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In the course of designing a research project, researchers may deem a focus group as the best way to gather data from several participants in a short amount of time. Focus groups are an important method for data collection in qualitative research.  The use of video, audio, and digital recordings are other means of collecting data. While they offer many advantages to both researchers and research participants, they also raise some unique ethical concerns.

The purpose of this standard operating procedure (SOP) is to ensure that adverse and serious adverse events are defined, recorded, reported, and evaluated as required by the CSS Institutional Review Board (IRB).  Principal Investigators are required to immediately submit to the IRB any unanticipated problems involving risk to human subjects or others. The notification to the IRB must occur no later than 2 weeks from the time of identification of the unanticipated problem.

The CSS IRB will assure that additional protections are implemented, as necessary, to protect vulnerable research subjects (such as those with impaired decision-making capacity, neurological, developmental or psychiatric disorders; educational disadvantages; medical, social, or economic conditions; or other circumstances that might restrict the individual’s capacity to provide inform). The extent of additional protection afforded should depend upon the risk of harm and the likelihood of benefit.

The CSS IRB must follow written procedures for ensuring prompt reporting to the IRB of proposed modifications in a research activity, and ensuring that changes in approved research, during the period for which IRB approval has already been given, may not be initiated without IRB review and approval except where necessary to eliminate apparent immediate hazards to the human subjects.

The new provision for limited IRB review (45 CFR §46.104 d(2)(3), §46.111 (a)(7)). review allows certain research to be categorized as exempt, even when the identifiable information might be sensitive or potentially harmful if disclosed. In order to qualify for exemption, the study must meet the standards of the limited IRB review.

The CSS IRB requires that human subject research activities be reviewed in accordance with federal regulations (CFR 45 §46.109 (e) (f)) and at intervals appropriate to the degree of risk.

When participating in a cooperative project with another institution, the CSS IRB may enter into a joint review arrangement, rely upon the review of another qualified IRB, or make similar arrangements for avoiding duplication of effort (45 CFR § 46.114 (c)).
The CSS IRB may agree to delegate the responsibility for initial and continuing review to another institution's IRB. In turn, that institution’s IRB agrees to assume responsibility for initial and continuing review.

The default in the US regulations is that the consent document is signed by the research participant. However, the regulations also contain flexibility to approve a waiver of the documentation of consent, in essence, while there is a consent process and information is communicated to the potential subject, the person does not have to sign a consent document. Note that a waiver of documentation of consent is different than a waiver or alteration of consent.

Both the HHS regulations at 45 CFR 46.115(a)(2) and the FDA regulations at 21 CFR 56.115(a)(2) specifically require that an institution, or when appropriate, an IRB, prepare and maintain adequate documentation of IRB activities.

The College of St. Scholastica (CSS) requires that legally effective informed consent of the subject or of the subject’s parents or guardian before an investigator can involve the person in research. Consent must be documented in writing in accordance with applicable federal regulations unless the IRB finds that the conditions for a waiver of consent (CSS IRB SOP #15 Waiver or Alteration of Consent (Waiver Request Form Reviewer Checklist) or a waiver of documentation of consent (CSS IRB SOP #18

Common Rule regulations (45 CFR 46.116) allow the IRB to waive the requirement for obtaining informed consent or parental permission or to approve a consent procedure that leaves out or alters some or all of the elements of informed consent otherwise required under the regulations. The purpose of this Standard Operating Procedure (SOP) is to provide guidance on obtaining and approving requests for a waiver of informed consent at The College of St. Scholastica (CSS).

It is the policy of The College of St. Scholastica to allow the use of deception or incomplete disclosure of information in research with human participants when the deception or incomplete disclosure is of scientific value and does not place the research participant in significant financial, physical, legal, psychological, or social risk. The Human Subject Regulations do not address research involving deception.

Minimal risk means that the probability and magnitude of harm or discomfort anticipated in the research are not greater in and of themselves than those ordinarily encountered in daily life or during the performance of routine physical or psychological examination or tests (45 CFR 46.102(i). The regulatory definition of minimal risk is problematic and imperfect. This SOP is a guide in making minimal risk determinations.

All research proposals that intend to enroll human subjects must meet certain criteria before study related procedures can be initiated. Three core principles: respect for persons, beneficence and justice, as discussed in the Belmont Report are the basis of the criteria for IRB approval. All regulatory criteria must be met, and any applicable state or local laws apply. In addition, certain other criteria that are unique to The College of St. Scholastica may apply and must be met as well.

The Secretary of the Department of Health and Human Services and the Food and Drug Administration have established and published in the Federal Register a list of categories of research that may be reviewed by the IRB through an expedited review procedure (45 CFR §46.110). This policy describes the categories and IRB procedure for expedited review.