Research and Experiments Involving Human Subjects

Non Medical Experiments involving human subjects

Medical Experiments Involving Human Subjects (Helsinky)

Non Medical Experiments involving human subjects

Research involving human participation must conform to ethical standards, both during and following the experiment. The subject’s rights and welfare must be protected. Researchers, students and auxilary or technical staff must be familiar with university regulations and ethical guidelines, must have received training in conducting research involving humans, and must have been approved by the Ethics Committee for Research Involving Human Subjects.

Important information, procedures and forms for requests for ethical approvals for research involving humans can be found below:

Additional Rules and Guidelines for Non Medical experiments involving human subjects

Some Important Points for Conducting Research Involving Human Subjects:

To the extent that a vulnerable population is involved – approval must be obtained in advance from the authority/institution responsible for that particular population group (such as the Ministry of Education, the Prison Service, the Ministry of Defence etc.). Such approval constitutes an alternative to approval from the University committee that approves the research.
It must be determined in advance whether the funder requires a review of the application according to the IRB standard (or its European equivalent), and the application must be sumitted to the relevant committee accordingly.
In the event of a mishap or the post facto discovery of a risk to those involved in the research – the committee that approved the research must be informed immediately.
A copy of the approval of the application must be submitted to the Authority for Research and Development.
The original approval must be retained for review by the funders or the State authorities.
Any person submitting an application for ethical approval must undergo training in ethics in research through the CITI program.

Submitting an Application for the Approval of the Ethics Committee

An application for the approval of committees for ethics in research will be subitted using the standard form that can be downloaded here.

Researchers, teachers, graduate and post-graduate students whose research involves human subjects require a certificate proving that they have undergone ethics training. As of the 2012-2013 academic year, the ethics committees will not approve applications of researchers for a grant or of students for research who do not have a valid certificate attesting to their having undergone ethics training.

Research Activity in the Framework of Teaching

Research proposals of students in the framework of research seminars will be examined and approved by the teachers of the course and an additional teacher from the department. Responsibility for receiving approval from the additional teacher lies with the teacher of the course, who will be asked to notify the chairman of the faculty ethics committee of approval of research proposals. The teachers approving research proposals in the framework of their teaching, too, will be required to undergo training for ethics in research through the CITI program.

Personal Data Protection

HEBREW UNIVERSTY PRIVACY NOTICE

This Privacy Notice provides information on how The Hebrew University collects and uses personal information when a human subject takes part in one of our research projects.
It is important that the research participant will read this privacy notice. For this purpose any informed consent information sheet shall include the following statement:

This research will collect data about you that can identify you. Please read our Privacy Notice carefully for detailed information on privacy and data protection. The Privacy Notice can be downloaded from this link, a hard copy will be provided to you by the researcher. Ensure you fully understand all aspects of data protection and privacy related to this research, including what kind of data is obtained from you, how it is used and shared, your data subject rights, and how your personal information will be protected.

The up-to-date Privacy Notice can be downloaded from here.

For any question regarding this Privacy Notice please contact:

- The Hebrew University DPO by e-mail at privacy@huji.ac.il

Training Requirement for research involving human subjects

The policy of the University concerning research in which human subjects are involved states as follows:

Researchers, teachers, graduate and post graduate students whose research involves human subjects require a certificate proving that they have undergone ethics training for the purpose of engaging in research of this type.
As of the 2012-2013 academic year, the ethics committees for this purpose will not approve applications for research permits of researchers, teachers or research students who do not have a valid certificate attesting to their having undergone ethics training relating to this subject.

In order to assist all relevant persons in complying with this requirement, the University has acquired a subscription to the internet program of CITI (Collaborative Institutional Training Initiative), which issues a certificate upon completion of the training. CITI is a body that promotes digital use of uniform programs to train staff members in research institutions in the area of proper conduct in research, including that which deals with experimentation on human subjects. Researchers and research students who wish to conduct research involving human subjects may access the system, learn the required material and receive attestation as to having undergone the training.

Instructions for accessing and using the program:

Log onto the program website: www.citiprogram.org
New users should click on Register
In the “Participating institutions” field, choose “Hebrew University of Jerusalem”.
Fill in the personal details and choose the appropriate model. The basic course, “Social Behavioral Basic Research” is the most general and suitable for all.
Press ENTER and begin the course. For speakers of English at the mother-tongue level, the course takes about 4 hours.
After each section, there is a questionnaire which must be answered.
At the end of the course, the certificate is issued.

Medical Experiments Involving Human Subjects (Helsinki)

Experiments involving human subjects are committed to complying with the principles and rules set by the state, and world-accepted rules:

In accordance with the Declaration of Helsinki, only researchers holding the degree of medical doctor (M.D.) are authorized to conduct medical experiments involving human subjects, and only after applying and receiving approval from the medical center's Helsinki Committee. Such authorization will be granted to Hebrew University researchers under certain conditions, supervised by the Helsinki Committee of the relevant medical center.

Relevant information about the Helsinki Committee can be found on Hadassah University Hospital's website.