Information for researchers
Researchers must have the protection of the rights and welfare of research participants as a primary concern. Competent, informed, conscientious, compassionate, and responsible researchers provide the best possible protection for human research participants. (AAHRPP/Accreditation Reference: Domain III: Researcher and Research Staff)
- Have the appropriate qualifications (by training and experience) for their research roles, including knowledge of applicable laws, regulations, codes, and guidance; relevant professional standards; and MU’s policies and procedures regarding the protection of research participants. This includes completing the required CITI basic training and reading The Belmont Report which identifies ethical principles and guidelines for the protection of human participants.
- Maintain appropriate oversight of each research study, as well as research staff and trainees, and appropriately delegate research responsibilities and functions.
- Report to the IRB any unanticipated problems, unresolvable complaints, noncompliance, and suspensions or terminations according to the MU IRB policies.
- Have a process to ensure that all persons assisting with the research are adequately informed about the protocol and their research-related duties and functions.
- Have the resources required to conduct research in a way that will protect the rights and welfare of participants and ensure the integrity of the research.
Application, Protocol and Documentation Requirements
In order for the MU IRB to approve studies, researchers must ensure the following requirements are addressed within the IRB application, protocol, and supportive documents: (Regulatory Reference: 45 CFR 46.111 and 21 CFR 56.111)
- Risks to subjects are minimized.
By using procedures that are consistent with sound research design and that do not unnecessarily expose subjects to risk, and whenever appropriate, by using procedures already being performed on the subjects for diagnostic or treatment purposes. Researchers should design research studies so that the research will most likely develop or contribute to generalizable knowledge and be designed according to standards and ethical practices of the discipline. When researchers do not design a research study, they should judge the research design to be sound enough to meet the study’s objectives before agreeing to enroll participants. (MU IRB SOP: Initial Review; Amendments; Annual Review of Research)
- Risks to subjects are reasonable in relation to anticipated benefits, if any, to subjects, and the importance of the knowledge that may reasonably be expected to result.
In evaluating risks and benefits, the IRB will consider only those risks and benefits that may result from the research (as distinguished from risks and benefits of therapies subjects would receive even if not participating in the research). The IRB will not consider possible long-range effects of applying knowledge gained in the research (e.g., the possible effects of the research on public policy) as among those research risks that fall within the purview of its responsibility. (MU IRB SOP: Initial Review; Amendments; Annual Review of Research)
- Selection of subjects is equitable.
In making this assessment, the IRB will take into account the purposes of the research and the setting in which the research will be conducted. The IRB will be particularly cognizant of the special problems of research that involves a category of subjects who are vulnerable to coercion or undue influence, such as children, prisoners, individuals with impaired decision-making capacity, or economically or educationally disadvantaged persons. (MU IRB SOP: Recruitment Process; Informed Consent Requirements)
- Informed consent will be sought from each prospective subject or the subject's legally authorized representative, in accordance with, and to the extent required by, 45 CFR 46.116. Consent will also be documented appropriately in accordance with 45 CFR 46.117.
Researchers must employ consent processes and methods of documentation appropriate to the type of research and the study population, emphasizing the importance of comprehension and voluntary participation to foster informed decision-making by participants.
Researchers must have a process in place to address participants’ concerns, complaints, or requests for information; typically addressed within the consent document. Researchers may need to involve the IRB and other components of the HRPP in response to complaints or request for information.
Researchers should understand the concept of respect for persons and the obligation to obtain the consent of participants or their legally authorized representatives, and understand consent is a continual process, and conduct the consent process in a way that meets the criteria for legally effective consent. New information that might affect the willingness of participants to continue to participate must be provided to the participant by informing them or formally re-consenting. (MU IRB SOP: Informed Consent Requirements)
- When appropriate, the research plan makes adequate provision for monitoring the data collected to ensure the safety of subjects, and adequate provisions to protect the privacy of subjects and to maintain the confidentiality of data. (MU IRB SOP: Initial Review; Amendments; Annual Review of Research)
- When some or all of the subjects are likely to be vulnerable to coercion or undue influence, such as children, prisoners, individuals with impaired decision-making capacity, or economically or educationally disadvantaged persons, additional safeguards have been included in the study to protect the rights and welfare of these subjects. (MU IRB SOP: Additional Protections for Vulnerable Populations, International, and Non-English Speaking Participants)