Introduction to Institutional Review Board at Weizmann Institute of Science
‘Declaration of Helsinki’ that is encapsulating ethical principles regarding human experimentation, was developed by the World Medical Association and is regarded as a constitutive document on human research ethics.
‘The Common Rule’ is a US rule of ethics regarding biomedical and behavioral research, involving human subjects (45 CFR 46) that follows on the Declaration of Helsinki.
‘WIS IRB’ is the Institutional Review Board at Weizmann Institute of Science that holds its researchers to a human subject research policy, based on the principles of the US Common Rule.
‘Helsinki Committee’ is an Israeli name for a Hospital Institutional Review Board (IRB), approving human clinical research. The name is enshrined in the Declaration of Helsinki. Israel also operates Supreme Helsinki Committee, for genetics / fertility experiments. WIS IRB is independent of Israeli Helsinki Committee system.
What Qualifies as Human Subject Research
This Policy applies to Research Involving Human Subjects conducted at Weizmann by Principal Investigators and all their research team members.
In order for a research to be considered as Research Involving Human Subjects , it must meet the following definitions:
“Research”: a systematic investigation, including research development, testing and evaluation, designed to develop or contribute to generalizable knowledge.
“Human subject”: a living individual about whom a Principal Investigator and additional Investigators conducting research obtain data through intervention or interaction with the individual or identifiable private information. A subject may be either a healthy individual or a patient.
“Principal Investigator” / “Investigator”: Principal Investigator (‘PI’) is a scientist affiliated with one of Weizmann faculties. Investigator includes the Principal Investigator and any Feinberg Graduate School trainee (student, postdoc) or Weizmann personnel conducting research (hereinafter together: “Investigator”). The PI is the leader of the studies and is responsible for all ethical aspects of the research.
“Obtaining Data”: Receiving or accessing identifiable private information or identifiable specimens for research purposes. Obtaining is interpreted to include an Investigator’s use, study, or analysis for research purposes of identifiable private information or identifiable specimens already in the possession of the Investigator.
“Intervention”: Includes both physical procedures, by which data are gathered (for example, venipuncture) and manipulations of the subject or the subject's environment that are performed for research purposes (including interviews and surveys).
“Interaction”: Includes communication or interpersonal contact between Investigator and subject (including online surveys).
“Identifiable Private Information”: Includes information, which has been provided for specific purposes by an individual and which the individual can reasonably expect will not be made public (for example, a medical record, school grades, or height and weight measurements). It also includes information about behavior that occurs in a context in which an individual can reasonably expect that no observation or recording is taking place. Private information must be individually identifiable (i.e., the identity of the subject is or may readily be ascertained by the Investigator or associated with the information), in order for obtaining the information to constitute research involving human subjects. Examples of studies using private information include chart reviews, obtaining lab studies on identifiable tissues and specimens, or using identifiable information from data or tissue repositories, obtaining school grades, private interviews, or surveys of opinions and attitudes.
“Coded information”: Data or specimens are considered coded when identifying information that would enable the Investigator to readily ascertain the identity of the individual to whom the private information or specimens pertain (e.g., name, social security number, etc.) has been replaced (e.g. ,by a number, letter, symbol, or combination thereof), and a key to decipher the code is required in order to enable linkage of the identifying information to the private information or specimens.
The following activities are not considered to involve human subject(s):
Cadaveric or autopsy specimens or data. Includes also autopsy specimens or data taken from live individuals who had deceased prior to the initiation of the research.
Private data or specimens, which were not collected specifically for the currently proposed research through an intervention or interaction with living individuals AND given that the Investigator(s) cannot readily ascertain the identity of the individual(s) to whom the coded private information or specimens pertain. For example, if information is coded and the Investigators enter into an agreement with the holder of the de-coding key, prohibiting the release of the key to the Investigators under any circumstances, until the individuals are deceased.