4.8. Minimal Risk

The following is taken from Chapter 5 of the UBC REBs Clinical Guidance Notes: http://research.ubc.ca/ore/creb-forms-guidance-notes 

 

Article 5.1:  The Principle of Proportionate Review

 

UBC’s  REBs use a proportionate approach to review research involving human participants.  They review applications in accordance with the level of risk that the proposed study poses to the research participants; the lower the level of risk, the lower the level of scrutiny; the higher the level of risk, the higher the level of scrutiny.  In accordance with the TCPS2, full review by a fully convened REB is the default requirement, unless the REB has determined that the research is of minimal risk and that delegated review by one or more experienced reviewers appointed by the REB is appropriate.  UBC’s REBs have different procedures for delegated review, in accordance with individual Board policies.  UBC REBs retain the right to decide to put any application submitted for minimal risk review forward for full board review.

 

 

UBC also strives to use a proportionate approach for multi-jurisdictional studies, i.e. research studies that require review and approval by more than one Canadian research ethics board as a result of the requirements of the TCPS2[1] or due to UBC’s institutional policies.  UBC is implementing a variety of processes and entering into agreements with other Canadian Institutions in an effort to avoid duplicative ethical reviews of research, in particular, duplication of review by a fully convened UBC REB in circumstances where a research study has previously been reviewed by a fully convened REB at another Canadian institution. 

 

Article 5.2:  Definition of Minimal Risk

 

Minimal risk is defined in the TCPS2 as follows: if potential participants can reasonably be expected to regard the probability and magnitude of possible harms implied by participation in the research to be no greater than those encountered by the participants in those aspects of their everyday life that relate to the research. UBC currently recognizes the following categories of clinical research as meeting the criteria for minimal risk and being eligible for delegated review.

 

Note:  If  a study is funded or supported by the US Federal government or is subject to the US Food and Drug Administration regulations, ONLY studies that meet the US definition of minimal risk AND that are listed in the US Federal Register may be considered as qualifying for delegated / expedited review. 

 

Article 5.3: Types of Minimal Risk Research Studies that may qualify for Delegated Review

 

5.3.1    Studies relying exclusively on secondary use of data, e.g. previously collected / existing clinical data, medical records, or other personal records

1.      Studies using existing database/ registries or linking information between databases ]

2.      Studies using previously collected data from existing documents or records or charts (generally “retrospective chart reviews”).  Case reports involving 1 or 2 clinical cases do not require REB review; however, reviewing more than 2 cases is considered research and requires REB review. 

3.      Studies using previously collected  clinical specimens where there is no current or future clinical need for the specimens

 

5.3.2    Studies intending to collect and analyse specific types of data

1.      Studies that will involve only the collection of hair, nail clippings, deciduous teeth, excreta, salivary secretions, additional swabs or other external secretions that have been collected in a non-invasive manner and that may also be collected as part of routine clinical care.

2.      Studies that involve only the collection of placenta or amniotic fluid as a consequence of childbirth, or fetal tissue collected as a consequence of therapeutic abortion or miscarriage.

3.      Studies that involve only the collection of blood samples by venipuncture, or a central line already present as part of clinical care  that was installed as part of clinical care.

4.      Studies that involve clinical data collected prospectively as part of clinical care.

 

5.3.3    Studies that involve only questionnaires or surveys

1.      Studies that involve only questionnaires or surveys should generally be sent to the Behavioural Research Ethics Board, unless they are clinical in nature.  If the questionnaires involve sensitive information from vulnerable populations or significant nuisance or inconvenience they will generally not qualify for delegated review.

 

5.3.4    Exercise Studies

1.      Studies that will involve the collection of output data obtained as a result of moderate exercise undertaken by healthy volunteers

2.      Studies that will involve the collection of output data obtained as a result of maximal exercise by healthy volunteers who are less than 40 years old.  In these cases, the REB must receive and approve a safety protocol.

 

Note: Exercise in a patient population will generally be referred to the full board unless the exercise being observed is part of standard care.

 

5.3.5    Scans

1.    Studies using data recorded using non-invasive procedures such as EEG, EKG, MRI, ultrasound or x-rays will generally meet the criteria for minimal risk.

 

Note: X-rays will not be expedited if the radiation exposure is in excess of 0.01 mSv (the approximately equivalent of one return transcontinental airline flight).  

  

5.3.6    Stem Cell Research

1.                   Stem cell research qualifies for delegated review with the exception of any research that concerns the derivation of stem cell lines from human somatic tissue, umbilical cord or placenta OR research involving the grafting of stem cell lines into humans.

2.                   Research that uses permanent stable cell lines in laboratory research (i.e. in vitro) does not require ethical review.

  

5.3.7    Observational research on Standard Treatment(s)

1.                   Observational research on standard treatment(s) where the treatment(s) is (are) determined clinically and not assigned by research methodology (e.g. randomization).

 

 

Article 5.4:  Types of Minimal Risk Studies That Require Full Board Review

 

The following types of studies may require full board review depending upon board specific policy.

           

1.      Studies whose purpose it is to collect or use tissue / DNA for the purpose of creating a  tissue /DNA“ bank or adding new sources of tissue to a tissue/DNA bank.

2.      Studies whose purpose it is to collect or use tissue / DNA for genetic research related to determining susceptibility of acquiring a disease; or studies whose purpose it is to collect or use tissue/DNA  for genetic research the results of which could  be  potentially harmful to participants if disclosed. 

3.      Studies whose purpose is the derivation of stem cell lines from human somatic tissue, umbilical cord or placenta OR research involving the grafting of stem cell lines into humans.

4.      Minimal risk studies where a waiver of consent or alteration of the required elements of informed consent is being requested.

 

 The following types of studies do not require full board review when a waiver of consent or an alteration of the required elements of informed consent is being requested.

 

a.      retrospective chart reviews,

b.      studies using data obtained from previously banked anonymized tissue that is not linked to other sources of data,

c.       studies using data from provincially regulated databases/registries (e.g Medical Services Plan, BC Centre for Disease Control) or from disease specific registries with data collected from subjects who have already consented to its use for the sort of research being done.

d.      Prospective chart or medical record reviews where the data has been de-identified through an acceptable privacy guardian program or anonymized (i.e., there is no way to link the data to the participant), and there is no potential harm to the subject.

e.      Prospective chart or medical record reviews where members of the research team are not in contact with subjects during the data collection and where the researcher has provided an appropriate justification for why contacting the participants to obtain consent would be impracticable.

[1] TCPS2, Article 2.1.


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