ICTR





The ICTR offers research ethics consultation services to all those engaged in research at Baylor College of Medicine. Directed by the faculty of the Center for Medical Ethics and Healthy Policy, this service provides recommendations for the responsible management of ethically controversial issues in biomedical research.

 

To submit a Research Ethics Consultation request, please complete the online Consultation/Service Request Form.


    A research ethics consultation (REC) is an advisory service available through the ICTR. The purpose of the interaction is for informational purposes only: to identify and analyze ethical issues, and provide recommendations for a course of action through formal or informal mechanisms. Research ethics consultants serve as advisors only and are not providing legal advice, approving study protocols, or making decisions for the investigators. A REC is most appropriate for controversial cases that have no clear-cut right or wrong answer. The consultants will use their reasoned judgment to make a recommendation based on the literature and ethical analysis thereof, and in some circumstances, there will be multiple options for the researcher to consider.
  • Study Design
    • Is a randomized controlled trial (RCT) ethically permissible?
    • Is it ethical to include a sham intervention in your study design?
  • Inclusion/Exclusion Criteria
    • Is it ethical to include/exclude pregnant women in a particular study?
    • Is it ethical to include/exclude participants based on psychosocial factors?
  • Special/Vulnerable Populations
    • How to ethically conduct research involving cognitively impaired participants?
    • How to ethically conduct research in developing countries?
  • Methods of Recruitment
    • How to appropriately conduct community consultation for emergency research?
    • When should compensation for participation be considered undue influence on potential participants?
  • Consent
    • What are the ethical considerations in enrolling adolescents into contraception research without parental consent?
    • Should you obtain consent from family members for research using biological specimens from deceased individuals?
  • Participant privacy/confidentiality
    • When is it ethically appropriate to breach confidentiality for the protection of a research participant?
    • When is it ethically permissible to share genomic data publicly?
  • Returning research results and incidental findings
    • Under what circumstances should research results be communicated to participants?
    • Under what circumstances should incidental findings be communicated to participants?
  • IRB Issues
    • You need help writing your IRB protocol or informed consent document
    • Questions regarding what is permissible under IRB guidelines and how to classify research
    • Please contact BCM IRB
  • Compliance Issues
  • Legal Issues
  • Animal Research
    • Questions regarding whether to get IACUC approval and permissible research using animals
    • Please contact BCM IACUC
  • Scientific Integrity and Research Misconduct
  • Conflicts of Interest
      A staff member from the Center of Medical Ethics and Health Policy will initiate contact with the requestor to gather additional information. If appropriate, you will receive a written report containing specific recommendation(s), as well as background research and analysis of applicable ethical, legal and social considerations.
    • Initial contact for the consultation: within 2 business days
    • Timeframe for delivery of recommendation: Will vary depending on type and intensity of consultation sought. When requesting a research ethics consultation, please provide ample time for necessary research and analysis of the issue(s). In your request, please indicate whether the recommendation is needed within a specific time frame.
      The research ethics consultation service operates independently of the IRB. We will keep a confidential database containing requests and recommendations; this database will not be shared with others. We are subject to all mandatory reporting regulations, and will breach confidentiality if required or ethically compelled to do so. We reserve the right to discuss the case/situation in a general manner if it can be done so without identifying the researcher and/or the scientific work involved. If there are particular concerns about confidentiality, please inform us when speaking with our faculty.
    • A short satisfaction survey will be emailed to all requestors within one week after receiving final recommendation(s).
    • Requests for further collaboration on conceptual papers and/or empirical projects related to the consultation topic, or requests for further engagement from our faculty members can be sent directly to the appropriate faculty member or to recs@bcm.edu
      An ethics consultation for research purposes is an advisory service to assist Baylor College of Medicine (“Baylor”) faculty, staff, and students in considering ethical challenges that arise in the design and conduct of human subjects research. The information provided is intended to be educational and helpful in decision-making processes. Recommendations made by our faculty are based on their reasoned judgment from the literature and ethical analysis thereof and are for educational and informational purposes only. The ethics consultants, however, will not make decisions for the investigators. Researchers are solely responsible for their choices and actions, even if such choices and actions were recommended by our consultants.

      Researchers must still comply with all applicable laws, institutional polices and IRB determinations, even if they are inconsistent with the recommendations of our consultants. Even after an ethics consultation, researchers must obtain formal Baylor IRB approval before initiating contact with human subjects in any research project. The Baylor IRB is not bound by the options presented by the consultants, nor are the alternatives presented by the consultants institutionally or legally binding.

      Although many of our faculty and staff have law degrees, we are not authorized to provide legal counsel to or on behalf of Baylor or any of its faculty or staff. Therefore, upon consultation, no attorney-client relationship is established; the recommendations are not considered legal advice and are non-binding. If legal advice is needed, please consult your own attorney, the Office of the General Counsel or the Office of Risk Management at Baylor.
    Our faculty conducts cutting edge multi-disciplinary research on emerging and perennial ethical issues arising in clinical and biomedical research. They have a broad range of experience and expertise in the field of bioethics and are considered leaders in the field. Please visit our website for more information.