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Categories of Research

 

Exempt Research

 

Research activities in which the only involvement of human participants will be in one or more of the following categories are considered exempt.

 

1. Research conducted in established or commonly accepted educational settings, involving normal educational practices, such as

 

(a) research on regular or special education instructional strategies, or

 

(b) research on the effectiveness of or on the comparison among instructional techniques, curricula, or classroom management methods.

 

2. This category does not extend to research conducted in a department setting but not related to the instruction in that institution. For example, an evaluation of two methods of fourth grade classroom instruction in a local school district would qualify as exempt research. A sociometric survey of children's preferences for playmates in the same school, involving the same children, would not qualify as exempt research. As the example indicates, research on minor students can be exempt if it is educational research in the sense intended here.

 

3. Research involving the use of educational tests (cognitive, diagnostic, aptitude, achievement), survey procedures, interview procedures or observation of public behavior, unless:

 

a. Information obtained is recorded in such a manner that the human participants can be identified, directly or through identifiers linked to the participants; and

 

b. Any disclosure of the participant's responses outside the research could reasonably place the participants at risk of criminal or civil liability or be damaging to the participants' financial standing, employability, or reputation.

 

4. Research involving the use of educational tests (cognitive, diagnostic, aptitude, achievement), survey procedures, interview procedures or observation of public behavior:

a. The human participants are elected or appointed officials or candidates for public office; or

b. Federal statute(s) require(s) without exception that the confidentiality of the personally identifiable information will be maintained throughout the research and thereafter.

 

5. 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 the participants cannot be identified, directly or through identifiers linked to the participants.

 

6. Research and demonstration projects which are conducted by or subject to the approval of the US Federal department or agency heads, and which are designed to study, evaluate or otherwise examine:

a. public benefit or service programs;

b. procedures for obtaining benefits or services under those programs; or

c. possible changes in or alternatives to those programs or procedure; or

d. possible changes in methods or levels of payment for benefits or services under those programs.

 

7. Taste and food quality evaluation and consumer acceptance studies: a. if wholesome foods without additives are consumed or b. 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, by the Food and Drug Administration or approved by the Environmental Protection Agency or the Food Safety and Inspection Service in Jordan.

 

The following five categories of research are not exempt, and always require review.

 

o Research involving Prisoners

o Studies of pregnant women where the focus of the research is on pregnancy and/or the fetus

o Research on fetuses in utero

o Research on minor children unless the research qualifies as educational research in the sense of items 1 and 2 above, or where the research does not involve direct interaction with the child; and

o Research using non-public records.

 

Expedited Research

 

Research activities involving "no more than minimal risk" and in which the only involvement of human participants will be in one or more of the following categories may be reviewed using an expedited procedure by the Institutional Review Board Chair.

1. Collection of data from voice, video, digital or image recordings made for research purposes

 

2. 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, evaluation, human factors evaluation, or quality assurance methodologies.

 

3. Medical research with minimal risk:

 

a. Clinical studies of drugs and medical devices only when either of the following conditions is met. Research on drugs for which an investigational new drug application is not required. (Note: Research on marketed drugs that significantly increases the risks or decreases the acceptability of the risks associated with the use of the product is not eligible for minimal risk review.) Research on medical devices for which:

i. an investigational device exemption application is no required; or

ii.the medical device is cleared/approved for marketing and the medical device is being used in accordance with its cleared/approved labeling.

 

b."Collection of blood samples by finger stick, heel stick, ear stick, or venipuncture as follows:

i. From healthy, nonpregnant adults who weigh at least 110 pounds. For these participants, the amounts drawn may not exceed 550 ml in an 8 week period and collection may not occur more frequently than 2 times per week; or

ii. From other adults and children, considering the age, weight, an health of the participants, the collection procedure, the amount of blood to be collected, and the frequency with which it will be collected. For these participants, the amount drawn may not exceed the lessor 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.

 

c. Prospective collection of biological specimens for research purposes by noninvasive means. Example: Hair and nail clippings.

 

d. "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. (Studies intended to evaluate the safety and effectiveness of the medical device are not generally eligible for minimal risk review. This includes studies of cleared medical devices for new indications.

 

4. Research involving materials (data, documents, records, or specimens) that have been collected, or will be collected solely for non-research purposes (such as medical treatment or diagnosis). Explanation: This category allows the prospective use of data collected for non-research purposes. Data include information from medical records, insurance claim data, educational testing data, and other non-public information in identifiable form. Data set linkages could be considered in this category. The researcher must demonstrate that sufficient measures will be used to protect the confidentiality of the data to minimize the risk to participants of inadvertent disclosure.

 

5. 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 participants

 

ii. all participants have completed all research-related interventions; and

 

iii. the research remains active only for long-term follow-up of participants; or

 

b. where no participants have been enrolled and no additional risks have been identifies; or

 

c. where the remaining research activities are limited to data analysis.

 

6. Continuing review of research, not conducted under an investigational new drug application or investigational device exemption where categories 2 through 5 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." Explanation: This category applies to situations in which the full IRB conducts a continuing review of a study and determines that the following activity poses only minimal risks.

 

Research Requiring Full Board Review

 

All research conducted by faculty, staff, or students that is not determined to be exempt and is not eligible for expedited review must be discussed by the full board at a scheduled meeting.

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