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Presented to a Clinical Research Coordinators session on April 3, 2023 by Dr Omar Hasan Kasule Epidemiologist and bioethicist.
THREE MAIN CATEGORIES
- Exempt – no physical human risk. Approved immediately by the chairman and one or more members. Examples: interviews, questionnaires, and information from records.
- Expedited – minimal human risk comparable to the risk of routine outpatient procedures. Can be approved by the chairman with/without one or more members
- Full review – major risk due to intervention on the human body either using drugs or devices. The approval follows discussion in a full meeting of the committee. The researchers may be invited to explain. Experts may also be consulted.
EACH CATEGORY OF RESEARCH REQUIRES DIFFERENT FORMS
- Exempt application
- Exempt consent
- Expedited application
- Expedited consent
- Full review application
- Full review consent
EXEMPT CATEGORIES FOR RESEARCH ACCORDING TO NCBE-1
- NCBE has no explicit definition of an exempt study. It lists studies exempted from period follow-up in Article (10.32) stating ‘The local committee may exempt the following research projects from the periodic follow-up’
- First category of exemption: Research involving the study of information and data previously collected, provided one of the two following terms is fulfilled: (a) If the information is generally and publicly available; (b) If the information is recorded in a manner that does not reveal the identity of the source person.
EXEMPT CATEGORIES FOR RESEARCH ACCORDING TO NCBE-2
- Second category of exemption: Research including educational tests, surveys, interviews or public behavior monitoring, except in the two following cases: (a) If the information is recorded in a manner that reveals the identity of the source person. (b) If participation in the research should bring a person outside the scope of research to be subject to criminal or civil liability or jeopardize his financial position or career.
- Research conducted for educational purposes.
EXEMPT CATEGORIES FOR RESEARCH ACCORDING TO NIH-1:
- Category 1 of exemption: Research conducted in established or commonly accepted educational settings, involving normal educational practices, such as (i) research on regular and special education instructional strategies, or (ii) research on the effectiveness of or the comparison among instructional techniques, curricula, or classroom management methods.
- Category 2 of exemption: Research involving the use of educational tests (cognitive, diagnostic, aptitude, achievement), survey procedures, interview procedures or observation of public behavior, unless: (i) information obtained is recorded in such a manner that human subjects can be identified, directly or through identifiers linked to the subjects; and (ii) any disclosure of the human subjects' responses outside the research could reasonably place the subjects at risk of criminal or civil liability or be damaging to the subjects' financial standing, employability, or reputation.
EXEMPT CATEGORIES FOR RESEARCH ACCORDING TO NIH-2:
- Category 3 of exemption: Research involving the collection or study of existing data, documents, records, pathological specimens, or diagnostic specimens, if these sources are publicly available or if the information is recorded by the investigator in such a manner that subjects cannot be identified, directly or through identifiers linked to the subjects.
- Category 4 of exemption: Research and demonstration projects which are conducted by or subject to the approval of Department or Agency heads, and which are designed to study, evaluate, or otherwise examine: (i) Public benefit or service programs; (ii) procedures for obtaining benefits or services under those programs; (iii) possible changes in or alternatives to those programs or procedures; or (iv) possible changes in methods or levels of payment for benefits or services under those programs.
EXEMPT CATEGORIES FOR RESEARCH ACCORDING TO NIH-3:
- Category 5 of exemption: Taste and food quality evaluation and consumer acceptance studies, (i) if wholesome foods without additives are consumed or (ii) if a food is consumed that contains a food ingredient at or below the level and for a use found to be safe, or agricultural chemical or environmental contaminant at or below the level found to be safe.
EXPEDITED REVIEW CATEGORIES OF RESEARCH ACCORDING TO NCBE REGULATIONS (Article (10.18)-1
- If the risk that the human subject may be exposed to does not exceed the minimal risk level;
- If the research does not reveal the identity of the human subject;
- If the research deals with clinical studies on drugs or medical equipment, provided: 1. The drug is used in accordance with its licensing and dosages approved by the concerned party, and does not entail any increase in potential risk for the human subject; 2. The medical equipment in use has originally been licensed by the concerned party and has already been utilized accordingly.
- If taking biological samples for research purposes is carried out via non-invasive methods such as analysis of urine, saliva, nail or hair clippings, etc.
EXPEDITED REVIEW CATEGORIES OF
RESEARCH ACCORDING TO NCBE REGULATIONS (Article (10.18)-2
5. If research data is to be
collected by using medical equipment approved by the concerned party, such as:
Sensors which are directly applied on body surface or at a close
distance thereto and which do not expose the body to a
significant amount of energy and do not violate the privacy of the human
subject; Weight taking or audiometry devices; Magnetic resonance imaging (MRI)
or ultrasonography imaging devices;
6. Electrography (ECG & EEG),
Thermal Imaging, normal nuclear radiation rate measuring, infra-red imaging,
blood flow measurement with ultrasound imaging (Doppler sonography), and
echocardiography devices;
7. Moderate exercise, muscle
strength, body ratios (such as body fat ratio) and measurement of joint and muscle
flexibility devices, provided these tests are deemed appropriate after taking
age, weight and health condition into account;
EXPEDITED REVIEW CATEGORIES OF
RESEARCH ACCORDING TO NCBE REGULATIONS (Article (10.18)-3
8. Search for information, records or
samples that were previously collected or will be collected in the future for
non-research purposes;
9. Collect information via audio or
video taping (static or moving) for the purpose of looking for the attributes
or behavior of an individual or group without violation of privacy of the human
subject. However, excepted from these devices is the use of X-ray or
electromagnetic microwavedevices.
EXPEDITED
CATEGORIES OF RESEARCH ACCORDING TO NIH (not more than minimal risk)-1
(1) Clinical studies of drugs and medical devices only when condition (a) or (b) is met. (a) Research on drugs for which an investigational new drug application is not required. (b) Research on medical devices which are cleared/approved for marketing and the medical device is being used in accordance with its cleared/approved labeling.
(2) Collection of blood
samples by finger stick, heel stick, ear stick, or venipuncture as follows: (a) from healthy,
nonpregnant adults who weigh at least 50 kg. For these subjects, the amounts
drawn may not exceed 10 ml/sample, or 160 ml in an 8 week period and collection
may not occur more frequently than 2 times per week; or (b) from other adults
and children, considering the age, weight, and health of the subjects, the
collection procedure, the amount of blood to be collected, and the frequency
with which it will be collected. For these subjects, the amount drawn may not
exceed the lesser of 50 ml or 3 ml per kg in an 8 week period and collection
may not occur more frequently than 2 times per week.
EXPEDITED
CATEGORIES OF RESEARCH ACCORDING TO NIH (not more than minimal risk)-2
(3)
Prospective collection of biological specimens for research purposes by
noninvasive means.
Examples:
(a) hair and nail clippings in a no disfiguring
manner; (b) deciduous teeth at time of exfoliation or if routine patient
care indicates a need for extraction;
(c) permanent teeth if routine patient care
indicates a need for extraction;
(d) excreta and external secretions (including
sweat); (e) uncannulated saliva collected either in an un-stimulated
fashion or stimulated by chewing gumbase or wax or by applying a dilute citric
solution to the tongue;
(f) placenta removed at delivery; (g) amniotic fluid
obtained at the time of rupture of the membrane prior to or during labor; (h) supra- and
subgingival dental plaque and calculus, provided the collection procedure is
not more invasive than routine prophylactic scaling of the teeth and the
process is accomplished in accordance with accepted prophylactic techniques; (i) mucosal and skin
cells collected by buccal scraping or swab, skin swab, or mouth washings; (j) sputum collected
after saline mist nebulization.
EXPEDITED
CATEGORIES OF RESEARCH ACCORDING TO NIH (not more than minimal risk)-3
(4) Collection of data
through noninvasive procedures (not involving general anesthesia or sedation)
routinely employed in clinical practice, excluding procedures involving x-rays
or microwaves. Where medical devices are employed, they must be
cleared/approved for marketing. Examples:(a) physical sensors that are applied
either to the surface of the body or at a distance and do not involve input of
significant amounts of energy into the subject or an invasion of the subject=s
privacy; (b) weighing or testing sensory acuity; (c) magnetic resonance
imaging; (d) electrocardiography, electroencephalography, thermography,
detection of naturally occurring radioactivity, electroretinography,
ultrasound, diagnostic infrared imaging, doppler blood flow, and
echocardiography;
(e) moderate exercise, muscular strength
testing, body composition assessment, and flexibility testing where appropriate
given the age, weight, and health of the individual.
EXPEDITED
CATEGORIES OF RESEARCH ACCORDING TO NIH (not more than minimal risk)-4
(5) Research involving
materials (data, documents, records, or specimens) that have been collected, or
will be collected solely for nonresearch purposes (such as medical treatment or
diagnosis).
(6) Collection of data
from voice, video, digital, or image recordings made for research purposes.
(7) Research on
individual or group characteristics or behavior (including, but not limited to,
research on perception, cognition, motivation, identity, language,
communication, cultural beliefs or practices, and social behavior) or research
employing survey, interview, oral history, focus group, program evaluation,
human factors evaluation, or quality assurance methodologies.
EXPEDITED
CATEGORIES OF RESEARCH ACCORDING TO NIH (not more than minimal risk)-5
(8) Continuing review of
research previously approved by the convened IRB as follows: (a) where (i) the
research is permanently closed to the enrollment of new subjects; (ii) all
subjects have completed all research-related interventions; and (iii) the
research remains active only for long-term follow-up of subjects; (b) where no
subjects have been enrolled and no additional risks have been identified; or (c) where the remaining
research activities are limited to data analysis.
(9) Continuing review of
research, not conducted under an investigational new drug application or
investigational device exemption where categories 2 through 8 do not apply but
the IRB has determined and documented at a convened meeting that the research
involves no greater than minimal risk and no additional risks have been
identified.
EXERCISES: Classify the risk category for each of the
following abstracts:
1. Efficacy
of resveratrol against breast cancer and hepatocellular carcinoma cell lines. Nouf A. Alkharashi Saudi Medical Journal March
2023, 44 (3) 246-252;
Objectives: To evaluate the
anti-cancer effect of resveratrol on Michigan cancer foundation-7 (MCF-7) and
hepatoblastoma cell line (HepG2) cells.
Methods: The study was
carried out at the Department of Botany and Microbiology, Prince Sattam bin
Abdulaziz University, Al-kharj, Saudi Arabia, from August 2022 to October 2022.
Different concentrations of resveratrol were added to the MCF-7 and HepG2 cell
lines. Cell death and proliferation were measured with MTT and Trypan blue
exclusion assays. Apoptosis markers were assessed by using a quantitative PCR
assay (qPCR).
2. Patellar
height changes after treatment of tibia plateau fractures: A radiological analysis.
Özgür
Doğan, Ahmet Çulcu and İhsaniye Süer Doğan. Saudi Medical
Journal March 2023, 44 (3) 306-313;
Objectives: To determine the
impact of tibial plateau fractures on patellar height and the factors affecting
this impact.
Methods: A total of 40
patients treated for plateau fractures between 2017-2021 were evaluated in this
retrospective prognostic study. The patient group consisted of lateral
radiographs of the operated knees, whereas the control group consisted of
lateral radiographs of the healthy sides of the same patients. Insall-Salvati,
Caton-Deschamps, Blackburne-Peel, and modified Insall-Salvati indices were
measured for both groups. In addition, Schaztker and Luo classifications, as
well as the demographic profiles of the patients, were analyzed.
3. Effectiveness
of Peng’s Shengjing recipe on male asthenospermia caused by kidney yang
deficiency: A randomized pilot study.
Guangyao
Xu, Yu Peng and Chunyan Chen. Saudi Medical
Journal March 2023, 44 (3) 253-259;
Objectives: To examined the
efficacy and safety of Peng’s Shengjing recipe in treating asthenospermia with
deficiency and failure of kidney yang. The traditional Chinese medicine (TCM)
Peng’s Shengjing recipe might have benefits in treating male asthenospermia.
Methods: This randomized,
positive drug-controlled, single-blind pilot study enrolled outpatients from
the Third Department of Traditional Chinese Medicine Surgery, Shanghai
University of Traditional Chinese Medicine, Shanghai, China, between April 2020
and September 2020. A total of 99 participants were randomized to Shengjing
recipe (n=50) and Xuanju capsule (n=49). They were treated for 12 weeks. The
primary endpoint was routine semen examinations, including the percentage of
sperm motility rated grade A, A+B, and A+B+C, and the clinical effective rate.
The secondary endpoints were the levels of gonadotropins.
4. Self-care
practices among heart failure patients A cross-sectional study in Saudi population.
Khalid
A. Aljohani. Saudi Medical Journal March
2023, 44 (3) 277-283;
Objectives: To describe
self-care practices among Saudi heart failure (HF) patients and identify
sociodemographic characteristics contributing to self-care practices.
Methods: A cross-sectional
study utilizing the Arabic-language version of the revised Self-Care of Heart
Failure Index (SCHFI), version 7-2. A convenience sample of 245 people treated
for HF at a tertiary heart center in the Kingdom of Saudi Arabia were recruited
from June to August 2020.
5. CYP2D6 genetic
polymorphisms in Saudi systemic lupus erythematosus patients: A cross-sectional
study.
Objectives: To
determine the prevalence of selected single nucleotide polymorphisms
(rs1080985, rs28624811, rs1065852, rs28371725, and rs1135840) in cytochrome P450 2D6 (CYP2D6) gene among Saudi systemic lupus erythematosus
(SLE) patients and to investigate the association between the genetic variants
and clinical features of SLE.
Methods: This
cross-sectional study was carried out on adult Saudi patients at King Khalid
University Hospital, Riyadh, Saudi Arabia. Patients with confirmed SLE based on
the 2012 Systemic Lupus International Collaborating Clinics classification
criteria were included in the study. Peripheral blood was collected for genomic
deoxyribonucleic acid extraction and TaqMan® technologies
were used for target genotyping. For statistical analysis, differences in
genotype frequencies were determined using the Chi-square test, and the
association between the variant genotypes and SLE features was evaluated using
logistical regression models.
6. Phenotypical evaluation of lymphocytes and monocytes in patients with
type 2 diabetes mellitus in Saudi Arabia.
Objectives: To
evaluate the levels of total lymphocytes, B-lymphocytes (CD19+), T-lymphocytes
(CD3+), natural killer (NK) cells (CD3-/CD56+), and monocyte subsets in type 2
diabetes mellitus (T2DM) patients in Saudi Arabia. In addition, this study
aimed to evaluate whether B- and T-lymphocyte subsets are frequently altered in
patients with T2DM.
Methods: A
case-control study included 95 participants recruited in the study: 62 patients
with T2DM and 33 healthy individuals. All the patients were admitted to the
Diabetic Centre in Taif, Saudi Arabia. Blood samples were collected between
April and August 2022. The hemoglobin A1c (HbA1c) level was evaluated in all
patients. Flow cytometry was used to measure the expression of B-lymphocyte,
T-lymphocyte, NK cells, and monocyte markers. The unpaired t-test was carried
out to evaluate the differences in these markers between T2DM patients and
healthy individuals.