Does the study meet criteria for enrolling such subjects?

Minors

Jail detainees

Persons not competent to consent to research

Employees or students

Pregnant women or fetuses

Must be minimal risk and meet one of the following 7 criteria:

1. Clinical studies of drugs when an investigational new drug application (IND) is not required. (However: 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 expedited review.), or

Research on medical devices for which (i) an investigational device exemption application (IDE) is not 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.

2. Collection of blood samples: 

(a) From healthy, nonpregnant adults who weigh at least 110 pounds: No more than 550 ml in an 8 week period, and no more frequently than 2 times per week; or

(b) from other adults and children, the lesser of 50 ml or 3 ml per kg in an 8 week period and no more frequently than 2 times per week.

3. Prospective collection of biological specimens for research purposes by noninvasive means. 

Examples: 

(a) hair and nail clippings in a nondisfiguring manner;

(b) deciduous teeth at time of exfoliation or if routine 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 unstimulated 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 prophylatic 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.

4. Collection of data through noninvasive procedures 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.

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 or research employing survey, interview, oral history, focus group, program evaluation, human factors evaluation, or quality assurance methodologies.

This a minor textual or administrative change (i.e. corrections of misspellings or inconsistencies, change in name of investigational drug, change in non-key study personnel )

The experience of subjects in the study remains unchanged;

The risks and benefits to subjects in the study remain unchanged;

The consent document remains essentially unchanged (no more than minor changes in wording or spelling which do not alter the pertinent information provided to subjects);

The fundamental design of the study (including number and type of subjects) remains unchanged.

For studies originally approved by expedited review:

The design, apparent risks and consent procedure remain unchanged.

1. No subjects were enrolled, and no additional risks were identified in the past year.

2. The research is permanently closed to the enrollment of new subjects; and all subjects have completed all research-related interventions; and the research remains active only for long-term follow-up of subjects.

3. The remaining research activities are limited to data analysis only.

Note that expedited review is not allowed for Adverse Event Reports of serious events.

The Primary Reviewer is asked to make following determinations about the report:

1) Was this a serious event? 
 

If NO: I

f this is not a serious event, the event report is accepted without bringing it to the IRB meeting
 

If YES: 
 

2) What action do you recommend?

 
A) That the IRB accept the report without further action; or

B) That the IRB take a specific action when the event raises new questions about risks to participants. Such actions may include a request for further clarification from the investigator, requests for changes in the protocol or the consent form; a change in the schedule for Progress Reports; or suspension of the study.

1. Can you rule out the investigational drug or device as the cause of this event? 

2. How severe do you judge this event to be? 

3. Was this event unexpected? (Is the possibility of this event described in the consent form for this study?)

4. Based on this event, would you recommend additional monitoring of other patients in the study to detect similar problems early?

5. Do you recommend revision of the consent procedure to include information about events like this, or precautions that patients should take because of the possibility of events like this?

6. Is the seriousness and likelihood of this event great enough that patients already enrolled in the study should be informed about it? 

The Risk/Benefit Level, from 1 to 4, must be determined and noted in IRB Minutes

(b) the relationship of risk to benefit is at least as favorable as any available alternative approach

(b) the intervention or procedure presents experiences to subjects that are reasonably commensurate with those inherent in their actual or expected medical, dental, psychological, social, or educational settings; and 
 

(c) the intervention or procedure is likely to yield generalizable knowledge about the subject's disorder or condition that is of vital importance for the understanding or amelioration of the subject's disorder or condition.

1. Survey, interview or focus group research with children may not be exempted;

2. Children over age seven should be asked for assent;

3. The permission of both parents should be obtained when feasible;

4. Research involving older adolescents who may consent on their own for selected treatments (e.g., treatment for venereal disease, drug abuse, or emotional disorders) may not require parental permission. The IRB must determine for each project requesting such an exception if it may be allowed, and this decision must be recorded in the Minutes.

1. Are there provisions for protecting subjects against real or perceived job or training repercussions if they refuse to participate, if they drop out of the study, or if they provide sensitive information as part of the study?

2. Are those provisions reflected in the consent form?

Only studies in one or more of these 4 categories may be approved:

1. Studies (involving no more than minimal risk or inconvenience) of the possible causes, effects, and processes of incarceration and criminal behavior; 

2. Studies (involving no more than minimal risk or inconvenience) of prisons as institutional structures or of prisoners as incarcerated persons; 

3. Research on particular conditions affecting prisoners as a class (providing the Secretary, HHS, has consulted with appropriate experts and published [his or her] intent to support such research in the Federal Register);

4. Research involving a therapy likely to benefit the prisoner subject (and if the therapeutic research also involves nontherapeutic research with a control group, the Secretary, HHS, must also consult with appropriate experts and publish [his or her] intent to support the research in the Federal Register).

Risk of physical or psychological harm that is no greater in probability and severity than that ordinarily encountered in the daily lives, or in the routine medical, dental or psychological examinations of healthy persons. "Healthy persons" refers to non-prisoners.

1. The advantages offered by participation in the research are so great as to be coercive;

2. Confidentiality will be maintained to the maximal degree possible;

3 The prisoner or detainee is not being offered, implicitly or explicitly, any additional inducements to participate such as early release, and this is clearly stated in the consent procedure;

4. The risks involved in the research are commensurate with risks that would be accepted by nonprisoner volunteers;

5. That the procedures for selecting subjects are fair and immune from arbitrary intervention by prison authorities or prisoners. 

Research involving pregnant women and fetuses may be allowed only if the purpose of the activity is to meet the health needs of the mother or the particular fetus, the risk to the fetus is minimal and, in all cases, is the least possible risk for achieving the research objectives. The IRB must decide when there is an acceptable benefit/risk balance for both mother and fetus.

Consent and review procedures depend on:

1. Whether mother or fetus is the subject of the research; and 

2. What the risks are for each.

When the mother (not the fetus) is the subject of the research, the law says: "No pregnant woman may be involved as a subject ... unless: (1) the purpose of the activity is to meet the health needs of the mother and the fetus will be placed at risk only to the minimum extent necessary to meet such needs, or (2) the risk to the fetus is minimal." If the research qualifies:

1. Her consent alone suffices;

2. Her needs may outweigh risks to the fetus, as long as risks imposed on the fetus are minimized

1. Both the father's and mother's consent will normally be required. Exceptions are when:(a) the father's identity or whereabouts cannot reasonably be ascertained; (b) the father is not reasonably available; or (c) the pregnancy resulted from rape.

2. Research on the fetus is allowable if: (a) the purpose of the research is to meet the health needs of the fetus and is conducted in a way that will minimize risk or

(b) the research poses no more than minimal risk to the fetus and the purpose of the activity is the development of important biomedical knowledge that is unobtainable by other means 

Exemptions from review are not allowed

Blood draws are limited under expedited review

The Protocol must include methodology for determining lack of decision making capacity

The IRB should include a member or consultant with relevant expertise

1. Surrogate must be chosen according to the hierarchy prescribed by Illinois law;

2. Research must have potential to benefit the subject;

3. The subject must be present during informed consent procedure. Subject should be asked for assent whenever possible

4. Relationship of surrogate to subject and presence of subject must be documented on consent form

5. An independent physician must sign the consent form to indicate criteria have been met

Legally effective informed consent shall:
 

• Be obtained from the subject or the subject's legally authorized representative;

 
• Be in language understandable to the subject or representative;

 
• Be obtained under circumstances that provide the subject with an opportunity to consider whether or not to participate, and that minimize coercive influences;

 
• Not include language through which the subject is made to waive any of his legal rights or which releases the investigator, sponsor or institution from liability for negligence.

 

• A statement that the study involves research; 

 
• an explanation of the purposes of the research;

 
• the expected duration of the subject's participation;

 
• a description of procedures to be followed; 

 
• identification of any procedures which are experimental.

 
• A description of the expected risks or discomforts to the subject.

 
• A description of benefits to the subject or to others.

 
• A disclosure of alternative procedures, if appropriate.

 
• A description of the extent to which confidentiality will be maintained.

 
• For FDA-regulated research, a statement that the FDA may inspect the records.

 
• For research involving more than minimal risk, an explanation as to whether compensation and medical treatments are available if injury occurs.

 
• An explanation of whom to contact if questions arise about the research, the subjects' rights, or whom to contact if a research-related injury occurs.

 
• A statement that participation is voluntary, that refusal to participate involves no penalty or loss of benefits, and that the subject may discontinue at any time.

 

 
1. A statement that a procedure may involve unforeseeable risks.

2. A description of circumstances under which the subject's participation may be terminated by the investigator without the subject's consent.

3. Additional costs to the subject resulting from participation in the research.

4. The consequences of the subject's decision to withdraw from the research.

5. A statement that significant new findings developed during the research which may relate to the subject's willingness to continue will be provided to subject.

6. The approximate number of subjects involved in the study.

Studies may qualify for exemption if they meet one of the following 6 criteria:

(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.
 

(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.

3.   Research involving the use of educational tests (cognitive, diagnostic, aptitude, achievement), survey procedures, interview procedures, or observation public behavior that is not exempt under paragraph (b)(2) of this section, if:
 

(i) the human subjects are elected or appointed public officials or candidates for public office; 

or 

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

4.   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.

5. 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.

6. 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 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 of the U.S. Department of Agriculture.

RESEARCH                                          CLINICAL CARE OR QA ONLY -->>No IRB Interaction Required 

YES                              NO

NO                                   YES

YES                               NO

YES               NO

NO                                            YES

    YES                                                                                                                              NO

(If NO, protocol must include methodology for  determining lack of decision making capacity)
 

  YES                                                                            NO

Limits on blood draws under expedited review
 

Research involving more than minimal risk usually must hold potential for subject's benefit

    YES                             NO

    YES                                 NO

Limits on blood draws under expedited review
 

Must consider risks to both mother and fetus

YES                        NO

Prisoner advocate must participate in review
 

Research must potentially benefit the individual or a group to which he/she belongs

     YES OR NO                                                        YES OR NO                                                             NO

NO                                             YES

 YES                                                                             NO

YES                     NO

IF:

A waiver or alteration will not adversely affect the rights and welfare of the subjects;
 

AND
 

Whenever possible, subjects will be provided with additional pertinent information after they have participated in the study.

IF:
There may be a significant risk to the subject from linking a consent document to him/her

An independent witness to the oral presentation signs the summary;

AND

Copies of the signed summary and short form are provided to subject and witness, with short form in language understandable to subject 

YES                                                                         NO

NO                                   YES

     NO                               YES

This is research on clinical services which adolescent may receive without parental permission
 

OR

Subject is legally emancipated

ONLYIF:
All regulatory requirements have been met for waiver of consent in emergency medical research
 

OTHERWISE:
Subject may not be enrolled

Relationship of surrogate to subject and presence of subject must be documented on consent form
 

Subject should be asked for assent whenever possible