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Note that activities described as being done by the Coordinator are also done by the Associate Coordinator. HSCL receives an average of 50 applications every month, with most applications coming in the fall semester followed closely by applications received in the spring semester. The HSCL coordinator gives a preliminary review to each application. If the application satisfies criteria for expedited review the coordinator may approve the application or request modification to the application so that it satisfies federal and University requirements for approvable research.
The applications may come in hard copy format via surface mail, or by fax or e-mail.
The administrative assistant stamps the date the application was received in the HSCL office. Certain information in the application, such as the date received, PI's first and last name, co-researchers, and research supervisor (for student applications), campus or home address, university department or other university office, title, number of subjects, whether or not the application is federally funded, whether or not the application comes under HIPAA, umbrella number if applicable, and funding source are entered on the HSCL database.
If the application requires full board review, the coordinator provides copies to all of the board members and selects three board members to give a formal evaluation of the application. Upon receipt of evaluation from the three board members the coordinator summarizes their comments and passes them on to the researchers. Other board members may also submit comments concerning any applications, whether or not they are the designated reviewers. Unless a board member indicates that an application should be Not Approved or Disapproved the coordinator may evaluate the researcher's reply to the board review. Applications of this nature are given a Contingent designation.
The procedures described below pertain to both the preliminary review given by the Coordinator and that given by HSCL board members. However, the Coordinator does check for application completeness to ensure that board members are given complete applications for their review. Applications with missing components, such as consent forms or debriefing procedures, are withheld from distribution to the board until the missing items are received by HSCL. This helps to decrease the chances of an application being designated Not Approved by the board due to insufficient information in the application they receive. The application may be just the four page application or may include other materials, such as consent forms, survey instruments, or letters of permission from cooperating institutions.
An application with a date that falls on or before the 15th of the month must be reviewed and acted on by HSCL on or before the next monthly meeting, set for the first Thursday of each month. The Coordinator reads through the 4-page application and supporting documents, such as consent forms, assent procedures, survey instruments, and other information provided with the application.
The Coordinator looks at the first page and determines if the application is from someone with PI status (faculty or staff with PI status) or if not, if it has a signature or note of approval from someone with PI status. If a signature or note of approval is needed the Coordinator notifies the faculty supervisor and the student applicant that the faculty supervisor's approval is needed in order to review and approve the application.
The second page of the application contains a series of Yes or No questions that ask about use of drugs, substances given participants, payment to participants, risk, deception, ability of subjects to give informed consent, number of subjects, etc. The application may be viewed in the Appendix.
If an answer is "no" the reviewer looks for contradictory or supporting information in the application. For example, if 10a, drugs or other controlled substances, is checked "no" then the reviewer will be on the lookout for references to drugs administered. If 10a is checked "yes," then the reviewer will want to know about the drugs, the name, type, possible side effects, etc. This information should be given to the research participants also, so the reviewer checks the consent form to see that the information is passed on.
The same procedure is followed for other items. If a cooperating institution is indicated, (10c) then the HSCL wants the PI to state the name of the institution and, ideally, provide a letter of support or approval from that institution to carry out the project there. The cooperating institution's approval, however, is not necessary for HSCL to grant approval. The HSCL has found that some institutions withhold approval until receiving a copy of HSCL's approval, so to avoid putting the researcher in an impossible situation HSCL may approve a project knowing that the institution will require separate approval.
In the case of 10i being checked "yes" (i.e., an indication that the PI will research subjects who could be judged to have limited freedom of consent), then the HSCL will want a description of that population group, whether they are minors or have another reason for lacking the capacity to give informed consent.
Certain populations, children, retarded or developmentally delayed, institutionalized, and incarcerated individuals, are regarded as special populations. In some cases, a guardian's consent is all that is required. In others, such as incarcerated individuals, the research protocol must include someone who represents the interests of those people. HSCL has an ad hoc member who reviews applications and advises the board about issues concerning prison research. HSCL also has regular board members with experience in research and working with other populations that may be regarded as vulnerable, such as minors and individuals with impaired cognitive function.
Item 10k, which indicates the use of interviews, survey, questionnaires, audio or video recordings, is the most common item checked by investigators. The HSCL wants the PI to describe the interview procedures, or questionnaires and provide copies of them in most cases.
Examination of the interview description or sample questionnaires provides HSCL with some idea as to the relative discomfort or risk that may come to participants in research projects. For example, interviews dealing with sensitive topics such as religion, sex, death, and possible criminal activity may require the PI to provide counseling referrals to participants. The investigator should also state the frequency and approximate length of interviews.
Item 10m, which indicates the use of a written consent form, should be checked against what the applicant says in the application. For example, the purpose of the research as explained on the consent form should reflect the purpose as explained in item 12 of the application. Likewise, the consent form should describe what the participant will do in the project, and that description should tally with what is said in the abstract. Finally, the consent form should have a receipt statement, whereby the participant acknowledges receipt of a copy of the consent form. Also, information about the applicant's faculty supervisor should be included on the consent form. This information should include the faculty supervisor's name, department, department phone, and address, and the faculty supervisor should be designated as such.
Generally, the idea is to ensure that the consent form adequately explains the nature of the project to HSCL reviewers and to the participants, that there is no coercion involved in securing participants, and that their privacy and confidentiality is protected.
Applications that are evaluated as Disapproved or Not Approved will be discussed by the full board at the monthly meeting. If the researcher has not responded to the initial finding of Not Approved or Disapproved, the project is automatically held in the same category. The board will consider both the application and the response by the researcher to the board's concerns. Depending upon the researcher's response, the board may approve the application at the meeting, vote to move it to Contingent or retain the application in the category of Not Approved or Disapproved. Designation of a project as Contingent means the board still has questions or concerns and directs the researcher to respond to them. In the case of an application being designated Contingent, the coordinator is authorized to evaluate the researcher's response and may approve the application or ask the researcher for more information.
Whether an application has received expedited (i.e. Exempt or Expedited) or full board review, the researcher is given ninety days in which to respond in writing to any questions or concerns of HSCL. Applications which have outstanding questions or concerns after ninety days are designated Inactive. The researcher must re-apply to HSCL for review and approval.
All applications, regardless of the level of review, are subject to continuing review. HSCL sends reviewers a reminder letter and a Status Report Form which the researcher must complete and return to HSCL in order to retain approval for an additional twelve-month period. The Status Report or projects that received full board review requests more information than the Status Report for projects that received Exempt or Expedited approval.
The HSCL office sends reviewers a reminder letter and a Status Report Form about one month prior to the approval date anniversary which the researcher must complete and return to HSCL in order to retain approval for an additional twelve-month period. For example, if a project was approved on 11/03/2002, the PI would have been sent a Status Report Form notice the month before the approval anniversary date, in October 2003, in this case. See the Appendix for a sample of the notice of continued approval.
The Status Report form for projects that received full board review (see Appendix HSCL Documents) asks about the project status, that is, has the project completed, is the project is still in operation but no significant changes have been made, or are there changes requested in the approved procedures? The Status Report also asks about withdrawals and complaints, including asking the PI to indicate the number of participants who, for any reason, withdrew from the research after signing a consent form. The form asks the PI to indicate the number of subjects who registered complaints about the research with investigator(s), experimenters, project staff, or investigators' department.
PIs are to provide a summary of findings obtained thus far, and to provide a description of any adverse events or unanticipated problems involving risks to subjects or others. If there are none, PIs are directed to explicitly state "none." PIs are to provide a description of any unforeseen risks and unanticipated benefits associated with the research that emerged during the project approval period If there are none, PIs are to explicitly state "none."
Finally, PIs are to attach a copy of their current consent form.
If the status report form is satisfactory, the HSCL office sends a letter to the PI that indicates approval for another twelve-month period, based upon the approval anniversary date. For example, if a project was approved on 11/03/2002, the notice of continued approval for a status report received in 2003 would state that approval was good for the twelve month period of 11/03/2003 to 11/03/2004..
HSCL may determine that certain projects need verification from sources other than the investigators that no material changes have occurred since previous IRB review. HSCL may randomly select projects, or may decide that complex projects involving unusual levels or types of risk to subjects should receive an extra measure of scrutiny. Also, HSCL may engage in full board discussion of continued approval for projects conducted by investigators who previously have failed to comply with the requirements of the HHS regulations or the requirements or determinations of the IRB. HSCL may seek information from research participants where concern about possible material changes occurring without IRB approval have been raised based upon information provided in continuing review reports or from other sources.
Researchers may use the Status Report Form or another written indication that their project has been completed or that they are withdrawing the project. Inactive projects are boxed and sent to the University Archives at Spencer Library.
Questions? Please contact:
David Hann
785-864-7429 | dhann@ku.edu
Coordinator | Human Subjects Committee of
Lawrence (HSCL)
— or —
Mary Denning
785-864-7385 | mdenning@ku.edu
Associate Coordinator |Human Subjects Committee of
Lawrence (HSCL)
