General
How do I know if my project qualifies as research?
Which operational or educational activities
might become research?
What are the federal requirements for approving
research?
Who oversees research at KUMC?
Does my study need HSC review?
What happens if I don’t apply for HSC
approval for my project before doing research?
Should I be submitting to the HSC Office directly, or should
I go through the Clinical Trials Office in the Research Institute?
Submission Process - New Application
What forms and supporting documents do I need
to submit for a new project?
How long does it take to get approval of a new
study?
How can I get the fastest review possible?
What is “Expedited” review, and
what types of submissions can the HSC review using an “Expedited” procedure?
What is “Exempt” review, and how do I know
if my study qualifies for “Exempt” status?
Who should be listed on the List of Study Personnel?
How will I be notified once my submission is reviewed?
When does a project also need review by the Radiation Safety
Committee?
When does a project also need review by the Institutional
Research Safety Committee?
Submission Process - Amending a Study
What types of changes require me to submit an
amendment, and how do I submit an amendment?
Do I need to submit a highlighted copy of the revised protocol
with my request to amend my study?
Submission Process - Problems
How do I report unanticipated problems that arise
during the study?
Submission Process - Continuing Review Form
What should I submit in order to renew my project?
Can I submit my Continuing Review Form
and an amendment request at the same time?
My study is closed to enrollment. Do I still need to recertify?
Once my study is complete, is there anything else that
I need to submit to the HSC?
Informed Consent & Subject Recruitment
How do I draft a legally effective informed
consent document?
Must I include a witness signature on my consent
form?
My study involves a vulnerable population (e.g.,
minors, pregnant women, prisoners, mentally disabled, etc.).
Do I need to do anything extra?
How do I consent children, and when is a child assent form
necessary?
How do I enroll a subject who does not speak English?
What is a waiver of consent and what criteria must my study
meet in order to request one?
May informed consent be obtained by telephone from a legally
authorized representative?
When is it necessary to inform subjects of changes in the
study and/or re-consent subjects?
Recordkeeping
How long should I keep my consent forms on file?
What HSC records should investigators keep in
a study file?
Tutorials
Who needs to take the Human Subjects Protection
tutorial?
I have taken the Human Subjects Protection
tutorial before. Do I need to take it again?
How do I access the tutorials?
Student Research
Several of my students want to conduct projects
involving human subjects. Do they need to file with HSC?
I am submitting my thesis proposal for HSC review. Do I
need to submit my entire proposal or just a condensed version?
My study is only a retrospective chart review. Do I need
HSC approval before I review the charts?
General
How do I know if my project qualifies as research?
Federal regulations define research as a systematic investigation, including research development, testing and evaluation, designed to develop or contribute to generalizable knowledge. Human subjects research occurs when an investigator interacts or intervenes with a living individual or uses the individual’s identifiable data for research purposes. Human subjects research takes many forms including: surveys and questionnaires, retrospective chart reviews, clinical trials, interviews, and creating tissue or data repositories. Human subjects research at KUMC also includes any activity involving human subjects that is defined by the U.S. Food and Drug Administration as a clinicial investigation. Examples of human subjects research include, but are not limited to:
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Which operational or educational activities might
become research?
Healthcare Improvement/Quality Improvement
Healthcare improvement projects are generally small-scale, local interventions
designed to improve an internal process or outcome at KUMC. These projects
aim to improve the care for specific patient populations. Because they
are limited to a particular setting, they may not be generalizable to other
environments. Healthcare improvement projects may become a research activity
if the results warrant dissemination outside the institution, if additional data analysis
is performed in order to publish the results, or if experimental elements
are added to the project.
Program Evaluations
Program evaluations are designed as a management tool to improve the provision of services to a specific population. Results of program evaluations are shared only with the program and entity in which the program operates; the activities are not intended to have any application beyond the specific organization in which they are conducted. Typically, program evaluations are performed under contract, and the program being evaluated is the owner of the evaluation data, results, and reports.
If the program evaluation involves the testing of a new, modified or previously untested intervention, service or program to determine whether it is effective and can be used elsewhere, the activity is research and must undergo review by the HSC. Assigning program participants into groups to compare outcomes also constitutes a research activity. Additionally, a systematic comparison of standard or non-standard interventions is considered to be research. Finally, program evaluations may become research if the KUMC faculty member keeps the evaluation data for presentations, further analysis or future grant proposals.
Off-label Use or Non-Standard Medical Practices
Off-label use of a marketed drug or device, or non-standard medical or surgical practices, may be pursued with the sole intent of enhancing the well-being of an individual patient. However, in certain circumstances, these activities should be categorized as research and undergo prior review by the HSC. In doing its analysis, the HSC will consider the following questions:
Single Case Reports
Single case reports, created for presentation or publication, are not considered research if the following conditions exist:
What are the federal requirements for approving research?
The federal government has established a system of institutional review
boards and given them authority to review and approve human research projects.
In order to approve human subjects research, an institutional review board
must determine that the research meets all eight federal criteria that
are listed in 45 CFR 46.111. The criteria are summarized as follows:
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Who oversees research at KUMC?
The Human Subjects Committee (HSC) is the institutional review board (IRB) for KUMC. You may contact the HSC at G006 Sudler or by calling 913.588.1240.
Does my study need HSC review?
The HSC must review all research involving human subjects carried out by the KUMC faculty, students and employees, both on campus and at off-site locations. Additionally, the HSC reviews any proposed human subjects research that uses the physical or patient resources of the institution to determine whether or not its jurisdiction applies. All research conducted by full-time faculty is subject to HSC review (this extends to research studies performed at off-campus sites if the faculty member is the principal investigator or a listed co-investigator on the research study). Research conducted by part-time or volunteer faculty is subject to HSC review when the individual is acting in his/her university capacity. “University capacity” shall mean that the individual is acting on behalf of KUMC in fulfillment of its clinical, education or research mission.
If you have any questions about whether or not you are using human subjects and are thus engaged in human subject research, please contact the HSC office at 8-1240.
What happens if I don’t apply for HSC approval for my project before doing research?
If you are conducting research involving human subjects without HSC approval, stop immediately and contact the HSC office at 8-1240. The HSC is charged with protecting human subjects involved in research, and research conducted without prior HSC approval is viewed as a breach of compliance that may expose risk to the subjects, KUMC, as well as the individual investigator.
Should I be submitting to the HSC Office directly, or should I go through the Clinical Trials Office in the Research Institute?
If the study is a funded clinical trial or the just-in-time request has been received, the Research Institute/Clinical Research Administration (RI/CRA) Division is available to assist with HSC submissions. The division can assist with the entire set-up of the study. This includes consent form preparation and initial HSC submission, collecting and sending essential documents to sponsor (as applicable), budget and RI checklist preparation, and contract review. Contact RI/CRA Division Assistant Director Kelly Daniels at kdaniels@kumc.edu or 913-588-1484 if you have questions.
If you are seeking funding, regardless of funding
source the Research Institute must receive a Research Administration
checklist for administrative sign-off and fiscal management
of the study. This checklist with a description of the required
attachments is located at: http://www2.kumc.edu/researchinstitute/spa/proposal_development.html
Click on "Checklist Forms".
Submission Process - New Application
What forms and supporting documents do I need to submit for a new project?
The application must be accompanied by a complete study protocol describing
the objectives and methodology of the project, a protocol summary,
a list of study personnel, institutional research safety form, evidence
of training in human subjects protection for any external study personnel,
the proposed consent form (when applicable), recruitment materials
(when applicable), copy of grant application (when applicable), and
thesis/dissertation proposal (when applicable). For studies of investigational
agents, an investigator’s drug or device brochure also is required.
Only complete applications will be reviewed. Complete applications will
be assigned an HSC number and screened to determine the appropriate level
of review.
How long does it take to get approval of a new study?
Applications which fall under the Exempt and Expedited categories will be initially screened within five business days of receipt. These applications are screened and reviewed on a rolling basis. Applications which require full committee review will be reviewed at the next convened meeting based on when it was received in the deadline cycle. The committee convenes on the second and fourth Tuesdays of each month, except for December when the committee meets only on the first Tuesday.
Securing approval is often delayed by incomplete submissions. The HSC must review all documents relevant to the proposed research project. The list may include, but is not limited to, sample inventories, survey instruments, focus group or interview questions, oral consent scripts, written consent, parental consent and youth assent forms, sample testing materials, recruitment ads, funding or grant proposals, permission letters from the authorizing individual at the research site, organization, company, association, etc. (i.e. superintendent, principal, CEO, president, institution’s authorizing agent, website addresses, etc.). The List of Submission Requirements can be found at http://www2.kumc.edu/researchcompliance/doc/HSC_Submission_Req_2005_03_11.pdf
How can I get the fastest review
possible?
To avoid delay and receive a “fast” review, submit all items
listed in the List of Submission Requirements which can be located at http://www2.kumc.edu/researchcompliance/forms/HSC_Submission_Req_2005_03_11.pdf.
Also, when you receive a letter or e-mail from the HSC, responding in a timely manner will assist you in receiving approval because items are reviewed by the HSC in the order they are received.
What is “Expedited” review, and what types of submissions can the HSC review using an “Expedited” procedure?
Expedited” review is conducted by the HSC Chair or other voting HSC members designated by the Chair. Federal regulations permit expedited review for certain types of research involving no more than minimal risk and for minor changes in previously approved research (45 CFR 46.110).
Examples include: collection of blood samples,
prospective collection of data and specimens using noninvasive
procedures, surveys and/or interviews which contain personal
identifying information, focus groups, program evaluation,
quality assurance methodologies, research on individual
or group characteristics or behavior. For a complete list
of the “Expedited” categories, go to the following: http://www.hhs.gov/ohrp/humansubjects/guidance/expedited98.htm.
What is “Exempt” review, and
how do I know if my study qualifies for “Exempt” status?
“Exempt” review is
the level of review for human subject research projects
that pose little, if any, risk to human subjects. Pursuant
to KUMC’s Federal Wide Assurance with the federal
government, the HSC determines whether or not a project
is Exempt. The Exempt review process must meet the same
ethical, federal and state requirements as any other application
submitted to the HSC (45 CFR 46.101(b)).
Examples include: Surveys and/or interviews which do not contain personal
identifiers (i.e., anonymous), Taste/Food Quality Evaluations, Certain
classroom activities (see below), Secondary Data (see below).
Classroom activities: pursuant to 45 CFR 46.101(b)(1), research conducted in established or commonly accepted educational settings, involving normal educational practices, such as research on regular and special education instructional strategies, or research on the effectiveness of or comparison among instructional techniques, curricula or classroom management methods falls within the exempt category.
Secondary data, sometimes called "existing data" is defined as data collected (i.e., on the shelf) prior to the research for a purpose other than the proposed research. It includes data or specimens collected in research and non-research activities. It also includes many types of medical chart reviews. In order to be exempt from IRB review, the secondary data used in research must be either publicly available data or the data obtained must be recorded in such a way that individuals cannot be identified, either directly or through identifying links.
Who should be listed on the List of Study Personnel?
Any person who will interact with study subjects or their identifiable research data should be listed on the list of study personnel.
How will I be notified once my submission is reviewed?
You will receive formal notification of the outcome of the HSC review by mail.
When does a project also need review by the Radiation Safety Committee?
There are two levels of human research involving use of radiation. Both levels require prior approval from the KUMC Radiation Safety Committee (RSC).
Level 1: The use of radiation/radioactive
materials is an FDA approved use however, the subject will
be receiving additional tests/scans/procedures that are
for research purposes only. Examples of research procedures
include x-rays, CT scans, radiation therapy, and nuclear
medicine scans such as bone scans, MUGA, gastric emptying.
[Studies that only employ dexa scans or a single screening
chest x-ray have blanket RSC approval; additional RSC review
is not required.]
Example: During the treatment of cancer the patient would routinely receive
CT scans every eight weeks for six months resulting in three CT scans.
If this patient is enrolled in a research study in which the CT scans are
done every month, the patient will be exposed to three additional CT scans
for research purposes only. It is these three extra CT scans that require
RSC review.
Level II: A PI wants to conduct a research study in which the use of radiation/radioactive materials is not FDA approved. In Level II, the use of the radiation/radioactive material is being researched.
More information is posted at:http://www2.kumc.edu/safety/labsafety/radsafety/ or you may call the Safety Office at 913-588-6126.
When does a project also need review
by the Institutional Research Safety Committee (IRSC)?
The IRSC reviews projects that involve hazardous chemicals, recombinant
DNA, human etiologic agents classified as BL2 or higher, tissues or blood
that are classified as BL3, and human gene therapy. IRSC forms submitted
with HSC applications are screened to determine need for IRSC review. Further
information is available from the Office of Compliance at 913-588-5492.
Submission Process—Amending a Study
What types of changes require me to submit an amendment, and how do I submit an amendment?
Federal regulations require the HSC to review and approve all modifications and additions to approved research prior to implementation, except when necessary to prevent an immediate hazard to subjects. Minor changes not impacting the risks to the subjects may be reviewed using an expedited review procedure. Major changes to the protocol or to the informed consent, or changes that pose additional risk to subjects, must be reviewed by the HSC at a convened meeting. The review and approval of modifications to an approved project does not extend the original expiration date of the project.
When requesting to amend the research, investigators need to provide a letter, or other documentation, clearly defining the modification and/or addition to the previously approved research. Investigators must submit the items being modified. Examples include the revised protocol, revised consent form (one copy with revisions highlighted and one clean copy), new advertisements or recruitment strategies, changes to study personnel, change in performance sites, investigator brochures, changes in FDA-approval status, and any other information to be presented to subjects.
Do I need to submit a highlighted copy of the revised protocol with my request to amend my study?
No. When requesting to amend the research, provide a letter, or other documentation, clearly defining the modification and/or addition to the previously approved research along with the new revised protocol.
Submission Process - Problem Reports
How do I report unanticipated problems that
arise during the study?
Investigators are required to report problems associated with study participation. A problem affects the rights, safety or welfare of subjects or others. The event is associated with increased physical, psychological, social, economic or legal risk. Problems include, but are not limited to: protocol deviations, breaches of confidentiality, subject complaints, certain adverse drug events, unanticipated adverse device events, deaths, and any other event that indicates the possibility of a previously unsuspected risk. For additional details, Investigators should consult the HSC fact sheets on reporting problems and reporting adverse events, posted at: http://www2.kumc.edu/researchcompliance/hrppfactsheet.htm
Investigators should use the appropriate form for reporting internal (for KUMC subjects) or external (non-KUMC subjects) problems/adverse events. The form should be accompanied by all relevant documentation. The HSC reviews problem reports to determine the impact on the risk/benefit ratio of the research, whether the informed consent requires revision, and whether past or current subjects should be informed and/or re-consented.
Submission Process - Continuing Review Form
What should I submit in order to renew my project?
When requesting to amend and recertify a project at the same time, you must submit the following materials:
Can I submit my Continuing Review Form and an amendment request at the same time?
No. Proposed changes to research should be submitted as a study amendment.
My study is closed to enrollment. Do I still need to recertify?
Yes. If there are ongoing study-related activities taking place such as follow-up visits or data analysis, then you should keep your project “open” and recertify it.
The primary difference in the continuing review submission process is that you do not need to submit a clean consent form because you are no longer enrolling subjects.
Once my study is complete, is there anything else that I need to submit to the HSC?
If your study is complete (i.e., all subject follow-up monitoring is complete and all data analysis is complete), you must submit a Study Closure Request, indicating that you are discontinuing the study because of study completion.
Informed Consent & Subject Recruitment
How do I draft a legally effective informed consent document?
Federal regulations require certain statements in a legally effective informed consent document. Because all projects are unique in their purposes and procedures, the specific wording in consent forms differs on a case-by-case basis. The HSC does provide a template for investigators to utilize as a starting point in drafting their consent forms which can be found at http://www2.kumc.edu/researchcompliance/hscforms.htm
The general criteria for an informed consent document can be found at http://www.hhs.gov/ohrp/humansubjects/guidance/45cfr46.htm#46.116. Additionally, the HSC website has a quick-reference Informed Consent Checklist consent, posted at: http://www2.kumc.edu/researchcompliance/hscadditionalresources.htm
Must I include a witness signature on my consent form?
Yes. The HSC currently requires someone to witness the consent signature and provides a signature block for the witness on its consent template. This witness cannot be an individual involved in conducting the research.
It is important to know that this witness is only a witness to the authenticity of the subject’s signature. The witness is not verifying whether or not the subject comprehended the consent process. It is the responsibility of the PI and those consenting subjects to confirm the subject’s understanding of the information in the consent form and at all other times during the course of the study.
My study involves a vulnerable population (e.g., minors, pregnant women, prisoners, mentally disabled, etc.). Do I need to do anything extra?
Investigators should be mindful of their intended subject population, and the consent form and accompanying consenting process should be developed toward a level of understanding appropriate for that population.
The following sites pertain to research involving certain populations that have been viewed as “vulnerable”. If you are working with these subject populations, please refer to this guidance material:
Fetuses and In Vitro Fertilization: http://www.hhs.gov/ohrp/irb/irb_chapter6.htm#g2
Women: http://www.hhs.gov/ohrp/irb/irb_chapter6.htm#g3
Children and Minors: http://www.hhs.gov/ohrp/irb/irb_chapter6.htm#g4
Cognitively Impaired Persons: http://www.hhs.gov/ohrp/irb/irb_chapter6.htm#g5
Prisoners:http://www.hhs.gov/ohrp/irb/irb_chapter6ii.htm#g6
Traumatized and Comatose Patients:
http://www.hhs.gov/ohrp/irb/irb_chapter6ii.htm#g7
Terminally Ill Patients: http://www.hhs.gov/ohrp/irb/irb_chapter6ii.htm#g8
Elderly/Aged Persons: http://www.hhs.gov/ohrp/irb/irb_chapter6ii.htm#g9
Minorities: http://www.hhs.gov/ohrp/irb/irb_chapter6ii.htm#g10
Students and Employees:http://www.hhs.gov/ohrp/irb/irb_chapter6ii.htm#g11
International Research:http://www.hhs.gov/ohrp/irb/irb_chapter6ii.htm#g11
How do I consent children, and when is a child assent form necessary?
When children or minors are involved in research, the regulations require the assent of the child or minor and the permission of the parent(s) in place of the consent of the subjects.
Given that children have not reached their full intellectual and emotional capacities and are legally unable to give valid consent, involving children in research requires the permission of their parents or legally authorized representatives. The HSC must ensure that adequate provisions are made for soliciting the assent of the children when in the judgment of the HSC the children are capable of providing assent.
While children may be legally incapable of giving informed consent, they nevertheless may possess the ability to assent to or dissent from participation. Out of respect for children as developing persons, children should be asked whether or not they wish to participate in the research, particularly if the research: (1) does not involve interventions likely to be of benefit to the subjects and (2) the children can comprehend and appreciate what it means to be a volunteer for the benefit of others. The HSC must determine for each protocol depending on such factors as the nature of the research and the age, status and condition of the proposed subjects whether all or some of the children are capable of assenting to participation. When appropriate, the HSC may choose to review on a case-by-case basis whether assent should be sought from given individual subjects. The federal regulations do not require that assent be sought from children starting at a specific age, but that their assent should be sought when, in the judgment of the HSC, the children are capable of providing their assent. The HSC will take into account the ages, maturity and psychological state of the children involved.
When the HSC determines that the assent of the child is required, it must also determine that the provisions for obtaining and documenting assent are adequate. The child should be given an explanation of the proposed research procedures in a language that is appropriate to the child's age, experience, maturity and condition. This explanation should include a discussion of any discomforts and inconveniences the child may experience if he or she agrees to participate.
How do I enroll a subject who does not
speak English?
The informed consent document should be in language understandable to the
subject (or the subject’s legally authorized representative). When
the consent interview is conducted in English, the consent document should
be in English. When the study subject population includes non-English speaking
people or the clinical investigator or the HSC anticipates that the consent
interviews will be conducted in a language other than English, the HSC should
require a translated consent document to be prepared and assure that the
translation is accurate.
A signed copy of the consent document must be given to each subject, and in the case of non-English speaking subjects, this would be the translated document. While a translator may be helpful in facilitating conversation with a non-English speaking subject, routine ad hoc translation of the consent document should not be substituted for a written translation.
What is a waiver of consent and what criteria must my study meet in order to request one?
The HSC may approve a consent procedure that does not include or that alters, some of the informed consent elements or it may waive the requirements to obtain informed consent provided that the HSC finds and documents that:
To be considered for such a waiver, the principal investigator must request a waiver of the informed consent requirement and must address each of the above criteria, including a justification of its applicability to the proposed research and/or the subject population for whom the waiver of consent is being requested.
May informed consent be obtained by telephone from a legally authorized representative?
No.
When is it necessary to inform subjects of changes in the study and/or re-consent subjects?
Informed consent is a process, not only a piece of paper. To that end, those subjects who are presently enrolled and actively participating in the study should be informed of any changes if the changes might relate to the subjects' willingness to continue their participation in the study. Changes must receive HSC review and approval before they are implemented, unless an immediate change is necessary to eliminate an apparent hazard to the subjects.
Re-consenting of subjects is not required for those subjects who have completed their active participation in the study, or for those subjects who are still actively participating when the change will not affect their participation (e.g., when the change will be implemented only for subsequently enrolled subjects).Recordkeeping
How long should I keep my consent forms on file?
Consent forms must be retained in accordance with the KUMC Research Records Retention Policy. The policy can be found at http://www2.kumc.edu/researchcompliance/doc/Records_Retention_Policy_KUMC.DOC
What HSC records should investigators
keep in a study file?
The importance of an investigator maintaining an organized and thorough study
file cannot be overstated. This file, which is subject to HSC inspection
as well as inspection by federal and state agencies should include, but is
not limited to, the following:
Tutorials
Who needs to take the Human Subjects Protection tutorial?
In order for a research project to be approved, all members of the research team must maintain current training in human subject protection, as determined by the KUMC Human Research Protection Program. Current training must be maintained by persons who have any role in the review, design, and/or conduct of human subjects research at KUMC.
It is important to know that in addition to training, KUMC research personnel also must have on file a current Conflict of Interest disclosure form.
I have taken the Human Subjects Protection tutorial before. Do I need to take it again?
Individuals who have previously completed the Human Subjects Protection tutorial (modules 1-7) are not required to complete the full tutorial again; however, they do need to take the Human Subjects Protection Refresher tutorial yearly.
For example, if you completed the full Human Subjects Protection tutorial in 2004, you will need to complete the Human Subjects Protection Refresher tutorial in 2005 to re-certify your training. Re-certification occurs during the compliance re-certification window during the January - March timeframe.
How do I access the tutorials?
Information on accessing the tutorials can be
found at:
https://www2.kumc.edu/chalk2
Please direct any questions about these tutorials to Sharon Cooper at 913-588-2188 or scooper@kumc.edu .
Student Research
Several of my students want to conduct projects involving human subjects. Do they need to file with HSC?
It depends. If it is only a classroom project, and the data is not being used beyond normal classroom activities, HSC review and approval is not required. However, students should always remember to conduct their projects in an ethical manner, respecting their fellow students.
If the student’s project is intended to be a systematic study with the intent to contribute to a larger body of knowledge, then it falls underneath the federal definition of research and needs HSC approval.
I am submitting my thesis proposal for HSC review. Do I need to submit my entire proposal or just a condensed version?
So that the HSC can conduct a thorough review of the proposal, submit the entire proposal. If the student’s project is intended to be a systematic study with the intent to contribute to a larger body of knowledge, then it falls underneath the federal definition of research and needs HSC approval.
My study is only a retrospective chart
review. Do I need HSC approval before I review the charts?
Yes. Retrospective chart reviews are considered research activities that
need prior approval by HSC and HIPAA. Additional information on requirements
for retrospective chart reviews is available at: http://www2.kumc.edu/researchcompliance/forms/retrospective_chart_review.pdf
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