Institutional Review Board (IRB)

The purpose of the review is to protect the rights and welfare of volunteers in research projects as required by federal regulations. The IRB has the authority to approve, require modifications in (to secure approval), or disapprove research based on its review. In conducting the review the IRB assures that:  

1. Risks to volunteers are minimized by using procedures consistent with sound research design and which do not unnecessarily expose volunteers to risk, and whenever appropriate, by using procedures already being performed on the volunteers for diagnostic or treatment purposes. Risks arising from potential conflicts of interest of the investigators must be minimized.
2. Risks to volunteers are reasonable in relation to anticipated benefits, if any, to volunteers, and the importance of the knowledge that may be expected to result.
3. Selection of volunteers is equitable.
4. Informed consent will be sought from each prospective volunteer or the volunteer’s legally authorized representatives (i.e., an individual authorized under applicable law to consent on behalf of a subject for the subject’s participation in the research) and will be documented in accordance with, and to the extent required, by federal informed consent regulations.
5. Where appropriate, the research plan makes adequate provision for monitoring the data collected to ensure the safety of volunteers.
6. There are adequate provisions to protect the privacy of volunteers and to maintain the confidentiality of data.
7. Appropriate additional safeguards have been included in the study to protect the rights and welfare of volunteers who are members of a particularly vulnerable group.
8. Appropriate additional safeguards have been included for identifiable private information and biospecimens, whether or not the specimens will be used for future research studies.

To make these determinations, the IRB weighs the following: 

• Knowledge to be gained from the study 
• Prior experimental and clinical findings 
• Potential benefits to the volunteer 
• Potential risks and procedures to minimize these risks 
• Confidentiality procedures 
• Informed consent process 

Only when the IRB has decided that the answers to the above are adequate for the protection of the volunteer, does it approve the project.  Further information and procedures related to each of these areas may be obtained from the IRB Chair. 

Research investigators, department heads, and thesis/dissertation or faculty advisors are responsible for insuring that ALL research involving human subjects is submitted to the IRB for review. Definitions from the federal rules for human subject research 45 CFR 46.102:

Human subject means a living individual about whom an investigator (whether professional or student) conducting research:

1. Obtains information or biospecimens through intervention or interaction with the individual, and uses, studies, or analyzes the information or biospecimens; or
2. Obtains, uses, studies, analyzes, or generates identifiable private information or identifiable biospecimens.

Research: A systematic investigation, including research development, testing and evaluation, designed to develop or contribute to generalize knowledge

The following activities are deemed not to be research:

1. Scholarly and journalistic activities (e.g., oral history, journalism, biography, literary criticism, legal research, and historical scholarship), including the collection and use of information, that focus directly on the specific individuals about whom the information is collected.
2. Public health surveillance activities, including the collection and testing of information or biospecimens, conducted, supported, requested, ordered, required, or authorized by a public health authority.
3. Collection and analysis of information, biospecimens, or records by or for a criminal justice agency for activities authorized by law or court order solely for criminal justice or criminal investigative purposes.
4. Authorized operational activities (as determined by each agency) in support of intelligence, homeland security, defense, or other national security missions.

All research involving human subjects will be reviewed if:

• The research is sponsored by the University.
• The research is conducted by or under the direction of any employee, student or agent of the University in connection with his or her institutional responsibilities.
• The research is conducted by or under the direction of any employee, student or agent of the University using any property or facility of the University.
• The research involves the use of the University’s nonpublic information to identify or contact human research subjects or prospective subjects.

In contrast to research, projects that entail quality improvement or program evaluation may not need IRB review.  These studies focus on a particular group or setting and are not intended to result in generalizable findings. In these cases, investigators should request a determination memo from their study site and attach it to their Cayuse IRB submission. A Cayuse submission is still needed, in order to receive the determination letter.  Please contact the IRB for more instructions. 

Most projects with minimal risk will be reviewed by the chair alone, and whether or not a full board review will be necessary can usually be ascertained by contacting the IRB chair at IRB@udmercy.edu. 

1. A completed New Submission application.  The information requested in this application includes names of all investigators, study purpose, participants, design, procedures, participant protections, and ethics training documentation for investigators.
2. A copy of the exact Informed Consent Form or Research Information Sheet that will be used with the study volunteers along with the advertisements for study volunteers. IRB review is necessary to ensure that the information is not misleading to volunteers, especially when a study will involve persons with physical or mental illness or persons who are economically or educationally disadvantaged. Advertisements should include the purpose of the research and, in summary form, the eligibility criteria that will be used to admit volunteers to the study; and a straightforward and truthful description of the benefits (e.g., payments or free treatment) to the volunteer from participation in the study. 
3. Consent forms must include all items identified in the template and must be readily understandable by the average lay person. If the volunteers are children, see #7 below. Consent forms provided by a funding agency must be amended to conform to the above referenced policy statements or will be returned for amendments prior to IRB review.
4. Copies of the complete questionnaires and interviews, when applicable.
5. A copy of your CITI training completion certificate.  CITIprogram.org provides an online course on human research ethics, along with training in research responsibility. Please consult with the IRB to determine the appropriate level of training for your research. Further instructions about registration are given here “Citi Programs for IRB“.
6. A copy of the Investigators Brochure (supplied by the Drug Company), when applicable.
7. A letter of approval authorizing the use of their site, signed by an appropriate official, if research volunteers are to be used at sites other than Detroit Mercy or Detroit Mercy affiliated hospitals (i.e., schools, shelters, social agencies, nursing homes).
8. Research with children or adolescents requires a Parental Consent Form (which can be adapted from the Consent Form above) and a Child Assent Form. The assent form must be written to be understandable by the age group of your participants. Minor Assent forms for children 7-13  “Elementary” are written at the third grade level, Minor Assent forms for adolescents 14-17 “Secondary” are written at the fifth grade level.) If the research is minimal risk, only one parent must consent. If the research is more than minimal risk, both parents must consent.  Researchers should be aware that any studies involving minors that are more than minimal risk may be subject to additional requirements.  Please see the HHS website for additional information.  

What needs to be submitted throughout your study?

If you have significant changes in your research protocol, please submit a Modification submission in Cayuse IRB to amend your application. Please report any adverse events immediately using the Incident submission in Cayuse. 

RESEARCH ACTIVITIES THAT MAY BE EXEMPT FROM REVIEW 

The IRB reviews all research involving volunteers regardless of whether the research is funded by a federal agency or not. 

The information which follows is meant to help clarify those instances when there is uncertainty as to whether there is a need for an IRB review. However, under 

no circumstances may investigators exempt themselves, nor may investigators be exempted by department heads or dissertation advisors; all exemptions require concurrence by the IRB. Neither can exemptions be requested orally, in person or by telephone. 

EXEMPTION CATEGORIES 

According to Federal regulations (45 CFR 46.104(d)), unless otherwise required 

by department or agency heads, research activities in which the only involvement of human subjects will be in one or more of the following categories are exempt from this policy: 

1. Research, conducted in established or commonly accepted educational settings, that specifically involves normal educational practices that are not likely to adversely impact students’ opportunity to learn required educational content or the assessment of educators who provide instruction. This includes most research on regular and special education instructional strategies, and research on the effectiveness of or the comparison among instructional techniques, curricula, or classroom management methods.
2. Research that only includes interactions involving educational tests (cognitive, diagnostic, aptitude, achievement), survey procedures, interview procedures, or observation of public behavior (including visual or auditory recording) if at least one of the following criteria is met:
   
   i.  The information obtained is recorded by the investigator in such a manner that the identity of the human subjects cannot readily be ascertained, directly or through identifiers linked to the subjects; 
   ii.  Any disclosure of the human subjects’ responses outside the research would not reasonably place the subjects at risk of criminal or civil liability or be damaging to the subjects’ financial standing, employability, educational advancement, or reputation; or
   iii.  The information obtained is recorded by the investigator in such a manner that the identity of the human subjects can readily be ascertained, directly or through identifiers linked to the subjects, and an IRB conducts a limited IRB review to make the determination required by § ll.111(a)(7).  
   
   
3. (i) Research involving benign behavioral interventions in conjunction with the collection of information from an adult subject through verbal or written responses (including data entry) or audiovisual recording if the subject prospectively agrees to the intervention and information collection and at least one of the following criteria is met:
   
   A.  The information obtained is recorded by the investigator in such a manner that the identity of the human subjects cannot readily be ascertained, directly or through identifiers linked to the subjects; 
   B.  Any disclosure of the human subjects’ responses outside the research would not reasonably place the subjects at risk of criminal or civil liability or be damaging to the subjects’ financial standing, employability, educational advancement, or reputation; or
   C.  The information obtained is recorded by the investigator in such a manner that the identity of the human subjects can readily be ascertained, directly or through identifiers linked to the subjects, and an IRB conducts a limited IRB review to make the determination required by § ll.111(a)(7).
    
   (ii)  For the purpose of this provision, benign behavioral interventions are brief in duration, harmless, painless, not physically invasive, not likely to have a significant adverse lasting impact on the subjects, and the investigator has no reason to think the subjects will find the interventions offensive or embarrassing. Provided all such criteria are met, examples of such benign behavioral interventions would include having the subjects play an online game, having them solve puzzles under various noise conditions, or having them decide how to allocate a nominal amount of received cash between themselves and someone else. 
   (iii)  If the research involves deceiving the subjects regarding the nature or purposes of the research, this exemption is not applicable unless the subject authorizes the deception through a prospective agreement to participate in research in circumstances in which the subject is informed that he or she will be unaware of or misled regarding the nature or purposes of the research. 
   
   
4. Secondary research for which consent is not required: Secondary research uses of identifiable private information or identifiable biospecimens, if at least one of the following criteria is met:
   
   i.  The identifiable private information or identifiable biospecimens are publicly available; 
   ii.  Information, which may include information about biospecimens, is recorded by the investigator in such a manner that the identity of the human subjects cannot readily be ascertained directly or through identifiers linked to the subjects, the investigator does not contact the subjects, and the investigator will not re-identify subjects;
   iii.  The research involves only information collection and analysis involving the investigator’s use of identifiable health information when that use is regulated under 45 CFR parts 160 and 164, subparts A and E, for the purposes of ‘‘health care operations’’ or ‘‘research’’ as those terms are defined at 45 CFR 164.501 or for ‘‘public health activities and purposes’’ as described under 45 CFR 164.512(b); or
   iv.  The research is conducted by, or on behalf of, a Federal department or agency using government-generated or government-collected information obtained for nonresearch activities. 
   
   
5. Research and demonstration projects that are conducted or supported by a Federal department or agency, or otherwise subject to the approval of department or agency heads (or the approval of the heads of bureaus or other subordinate agencies that have been delegated authority to conduct the research and demonstration projects), and that are designed to study, evaluate, improve, or otherwise examine public benefit or service programs, including procedures for obtaining benefits or services under those programs, possible changes in or alternatives to those programs or procedures, or 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 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 of the U.S. Department of Agriculture.
7. Not applicable at this time.
8. Not applicable at this time.

RESEARCH ACTIVITIES THAT MAY BE REVIEWED THROUGH EXPEDITED PROCEDURES

The IRB reviews all research involving volunteers regardless of whether the research is funded by a federal agency or not.

The information which follows is meant to help clarify those instances when there is uncertainty as to whether there is a need for a full IRB review. However, under no circumstances may investigators expedite reviews themselves, nor may reviews be expedited by department heads or dissertation advisors; all expedited reviews
require concurrence by the IRB. Neither can expedited reviews be requested orally, in person or by telephone.

Federal regulations 45 CFR 46.110, unless otherwise required by department or agency heads, state the following about research that may be reviewed through an expedited process:

Categories of Research That May Be Reviewed by the Institutional Review Board (IRB) through an Expedited Review Procedure1

Applicability

(A) Research activities that (1) present no more than minimal risk to human subjects, and (2) involve only procedures listed in one or more of the following categories, may be reviewed by the IRB through the expedited review procedure authorized by 45 CFR 46.110 and 21 CFR 56.110. The activities listed should not be deemed to be of minimal risk simply because they are included on this list. Inclusion on this list merely means that the activity is eligible for review through the expedited review procedure when the specific circumstances of the proposed research involve no more than minimal risk to human subjects.

(B) The categories in this list apply regardless of the age of subjects, except as noted.

(C) The expedited review procedure may not be used where identification of the subjects and/or their responses would reasonably place them at risk of criminal or civil liability or be damaging to the subjects= financial standing, employability, insurability, reputation, or be stigmatizing, unless reasonable and appropriate
protections will be implemented so that risks related to invasion of privacy and breach of confidentiality are no greater than minimal.

(D) The expedited review procedure may not be used for classified research involving human subjects.

(E) IRBs are reminded that the standard requirements for informed consent (or its waiver, alteration, or exception) apply regardless of the type of review–expedited or convened–utilized by the IRB.

(F) Categories one (1) through seven (7) pertain to both initial and continuing IRB review.

Research Categories

(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 (21 CFR Part 312) 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 expedited review.)
(b) Research on medical devices for which (i) an investigational device exemption application (21 CFR Part 812)
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 by finger stick, heel stick, ear stick, or venipuncture as follows:
(a) from healthy, nonpregnant adults who weigh at least 110 pounds. For these subjects, 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
(b) from other adults and children2, 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.

(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 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 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 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.

(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. (Studies intended to evaluate the safety and effectiveness of the medical device are not generally eligible for expedited review, including studies of cleared medical devices for new indications.)
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). (NOTE: Some research in this category may be exempt from the HHS regulations for the protection of human subjects. 45 CFR
46.101(b)(4). This listing refers only to research that is not exempt.)

(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. (NOTE: Some research in this category may be exempt from the HHS regulations for the protection of human subjects. 45 CFR 46.101(b)(2) and (b)(3). This listing refers
only to research that is not exempt.)

(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; or
(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 two (2) through eight (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.
_______________________
1 An expedited review procedure consists of a review of research involving human subjects by the IRB chairperson or by one or more experienced reviewers designated by the chairperson from among members of the IRB in accordance with the requirements set forth in 45 CFR 46.110.

2 Children are defined in the HHS regulations as “persons who have not attained the legal age for consent to treatments or procedures involved in the research, under the applicable law of the jurisdiction in which the research will be conducted.” 45 CFR 46.402(a).

Source: 63 FR 60364-60367, November 9, 1998.