BS ISO 29943-1:2017 pdf download – Condoms — Guidance on clinical studies Part 1: Male condoms, clinical function studies based on self-reports
5.4 Informed consent The purpose and requirements of the study should be explained before prospective couples are presented with informed consent forms. Subjects should also be advised that more detailed information about sexual activity will be collected than is typical of most family planning visits. Subjects should be given an opportunity to ask questions about the study and/or the content of the informed consent. Couples should be informed that both partners should agree to participate in the study in order for them to join. If both members of the couple agree to participate, they should each be given a separate informed consent form to sign. All volunteers should provide written informed consent before they are enrolled in the study. All participants should receive a copy of their signed informed consent forms. Subjects should be informed about the potential for condom failure and the availability of emergency contraception in the event of condom failure (if not otherwise using a highly effective alternate method of contraception).
NOTE Useful information regarding informed consent is available in Reference . Also see Reference .
5.5 Test and control condoms 5.5.1 General Both control and test condoms should be evaluated according to ISO 16037. This is important because these results are used to establish the specifications of the new condom and to verify that the control condom represents a typical condom already approved for market. When the test condom is synthetic, then sufficient sample sizes should be used to establish baseline properties as specified in ISO 23409. NOTE ISO 16037 is a test method and not restricted to rubber products. The protocol for the clinical function study should provide physical description of both test and control condoms, including material, length, lay-flat width, thickness, lubricant formulation and appearance.
5.5.2 Test condom The test condom should meet performance specifications throughout the study.
a) Test condoms used in the clinical study should be manufactured using the same manufacturing process(es), equipment, specifications and quality assurance procedures as the product to be commercially marketed. Test condoms for the clinical study should be selected from a normal production run.
b) Test condoms should be selected from a single lot. As stated above, when the test condom is synthetic, the compliance of the lot with the specification should be assessed using the sample plans specified in ISO 23409:2011, Annex B. If test condoms for the clinical study are selected from more than one lot, then precautions should be taken to ensure that the individual lots comply with the specification and are of a similar age and from a similar period of production, e.g. within 3 months. It is not acceptable to mix samples from lots produced using significantly different processes or equipment.
c) As specified in ISO 23409:2011, Clause 11, when the test condom is synthetic the airburst properties of test condoms from all lots (preferably only a single lot) should be determined using a sample size of at least 2 000 condoms. Other properties of the condom should be determined and recorded using the principles underlying ISO 16037.
d) For the purposes of the trial, the test condoms can be packed in non-standard packaging, i.e. showing sequence and randomization allocation without typical brand. However, the packaging should provide the same level of protection to the condom as normal production packaging. If non- standard packaging is used, the manufacturer or the organization responsible for the trial should ensure that the proper labelling information (such as that specified in ISO 23409:2011, 16.2 for synthetic condoms) is made available to the study participants.
NOTE Local regulations can require additional labelling.
5.5.3 Control condom made from natural rubber latex
The control condom selected for the breakage and slippage study should meet the following conditions.BS ISO 29943-1 pdf download.