May 31, 2021
The University of Tokyo is providing free COVID-19 antigen test kits to participants of certain activities specified by the university, who agree to be tested for a research project aimed at bolstering infection control measures at the university. The volunteer subjects will be asked to self-test at home on the day of their specified activity and report their result for the study.
This initiative is being implemented under the research project titled "Examination of Infection Control by Pre-Distribution of the SARS-CoV-2 Antigen Detection Kit at Events, Classes, Etc." (21-79), approved by the University of Tokyo Research Ethics Review Board on May 28, 2021.
Subjects for the study are chosen from among people participating in each activity that has been carefully picked for the research. An announcement will be sent out to notify those selected to participate in the study, with guidance on the next steps.
An overview of the research project is provided below. Those choosing not to participate in the study should elect not to receive the antigen test kit or return the unopened kit to the University of Tokyo Health Service Center.
*Regardless of whether or not you are participating in the study, be sure to contact the Health Service Center if you get a non-negative result from any antigen test, including commercial products available over the counter.
As some over-the-counter products are said to be below standard or lack sufficient sensitivity or specificity, self-diagnosis with such products is not recommended to determine whether or not you are infected.
As in this study, a test kit that meets certain standards paired with medical supervision is considered vital for proper diagnosis.
<Research Overview>
Studies suggest that preliminary screening test and personal health management regimens fall short in preventing the spread of infection, which is caused by infected people who are not blocked by such measures who slip through and engage in various in-person activities.A certain proportion of infected people are thought to get a negative result in preliminary tests because they are tested before the onset of disease, when their viral load is low.Therefore, the university is conducting a study to investigate whether taking a simple antigen test on the day of an in-person activity, such as a university ceremony held in an event hall, or a class or extracurricular activity, is effective in preventing the spread of infection.
People who volunteer for the study are asked to follow the below guideline. Participation is limited to those attending certain events, classes and other activities that the university has designated for recruiting research subjects, who are notified by the university of their eligibility to participate in the study. Participation is voluntary, and the decision is left entirely to each individual’s discretion. You may withdraw consent after initially agreeing to participate. If you do so, notify the contact listed at the bottom. However, reporting COVID-19 cases to control the spread of infection is required by law. Therefore, although you are allowed to withdraw from the study itself, even after participating in the research has revealed you are suspected of being infected, you are not exempted from following the procedures and infection control measures as stipulated by law. Also, if your results are included in outcomes that have already been released, your data cannot be removed.
Personal information collected in connection with research will be handled and managed under strict supervision in accordance with existing laws and regulations. Information on research participants will not be disclosed indiscriminately and without reason to third parties. Utmost attention is given with respect to individual privacy. Research findings will be announced after being tabulated, and released in such a way that individuals cannot be identified. However, if it becomes necessary to report positive cases to the public health center in accordance with laws and regulations, at that point your information will no longer be handled on the basis of research, and will be used for medical purposes by the public health center or the medical institution you consulted. Furthermore, aggregated results (which do not include personal information and are limited to reporting the number of responses, number of positives, etc.) may be shared with the University of Tokyo administration office, as part of the ongoing infection control measures at the university.
While research participants are provided the antigen test at no cost, there is no tangible benefit to you. If knowledge for effective infection control is obtained through this research project, it could lead to a future environment where university activities are carried out with low risk of infection. Although the possibility of infection by participating in this research project is not anticipated, should the study reveal that you are infected, the health authorities will require you to get medical treatment as set out by law and regulations, and your activities will be restricted for a given time period. There are no direct disadvantages linked to participating in the research; however, it should be noted that the likelihood of situations arising that require medical treatment and activity restrictions, as described above, cannot be ruled out. Also, if you are found to be infected, you shall report to your university department and be interviewed by the contact point of the department, according to the University of Tokyo's Guidelines for Strengthening Measures to Prevent Novel Coronavirus Infection.
There are no costs to participate in the study. However, if you receive a test result that necessitates a medical visit, you will need to bear such medical and health expenses. If a visit to the Health Service Center is required based on the results of the antigen self-testing kit provided, you will not be asked to bear the examination costs at the health center, but you will be responsible for covering the transportation expenses for the visit. Costs for drug prescriptions necessary for treatment or expenses for non-COVID testing also are not covered.
As mentioned at the outset, this research is being carried out with the approval of the University of Tokyo Research Ethics Review Board. Research costs are covered under the operating expenses of the university. There are no conflicts of interest to disclose regarding the study.
<Examples of target activities> (All in-person/face to face)
- ・ Events held in halls, such as symposiums, lectures, ceremonies
- ・ Classes (lectures, practical training, etc.)
- ・ Extracurricular activities
<Information about the antigen test kits that are being distributed >
- ・ Equivalent to those used by medical institutions to assist in diagnosing coronavirus infections.
- ・ Although the kits are approved for medical use in Japan, the sensitivity and specificity of the tests are said to be somewhat lower than PCR tests.In other words, the possibility of false negative or false positive results should be taken into account when evaluating and interpreting the results.Since research participants are asked to self-test, the tendency to end up with more false results could be greater than when the test is performed by professional medical staff who are familiar with operating such test kits.
- ・ As the kits are classified as a prescription drug, passing them on to another person is not allowed without permission.
- ・ The test kits used in the study were selected from among kits reported in Japanese and international scientific papers, and for which comparative review information on their performance is available from third parties.
- ・ Test kit manufacturers and other parties are not covering any of the research costs and have not donated any of the kits.
<Procedure for participants>
| １） |
Particpants will be notified in advance and separately for each activity.(Contact point for inquiries and distribution method of the kits vary, depending on the activity.) If after reading the explanation above, you agree to participate in the study, proceed to the next steps. |
|
| ２） |
Follow the test kit instruction manual and collect your own sample at home. Wait until the amount of time to evaluate the test result, as indicated in the manual, has elapsed, then line up the used kit with the result side up and your university ID card, and take a photo with a digital camera, smartphone or other device.
|
|
| ３） | Register your test result using the online reporting form (link). |
|
| ４） | If your result is negative, proceed with the next steps as planned according to the original schedule. |
|
| ５） | If your result is non-negative, contact the Health Service Center to consult about your next steps, regardless of whether or not you have withdrawn your consent to participate in the research. |
|
| A non-negative result does not necessarily mean you have tested positive and are infected with the coronavirus. In the case of self-testing, the results and the evaluation (interpretation) of a certain proportion of cases are thought to be inaccurate. If you get a result that appears to be non-negative, do not rush to conclusions, stay calm and contact the Health Service Center. |
|
For personnel at medical institutions/public health centers (Present the information in this link when you need to visit / contact medical facilities.)
<Contact information for inquiries and withdrawal of consent to participate in research>
・ Regarding events, contact the department in charge of operation.
- ・ Hongo Health Service Center 03-5841-2573 (ext. 22573) Email: hoken-kanri-▲▲▲.adm@gs.mail.u-tokyo.ac.jp (replace ▲▲▲ with “hongo”)
- ・ Komaba Health Service Center 03-5454-6168 (ext. 46168) Email: (Replace ▲▲▲ in the above email with “komaba”)
- ・ Kashiwa Health Service Center 04-7136-3040 (ext. 63040) Email: (Replace ▲▲▲ in the above email with “kashiwa”)
<Research Director>
UCHIDA Kanji, Special Adviser to the President / Professor, Graduate School of Medicine
Health Service Center staff involved in this study:
YANAGIMOTO Shintaro, Professor, Division for Health Service Promotion
7-3-1 Hongo, Bunkyo-ku, Tokyo 113-0033
