| Informed consent is an important part of any medical | | | | If the subject is a physician investigator's patient, |
| research involving humans. Consent means more than | | | | steps need to be taken to ensure the human subject |
| a simple signature on a form; instead it involves all | | | | does not feel an obligation or pressure to be part of |
| steps taken in the protection of human subjects. | | | | the trial. The investigator can have a conversation |
| Physicians in charge of clinical research studies must | | | | with or send a letter to the potential participant, but |
| be careful to educate potential subjects so they can | | | | he or she should ask a colleague to follow up with |
| make a truly informed decision. | | | | the patient. Investigators can also have nurses or |
| Informed consent begins from the first point of | | | | colleagues introduce the patient to the study to take |
| contact, which can be a commercial, letter or | | | | away any kind of undue pressure or stress on the |
| pre-screening call. Those in charge of the clinical | | | | patient. |
| research study must be sensitive to keep all the | | | | Obtaining consent from children or minors has a |
| information easy to understand and avoid medical and | | | | different set of ethical issues and ethical principles |
| technical jargon. Excessive use of terminology may | | | | than gaining consent from adults. Federal laws |
| put the patient in danger because he or she does not | | | | stipulate that consent must be given by a parent or |
| understand what is being said, but is too | | | | legal guardian, but many states have different laws |
| embarrassed to ask for clarification. | | | | regarding how many parents need to consent and |
| After the initial contact, an in-person consent | | | | how to establish legal guardianship. In most cases, |
| discussion should be arranged. This needs to be | | | | when the clinical trial involves minimal risk or has |
| scheduled well in advance of the clinical trial start date | | | | greater than minimal risk but proposed direct benefit |
| to give the potential human subject time to consider | | | | to the child, only one parent needs to consent. |
| their participation. During this session, give the subject | | | | However, when clinical research involves greater than |
| general information about the clinical trial studies in | | | | minimal risk and has no prospect of direct benefit for |
| which the person can participate. | | | | the child, both parents must give their permission If |
| You will also be reviewing the purpose of the | | | | the other parent is deceased, unknown, incompetent |
| research, procedures, risks and potential benefits. | | | | or reasonably unavailable, you only need to contact |
| Give the participant a copy of the consent form so | | | | one parent. Be especially careful of these |
| he or she will be able to take it home, read it | | | | circumstances and document your reasons for only |
| carefully and talk about it with family and a personal | | | | speaking with one parent. Try to obtain |
| physician. If the person agrees to take part in the | | | | documentation proving the other parent's death, |
| research trials, obtain the signed and dated consent | | | | incompetence, etc. |
| form and give the participant a copy. | | | | Assent should also be gained from children seven |
| When there is minimal or more than minimal risk or | | | | years of age and older. Before beginning a discussion |
| during an investigational device and drug trials, a | | | | about the risks and potential benefits with the child, |
| licensed physician investigator listed on the protocol | | | | investigators should assess the potential subject's |
| should get consent from the human subject. Study | | | | maturity and psychological state. If the investigator |
| nurses and staff can help in the consent process, but | | | | feels the child will not be able to process the details |
| the physicians should be actively involved in explaining | | | | of the clinical trial, he or she should document why |
| risks and potential benefits. | | | | assent was not pursued. |