates the foreign country’s guidelines for human participants research, and if the foreign guidelines are found to be equivalent to U.S. regulations, the investigator is permitted to substitute those foreign procedures.

Research Requiring Review More Frequent Than Annually

The IRB will require that continuing review occur more often than annually in the following circumstances:

  • The research involves the use of procedures that have not been studied in humans.
  • The research is expected to result in a high frequency of morbidity or mortality.
  • The investigator has a history of serious or continuing noncompliance that the IRB believes necessitates closer monitoring.
  • Any other situation in which the IRB believes that more frequent continuing review is warranted.

 

Verification from Sources Other Than Investigators:

The IRB will require independent verification from sources other than the investigator that no material changes (i.e. changes that are both relevant and consequential) have occurred since previous IRB review in the following situations:

  • When there is inconsistency in the information presented by the investigator to the IRB and those inconsistencies cannot be easily resolved.
  • When the IRB questions the ability or the willingness of the investigator to provide accurate information.
  • When concerns have been raised, via continuing review or from other sources, that material changes have been implemented without IRB approval.
  • Other circumstances for which the IRB deems independent verification is needed.

 

In most cases the Research Compliance Monitor will conduct the verification.  The monitor has access to all research data and may observe the research and consent process.  The IRB may require that an ad-hoc consultant with particular expertise review the research activity.  Such consultants will not have a professional or financial interest in the research.  The IRB Chair may determine who will act as the consultant and will also confirm that no conflicts exist.  The individual performing the verification will provide the IRB staff with a written statement of the verification.  The IRB staff will make this information available to the IRB members and also place a copy in the IRB study file.

Scientific Review

The Common Rule and corresponding FDA regulations require the IRB to determine that the study is designed so that risks to participants are minimized and justified by potential benefits (refer to 45 CFR 46.111(a)).  Therefore, the IRB will carefully consider the study design and overall scientific quality of each study, particularly those studies that are investigator-initiated and/or unfunded.  In evaluating the scientific design, the primary reviewer (exempt and expedited studies) or the primary reviewer and convened IRB (full board studies), will consider the following:

  • clarity of the research question
  • appropriateness and efficiency of design
  • rigor and feasibility of methods
  • qualifications and expertise of the research team
  • scholarship and pertinence of background material and rationale
  • adequacy of sample size and relevance of controls and
  • the validity of the statistical analysis plan.

 

When necessary the IRB may ask consultants with additional expertise to review the research study.

Categories of Study Status

Submissions to the IRB will fall into one of the status categories noted below:

  • Approved  –   This decision is used when a study is given final approval either through the exempt, expedited, or full board review process.  Final approval of a full board study means that all modifications initially required have been addressed.  If the study is approved through the expedited or exempt review process, the specific category by which expedited or exempt review is permissible is noted.  A study can begin only after final approval is granted.  This category is also used to reflect approval of requests for continuations and amendments.
  • Modifications Required in Order to Secure Approval –    This decision is used when the full board has reviewed a study at a convened meeting and requires minor modifications before final approval will be given.  This category may also be used for expedited review, requests for continuation (re-approval), and amendments.  Upon satisfactory response to the request for modifications, the Chair or his/her designee is authorized to grant final approval without re-review by the full board. The IRB may also request that the PI make modifications to an application for initial or continuing expedited or exempt review.  This is communicated to investigators through letters from the IRB.  Final approval of an expedited or exempt study means that the requested modifications initially identified have been satisfactorily addressed.
  • Deferred  –   This decision is used when the full board has reviewed a study at a convened meeting and has significant concerns with the protocol, consent document or other relevant material, or requires substantive clarifications on issues that relate to the required criteria for approval.  For example, if the protocol contains insufficient information to assess the nature and purpose of the study, or if the IRB requires clarification as to why a procedure is being followed in the study, the study will be deferred until the convened IRB can determine that risks to participants are minimized.  The PI is encouraged to make a point-by-point response in writing, and must resubmit the application for full board review.  This category may also be used for requests for continuation and amendments.
  • Disapproved  –  This decision is used when the full board reviews a study and determines that one or more of the elements required for approval (refer to Criteria for Approval section) has not been met, and in the Board’s opinion, cannot be satisfied through revisions to the application (for example, if the Board determines that balance of risks to benefits is unacceptable).  This category may be used for requests for continuation and amendments.  The decision is made by the convened IRB.  Protocols may not be disapproved by the expedited or exempt review mechanism.
  • Tabled  –   This category is used only when a study is not reviewed at the meeting for which it was originally scheduled, for example, due to loss of quorum.  This category may also be used for requests for continuation and amendments.
  • Closed   –   This decision is used to reflect that a study is closed/completed.  An investigator may request closure of a study when the research project will no longer be pursued, or when data analysis is finished, and the essential work of the study is completed.
  • Terminated  –  This decision is used to reflect that a study has been closed by the IRB.  A study may be terminated due to failure to request continuing review beyond a 30-day grace period after the study expiration date.  The IRB may terminate a study for noncompliance or due to the occurrence of serious or unexpected risks to participants.  Termination of previously approved research is defined as a permanent withdrawal of study approval that requires all study related activity to cease.  The investigator will be notified of studies terminated by the IRB.  Terminations are not reportable events.
  • Suspended  –  This decision is used to reflect the imposition of a temporary hold on any or all research activity associated with a study, or a permanent stop to some portion of a previously approved research activity.