8. Criteria for CUHS Approval of Research

8 Criteria for CUHS Approval of Research

8.1 Risk/Benefit Assessment

8.1.1 Scientific Merit

8.2 Equitable selection of subjects

8.2.1 Recruitment of Subjects

8.3 Informed Consent

8.4 Data Safety Monitoring

8.5 Privacy and Confidentiality

8.6 Vulnerable Populations

8 Criteria for CUHS Approval of Research 

As stated at 45 CFR 46.111, in order to approve research, the CUHS must determine that all of the following requirements are satisfied: 

(1) Risks to subjects are minimized: (i) by using procedures which are consistent with sound research design and which do not unnecessarily expose subjects to risk, and (ii) whenever appropriate, by using procedures already being performed on the subjects for diagnostic or treatment purposes. 

(2) 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 should 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 should not consider possible long-range effects of applying knowledge gained in the research (for example, the possible effects of the research on public policy) as among those research risks that fall within the purview of its responsibility. 

(3) Selection of subjects is equitable. In making this assessment the IRB should take into account the purposes of the research and the setting in which the research will be conducted and should be particularly cognizant of the special problems of research involving vulnerable populations, such as children, prisoners, pregnant women, mentally disable persons, or economically or educationally disadvantaged persons. 

(4) 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 §46.116. 

(5) Informed consent will be appropriately documented, in accordance with, and to the extent required by §46.117. 

(6) When appropriate, the research plan makes adequate provision for monitoring the data collected to ensure the safety of subjects. 

(7) When appropriate, there are adequate provisions to protect the privacy of subjects and to maintain the confidentiality of data. 

(8) When some or all of the subjects are likely to be vulnerable to coercion or undue influence, such as children, prisoners, pregnant women, mentally disabled persons, or economically or educationally disadvantaged persons, additional safeguards have been included in the study to protect the rights and welfare of these subjects. 

8.1 Risk/Benefit Assessment 

The goal of the assessment is to ensure that the risks to research subjects posed by participation in the research are justified by the anticipated benefits to the subjects and/or to society. Toward that end, the CUHS must: 

1. judge whether the anticipated benefit, either of new knowledge or of improved health or welfare for the research subjects, justifies asking potential subjects to undertake the risks; 

2. disapprove research in which the risks are judged unreasonable in relation to the anticipated benefits. 

In assessing the risks and benefits of proposed research the CUHS must: 

1. identify the risks associated with the research, as distinguished from the risks of therapies the subjects would receive, or the risks that the subject would experience in his/her everyday life, even if not participating in research; 

2. determine whether the risks will be minimized to the extent possible; 

3. identify the probable benefits to be derived from the research; 

4. determine whether the risks are reasonable in relation to the benefits to subjects, if any, and assess the importance of the knowledge to be gained 

8.1.1 Scientific Merit 

In judging the benefits of the proposed research, in order to compare benefits to the risks posed to subjects the CUHS must determine that: 

1. The research uses procedures consistent with sound research design; 

2. There is reason to expect that the research may answer, or contribute to knowledge about, the proposed question; and 

3. The knowledge expected to result from the research is sufficiently important to justify any anticipated risk to subjects. 

In making this determination, the CUHS will first consider the potential risks to subjects; scrutiny of scientific merit will increase in proportion to the degree of risk. In considering the question of scientific merit, the CUHS may draw on its own knowledge and disciplinary expertise, or on the knowledge and disciplinary expertise of others, such as reviews by a funding agency, or review by faculty or other experts, either within the University or outside. In the case of projects conducted by students or postdoctoral fellows under faculty supervision, the CUHS considers, in its review of scientific merit, that in approving an application, a faculty sponsor represents that s/he has reviewed the proposed procedures and is satisfied with the adequacy of the proposed research design. 

8.2 Equitable selection of subjects 

The CUHS will review the inclusion/exclusion criteria for the research to ensure equitable selection of subjects. In making this assessment the CUHS takes into account the purposes of the research and the setting in which the research will be conducted, and is particularly cognizant of the special problems of research involving populations that may be vulnerable to undue influence or coercion, such as children, prisoners, persons who are cognitively impaired, or persons who are economically or educationally disadvantaged (see Vulnerable Populations, Section 10). 

8.2.1 Recruitment of Subjects 

The CUHS will review all recruitment procedures, materials, and advertisements to ensure that they are consistent with the protocol, accurate, and non-coercive. 

The CUHS will review advertisements to ensure that they do not contain exculpatory language or unduly emphasize the amount subjects receive in compensation. 

When examining advertisements, the CUHS will consider: 

• The information contained in advertisements. 

• The mode of their communication. 

• The final copy of printed advertisements. 

• The final audio/video taped advertisements. 

When subjects are being paid, the CUHS will review both the amount of payment and the proposed method and timing of disbursement to assure that neither is coercive. Payment to subjects should not be considered a benefit of participation in assessing the proportionality of risk and benefit. 

8.3 Informed Consent 

The CUHS will ensure that 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 and 21 CFR 50.20. In addition, the Committee will ensure that informed consent will be appropriately documented in accordance with and to the extent required by 45 CFR 46.117. See Section 9 below for detailed policies on informed consent. 

8.4 Data Safety Monitoring 

If research involves more than minimal risk, it must include adequate provisions to monitor data to ensure the safety of subjects. 

If a protocol includes a data safety monitoring plan, the CUHS will review the data safety monitoring plan during initial review and at continuing review to determine that the protocol includes adequate provisions to monitor the data to ensure the safety of subjects. 

8.5 Privacy and Confidentiality 

The CUHS will determine whether a protocol design adequately protects the privacy of subjects and maintains the confidentiality of the data

Definitions 

Privacy - control of the extent, timing, and circumstances of sharing aspects of oneself (physical, behavioral, or intellectual) with others. 

Confidentiality - prohibition against the improper disclosure of subjects’ identity or information obtained by researchers. 

Anonymity – total absence of means of identifying subjects. 

Regulations 

[45 CFR 46.102(f)] Human subject means a living individual about whom an investigator … conducting research obtains 

(1) data through intervention or interaction with the individual, or 

(2) identifiable private information. 

  • Private information - information that has been provided for specific purposes by an individual and that the individual can reasonably expect will not be made public (for example, a medical record). 
  • Identifiable information – information where the identity of the subject is or may readily be ascertained by the investigator or may readily be associated with the information. 

The CUHS protects subjects’ privacy interests by reviewing protocols to ensure that investigators do not gather unnecessary personal information and that data are not linked to subjects needlessly. Data should be stored securely, for no longer than needed for the purposes of the research. When future uses, such as teaching demonstration or publication are proposed, the CUHS will ensure that consent has been obtained, and that a plan has been made to retain only the data that is appropriate for the future use. 

See Section 16.1 for detailed information regarding Certificates of Confidentiality. 

8.6 Vulnerable Populations 

The CUHS shall determine if appropriate additional safeguards are in place to protect the rights and welfare of subjects if they are likely to be members of a vulnerable population (e.g., persons with diminished autonomy). See Section 10 below for detailed policies on vulnerable populations.