招募研究主题beplay苹果手机能用吗
Guideline
Recruitment and selection of subjects must be公平within the confines of the study. The investigator may not arbitrarily exclude participants on the basis of gender, race, national origin, religion, creed, education, or socioeconomic status.
Equitable - fair or just; used in the context of selection of participants to indicate that the benefits and burdens of research are fairly distributed.
Inclusion of Women and Minorities in Clinical Research
Cultural diversity in subject selection is strongly encouraged. Clinical studies should be inclusionary, designed in such a way that the subject pool is representative in gender, race, ethnicity, and age of the local population affected by the condition being studied. Exclusion of particular subgroups may be justified in the following cases:
- A specific scientific question is more appropriately addressed with a more targeted group,
- Specific known risks of intervention (or other participation) warrant exclusion of specific groups,
- Gender- or racial-neutrality has been previously demonstrated,
- Redress of gaps in medical knowledge about specific groups,
- Multicenter studies may achieve overall balance by choosing centers with complementary minority representation.
Subject enrollment need not be sufficient to provide high statistical power for calculating effects of gender and minority status on intervention effect in all cases. Investigators planning phase 3 clinical trials in which prior studies suggest a clinically “significant difference” in effect among subgroups or those in which differential effects are uncertain are encouraged to design the subject pool in sufficient numbers so as to provide a “valid analysis” in each subgroup.
经济不利的科目
研究人员应考虑与研究有关的增加成本，以阻止经济上的处境不利。beplay苹果手机能用吗此类费用的理由必须在IRB申请中充分说明。
Financial remuneration, reward, reimbursement for expenses, or other inducement for participation should not be so great as to be coercive to potential participants and should constitute reasonable compensation for the inconvenience of participating.
Subject Recruitment
应将临床研究宣传并使一群公平的人可以访问。如果很难招募和/或保留妇女或少数民族的招聘和/或保留妇女或少数民族，则可以采用积极的计划。鼓励在接近潜在主题的文化敏感性（例如，尊重语言和习俗）。应预期并克服参与代表性不足的团体的障碍（例如，赔偿儿童保育，损失工资或运输；放弃居住要求；对广告或教育文献的翻译以及对非英语说话者的知情同意）。CPHS将对薪酬的程度进行批判性审查，以确保其适合研究背景，而不是潜在地强制对弱势亚组的强制性。为了确保具有足够统计能力的多样化研究人群来检查重大的性别和种族影响，大型研究可以考虑使用配额系统来管理入学。
To overcome lingering distrust of the medical and scientific establishment in minority populations, outreach programs may be used to inform local minority groups about the individual and collective benefits of participation in biomedical research. Follow-up in these groups with modest advertising of individual projects and discussion of results may be employed.
Recruitment Scripts
Prospective participants often have their first contact with a research coordinator or third party who follows a script to determine basic eligibility for the specific study. The IRB must review these procedures to assure that they adequately protect the rights and welfare of the prospective participants. The IRB must have assurance that any information collected about prospective participants will be appropriately handled. An investigator may contact potential subjects by telephone only if the investigator has ethically permissible access to the potential subject. If not, a recruitment letter stating that the investigator may call should be sent to the potential subjects. Repeated attempts to contact a research subject may be necessary and appropriate. However, once a subject is contacted, a single informed refusal to participate concludes the investigator's efforts. If an investigator plans to make repeated attempts to contact a subject, the subsequent methods should be described in the original protocol or in a request for change
Internet Recruitment
All advertisements and recruitment methods must be reviewed and approved by the IRB prior to implementation to assure that the information does not promise or imply a certainty of benefit beyond what is contained in the protocol and the informed consent document.
Students and UT Employees as Subjects
It is acceptable to enroll students in the UT Health Science Center at Houston, provided that:
- The students are not working in the same laboratory as the PI;
- The students do not report directly to the PI;
- 学生不在PI直接责任的课堂上；
- 参加研究的学生，员工或技术人员不在PI影响力领域的实验室工作；
- Recruitment does not involve coercion or undue influence.
Dear Patient Letters
The investigator may ask physician colleagues to send out general “Dear Patient” letters describing the study. The investigator may draft the letter with the treating physician’s signature, but may not have access to the patient names or the mailing addresses. If the investigator wants the letters to be individualized for the patients, the personalized information would have to be entered by the treating physician. Dear Patient letters should be submitted to CPHS for review and approval.
Dear Doctor Letters
The investigator may send a letter to colleagues (“Dear Doctor letter”) asking for referrals of potential or eligible subjects who are interested in the study. Communications directed to colleagues do not require IRB approval, but this method of recruitment should be stated in the protocol.
External Groups
如果调查员计划使用企业，列表服务，学校，倡导小组等来招募受试者，那么IRB将需要查看该组织的一封信，授予调查员的许可。
Guidelines for Recruitment Flyers, Ads, Posters, & Brochures
招聘信息应包括以下一些元素（强制性的元素）：
- 指beplay苹果手机能用吗定“研究”。
- 资格的年龄。
- Inclusion/Exclusion criteria (e.g., “Right-handed Participants only”).
- The purpose of the research must be clearly stated.
- The amount of time required to complete the study.
- Any benefits (Note: a straightforward and truthful description of the benefits to the subject for participation in the study, e.g., no charge for taking part in the study, no-cost health examination, or providing treatment and counseling for the drug addictions.)
- Any risks.
(Note: most research will be “minimal risk”. That is, research involves no more risk than those associated with ordinary daily life. This may be communicated as something like: “There are no known risks associated with this study other than the potential for mild boredom or mild fatigue.” If there are minimal risks other than mild boredom or mild fatigue, you may either include them or state that they will be discussed prior to the beginning of the study.) - The contact person’s name is identified.
- 确定了该机构。
- Monetary compensation information is optional.
(Note: Although the consent document must specify the EXACT amount of any financial compensation, recruitment materials should state that monetary compensation will be provided. - 研究的位置。beplay苹果手机能用吗
Things that should be avoided:
Donotemphasize monetary compensation.
Donot国家赔偿的数量。
Donotuse catchy words such as “exciting”, “cutting-edge”, etc.
Donotrecruit children directly.
Donotmisstate information contained within the protocol.
Other methods may be acceptable. Please contact the IRB office (cphs@uth.tmc.edu）如果方法值得怀疑，或者您不确定是否合适，请提供帮助。
CPHS HELPLINE 713-500-7943
Iris Holpline 713-500-7960
UTHealth’s Compliance Hotline (1-888-472-9868)
保护人类受试者委员会 IRIS Support713-500-7960 |
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CLINICAL TRIALS RESOURCE CENTEROFFICE OF RESEARCHENVIRONMENTAL HEALTH & SAFETY |
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