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INFORMATION FOR RESEARCHERS CONCERNING INFORMED DECISION MAKING:
WHAT IS AN INFORMED CONSENT FORM?
To assist rearchers, WHO has developed Informed Connt Form templates for various types of rearch studies. Click here to view the.
家有九夫Whenever you are proposing rearch with human participants you must provide a form, known as an Informed Connt Form (ICF), with each proposal to indicate that the rearch participant has decided to take part in the rearch of her/his own free will. If the rearch involves more than one group of individuals, for example healthcare urs and healthcare providers, you must provide a parate informed connt form for each group which has been tailored specifically for them. This ensures that each group of participants will get the information they need to make an informed decision. For the same reason, each new intervention also requires a parate informed connt form.
Once approved by the WHO ethics review committee (ERC), the connt forms become part of the project protocol. Forms should be written in the prospective participants' mother tongue, and when this is not English, an English language translation should be provided as well. If you prefer, connt forms can be written in the language which the rearcher is most comfortable with and translated into the pa
英雄颂rticipants' mother tongue and English. Ideally, translated connt forms should be back-translated and compared with the original to ensure accuracy. For review purpos, both the local language and the English version of the ICF should be submitted.
For multi-centre rearch studies, a common connt form will be taken as a minimum requirement to which additions may be made as dictated by local circumstances. In such cas, the common connt form should be written in either the rearcher's mother tongue, or the language which the rearcher is most comfortable with, and translated into English and other languages as required. Institutes participating in multi-centre trials must inform WHO whether they will u the common connt form and, if the common connt form will not be ud, the institutes should provide a copy of the amended and/or translated version that will be ud.
The connt form has two parts: (a) an information sheet describing the rearch and the nature of the participant's involvement in it, and (b) a certificate of connt attesting to the participant's connt. Both parts should be written in sufficiently large letters and in simple language so that the participant can easily read and understand the contents. The information sheet should be written in third person (e.g. "you will meet with the rearcher…") whereas the certificate of connt should be written in first person (e.g. "I have been informed that…."). Medical terminology should be avoided in 广告剧本
小班反思writing up the informed connt form.
The information sheet is given or read to each prospective participant. Any questions the participant may have are then answered and, if connt is given, the certificate is signed by the participant. If connt is oral, the certificate is signed by a literate witness who was prent when the information was read to the participant and who confirms that the information was understood, and connt was given freely. The rearcher/staff member who provided the information to the participant also signs the certificate, likewi confirming that the information was provided and understood, and that connt was voluntary. A signed certificate of connt must be obtained in this way for each participant admitted to the rearch study and a copy of the entire informed connt form must be offered to the participant.
There are often times when the agreement of community leaders or reprentatives is either mandatory or good practice. When community agreement is advid, it is obtained prior to, but does not replace, the connt of individual participants. In general, community agreement is obtained through a process of discussions and meetings with community leaders and does not require signed agreement. However, there are some countries and communities which require written evidence of community agreement. It is the rearcher's responsibility to become aware of, and respect, the re
quirements.
When rearch involves children or people considered to be unable or not competent to sign for themlves, a connt from a parent or guardian is required. However, children or others considered to be unable to sign for themlves, should be given the opportunity, where at all appropriate, to have their permission or concerns recorded as well. This is known as Asnt and there is a parate form for the recording of asnt. The age at which asnt is required depends upon local legal requirements or, in their abnce, upon both the local culture and the content of the rearch. In general, rearchers should consider obtaining asnt from children over 7 years with mandatory asnt required from the age of 12. Asnt which is denied must be taken very riously.
手工劳动If the rearch involves HIV testing, testing for Hepatitis B or C, pregnancy testing, or other tests that may have further implications for follow up or treatment, participants must be offered pre and post-test counlling relevant to the tests. If any of the tests are pre-requisites to the primary rearch, or are required at any time during the cour of the main rearch, an additional and parate informed connt for permission to test will be necessary. Links are provided here to specific documents which may be of interest to rearchers:
UNAIDS/WHO Policy Statement on HIV Testing
Ethical considerations in HIV preventive vaccine rearch (UNAIDS)
In writing up the information sheet take note of the following points:
•Indicate that this is a rearch study to distinguish it from routine care.
•Clearly state that participation is voluntary and, if applicable, that current care will not be negatively affected. Stating the voluntary nature of participation at the outt allows the potential participant to hear the rest of the information in that context and to hear it when they are most alert. It can be repeated near the end of the information sheet as well.
香木盆栽•Explain why the rearch is being done and why the prospective participant is being asked to participate.
•Describe, in quence, what will happen in the cour of the rearch, giving enough detail for the participant to gain a clear idea of what to expect.
•Explain the nature, likelihood and treatment of anticipated risks, discomfort or adver effects, including psychological and social risks, if any. Where relevant, include a comparison with risks pod by standard treatments or drugs, and an indication of whether the drug or procedure under inv
estigation bears risks equal to, greater than, or less than the standard. If the risks are unknown or a comparative risk cannot be given it should be so stated.
•Explain whether or not the rearch procedures offer any benefits to the participant or to others. The rearch may not offer any benefit to the participant and this should be stated clearly.
•Where relevant, explain what will be done with the 'excess' biological samples that may be taken as part of the rearch protocol - how soon after the rearch will they be discarded or destroyed or for how long will they be stored, how will they be stored and who will have access to the samples and under what circumstances. Who will have the responsibility to eventually destroy or discard the samples? Note that if unud samples are to be stored for future u, further connt is needed from the participant and perhaps from the community in cas where the rearch is of a nature that the community may be involved or affected. This is discusd in the last paragraph of this document. •State that all records are to be kept confidential. If absolute confidentiality cannot be guaranteed, explain why this is so. Explain the extent to which the confidentiality of participant-specific information will be protected during the rearch and in any resulting public disclosures at meetings or in publications. Also state which persons other than the rearchers may have access to the records
and/or to whom information may be disclod. State where and in what form participant-specific information will be stored, and when, how and by whom it will be destroyed.
•State that the participant has the right to refu to participate or withdraw from the rearch at any time without their current or future care being affected. State what alternative treatments or procedures are available for both tho who choo not to participate in the rearch and for tho who withdraw.
•Explain how you will be sharing the rearch findings with participants. If you have a plan and a timeline, state this in the information sheet. You should also state that you will be sharing the rearch findings more broadly and provide information about how this is to be done, i.e. through scientific reports.
•Contact information. The name, address and telephone number must be included on the form of the person(s) to be contacted by the rearch participant if they have questions about, or experience any problems during the cour of, the rearch. The should be persons who are available on site, intimately involved with the rearch project and easily accessible to rearch participants, not chairpersons of ethics committees or deans of schools or heads of departments.
•The Certificate of Connt is the cond part of the Informed Connt Form and is not a stand alone document.By prenting it as a continuation, or part two, of the informed connt rather than as its own parate document, both rearchers and participants can be assured that the information about the study and about the participant's rights have been shared with the participant.
The certificate of connt should be written the first person (e.g. "I have been informed…") and should have a paragraph such as the following:
I have read the foregoing information, or it has been read to me. I have had the opportunity to ask
questions about it and any questions that I have asked have been answered to my satisfaction. I connt voluntarily to participate as a participant in this study .
The informed connt document is to be signed and dated by the participant or, when the participant is illiterate or physically unable, by a literate witness who ascertains that it was understood and confirms that connt was given freely. Whenever possible, the witness should be lected by the participant and he/she should not be connected with the rearch team. Whenever feasible, the recruitment of illiterate participants should take place in the prence of a literate witness.
The witness and the rearcher each sign under a statement such as the following:
I have accurately read or witnesd the reading of the connt form to the potential participant, and the
individual has had the opportunity to ask questions. I confirm that connt was given freely.
骑行裤•Statement of Connt for Storage and Future U of Unud Samples. If the protocol calls for the storage and future u of samples, this parate connt form should provide the reasons for requesting storage of the samples (or data), option of either immediate destruction or maintenance and u of samples for future rearch on either the same subject or for future approved rearch. This ction should also provide the option for samples to either be destroyed after a certain period of time or kept indefinitely, as well as the option for the participant’s identity to either be removed or kept with the unud samples. It is important that this statement of connt be prented in clear language and that the concepts can be readily understood.
