Faculty of Medicine Research Thesis Regulations · 2020-02-02 · 7. Thesis topics will be published from time to time by the thesis coordinator on the faculty website. 8. Statistic

Ruth and Bruce Rappaport Faculty of Medicine

Faculty of Medicine

Research Thesis

Regulations For the TeAMS program’s students

Research Theses

[email protected]

January 2020

mailto:[email protected]


Chapter 1: Information and general guidelines

1. During their studies, students will complete a research thesis which is an integral part of the requirements for receiving a medical degree. The purpose of the thesis is to train the medical student in the following areas:

A. Scientific writing and evaluation of scientific work. B. Definition and formulation of issues of interest in the basic sciences of medicine

and/or clinical professions. C. Editing a research proposal that shows an experimental way to solve a problem. D. Actual implementation of a proposed study. E. Analysis summary, critical evaluation of findings, and assessment of the findings’

contribution to existing knowledge in the field. 2. Work on the thesis can commence at any stage of the academic studies and a student must

submit their proposal no later than the beginning of the 2nd year. The final thesis must be submitted before the official end of the 3rd year of study. Students who do not turn in their thesis by March 1 of the 4th year of study will not graduate on time.

3. Submission of the final thesis must be within 12 months after completing all other requirements for the MD Degree in order to graduate in accordance with Technion policy.

4. The average period of time between submitting a thesis proposal and receiving a final grade and approval of the thesis is approximately six months and this is to be taken into account when planning the study (assuming students are not required to make any corrections).

5. Students whose thesis does not progress over a period of more than six months for reasons not under their control must contact the thesis coordinator. In the event work cannot be continued, students shall submit a new proposal to the thesis coordinator. When submitting a new proposal to the thesis coordinator, students must attach a letter from their previous supervisors releasing them from completing their work stating the reasons for discontinuing their shared work.

6. Submission of a thesis is agreeing to the submission procedures and approving thesis publication on the Technion network and on the Internet, including the Library of Medicine.

7. Thesis topics will be published from time to time by the thesis coordinator on the faculty website.

8. Statistic assistance: A prerequisite for good scientific research is advanced planning of the goals, methods, research process, data collection and processing. To this end, the faculty allows every student 4 free hours of statistic assistance on their thesis. Statistic consultation is mainly intended to assist at the planning and study proposal stages. In order to receive this assistance, fill out a statistic assistance form (see appendix 3) and email to: [email protected] with your thesis proposal and sample data in an Excel file.

9. Thesis submission process stages: A. Submitting a thesis proposal – below are the forms for submission:

Thesis proposal in a PDF file under the name: “Thesis Proposal + Student’s name” in duplicate: - One copy will be submitted without the names of the supervisors, department

and hospital. Ensure the names of the supervisors, department or hospital are not mentioned in the body of the work either.

- A second copy will be submitted with all the details in full together with a signed application form for approval of the proposal (student’s signature + supervisor/s’ stamp + supervisor/s’ signatures/s) (see appendix 1).

Authorization from the Helsinki Committee signed by the chairman and approval for executing the study signed by the hospital director. The Helsinki Committee authorization (authorization of the study) must be valid upon submission of the



proposal. Proposals submitted with an expired authorization from the Helsinki Committee shall not be received and it will not be possible to approve the proposal. In the event the Helsinki Committee authorization expires at the time of submitting the proposal, students shall refer to their supervisors, who shall refer to the Helsinki Committee for an extension. Despite the aforesaid, it will be possible for faculty members and assessors to begin evaluation of the proposals, however, final approval of the proposal shall not be sent to the student and supervisors until the thesis coordinator receives an extension from the Helsinki Committee, which must be valid for the evaluation. Both copies of the thesis proposal, the application form and Helsinki authorization are to be emailed to the thesis coordinator ([email protected]) with the student’s name and ID number.

It is preferable medical students do not take part in work requiring the approval of the top committee of the Ministry of Health, for example work in the field of medical equipment, genetics and research in children, because of the considerable waiting time for approval. The thesis coordinator should be updated immediately regarding any changes in the Helsinki Commission's approval status obtained during the study (studies put on hold and more). You may begin work on your thesis and submit it only after receiving official authorization by email for your thesis proposal from the thesis coordinator.

B. Submitting a research thesis – below are the forms you must submit: Final thesis (not a draft) in a PDF file under the name: “Thesis + Student name” in duplicate:

One copy will be submitted without the names of the supervisors, department and hospital. Ensure the names of the supervisors, department or hospital are not mentioned in the body of the work either.

A second copy will be submitted with all the details in full together with a signed application form for approval of the thesis (student’s signature + supervisor/s’ stamp + supervisor/s’ signatures/s) (see appendix 2). The supervisors must be the same supervisors who signed the approved thesis proposal. In the event a supervisor has been replaced, written authorization for this must be submitted to the thesis coordinator from the replaced supervisors.

“Deposit and approval of theses publication on the Technion network and on the Internet” form, typed and signed by the supervisors and the student – (forms can be found on the faculty website under ‘Student Information – Research Theses’ and all details can be typed directly into the forms which can then be saved and emailed to the thesis coordinator). After a thesis has received a final grade approved by the Thesis Academic Center, a copy of the thesis will be sent to the faculty library and the Technion central library.

Both copies of the thesis, the application form and thesis deposit form must be sent by email to the thesis coordinator ([email protected]) with the student’s name and ID number.

In the event a faculty member from the field and/or an external assessor asks a student to make amendments at any stage (proposal/thesis), such amendments must be submitted up to 30 days from receiving the request for amendments. Submission of amendments after the stated period of time will lead to a delay in the approval process for the proposal/thesis.




10. Grade components:

A passing grade is 60 A. Supervisor evaluation – constitutes 30% of the grade and is made up of 20% for the

thesis and 10% evaluation of the student’s conduct during the study. B. Assessor evaluation – constitutes 70% of the grade.

The Thesis Academic Center may, in exceptional cases (such as an unreasonable disparity) change the weight of the valuations and/or ask for a evaluation from an additional assessor. In the event the thesis grade is lower than 60, the thesis coordinator will inform the supervisor and student, enabling them to correct the grade in one of the following ways: improving and correcting faults in the thesis, writing a new thesis and resubmitting it or writing a thesis on a new topic.

11. Joint thesis with other faculties at the Technion:

Medical students can do their thesis in collaboration with another faculty in the following ways:

A. A technological research thesis by an engineering student together with a medical student under the supervision of an engineering supervisor.

B. A technological research thesis by an engineering supervisor and student together with a medical supervisor and student.

C. Joint thesis between the faculty of medicine and the faculty of biomedical engineering – the thesis shall be overseen by the thesis initiator, a professional supervisor (with a background in engineering from the faculty of biomedical engineering) and a supervisor from the faculty of medicine. The maximum number of students that may participate on one thesis is three (two from biomedical engineering and one from medicine).

Writing the proposal for a technological research thesis and submitting the final essay will be carried out according to a joint decision between the two faculties, including the need for approval of the Helsinki Committee and determination of a final grade.

12. Exemption from writing a thesis:

A student who has submitted a thesis proposal that has been approved and wishes to apply for an exemption will submit the exemption application before the final thesis is submitted. It will not be possible to apply for an exemption after the thesis has been submitted! Below are the criteria by which you can apply for exemption:

A. A student whose thesis proposal has been approved by the Thesis Academic Center and been published or accepted for publication as an article in a peer review medical journal as an original article and which has an impact factor and/or in the medical journal Harefuah. It is clarified that the student must have written the article him/herself and appears as the lead author and/or secondary author with a system note stating that “These authors contributed equally to the manuscript”. A statement saying that “the work was performed as part of fulfilling some of the requirements of the Haifa Technion Faculty of Medicine for obtaining a Doctor of Medicine degree” must be added to the beginning of the manuscript.

B. A thesis written as part of M.Sc. studies with a thesis or when studying for a Ph.D. at a recognized academic institution in Israel.


C. A medical student with a B.Sc. from the Technion or another recognized academic

institution in Israel who has carried out an independent research project of at least 4 credits in the field of biology, life sciences or subjects associated with medicine.

D. Pre-doctoral thesis by a medical student on an M.D. / Ph.D. track. Authorization from the supervisor for the student’s conduct and for registration to a doctoral examination must be attached to the application.

E. Students on the dual track in Medicine and Biomedical Engineering and Medicine and Materials Engineering and Medicine and Computer Science who completed the final project as part of the BSc degree in Engineering provided that the project is in the life sciences / medical field.

It is clarified that any request for an exemption based on any of the criteria listed above requires authorization from the Thesis Academic Center who will examine whether the thesis is research based and in the fields of medicine and life sciences. Below are the documents to be submitted when applying for an exemption:

A letter from the student to the thesis coordinator detailing the request for an exemption.

A copy of the diploma / certificate of eligibility for a degree from certification studies (in cases B and C).

Graduate grade sheet with a grade on the paper approved by the Accreditation Studies Office, the Technion / academic institution recognized in Israel (in cases B and C).

The paper in a PDF file to be sent to the thesis coordinator by email.

Recommendation letter from the supervisor regarding the student’s conduct and his/her contribution to the research, with the exclusion of case A. In this case, the supervisor must forward a letter to the thesis coordinator stating that the article complies with the required criteria to award the student with an exemption.

Chapter 2: Information and general guidelines

1. The supervisor: The supervisor is required to have an academic appointment of lecturer or above, a specialist physician and anyone with a Ph.D. in one of the paramedical fields. In the event supervisors belong to a private/business company and are not tied to an academic institution, full disclosure is required in addition to written authorization from the business department of the Technion that there is no conflict of interest. In the event that during work an additional supervisor/consultant joins, authorization must be obtained from the Thesis Academic Center. The thesis coordinator must be provided with confirmation from the lead supervisor regarding the additional supervisor and a request to join from the additional supervisor. The joining supervisor must be a senior physician. The supervisor and/or any other team member carrying out the research cannot be related or have an employer-employee relationship. Supervisor role:

The supervisor will suggest topics for the thesis in accordance with regulations and be responsible for the thesis being completed on time, before the end of the sixth year and commencement of the internship.

The supervisor is responsible for the thesis proposal being written in accordance with regulation requirements, accompanying guidelines and will sign the first page as consent to acting as supervisor.

The supervisor will guide the student and oversee execution of the work.


The supervisor will guide the student in writing the final essay and oversee study findings and data processing in accordance with procedures.

At the end of the work and submission of the final draft to the thesis coordinator, the supervisor will submit structured assessment forms which will be sent to him by the thesis coordinator, his/her written assessment of the quality of work and student performance.

The supervisor will help the student to correct his/her work where necessary in accordance with comments from the other assessors and the Thesis Academic Center.

2. The assessor:

The role of the assessor is to go over the thesis proposal and notify the thesis coordinator of the offer's acceptability and his/her willingness to serve as an assessor for the final essay. In the event the assessor raises a fundamental and basic reservation about the proposal, the Thesis Academic Center will request the opinion of a second assessor. Once the proposal is approved, the student will begin his/her work under the supervision of the supervisor. The assessor will check the final work and grade it.

3. Thesis topic:

The final thesis can be completed in any field of medicine, but must be based on research methodology. The Faculty of Medicine is interested in encouraging the execution of basic research work. As part of the thesis objectives, the faculty sees the importance of exposing students to this type of research, i.e. learning the approach to solving scientific questions, designing a trial to obtain answers and exposing new techniques in fields of basic research. Meta-analysis theses will be accepted on condition students are proficient in statistical processing and have proven experience in performing complex statistical work of this magnitude.

In any work involving a nature of epidemiological research, one of the supervisors must be a researcher with background and experience in this field or alternatively should be included as a supervisor. It is permissible to try to recruit supervisors from the Faculty of Public Health and Community Medicine. Remember that in epidemiological work the student must:

o Precisely define the research question, general and specific goals and research hypotheses. This description should be in clear and measurable practical terms.

o Examine the research methodology and its suitability in testing the research question.

o Define the target population, sample size and selection criteria, sampling frame and sample selection method (random, systematic, clustering, etc.).

o Define the variables operatively, specifying measurement scale. o Describe in detail the data collection method, giving justification for the

method used and describe the tools, their originality, reliability and validity. o Describe in detail the method of data analysis, describing the dependent and

independent variables used by the student, especially with a description of multivariate analysis. In describing statistical tests used by students, examples should be given that link the specific variables (and not just indicate that they are quantitative or qualitative).

o Describe the sources of bias specifically, indicating that bias may affect the findings and the way bias is addressed in the design or analysis of the data. The Thesis Academic Center will ensure the existence of all of the above components in discussions to approve the proposal for a thesis.


Proposals for theses based on analysis of databases in Israel or abroad, which have a research question and the findings of the studies may be of great epidemiological value and use will be examined in their own right by the Thesis Academic Center.

The Faculty of Medicine encourages laboratory trials which expose future clinical doctors to this type of experience. Survey work will be easier to be exposed to in the future when they do not require laboratories and infrastructure, etc. It should be emphasized that this statement does not undermine the importance of epidemiological work or surveys. The statement is intended to emphasize that the opportunity for a student to use a lab while completing a thesis may be greater than it will ever be when he is a physician.

Case reports and literature reviews will not be accepted.

4. Guidelines for writing a thesis proposal: A. Proposal length shall be no more than 5 pages. B. The proposal must be legible (font size 10, 11) and include:

Summary – up to 300 words. At the end of the summary there will be 3-5 key words in English.

Introduction – one page only. Define the issue you are responding to; clearly state the character and scope of the issue you will be researching. Note relevant information from the literature regarding the issue you will be researching with suitable quotes.

Research hypothesis – briefly and clearly specify what questions you will answer in this work and what your expectations of the findings are. Try to focus on the main research questions.

Meaning – briefly state the theoretical/applied importance of the work to the field of medicine.

Methods – up to two pages. Research methodology – what type of research will you use: theoretical or analytical? Is the study observational (survey) or experimental? - If the study is observational – Is the study prospective (i.e. cohort), retrospective (usually case control) or cross sectional (generated hypothesis)? Will the data be collected in the future or based on existing data (such as medical records)? - If you are doing a trial – Is the trial controlled? Is the allocation to groups randomized? Blinded?

Study population – described in detail the population from which the subjects will be selected and how they will be sampled. Consider possible biases such as: Measurement bias, selection bias and whether the sample is representative.

Variables – define the main study variables. What is the main variable (dependent variable or outcome measure) according to which you will examine whether your hypotheses are true or false. In the event the study is descriptive, what is the variable whose characteristics you would like to estimate. Describe the work and measurement methods and document them.


If doing a trial, detail the experimental intervention or treatment that each group will receive and the duration of follow-up.

Calculating the sample size – you must calculate the minimal sample size required for the study. Specify what the hypothesis is at the base of your calculation, (and whether it is directional or bi-directional), what is the level of significance (P-value) and what is the volume.

Processing study findings – specify the statistical tools (statistical tests and/or theoretical statistics) you will use to analyze the findings. A statement such as “The data will be analyzed using the standard statistical methods with the help of one or another computer program” does not provide sufficient detail about the statistical analysis.

Ethical aspects – any study related to treatment or actively touching patients requires the approval of the Helsinki Committee. Any study related to testing on animals requires the approval of the Animal House Committee (see appendixes 4 and 5).

Specify the student’s active participation in the study. General statements such as: “The student will take part in lab work” – will not be accepted.

Literature review – the bibliography must be uniform, in the order in which it appears in the proposal, and follow the Index Medicus format.

Appendix 1 which includes the supervisor/s’ and student’s signatures.

Helsinki Committee authorization signed by the Chairman and by the hospital director.

When submitting the proposal, the supervisor will be asked to name two assessors who will be able to review the proposal and the final project when it is submitted. The faculty has the right to decide whether to use these assessors.

5. Guidelines for writing the thesis:

The thesis is to be submitted in Hebrew / English (academic level), clearly legible and double spaced. The scope of the work shall not exceed 40 pages and will include:

o First page – Title page – in accordance with the example in appendix 2. o Second page – Acknowledgements and dedications (optional). o Third page – Table of contents: including chapter names and page numbers.

Each chapter is to begin on a new page. o Fourth page – Abstract in Hebrew. o Fifth page – Abstract in English.

Abstract in Hebrew/English The abstract should be to the point and be clear to those who have not read the thesis and include as highlighted sub-sections the purpose of the work, materials and methods, findings and final conclusions. The abstract can also include major innovations and topics of value in the thesis. Full sentences should be used and abbreviations should be avoided. The abstract in English will be in accordance with the abstract in Hebrew. The scope of abstracts in each of the languages will be up to two pages long. List 3-5 key words at the end of the abstract in English. To be followed by: Introduction chapter


In this chapter, summarize the literary background and clearly define the objectives of the work. The literature review should be comprehensive, up-to-date, and critical. Care should be taken in filtering and formulating materials from the literature; do not collate articles with no connection between them. Authors' names, if they appear in the body of work, will be written in English. The literature review should clarify the open problems the student intends to solve in his/her work. The definition of work should appear at the end of the chapter in a separate paragraph. Materials and Methods chapter This chapter will give an accurate description of all the materials and methods used in the study. In describing human or animal trials, it should be explicitly stated whether the methods are in accordance with the Helsinki Declaration or with the approval of the Animal House Committee. The number of observations and the number of patients/animals who will participate and their statistical significance should be noted. Patient identifying names, hospital admission numbers or initials should not be used. All drugs and chemicals must be accurately identified, including generic names, doses, and means of administration. The statistical methods for processing and analyzing findings must be specified. Findings chapter The findings of the study must be presented using tables, charts or pictures. It is advisable to avoid displaying the same findings in more than one form (for example: both in a table and a chart). Text should present findings in a logical order and in the context of the work objectives. Findings should not be collated randomly with no relation to the study’s general outline. Tables – each table should include a short title and comments so that presented findings are clear without reading the text. If there are abbreviations in the table title, they are to be explained in the comments below. Abbreviations are to be the same as those used in the text. It is advisable to summarize data in averages and avoid including all the data received in the table. Graphic charts – each chart must have a short explanation with the same terms as those appearing in the text. Charts are to be numbered consecutively and referred to by these numbers in the text. All abbreviations and symbols in the chart must be detailed in the explanation. If the same symbols appear in all charts, they should only be listed in the first one. Discussion and Summary chapter The purpose of this chapter is to express the ability of self-thought, acquired knowledge, interpretation of findings obtained, conclusions drawn and contribution of the work to medicine. The chapter should begin with a brief summary of the main findings in the results – critically analyzing the findings and explaining them, pointing out their connections and implications, discussing their significance and their importance in light of the professional literature. Where possible, relevant articles should be cited. This chapter is also a platform to review the work itself – a discussion in favor and against the presented hypotheses. If the findings differ from those published by other researchers, it is important to explain this and back it up with references. At the end of the discussion chapter, the main conclusions of the work are to be summarized. Bibliography


Must include all the articles or chapters of the books directly related to the work and cited in the body of work. A long literature list does not necessarily indicate the quality of the work or familiarity with the study. The list is to be numbered according to the order in which quotations appear in the body of the work. Names of journals and magazines shall be notated as follows: author/s (all), article or publication, journal, year, volume number, first and last pages. In book quotes the publisher’s name and printing location are also to be noted. Abbreviations – authors’ first name initials shall appear after the family name without the addition of a full stop after each letter. Journal abbreviations as accepted in the Index Medicus. The magazine number and month of publication need not be specified.


Appendix 1

Thesis Proposal

Thesis topic

(Hebrew) __________________________________________________________________________

(English) ___________________________________________________________________________

Student details

First name: __________________ Surname: _______________________ ID no. __________________

Sex: M / F (circle) Year of study: _______________________________

Supervisor/s’ details

First name: ________________ Surname: ___________________ Mobile phone: ________________

Email: ______________________ Department: _______________ Medical center: _______________

Academic level of lead supervisor: ___________ From university: _____________________________

Location of study: ______________ Supervisor signature: ___________________ Date: ___________

(signature + stamp)





(signature + stamp)





(signature + stamp)


Appendix 2

Research Thesis

As part of the requirements for the degree of “Doctor of Medicine”

Thesis topic

(Hebrew) __________________________________________________________________________

(English) ___________________________________________________________________________

Student details

First name in Hebrew: ______________________ First name in English: _______________________

Surname in Hebrew: ________________________ Surname in English: ________________________

Supervisor/s’ details

First name: _______________________________ Surname: ________________________________

Department: __________________________ Medical center: _______________________________

Supervisor signature: ____________________________________ Date: _______________________

(signature + stamp)




(signature + stamp)




(signature + stamp)

The work has been submitted to the Senate of the Technion – Israel Institute of Technology Haifa, Israel

Hebrew submission date: ________________ (e.g. 1 Kislev 5776) Gregorian submission date: __/__/__


Appendix 3

Application form for statistical assistance

The application is to be sent to [email protected] along with the research proposal and sample data in an Excel file.

Student details

First name: _______________ Surname: ________________ Email: ___________________________

Research details

Topic: _____________________________________ Research term: From: _________ To: _________

Stages: A) _________________________ From: _________ To: _________

B) _________________ From: _________ To: _________ C) From: _________ To: _________

Data processing

Definition of statistical issue: __________________________________________________________

__________________________________________________________________________________

__________________________________________________________________________________

Data characteristics: _________________________________________________________________

__________________________________________________________________________________

__________________________________________________________________________________

No.

Variable

Quantity

Relation to variables:

Dependent, r

Submission method Name

Type: no., category

Measurement unit

Margins

Minimum Maximum

--- --- ---

Characteristics for defining sample size: Confidence ________, Power ________,

Early proportions 1) _______, 2) _______

Early sampling 1) _______, 2) _______ [or standards error] 1) _______, 2) _______

Averages 1) _______, 2) _______

Standard deviation 1) _______, 2) _______

Other: _________________________________

Submission of findings (characteristics, tables, charts…) __________________________________________________________________________________

__________________________________________________________________________________

__________________________________________________________________________________



Appendix 4

Helsinki Declaration

The Helsinki Committee can be contacted at any of the Technion's Faculty of Medicine affiliated medical centers or other university hospitals in the country where the trial will be conducted, to obtain a more detailed explanation of the manner and requirements for applying for the trial, as well as acceptable times for obtaining the Helsinki approval.

The statute that defines and determines the ethical principles for medical research involving human subjects was approved by the World Medical Association at a 1964 rally in Helsinki. The physician’s mission is to maintain the health of the people. His knowledge and conscience are sacred to the fulfillment of this mission. In the field of clinical research, there is a fundamental difference between clinical research with the purpose of healing the patient and clinical research whose main purpose is purely scientific and not for the purpose of healing the individual being treated for research purposes.

Basic principles:

1. Clinical research must conform to the principles of moral and scientific justification for medical research and must be based on laboratory experimentation on animals or other scientifically established facts.

2. Only persons with scientific qualifications under the supervision of a medical practitioner with appropriate qualifications may conduct clinical research.

3. Clinical research cannot be justified unless there is a reasonable relationship between its scientific importance and the risk that may arise during and after the trial.

4. Each task in clinical research must be preceded by a careful assessment of the possible risks while confronting the good that may arise from this to the subject of the trial or to others.

5. The physician performing a medical study must ensure that during the trial, no change is caused to the personality of the person involved in said trial, under the influence of drugs or due to the trial’s methods.

Clinical trial with the addition of professional treatment:

1. A physician treating a sick person should be free to use new means of healing if, in his/her judgment, they give hope of saving lives, restoring health or alleviating suffering. If feasible, the physician must obtain the patient's consent after the patient has received a full explanation. In the event the patient has no judicial capacity, the physician must obtain the consent of his/her legal guardian.

2. The physician can integrate clinical research into professional care if the goal is to acquire a new medical opinion, only to the extent that clinical research is justified in terms of its medical value to the patient.

Clinical trial without cure:

The physician must explain the nature of the study, its purpose and the risk involved to the research subject.

1. The person on whom the clinical research is conducted must be in a physical, mental and legal condition that will allow him/her full use of his/her ability to decide.


2. Written consent is usually required, but the responsibility for the clinical research is that of

the person conducting the study and said responsibility can never be placed on the person on whom the study is conducted, even after consent is obtained.

3. The researcher must respect the rights of every person to safeguard him/herself against harm to his/her person, especially if said person is in a dependent relationship with the physician.

4. The subject of the study, or his/her guardian, must be free to cancel any agreement to conduct the clinical research at any stage.

5. The researcher or team of researchers are obligated to discontinue the study if, in their judgment, the study may cause harm to an individual.

The protocol for applying for human experimentation must contain all of the following:

Background and rationale for the medical trial, including a review of the scientific literature.

Name and description of the research product, clinical labels and summary of preclinical knowledge and existing clinical information about it. When the trial entails using medical accessories and devices, state the manufacturer's name, model name, accompanying aids, software version identification number and how it is used in the trial.

Objectives of the medical trial.

Indices according to which the findings will be evaluated.

The number of participants in the trial, the number of centers planned to participate, the number of phases and the format of the medical experiment – open, covert, etc.

Criteria for inclusion, exclusion and removal from the medical trial.

Treatment plan for the study product / accessories and devices (including: doses, delivery method, treatment duration and number of treatments).

Clinical monitoring plan (it is advisable to attach a schedule and/or trial flow chart).

Laboratory tests and any other relevant test which will take place during the study and monitoring period.

Conditions for discontinuing the clinical trial.

Method for assessing safety and technique for reporting serious side effects.

Data analysis and processing method.

Ethical issues of the trial.

Clinical examinations, questionnaires.

Relevant literature.

CRF (case file report) examples.

Update to GCP requirements –

In the July 2010 forum of the Helsinki Committee Directors, it was decided that a medical student may be a secondary investigator and the list of authorities must include the actions the student may carry out. The student may not sign a consent form and it is advisable not to risk allowing him to carry out invasive procedures. It is emphasized that the principal investigator is responsible for all the secondary investigators, including the student, and he oversee the student’s actions in the trial, in accordance with GCP requirements.

Attention: The Helsinki Authorization must be signed by both the

Helsinki Committee Chairman and hospital director.


Appendix 5

Technion regulations for animal experimentation

The Technion carries out animal experiments to promote knowledge in life sciences and medicine through basic and applied research and teaching needs in medicine and life sciences. The responsibility of researchers and the institution regarding animal experiments is defined in the Animal Welfare Law (Experiments on Animals), 5754-1994. In accordance with this law, a researcher at the Technion who intends to conduct an experiment or demonstration for teaching purposes on an animal (vertebrate) will submit his/her work plan for approval of the Technion Committee for Animal Experimentation (i.e. the Ethics Committee, Animals), in accordance with the detailed instructions. For this purpose, a researcher will have an academic subscription (regular or clinical track) at the Technion. A person not from the Technion wishing to use the Technion's Experimental Surgery Unit will submit a detailed work plan for approval by the Technion Committee for Animal Experimentation. A representative with veterinarian status will accompany the trial and be responsible on behalf of the Technion throughout the trial, from submission of the application to its overall execution and will be listed on the application as a researcher. Every lab in which experiments are conducted in collaboration with Technion staff will be open to visits from members of the Animal Ethics Committee. Also, any facility where laboratory animals are kept, and any supplier of these animals will be approved by the above committee. In conducting experiments on animals, the researcher should consider the following: Ensure animal care is always the best possible and that suffering caused to animals is as minimal as possible. Proper care, minimization of pain, and human handling of laboratory animals require professional and scientific judgment based on knowing the needs of the animals, both in general of each breed, and unique to that research or demonstration. Researchers are responsible for the proper handling of their subject animals. You may not experiment in laboratory animals without considering the scientific value that the experiment may yield. Animal experiments will not be performed when similar results can be obtained in other ways. If animal experimentation cannot be avoided, the smallest number of animals should be used, from the lowest level on the phylogenetic scale that allows the study to be performed (for the purpose of this document, lab animal refers to any vertebrate animal separated from its natural environment and used for research or teaching purposes). Proper structures and proper equipment are important for the proper maintenance of lab animals, but more important are the discretion and sincere concern of all people who come into contact with the animals. In order to fulfil the rules mentioned above and to comply with the law and conditions for receiving research funds, all persons using animals for research are required to read these procedures and guidelines and sign the experiment approval form, undertaking to follow them. Animal Research – Procedures and Audits: Principles:

A. Experiments in animals shall not be carried out other than in accordance with the provisions of these regulations.

B. Performing an experiment on animals is subject to prior approval of the Technion Committee for Animal Experimentation (Ethics Committee, Animals). A copy of the ethics authorization must be sent to the thesis coordinator, signed by both the Technion Animal Experiment Committee Chair and by the Animal House head veterinarian.

C. The principal investigator is responsible for maintaining procedures during the experiment. He must ensure researchers and technicians working with the animals have appropriate training and s/he is responsible for the duty of reporting to the Animal Ethics Committee.


D. All staff participating in animal research will attend a course dedicated to the subject that will

be given at the Faculty of Medicine once a year. New researchers will be enrolled in the course closest to the start of their work.

E. All experiments and treatments will be carried out under the supervision of a licensed veterinarian who will be at the disposal of the researchers for counseling and training and will ensure the health and welfare of the animals.

F. Use of animals for teaching purposes will only be permitted after receiving approval from the Ethics Committee, Animals.

G. Experiments in animals that may cause pain, suffering or discomfort as well as all types of surgery, will be performed under general, local or other appropriate anesthesia according to standard veterinary practices.

H. Performing a painful experiment with central or peripheral muscle relaxation is prohibited except under general anesthesia.

I. Animals undergoing recovery from surgery should be given pain prevention treatment. To do this, consult your licensed veterinarian.

J. Restraints will be used for the shortest possible time and only after all other non-distressing measures have been rejected or proved ineffective.

K. Small quantities of blood can be taken for diagnostic purposes without the need for pain killers. In the case of large quantities (up to 10% of the total blood volume and at a frequency of no more than once every 8 weeks), or terminal quantities, the animal should be euthanized prior to taking the blood.

L. Animals suffering from chronic pain, prolonged discomfort or defects that cannot be corrected – will be euthanized.

M. Animal euthanasia should be done by a skilled practitioner in the least painful and quickest way possible and in accordance with one of the accepted methods. For partial details of the methods – see Work Procedures for Lab Animals.

N. Euthanasia after general anesthesia will be performed as soon as possible and before the animal comes around.

O. At the end of the experiment, the researcher must take care of euthanizing the animals, storing their bodies in plastic bags and bringing them to their designated places. The carcasses will be stored in a freezer at Animal House in designated refrigerators and disposed of as required by a competent governmental licensed body. Carcasses and radioactive waste shall be stored in separate refrigerators marked with the usual marking for radioactive materials and disposed of as required at the responsibility of the Technion's Radiation Protection Safety Unit.

P. Providing information regarding the use of animals for experiments, including principles, policies, rules, and practical guidelines and instructions, as well as the actual use of animals at the Technion, will be carried out in coordination with the chair of the Technion's Animal Ethics Committee, the Technion's veterinarian, or the spokesperson.

Q. Each trial is subject to the provisions of every law in Israel and the principles, general policy and practical instructions do not derogate from the instruction of any law. Knowledge of the law is the responsibility of every user, and no one else, including the institution or any of its directors, its officers and/or employees, is responsible for the user's knowledge of any law.

Fate of animals no longer being used for experimentation:

A. Unhealthy animal or those that due to the treatments they have undergone are feared to be harmful to their environment – will be euthanized.

B. Healthy animals no longer required for experimentation: 1. Mice and rats will be euthanized unless it is possible to transfer them to a zoo while

maintaining the instructions of the Animal Welfare Law.


2. Cats and dogs – an effort will be made to find them adoptive homes within a

reasonable time, otherwise they will be euthanized. 3. Primates – the internal committee must contact the Nature Conservation Authority

to check whether they can be absorbed into a suitable environment, otherwise they will be euthanized.

4. Other animals – in accordance with that stated in clauses 1, 2 and 3 accordingly. Technion ethics committees for use of lab animals: All experiments using animals, including teaching labs, must receive authorization from the Ethics Committee, Animals. This committee is responsible for application of the Animal Welfare Law – Animal Experimentation, in any activity at the Technion, including keeping and caring for the animals. The committee's authority includes drafting guidelines for holding, handling, use and euthanasia of animals, as well as overseeing the animals' holding facilities at the Technion and issuing permits to conduct animal experiments within the Technion's research and teaching facilities. The committee follows the rules of the National Council, and also according to US National Institutes of Health (NIH). In detail, the Committee's functions include:

A. Technion representation with the National Council for Animal Experiments (the “Council”) and government officials concerned with animal experimentation.

B. Promise to comply with procedures for proper handling of animals at the Technion. C. Supervision of the facilities used for animal husbandry and experimentation. D. Approval of requests to use animals. E. Communication with the public through the Technion spokesperson when it comes to the use

of animals at the Technion. F. Periodic reporting to the Council on behalf of the Technion, as required by law, regarding

approved applications. Provision of a course on practices for working with animals and certification of employees after training in accordance with National Council directives. Review of faculty or Technion programs using animals, including programs to change or build facilities for maintenance or work with laboratory animals. Composition of the Committee: The Animal Ethics Committee will include representatives (one or more) of all units in which animal experiments are conducted. The committee will also include the Technion's veterinary doctor, one faculty member whose work at the Technion is unrelated to animal experiments and one member not related to the Technion in employer-employee relations. The number of committee members (including the chairman) shall exceed six.

Documents

Faculty of Medicine Research Thesis Regulations · 2020-02-02 · 7. Thesis topics will be published from time to time by the thesis coordinator on the faculty website. 8. Statistic