View the IRB Decision Tree (PDF)
Pre-screening of potential subjects over the telephone or in person to determine their initial eligibility for and interest in a study is a common strategy. All pre-screening activities are considered to be part of the subject selection and recruitment process. When using this strategy, investigators must protect the privacy of the potential subject and the confidentiality of information collected about him/her.
What is the difference between screening and pre-screening?
“Pre-screening” for IRB purposes, is the term used to describe activities before obtaining informed consent (i.e., before enrollment). Pre-screening may not include any research procedures.
“Screening” is the term used to describe activities performed after obtaining consent to ensure subjects are qualified for the study.
What information can I collect during pre-screening?
Questions appropriate for pre-screening address the specific inclusion/exclusion criteria for the study and other issues of suitability, for example, an individual's ability to come to the research site multiple times. It is not appropriate to gather information that is not directly related to assessing eligibility and suitability. Administering eligibility tests and medical exams is considered research activity and may not be conducted during pre-screening but rather only after the participant has been deemed eligible, agreed to participate, and has given their consent to participate.
How should pre-screening over the telephone be done?
To begin a phone pre-screening conversation, the study team member should identify himself or herself as such. Then, potential subjects should be:
Next, the study team member should explain that a set of questions will be asked to determine eligibility. Whenever possible, the potential subject should be asked to indicate if s/he appears to be eligible only after all questions have been asked. Sometimes this is not possible, for example, when pre-screening for specific medications or levels of activity. The investigator should consider this carefully when designing pre-screening procedures. In the interest of confidentiality, only the potential subject's first name or initials should be recorded at the beginning of the pre-screening conversation. After the screening conversation, if s/he appears to be eligible and is interested in pursuing the study, contact/identifying information can be recorded with the person’s permission to record such information.
Note: The protocol must address what will be done (such as destroying) with any collected information if the person is not eligible. See “Can I retain information from individuals who are pre-screened but not enrolled?”
How should pre-screening in person be done?
Pre-screening is usually done in person when potential subjects are finding out about research during routine, non-research activities. This is most often applicable in the clinical care setting, but may be used for non-clinical research. The guidelines for the conduct of pre-screening in person are the same as those for conducting prescreening over the telephone. Regardless of the setting, only information pertaining to the participant’s eligibility should be gathered during pre-screen. It may be acceptable to perform very limited routine clinical procedures as part of a pre-screen if they directly relate to eligibility determinations and an individual verbally consents to have them performed. For example, it may be acceptable to weigh an individual in order to ascertain whether s/he qualifies for a dietary study. Such exceptions may be made by the IRB in certain specific circumstances in the interest of the convenience of the research subject. Complete medical histories, physical exams, full body skin exams and laboratory testing cannot be done until a subject has given informed consent to participate in the research.
Can I conduct pre-screening online?
Yes. The guidelines for the conduct are the same as those described above for other methods. However, because online survey tools have different privacy policies and terms of use, it is up to the investigator to provide documentation regarding privacy and confidentiality protections. This documentation must be included in your submission.
Can I retain information from individuals who are pre-screened but not enrolled?
Yes, you can retain non-identifying information about individuals who are pre-screened for a study, but do not actually pursue the study or enroll. In fact, this is often desirable or requested by sponsors to obtain information about the entire pool of individuals interested or potentially eligible for the study. Pre-screening sheets from individuals who did not provide identifying information can be retained with no further action. Pre-screening sheets with identifying information may also be retained in research files, however, identifiable information must be blacked out or cut off as soon as it is clear that the individual will not be enrolled. Maintaining identifiable information from potential participants that are found to be ineligible or chose to not participate in the research for research purposes is not permissible as it would require consent from that individual.
What do I need to include in my submission for IRB review?
Protocol: All pre-screening activities are considered part of the subject selection and recruitment process and must be reviewed and approved by the IRB prior to initiation. Pre-screening procedures should be described in the protocol document. In addition, the specific inclusion/exclusion criteria for the study should be stated. The IRB will compare the screening tools with these inclusion/exclusion criteria, to ensure that the questions asked during pre-screening are not beyond the scope of the criteria.
Screening tools: The questionnaires, checklists, or other screening tools that will be used must be submitted for IRB review. If pre-screening is to be done over the telephone, investigators should provide a script for IRB review. The script should follow the points outlined above (How should pre-screening over the telephone be done? section).
Consent form: Pre-screening does not need to be described in the consent form because it is done before the consent discussion and documentation of consent takes place.
Only the IRB can determine whether a proposal is eligible for exempt status.
However, exempt does not mean that IRB review is not required. At UMKC, all research projects involving human subjects are reviewed to ensure adherence to the ethical standards required by federal and university regulations. UMKC policy requires review of all levels of research that involves human subjects, even projects that meet the federal definition of "exempt.”
You must first submit an initial application. Once the IRB receives the application it can be administratively approved.
University and federal regulations require the principal investigator to maintain records of all correspondence, relating to the use of human subjects in research.
Copies of the application, research progress reports, notices of approval and signed informed consent documents must be maintained in the investigator’s records. Copies of these research records must be retained for three years after the close of the study and are subject to inspection by federal authorities and the IRB.
The principal investigator (PI) and the institutions share responsibility for ensuring that PIs, co-investigators, and all other personnel involved in the conduct of human subjects research fulfill basic educational requirements in compliance with all applicable laws, regulations and institutional policies.
The University of Missouri Kansas City defines ‘research staff’ as persons who have direct contact with subjects2, contribute to the research in a substantive way, have contact with subjects’ identifiable data or biological samples (e.g., tissue, blood, urine, plasma, saliva), or use subjects’ personal information.
This guidance offers support to researchers who must register and report clinical research trials to ClinicalTrials.gov, a database of clinical research trials conducted in the United States and around the world.
ClinicalTrials.gov is a registry of federally and privately supported research studies conducted in the United States and around the world. Each entry is provided by the sponsor and includes a summary of the trial protocol, including the purpose, recruitment status, and criteria for patient participation. Trial locations and specific contact information are provided to assist enrollment. Some entries provide summary study results, including number of participants starting and completing the trial, baseline characteristics, outcome measures, and adverse events information. ClinicalTrials.gov is a free service of the U.S. National Institutes of Health (NIH), developed by the National Library of Medicine.
Section 801 of the Food and Drug Administration (FDA) Amendments Act mandates the registration with ClinicalTrials.gov of certain clinical trials of drugs (including biological products) and medical devices subject to FDA regulations for any disease or condition. For details, see http://prsinfo.ClinicalTrials.gov.
The International Committee of Medical Journal Editors (ICMJE) requires trial registration as a condition for publication of research results generated by a clinical trial.
Trials that must be registered under the FDA Amendments Act of 2007 (FDAAA) are called “Applicable Clinical Trials.” Under the statute, these trials generally include:
• Trials of Drugs and Biologics: Controlled, *clinical investigations, other than Phase 1 investigations, of a product subject to FDA regulation; and
• Trials of Devices: Controlled trials with health outcomes, other than small feasibility studies, and pediatric post-market surveillance.
• ClinicalTrials.gov accepts registration of all clinical trials (1) approved by a human subject review board and (2) conforming to the regulations of the appropriate national health authorities. Both interventional and observational studies are accepted.
• Trials can be registered at any time, but many policies require registration prior to the enrollment of the first participant. Information about these policies and background materials are available at http://prsinfo.ClinicalTrials.gov.
* The FDA defines a clinical investigation as any experiment in which a drug is administered or dispensed to, or used, involving one or more human subjects. An experiment is any use of a drug except for the use of a marketed drug in the course of medical practice. Purely observational studies are exempt from registration requirements
Investigators should review the statutory definition of applicable clinical trial to identify if any of their trials must be registered to comply with the law. NIH encourages registration of ALL trials whether required under the law or not, and ICMJE advises that those who are uncertain whether their trial meets the ICMJE definition of eligible trials should consider registering if they wish to seek publication in an ICMJE journal. If you need additional clarification regarding registration of your clinical trial, please send an inquiry message directly to clinicaltrials.gov. via their website at: prsinfo.clinicaltrials.gov
Since responsibility for registering trials lies with the lead sponsor of the clinical study, most “industry sponsored” trials will be registered by the sponsor, which can be a pharmaceutical company or CRO. UMKC sponsor-investigator studies (also known as “investigator-initiated studies”), or those who hold an IND or IDE that meet the eligibility criteria, will all need to be registered by the investigator prior to study enrollment, where applicable. If the sponsor of a clinical trial is someone other than the PI, investigators should communicate with the study sponsor to determine the Responsible Party for protocol registration, and personally check the registry to ensure that all of the required registration elements are included.
The entity responsible for registering is the “responsible party.” The statute defines the responsible party as:
(1) the sponsor of the clinical trial (as defined in 21 C.F.R. 50.3) -or-
(2) the principal investigator of such clinical trial if so designated by a sponsor, grantee, contractor, or awardee, so long as the principal investigator is responsible for conducting the trial, has access to and control over the data from the clinical trial, has the right to publish the results of the trial, and has the ability to meet all of the requirements under this subsection for the submission of clinical trial information.”
By law, registration of Applicable Clinical Trials is required to occur within 21 days of first subject enrollment. However, UMKC recommends registration of all trials into the ClinicalTrials.gov database prior to first subject enrollment, to satisfy both the law and ICMJE requirements.
ICMJE guidelines currently define a clinical trial as, “any research study that prospectively assigns human participants or groups of humans to one or more health-related interventions to evaluate the effects on health outcomes.” Purely observational studies (those in which the assignment of the medical intervention is not at the discretion of the investigator) will not require registration.
Health-related interventions include any intervention used to modify a biomedical or health-related outcome (for example, drugs, surgical procedures, devices, behavioral treatments, dietary interventions, and process-of-care changes).
Health outcomes include any biomedical or health-related measures obtained in patients or participants, including pharmacokinetic measures and adverse events.
FDAAA requires reporting of study results for Applicable Clinical Trials no later than 12 months after the date of final data collection for the primary outcome measure, referred to as the “Primary Completion Date.”
Reporting of results can be delayed beyond the 12-month required timeline if:
• The trial is of a drug or device that has not been approved for marketing by the FDA for any indication; result reporting will be required within 30 days of initial approval;
• The trial is of a drug or device for which the manufacturer has filed or is preparing to file an application seeking approval of the new use studied in the trial; or
• A request for delay that “demonstrates good cause” has been granted by the Director of the NIH.
NOTE: Per FDAAA, sponsors must also include study results in the registry. The results submissions should include lay language summaries of subject demographics and characteristics, primary and secondary outcomes, and disclosures of any privacy agreements. Timelines for this information are set forth (see related links below). At this time, the ICMJE does not require the recording of study results in the ClinicalTrials.gov database. UMKC recommends that PIs stay informed about these requirements, as they evolve.
Adverse Event Reporting - information on the requirements for reporting adverse events
Pre-Submission Checklist (pdf) (DRAFT) - a short reminder checklist to assist in results data entry
Common errors (pdf) (DRAFT) - overview of common types of errors identified in submitted records with "basic results"
Helpful hints (pdf) - tips on entering results data, including three examples of common study models (parallel design, crossover design, and diagnostic accuracy studies), reporting measure types, including information on reporting outcomes measured with a scale.
"Basic Results" Data Element Definitions (DRAFT) - details on the information that is entered about results, including adverse events, via the PRS.
Results Detailed Review Items (pdf) (DRAFT) - describes items evaluated by ClinicalTrials.gov after results have been submitted.
Basic Results Provisions (pdf) - extracted from FDAAA 801.
Guidance for investigators regarding case reports and case studies
The UMKC IRB Office frequently receives queries regarding whether publishing a case report constitutes human subjects research and therefore requires IRB review. Case reports generally involve the description of medical treatment in a patient or a few patients with a unique treatment, disease course, or outcome based on a retrospective review of medical records or they can involve a description of a unique diagnostic finding or uncommon presentation. No predetermined hypothesis or research question guides case reports and publication of the information about the patients’ medical care is not planned prior to or during the patients’ treatment. In addition, case reports are usually prepared by clinicians who have personally provided care to those patients.
The question regarding when case reports constitute research is a difficult one to address. Several major research institutions have concluded that a case report involving the description of the medical cases of three or fewer patients does not constitute human subjects research and therefore outside the purview of the IRB. The UMKC IRB has agreed to adopt this approach. Consequently, case reports involving three (3) or fewer patients generally do not require review by the IRB because they are not viewed as meeting the definition of research under the Common Rule or HIPAA Privacy Rule, which define research as “a systematic investigation, including research development, testing and evaluation, designed to develop or contribute to generalizable knowledge.”
Case reports involving more than three patients are more likely to meet the criteria for research and would therefore require some level of IRB review or determination. Anyone who is unsure whether a project requires IRB review should contact the IRB Office for assistance.
Although a single case report involving up to three (3) patients may not require IRB review, those conducting such activities should be aware that certain HIPAA Privacy Rule provisions may apply and ethical concerns can arise if identifiable information is published. The use of protected health information to prepare a case report does not require IRB review for HIPAA Privacy Rule purposes. However, anyone who wishes to publish information that includes HIPAA identifiers or may identify the patient because of a description of a unique disease, condition, or outcome will need to obtain from the patient a signed "Written Permission to Release Information". This authorization does not need to be submitted to the IRB for review, but consultation with the Covered Entity HIPAA Privacy Officer is required.
University Health Privacy Officer:
UMKC School of Dentistry Privacy Officer:
University of Missouri-Kansas City
650 E. 25th St.
Kansas City, MO 64108
(816) 235-2100
Many journals now require a letter or other acknowledgement from an IRB prior to publication of a single case report or a case series. Anyone asked by a journal to provide documentation of IRB approval prior to publication of a submitted case report or case series should contact the IRB Office.
UMKC IRB Policy on Oral History
18.5. Oral History
“Oral history” is a technique in which the researcher conducts a series of recorded interviews with participants on a particular historical event or period. Often, the intention is that these recordings become available to the public at a specified future period of time (e.g., frequently after a substantial delay) in order to convey historical insight. In many cases, these interviews will be historical recollections of the character of a society or an institution rather than the interviewee's subjective perceptions. Such activities may or may not be considered human subjects research requiring the prospective review and approval of the IRB before commencing the activity pursuant to 45 CFR 46.101(b) (2) and 46.101(b)(3).
If in doubt, an oral history project should be submitted in advance to the Research Compliance Office to determine if the activity is considered human subjects research and subsequently whether it is subject to IRB review or, conversely, whether it is exempt from review.
The threshold question in determining whether or not an oral history is subject to human subject protections is whether or not the activity meets the definition of research. A decision whether oral history or other activities solely consisting of open ended qualitative type interviews are subject to the policies and regulations outlined in an institution’s Federal wide assurance (FWA) and HHS regulations for the protection of human subjects research is based on the prospective intent of the investigator and the definition of “research” under HHS regulations at 45 CFR 46.102(d); “a systematic investigation, including research development, testing and evaluation, designed to develop or contribute to generalizable knowledge”. Interviews conducted with questionnaires and anonymous sources, from which generalized conclusions are drawn, fit the definition of research. Open-ended, Individualistic interviewing about events that have occurred in the past represents a fundamentally different form of research than Federal regulations were intended to encompass.
Focus should be on the prospective intent of the PI and the definition of research (i.e., does it involve a “systematic investigation, including research development, testing and evaluation, designed to develop or contribute to generalizable knowledge."
An activity is considered to not be an oral history and not exempt if it satisfies both of the following requirements:
The following may be useful for evaluative purposes:
Investigators are advised to consult with the Research Compliance Office regarding whether or not their oral history project requires IRB review.
The UMKC Department of History has adopted the following OHA "best practices" as the standards of scholarship for the department.(particularly: A Guide to Oral History and the Law By John A. Neuenschwander)