How can I enlist into the study database?
In order to enlist into the database you need to go to the Recruitment Compartment of the investigating center (see Open hours) from Monday to Thursday, between 14:00-18:00, with your ID card.
How do I know when I can be called to participate to studies?
The Recruitment Compartment will make the selection from the database according to the imposed criteria and will contact the able subjects, in order to obtain a personal verbal agreement to participate in the next study.
I have lost the calendar; what should I do?
You can contact the recruitment compartment in order to obtain another calendar.
I have lost the ticket with the batch and reference; what should I do?
You can contact the recruitment compartment in order to obtain another ticket, based on your ID card.
What should I do if I can not get to a scheduled visit during the study?
You must call the technical compartment to announce in due time and to receive information regarding this issue.
What are the foreseeable risks of the participation in a study?
During the study may appear mild and reversible discomfort sensations such as stinging, itching, warmth sensation, slight redness.
The testing of cosmetic products may reveal an allergy already acquired to a cosmetic ingredient, in this case the reaction is usually limited to the experimental area. However, the occurrence of an allergic reaction during the study is very unlikely with these types of products.
The compensation that I receive is included in the annual statement of income?
Yes, the compensation that you receive must be included into the annual statement of income. You must do this operation by yourself, according to the laws in force. The investigating center pays the amount representing the income tax (16%) and this way you will be automatically registered into the 205 Declaration.
The compensation that I receive affects in any way the receiving of support/social grant?
It is possible, depending of the type of support that you receive and also in the case that it is exceeded the threshold required by the law of the income per family member. For further information feel free to contact us (see Contact subjects).
Which are the tested products?
The tested products can be:
- Cosmetic products:
- care products (for body, face, hands, feet, hair etc.), for example : moisturizing cream, sun protection cream;
- hygiene products (for body, face, hands, feet, hair etc.), for example: shampoo, shower gel, deodorant;
- for make-up and cleansing (for body, face, hands, feet, hair etc.), for example: nail polish, lipstick, makeup, cleansing milk; in the form of cream, milk, stick, lotion, powder.
- Several medical devices (for example: patches, etc.)
- Nutritional supplements
- Textile (for example: aloe vera nylon tights, etc.)
- Ingredients for the cosmetic industry.
What are the conditions that must be performed in order to become a subject?
In order to participate in the studies performed by our center you must accomplish the following criteria:
- your age should be between 18 and 70 years old;
- you should have a family doctor and medical insurance;
- you should talk and write in Romanian without any difficulties;
- you should live near the institute or to have means of transportation that will allow you to respect the schedule imposed by the studies in which you may participate;
- you must accept a psychological and medical check (lasting maximum an half of hour), performed by a psychologist and a doctor consisting in: psychological examination and a brief clinical exam, mainly based on the mental and physical state of health and on cosmetic habits;
- you must not be registered with diseases nor be under any medical treatments (unauthorized by the investigating doctor; which can influence the results of the study);
- you must not consume drugs or alcohol;
- you must give your written consent for inclusion into our database.
|If you are co-ensured, you must present us a proof of this fact, respectively a certificate from the family doctor.If you are house hold (without income), you must have health insurance paid.
If you are retired because of illness, early retired, unemployed or you are a beneficiary of social insurance, please contact us for further information at our center. There may be conflicts between the subject state and the one of social assisted.
What are the conditions that must be performed in order to be included in a study?
- you must be registered into our subjects’ database; this will allow the investigating center to regularly contact you;
- you must not be sick or under any medical treatment other than the one authorized by the investigator;
- you must not be pregnant and you must engage yourself that you will prevent this fact from happening during the study (if applicable)
- you must not be in the lactation period (if applicable);
- you must correspond to the specific criteria imposed by the study (example: sensitive eyes, oily skin, dandruff, etc);
- you must not be in the exclusion period;
- you must be available on all of the study duration as well as in the next period, in case that it is necessary to perform additional studies;
- you must not participate in the same time to another study in another experimentation center;
- you must read, understand and if you agree, sign the “Informed Consent Form”.
What are your guarantees?
- the studies are performed in accordance with the in force regulations by a competent, qualified and experimented personnel, which guarantees your safeness;
- confidentiality of your personal data provided to the institute, according to the law no. 677/2001;
- clear and accurate information, verbal and in written, regarding the ongoing study in which you participate and also the possibility to ask the institute’s staff about additional information;
- the study is performed with products provided by companies that benefits from civil liability insurance and which undertakes that the provided products are of good quality and for which the institute has sufficient safety data to eliminate all the risks of local intolerance;
- freedom to accept or to refuse the study that we propose or to withdraw your participation in the study that you have been included without being compelled to motivate your decision.
What are the constraints imposed to you during a study?
- to respect the using instructions and the constraints of the study, described verbally and in writing at the beginning of the study within the “Informed Consent Form”;
- to inform the institute of all the deviations from this consent and especially to describe the concomitant medication taken during the study;
- to comply with the dates and hours provided for coming to the institute and to announce the personnel from the Technical Compartment in case of absence from a valid reason;
- to respond correctly to the questionnaire (if applicable);
- to return the samples at the indicated date (in case of home using);
- to warn as soon as possible the institute if during the study you notice any adverse reaction or have discomfort sensations;
- to respect the exclusion period during which you cannot participate in any other study and whose duration is indicated in the “Informed Consent Form”.
- for safety reasons, during the visit to the institute you should not be accompanied by children who can not be left unattended (especially in the laboratories);
- for hygienic and safety reasons, pets are prohibited in the institute.
What should I do if I am requested to participate in studies?
- to inform the institute whether you are interested or not of the proposed study;
- to come at the established date and hour to the institute (if you are retained please announce us as soon as possible);
- to follow the study’s specific instructions.
Am I allowed to remove the patch from my back?
It is strictly forbidden to remove the patch by any other person except for the technical personnel from the investigating center; violation of this rule can lead to exclusion from the study (exceptionally, if it is requested, the patch can be partially removed, according to the precise indications of the technical personnel). In case of accidental removal, contact as soon as possible the investigating center and respect exactly the instructions provided by the Technical compartment.
What is the maximum compensation that I can receive?
There is no minimum or maximum compensation, the amount varies depending of the type and duration of the study.
I forgot at home the testing product or daily log; what should I do?
Inform the technical compartment and establish with one assent the modality of returning the objects, according to the study requirements.
What happens if, from reasons independent to my will, I cannot participate to the ongoing study?
In case of hospitalization, disease or accident, you must inform the investigator and then to bring the supporting documents (certificate, ticket for hospital discharge, etc.) and beginning with the final date of the study you will receive a part of the allowance provided.
What documents do I receive when I am included in a study?
- „Informed Consent Form”;
- calendar with visiting dates until the end of the study (if applicable);
- identification ticket with batch and reference (if applicable);
- daily log;
- the using instructions of products at home (if applicable).