Standard Operating Procedures - Chapter 11

IRB REVIEW AND APPROVAL CONSIDERATIONS

The IRB must determine that the following requirements are satisfied before it approves research during initial and ongoing reviews.

11.1 Scientific Review

Scientific validity is taken into account during the review process when the study involves risk to the participants. The IRB will judge scientific validity of each study, drawing on its own knowledge and disciplinary expertise. The IRB may also rely on the knowledge and disciplinary expertise of others with competence in special areas which require expertise beyond or in addition to that available on the IRB. This includes consultants independent of the investigators and the proposed research, reviews by funding agencies and other review committees.

11.2 Levels of Risk

The IRB considers the overall level of risk to participants while assessing the risk/benefit ratio during the evaluation process. When the IRB considers a request for expedited review, the IRB distinguishes research that is greater than minimal risk from research that is no greater than minimal risk. Research that is no greater than minimal risk may be eligible for exempt review; waiver or alteration of informed consent requirements; or waiver of the requirement to obtain written documentation of consent. A waiver is not usually appropriate for FDA regulated test articles. For further discussion on Levels of Review see IRB Guidelines – Levels of Review.

An accurate description of the risks must be clearly outlined in the application with a corresponding explanation in the consent form for the participants. The possibility of unknown risks must be clearly stated. Every possible precaution to minimize risks must be pursued by the investigator and also outlined in the consent form.

11.3 Risks: Minimized and Reasonable Relative to Anticipated Benefits

The IRB determines that risks are minimized by using procedures that are consistent with sound research design and do not expose participants to unnecessary risk. Scientific evidence is presented by the investigator in the application to support the expectation that anticipated benefits must be greater than anticipated risks. Special consideration is given by the IRB to protect vulnerable participants.

The research design and methodology are reviewed to determine that no obvious flaws would place participants at unnecessary risk. Experts are consulted when aspects of research design seem to pose a significant concern.

11.4 Equitable Selection of Participants

In making the determination for proper recruitment of the appropriate participant population, the IRB evaluates the purpose of the research, the research setting, the eligibility criteria, the expected outcome of the research and the following considerations:

• The IRB must determine that the selection of participants is equitable. This reflects the concept of ‘Justice’ from the Belmont Report. In making the determination for proper recruitment of the appropriate participant population, the IRB will evaluate the purposes of the research, the research setting, the inclusion/exclusion criteria, and the expected outcome of the research.
• The IRB will be especially cognizant of the problems of research involving vulnerable populations. Generally, participants that stand no chance of benefiting from the research should not be selected to assume the risk.
• The IRB will be mindful of the importance of including members of minority groups in research, particularly when the research holds out the prospect of benefit to the individual participant or the groups to which they belong. Non-English speaking participants will not be systematically excluded because of inconvenience in translating informed consent forms. The IRB will also ensure that participants are not taken from one group of people because of convenience.
• The IRB will be mindful of the feasibility and desirability of including both women and men as research participants and will not arbitrarily exclude the participation of persons of reproductive age. Exclusions of such individuals must be fully justified and based on sound scientific rationale.

11.5 Review of Informed Consent Requirements

To approve research, the IRB determines that informed and voluntary consent is sought from each prospective participant or the participants’ authorized representative, unless informed consent requirements can be waived or altered according to federal regulations. Informed consent is sought under circumstances that provide the participant (or the authorized representative) with sufficient opportunity to consider whether or not to participate and minimize the possibility of undue influence.

Informed consent information is presented in a language that is understandable to the participant (or authorized representative) and may not include any exculpatory language through which the participant is made to waive, or appear to waive, any of the participant’s legal rights or through which the investigator, the sponsor, or UMASS employees or agents are released from liability for negligence, or appear to be so released. Informed consent is obtained prior to initiation of any clinical screening procedures.

11.6 Informed Consent

Signed informed consent is required for all human participant research unless the activity meets regulatory findings stipulated for waiver or alteration of informed consent. Informed consent presumes two simultaneous concepts: informed decision-making and voluntary participation. See Chapter 12 for more detail concerning Informed Consent.

11.7 Review of Plans for Data and Safety Monitoring

Where appropriate, the research plan makes adequate provision for monitoring the data to ensure the safety of participants. For research in which risks are substantial, a general description of the data safety monitoring plan is submitted to the IRB as part of the proposal. The plan should contain procedures for reporting adverse events. Adequate provisions should be in place to monitor research data at least annually. For more guidance on Data Safety and Monitoring see IRB Guidelines – Data Safety and Monitoring.

The IRB determines that a data safety monitoring plan is established for research that is blinded, involves multiple sites, targets vulnerable participants, or employs high-risk interventions. The IRB has the authority to require a data safety monitoring board (DSMB) as a condition for approval of research where it determines that such monitoring is needed. When DSMBs are utilized, the IRB relies on current statements from the DSMB indicating that it has reviewed study-wide interim findings and any recent literature that may be relevant to the research.

11.8 Privacy of Participants and Confidentiality of Data

In reviewing confidentiality protections, the IRB considers the nature, probability, and magnitude of harms that would likely result from a disclosure of information outside the research. The IRB evaluates the effectiveness of proposed anonymizing techniques, coding systems, encryption methods, storage facilities, access limitations, and other relevant factors in determining the adequacy of confidentiality protections.

11.9 Additional Safeguards for Vulnerable Participants
See Chapter 16 for more information.

11.10 Information the Investigator Provides to the IRB

The IRB expects the investigator to thoroughly complete the initial application, Modification Request Form, and Continuing/Final Report Form.

11.11 Criteria for Requiring Review More Often than Annually

The following factors are considered in determining the criteria for which studies require more frequent review and what the time frames generally will be:

• Probability and magnitude of anticipated risks to participants
• Likely medical condition of the participants
• Overall qualifications of the investigator and other members of the research team
• Specific experience of the investigator and other members of the research team in conducting similar research
• Nature and frequency of adverse events observed in similar research at this and other facilities
• Vulnerable populations
• Other factors that the IRB deems relevant

In specifying an approval period of less than one year, the IRB defines the period and the meeting minutes clearly reflect the determinations. Research that may be considered for an approval period of less than one year include studies involving:

• Vulnerable populations
• Risks where there is no potential clinical benefit to the participant (i.e., Phase I Studies)
• Significant risk of serious impairment
• Any invasive surgical procedure, even if the experimental procedure replaces a standard surgical procedure that is thought to involve higher risk
• Withdrawal of therapy, whether or not it is replaced by experimental treatment, when there is significant risk of morbidity or mortality

11.12 Independent Verification from Sources Other than the Investigator that No Material Changes have occurred since the Previous Review

Protecting the rights and welfare of participants sometimes requires that the IRB verify independently, utilizing sources other than the investigator, that no material changes occur during the IRB-designated approval period. Additional sources may include: investigational pharmacy records, incident reports, radiation safety or source documents, as well as information from staff, research participants, families, sponsors or others. The IRB may also require the investigator to seek additional expertise or supervision to assess participant safety.

The IRB considers the following factors in determining which studies require independent verification:

• Probability and magnitude of anticipated risks to participants
• Likely medical condition of the potential participants
• Prior experience of the investigator and research team
• Other factors that the IRB deems relevant

In making the determination about independent verification, the IRB may prospectively require that such verification take place at predetermined intervals during the approval period, or may retrospectively require such verification at the time of continuing review.

11.13 Advertising and Recruitment Materials and Procedures

The IRB reviews all materials and procedures that will be used to identify and recruit study participants for the research prior to study initiation. Recruitment is directly related to the informed consent process and must be designed to assure that informed consent is given freely and is without coercion or undue influence. See IRB Guidelines - Subject Recruitment and Advertising for more information.

11.14 Payment to Research Participants

Payment may not be of such an amount or provided on a schedule that results in coercion or undue influence on the participant’s decision to participate or to continue participation (e.g., payment may not be withheld as a condition of the participant completing the research). If the participant withdraws early, payment must be prorated, if applicable, to reflect the time and inconvenience of the participant’s participation up to that point.

11.15 Certificates of Confidentiality

Where research involves the collection of highly sensitive information about individually identifiable participants, the IRB determines if special protections are needed to protect participants from the risks of investigative or judicial processes. In such situations, the IRB may require that the investigator obtain a Department of Health and Human Services (DHHS) Certificate of Confidentiality (CoC). The CoC protects against the involuntary release of sensitive information about individual participants for use in federal, state, or local civil, criminal, administrative, legislative or other legal proceedings.

The CoC does not prohibit voluntary disclosure of information by a participant. Investigators are still required to report communicable diseases to local authorities and obligated to break confidentiality if a participant is a threat of harm to him/herself or others. In addition, the CoC does not protect against the release of information for audit purposes. Conditions for the release of information must be stated clearly and explicitly in the informed consent form.

© University of Massachusetts Amherst. Site Policies.
This page is maintained by the Office of the Vice Chancellor for Research and Engagement.