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Institutional Review Board – Food and Drug Administration (FDA) Please note: These policies and forms comply with the pre-2018 common rule. Do not use these forms unless your project is/will be funded by the FDA. University of Detroit Mercy through its Institutional Review Board complies with the Food and Drug Administration (FDA) regulations as set forth in the Code of Federal Regulations codified at 21 CFR 50 and 21 CFR 56 . These regulations pertain to the protection of human research subjects participating in research projects conducted by the University of Detroit Mercy community of faculty, students, and administrators. The University is guided by the ethical principles regarding all research involving humans as subjects as set forth in the report of the National Commission for the Protection of Human Subjects of Biomedical and Behavioral Research entitled Ethical Principles and Guidelines for the Protection of Human Subjects of Research (the 'Belmont Report') . The charge to this committee, and its contribution to the life of the University, is to assure that the above identified ethical principles and regulations are complied with. Researchers are responsible for following the procedures outlined in the Research Project Procedures and Guidelines, below. Does your Research Plan need an IRB Review? 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 21 CFR 50.3 . Detroit Mercy IRB Policies and Procedures, Food and Drug Administration (FDA), Page 1

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Institutional Review Board – Food and Drug Administration (FDA)

Please note: These policies and forms comply with the pre-2018 common rule. Do not use these forms unless your project is/will be funded by the FDA.

University of Detroit Mercy through its Institutional Review Board complies with the Food and Drug Administration (FDA) regulations as set forth in the Code of Federal Regulations codified at 21 CFR 50 and 21 CFR 56. These regulations pertain to the protection of human research subjects participating in research projects conducted by the University of Detroit Mercy community of faculty, students, and administrators. The University is guided by the ethical principles regarding all research involving humans as subjects as set forth in the report of the National Commission for the Protection of Human Subjects of Biomedical and Behavioral Research entitled Ethical Principles and Guidelines for the Protection of Human Subjects of Research   (the 'Belmont Report') . The charge to this committee, and its contribution to the life of the University, is to assure that the above identified ethical principles and regulations are complied with. Researchers are responsible for following the procedures outlined in the Research Project Procedures and Guidelines, below.

Does your Research Plan need an IRB Review?

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 21 CFR 50.3.

Human Subjects: A living individual about whom an investigator (whether faculty or student) conducting research obtains:1. Data through intervention or interaction with the individual.2. Identifiable private information.

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

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.

Detroit Mercy IRB Policies and Procedures, Food and Drug Administration (FDA), Page 1

Some projects may be reviewed by the chair alone and whether or not a full board review will be necessary can usually be ascertained by contacting Michelle Wheater, chair of the IRB.

What needs to be submitted for IRB review?

Project proposals being submitted for IRB review should be sent to the Chair and must include:

1. A completed Project Summary Form2. A copy of the exact Informed Consent Form that will be used with the study volunteers

along with the advertisements for study volunteers. Consent forms must include all items identified in the model and must be readily understandable by the average lay person. If the volunteers are children the language must be age appropriate. 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.

3. A copy of the complete research project, including questionnaires and interviews when applicable.

4. A copy of your CITI training completion certificate.  CITI provides an on line course on human subjects protection in research. 

5. A copy of the Investigators Brochure (supplied by the Drug Company), when applicable.6. 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).

7. If the project uses a vulnerable population (patients, prisoners, or children), please provide documentation of an ethics review within that institution, such as an internal ethics committee, a similar oversight group or a medical director.

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. (Assent forms for children 7-13 are written at the third grade level, forms for adolescents 13-17 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.

Documents to be reviewed by the IRB must be submitted to the chair, IRB, at least three weeks prior to the next regularly scheduled board meeting.

What needs to be submitted throughout your study?

For ongoing review (yearly), submit the Review Report.At project completion, submit the Final Summary.The IRB shall notify the research investigator in writing of the IRB's decisions, conditions and requirements and provide the research investigator reasons for the IRB's decision to disapprove a research project and an opportunity for the research investigator to respond. Reasons for disapproval shall also be transmitted to the Academic Affairs Office by the IRB. Upon approval, the investigator will be sent an approval letter signed by the IRB chairperson. The letter will state the length of the IRB approval, and approval expiration date.

Detroit Mercy IRB Policies and Procedures, Food and Drug Administration (FDA), Page 2

IRB Procedures and Guidelines

The membership of the Institutional Review Board is appointed by the vice president for Academic Affairs in consultation with the deans of the colleges and schools. The IRB is comprised of members from diverse backgrounds to promote complete and adequate review of research activities, and has the professional competence necessary to review the specific research activities which are assigned to it. The board is sufficiently qualified through the experience and expertise of its members, and the diversity of the members' backgrounds including consideration of the racial and cultural backgrounds of members and sensitivity to such issues as community attitudes, to promote respect for its advice and counsel in safeguarding the rights and welfare of volunteers.

When research is reviewed involving a category of vulnerable volunteers (e.g., prisoners, children, individuals institutionalized as mentally disabled), the IRB shall include in its reviewing body one or more individuals who have as a primary concern the welfare of these volunteers. The board includes both male and female members as well as individuals representing a variety of professions. The Detroit Mercy IRB also includes several members who are not otherwise affiliated with the institution and who are not a part of the immediate family of persons who are affiliated with the institution.

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: 

A. 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.

B. 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.

C. Selection of volunteers is equitable.D. Informed consent will be sought from each prospective volunteer or the

volunteer's legally authorized representatives and will be documented in accordance with, and to the extent required, by FDA's informed consent regulations.

E. Where appropriate, the research plan makes adequate provision for monitoring the data collected to ensure the safety of volunteers.

F. There are adequate provisions to protect the privacy of volunteers and to maintain the confidentiality of data.

G. 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.

Detroit Mercy IRB Policies and Procedures, Food and Drug Administration (FDA), Page 3

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.

IRB Oversight and Reporting

IRB approval of the project does not end its oversight of the project. Prior to initiating any changes to the project, investigators are required to report any planned project or consent form changes to the IRB for approval. Investigators also must report any unforeseen complications that occur to the IRB within 48 hours of the occurrence. The IRB may, as a result of the complications, withdraw its approval of the project or require the investigator to add additional safeguards for the volunteer to the study before it can be resumed. The IRB conducts continuing reviews of research at intervals appropriate to the degree of risk, but not less than once per year. The IRB also has the authority to suspend or terminate approval of research that is not being conducted in accordance with the IRB's decisions, conditions and requirements or that has been associated with unexpected serious harm to volunteers.Additionally, the IRB has the authority and is responsible for promptly reporting information to Academic Affairs, the Office for Protection from Research Risks (OPRR), FDA, or each on a variety of issues. In conjunction with this requirement, the IRB is prepared to receive and act on information received from a variety of sources, such as volunteers, research investigators, or other institutional staff. For reporting purposes, the IRB will follow the procedures described below:

A. Any serious or continuing noncompliance by research investigators with the requirements of the IRB — This information shall be reported promptly to Academic Affairs and the appropriate federal office.

B. Injuries to volunteers — Information received by the IRB concerning injuries to volunteers shall be reported promptly to Academic Affairs and the appropriate federal office.

C. Unanticipated problems — Information received by the IRB concerning unanticipated problems involving risks to volunteers or others shall be reported promptly to Academic Affairs and to the appropriate federal office.

D. Suspension or termination of IRB approval — The IRB suspending or terminating approval of research projects shall include a statement of the reasons for the IRB's action and shall report the action promptly to the research investigator, Academic Affairs and the appropriate federal office.

IRB MeetingsThe Detroit Mercy IRB attempts to meet on a regular basis six times a year. A majority of the membership of the IRB constitutes a quorum. This quorum must include at least one member

Detroit Mercy IRB Policies and Procedures, Food and Drug Administration (FDA), Page 4

whose primary concerns are in nonscientific areas. A quorum is required in order to convene a meeting for the review of project protocols. When the IRB reviews an investigational new drug (IND) study, the FDA expects at least one physician member to be present at the meeting. This regulation also requires a majority vote of those present. Meeting dates may be confirmed, and placement on the IRB agenda may be accomplished, by contacting the chair. A project proposal must be received by the chair three weeks prior to a scheduled meeting.

Volunteer Recruitment AdvertisementsAdvertisements used to recruit volunteers should be prepared according to principles specified in Advertising for Study Volunteers. Such advertising copy must be submitted to the IRB for review and approval with the materials identified under what needs to be submitted for the IRB review on the IRB Home Page.

Continuing ReviewApproved projects require annual review and approval by the IRB. The need for continuing review is determined by the IRB appropriate to the degree of risk, but not less than once per year. The Review Report must be completed and returned to the chair at least one month prior to the IRB approval expiration date. When adverse events occur or changes are desired, a revised project protocol along with updated forms should be submitted to the chair with changes highlighted. While the IRB will notify the investigator when a study is due for renewal, the investigator is still responsible for ensuring that the study is not conducted after IRB approval has expired. The investigator need not attend the meeting as long as there were no unexpected side effects or changes to the consent form or project protocol. Only those projects which received an initial approval via expedited review may be granted a continuation via expedited review. The IRB will notify the investigator in writing of its decision.

Report of Human Volunteer Injuries and/or Serious-Unforeseen ComplicationsInvestigators are required to submit a Report of Human Volunteer Injuries and/or Serious-Unforeseen Complications to the Chair of the IRB within 48 hours of the occurrence of such incident. This is in addition to the requirement that such incidents must be reported to the sponsoring agency and the FDA.

If it becomes necessary to revise an approved project protocol or consent form, it is the responsibility of the investigator to submit, through their department heads, such a request for an amendment to the IRB chair in writing. The written request must include the following information:

1. Name and department of the investigator.2. Title of the research project.3. Project protocol number.4. Reasons which make the amendment necessary.5. A revised consent form with changes highlighted, if applicable.

Changes in research during the period for which IRB approval has already been given, may not be initiated by research investigators without IRB review and approval, except where necessary

Detroit Mercy IRB Policies and Procedures, Food and Drug Administration (FDA), Page 5

to eliminate apparent immediate hazards to the volunteers. Research investigators, department heads, and thesis/dissertation or faculty advisors are responsible for complying with all IRB decisions, conditions and requirements.

Projects Which May Qualify for an Exemption or an Expedited Review

The exemption or expedited approval of research on volunteers is a privilege, not an entitlement. An investigator who thinks a project qualifies for exemption (See Research Activities Which May Be Exempt From Review) or expedited review (See Research Activities Which May Be Reviewed Through Expedited Procedures) and approval should submit a memo of justification with the project, citing the appropriate clause from the Federal Regulations referenced in these documents. Under no circumstances may investigators exempt themselves, nor may investigators be exempted by department heads or thesis/dissertation advisors; all exemptions require concurrence by the IRB. Neither can exemptions nor expedited approvals be requested orally, in person or by telephone.

Investigators who believe their project qualifies for either exemption or expedited review must also submit one copy each of the Detroit Mercy IRB Project Information Summary, an informed consent form, and the research project. These materials should be submitted to the chair. They will be reviewed by the chair, who will determine if they are qualified for either exemption or expedited review. During such review, the chair will determine whether or not the use of the consent form will be required. If the project is of such a nature that a determination cannot be made by the chair alone, other members of the IRB may be asked to assist with the review. Investigators will be notified in most cases within 10 working days as to the disposition of their requests. The IRB will be notified in writing by the chair at each regularly scheduled meeting of all projects approved via expedited review in the interim between such meetings.

Federal Regulations require that research investigators provide the following information to each participant:

1. A statement that the study involves research, an explanation of the purposes of the research and the expected duration of the subject's participation, a description of the procedures to be followed, and identification of any procedures which are experimental.

2. A description of any reasonably foreseeable risks or discomforts to the subject.3. A description of any benefits to the subject or to others which may reasonably be

expected from the research.4. A disclosure of appropriate alternative procedures or courses of treatment, if any, that

might be advantageous to the subject.5. A statement describing the extent, if any, to which confidentiality of records identifying

the subject will be maintained.6. For research involving more than minimal risk, an explanation as to whether any

compensation and an explanation as to whether any medical treatments are available if injury occurs and, if so, what they consist of, or whether further information may be obtained.

Detroit Mercy IRB Policies and Procedures, Food and Drug Administration (FDA), Page 6

7. An explanation of whom to contact for answers to pertinent questions about the research and research subjects' rights, and whom to contact in the event of a research-related injury to the subject.

8. A statement that participation is voluntary, refusal to participate will involve no penalty or loss of benefits to which the subject is otherwise entitled, and the subject may discontinue participation at any time without penalty or loss of benefits to which the subject is otherwise entitled.

When required by the IRB, the research investigator shall provide one or more of the following additional elements of information to each participant:

1. A statement that the particular treatment or procedure may involve risks to the subject (or to the embryo or fetus, if the subject is or may become pregnant) which are currently unforeseeable.

2. Anticipated circumstances under which the subject's participation may be terminated by the research investigator without regard to the subject's consent.

3. Any additional costs to the subject that may result from participation in the research.4. The consequences of a subject's decision to withdraw from the research and procedures

for orderly termination of participation by the subject.5. A statement that significant new findings developed during the course of the research

which may relate to the subject's willingness to continue participation will be provided to the subject.

6. The approximate number of subjects involved in the study.7. A statement describing the extent of confidentiality of records.  On drug studies, this

should include a statement that the records may be reviewed by the FDA.8. A statement that informs the volunteer that he or she will receive a signed copy of the

consent form. 

In most cases, the IRB requires the informed consent be documented in writing. Language of the form should be aimed no higher than the eighth grade reading level.  Under certain circumstances, alteration or waiver of the standard written informed consent is granted by the IRB. Options that may be acceptable include oral consent (for telephone surveys), a short form consent for participants who do not speak English, and an information sheet in lieu of written consent.  Federal regulations govern the use of these options. Investigators may consult with the IRB for guidance.

Detroit Mercy IRB Policies and Procedures, Food and Drug Administration (FDA), Page 7

INSTITUTIONAL REVIEW BOARD

PROJECT INFORMATION SUMMARY1. Title of Proposed Project:      

2. Principal Investigator

Name:      

Department:     

Work Telephone:     

Home Address Street Number:     

City, State Zip:     

Email address:     

3. Name of Associate Investigator(s):          

4. Thesis/Dissertation or Faculty Advisor:     

5. Dates of Entire Project Period: (From)           (To)           

6. Amount of Funding and Source Thereof:     

7. “I/We agree to conform with all policies of the University of Detroit Mercy Institutional Review Board; to make no change affecting the rights of human subject volunteers without prior approval of the Board; when requested to do so, report to the Board on the progress of the research.

Signature Date

PrincipleInvestigator _____________________________________________ _________

AssociateInvestigator(s): _____________________________________________ _________

_____________________________________________ _________

Thesis/Dissertationor Faculty Advisor: _____________________________________________ _________

NOTE: Changes in Federal mandates pertaining to research involving human subjects necessitate special care in completing these forms, especially the Informed Consent Form.

Revised 6/11/07 Page 1 of 3

Institutional Review Board Project Summary Form

1. Objectives of Proposed Project:          

2. Brief Description of Research Plan:          

3. Listing of number of volunteers involved and the type of volunteer (age, sex, diseaseentity, etc.), and describe how the volunteers were recruited (see Advertising for StudyVolunteers handout):          

4. Listing of possible benefits which might accrue to the volunteers, or to others, as a resultof their participation in the project:          

5. Listing of possible risks to the volunteers which might occur as a result of the volunteersparticipation in the project:          

6. Listing of all invasive procedures to be performed on the volunteer:          

7. Listing of all medications, or chemical materials, and all appliances and devices, whichwill be in direct contact with the volunteer in the course of this study:          

Revised 6/11/07 Page 9 of 27

Institutional Review Board Project Summary Form

8. List all physical and/or medical tests to be performed on the volunteer.          

9. List all questionnaires to be answered as a part of this research (attach a copy of each):          

10. Describe how volunteers will be informed of possible benefits and/or risks (attach copy of Informed Consent Form):          

11. Describe how the confidentiality of the volunteers will be protected:          

12. Is a full copy (not merely a tentative draft) of the Informed Consent Form (including asignature page) included here? If not, indicate why:          

13. Other information investigator deems appropriate (e.g. description of monetary or other incentives planned. When volunteers are paid for their participation, the payment should accrue as the study progresses and not be contingent upon completion of the study).          

Revised 6/11/07 Page 10 of 27

INSTITUTIONAL REVIEW BOARD

MODEL INFORMED CONSENT FORMGENERAL INFORMATIONOn the following three pages is a model informed consent form. As it is based on federal regulations which must be met, it will be of advantage to you to pattern your consent form on this model.

In what follows, brackets [ ] have been used for two purposes. Where there is a choice of words given, include in your form only the choice that is appropriate; modify wording slightly if necessary. Secondly, brackets are used to give you instructions with regard to what information about your experiment/research you ought to include. Do not repeat instructions in your consent form, but simply put forth in your own words the information that the volunteer needs in order to provide an informed consent.

The Informed Consent Form is a legal document, which must include these three main elements:

a. Explanation to the prospective volunteer of the nature of the research and the procedures involved as these pertain to the volunteer as outlined on page 2.

b. A signature statement indicating that the volunteer has read and understands all of the explanations, and agrees to participate in the research.

c. A signature statement by the investigator that the volunteer exercised full freedom in agreeing to participate in the project.

Although the assent of children over the age of seven years must be obtained, where the volunteer is a minor or under some other legal disability, the volunteer's consent must be given by a legally authorized representative; this is necessary even if the minor (less than eighteen years of age) is willing to participate. In such instances a modified version of this form (b, above – available from IRB) must be used; this must include an indication of the relationship to the volunteer (parent, legal guardian, etc.) and the full address of the representative if different from that of the volunteer. Provision for all this must be included on the form.

Be sure adequate space is provided on the blank lines (signature, address, date, etc.) and between lines so that the writing is fully legible.

The entire complete consent form (not just the signature page) is to be prepared in duplicate for each volunteer involved in the research. One complete form with signatures is to be given to the volunteer, the other complete form with signatures is to be retained by the investigator (or Department) for a period of not less than three years following the official termination of the project.

Revised 6/11/07 Page 1 of 3

RESEARCH PROJECT DESCRIPTION

[BRIEF TITLE OF THE RESEARCH PROJECT]

TO _________________________________________: [Full Name of Volunteer]

My name is [give full name of principal investigator]. I am a [student, faculty member, etc.] in the Department of [name of department; college/school] at the University of Detroit Mercy. I have asked you to agree to be a volunteer in some research [an experiment, etc.] I plan to conduct. Before I can accept your consent, I want to make known to you the following information pertaining to the project.

1. Explanation of the Purpose. [Set forth here a fair explanation of the purpose of the research and the approximate number of volunteers involved in the study. Avoid language and word usage the volunteer in light of age, educational background, etc., is not likely to understand adequately well in order to provide a fully informed consent.]

2. Explanation of the Procedures. [Set forth here a fair explanation of the procedures to be followed and their purpose. Include identification of any procedures, which are experimental. Include a detailed account of what you are asking the volunteer to consent to do. Include the expected duration of the volunteer's participation. Avoid language and word usage the volunteer in light of age, educational background, etc., is not likely to understand adequately well in order to provide a fully informed consent.]

3. Expected Risks. [Set forth here a description of any attendant discomforts and risks reasonably to be expected. If there are none, state: There are no attendant discomforts or risks reasonably to be expected. If the research includes particular treatment or procedures that may involve risks to the volunteer(s) (or to an embryo or fetus, if the subject is or may become pregnant) which is currently unforeseeable, so state this.]

4. Expected Benefits. [Set forth here a description of any benefits, which reasonably might be expected to accrue to the volunteer or to others. If there are none, state: Other than participating in an important research project, there are no particular benefits, which reasonably might be expected to accrue to you or to others.]

5. Appropriate Alterative Procedures. [Set forth here a disclosure of any alternative procedures that might somehow be advantageous to the volunteer were they carried out in place of the intended research procedure planned here. If there is an alternative procedure that might somehow be advantageous to the volunteer, indicate clearly why the proposed procedure is being used. NOTE: If project does not involve a treatment or therapy then this section may be deleted.]

6. Confidentiality. [Describe how confidentiality will be maintained. If complete confidentiality cannot be maintained, describe any limits to confidentiality. Include the following statement: The confidentiality of the records will be maintained unless the law requires disclosure.

Confidentiality of records will be maintained by _______________________________________.Limits to confidentiality include ____________________________________________________.

NOTE: In certain cases the FDA may inspect the records, the sponsor may inspect the records, and/or the IRB may inspect the records.]

7. Offer To Answer Questions. [Text to include: I hereby offer to answer any questions you might wish to ask concerning the procedures used in this research at this time. Furthermore, I may be reached during the hours of ### AM until ### PM at ###-###-#### or by e-mail @ ######@udmercy.edu. You should also identify another individual who could be contacted regarding the research project (provide name, telephone number, e-mail address and street address). If you have questions concerning your rights as a volunteer, you may contact Dr. Elizabeth M. Hill, Chair, UDM Institutional Review Board, 313.578.0405 or [email protected].]

8. Freedom To Withdraw Consent. If you consent to be a volunteer in this research project [experiment, etc.], you are nonetheless free to withdraw your consent and discontinue participation at any time without prejudice to you. [This will include students participating in research projects within a course and no penalty to a course grade or class standing will precipitate from withdrawal as a subject.] You should also understand that the investigator has the right to withdraw you from the research project at any time. [Indicate anticipated

Revised 6/11/07

circumstances under which the volunteer's participation may be terminated without regard to the volunteer's consent. An example would be the failure of the volunteer to follow instructions given to them by the investigator.]

9. Compensation. [If applicable, specify the time period over which payments will be made to the subjects. If the volunteers are to be paid or compensated, specify dollar amount and address the matter of prorating if the volunteer withdraws or if the investigator terminates the study.]

10. Availability of Compensation and Medical Treatment for Injury. [For biomedical or behavioral research, which might result in injury or trauma of any kind, set forth an explanation regarding whether compensation and medical treatment (provide prearranged location) are available if such injury or trauma should occur. If compensation and medical treatment are available, indicate of what this consists and/or where further information may be obtained (provide the name, telephone number and address of the individual to contact regarding this). If compensation and medical treatment are not available, include the following statement:You [i.e., research subject] understand that if you are injured, no form of compensation is available. Medical treatment may be provided at your own expense or at the expense of your health care insurer (i.e. Medicare, Medicaid, BC/B.S., etc.) which may or may not provide coverage. If you have questions, you should contact your insurer. NOTE: If there is no risk of injury or trauma, you may omit this entire paragraph.]

11. Additional Costs. [If there are any additional costs to the volunteer that may result from participation in the research, outline them fully. When a research study includes randomization with several treatment plans involved, the consent form must indicate whether one plan may be more costly than another plan in the same research study.]

12. Significant New Findings. [A statement should be included that indicates that if any significant new findings are developed during the course of this research which may relate to the volunteer's willingness to continue participation, such new findings will be provided to the volunteer.]

13. Future Data Use. Occasionally, the same or another researcher will request the permission to review or use previously gathered data from a completed research project for a different project. If confidentiality of the data is protected and if the UDM Institutional Review Board has approved the study, would you be willing to give your permission to the release of your data collected from your participation in the current study without prior notification?

______Yes, I give my permission for the future use of data obtained in this study contingent on the preceding conditions.initials

______No, I do not give my permission for the future use of data from this study.Initials

Revised 6/11/07

INSTITUTIONAL REVIEW BOARD

ACKNOWLEDGMENT AND CONSENT

I, ___________________________________________

(Prospective Volunteer's Full Name)

of ________________________________________________________________________________ hereby state:

(Street address, City, State, Zip Code)

1. I have read all of the statements above pertaining to the research project entitled [brief title of research project] and I understand them.

2. I have been given the opportunity to ask any questions I wish concerning this research project [experiment, etc],and any questions I have asked have been answered to my satisfaction.

3. I understand a full copy, with signatures, of this document will be provided to me.

4. I hereby consent to be a volunteer in this research project [experiment].

_______________________________________________________________ ________________________________________Full Signature of Prospective Volunteer Date

As the investigator in the research project entitled [brief title of research project], I hereby state to the best of my knowledge and belief that all of the statements made in the above consent form are true and that in consenting the prospective volunteer exercised free power of choice without undue inducement or any element of force, fraud, deceit, duress, or any other form of constraint or coercion. In addition to the participation by the volunteer being voluntary, the volunteer has been advised that he or she may discontinue participation at any time without penalty or loss of benefits to which the volunteer is entitled.

_____________________________________________________ _______________________________Full Signature of Investigator Date

FINAL NOTE: The completed Informed Consent Form to be used must be submitted in its intended [not draft] form at the time the proposal is submitted to the Institutional Review Board for its approval.

Revised 6/11/07

INSTITUTIONAL REVIEW BOARD

MODEL CHILD WRITTEN ASSENT FORMChildren/Adolescents ages 7-17

GENERAL INFORMATIONOn the following pages is a model child assent form. As it is based on federal regulations which must be met, it will be of advantage to you to pattern your assent form on this model.

Brackets are used to give you instructions with regard to what information about your experiment/research you ought to include. Do not repeat instructions in your assent form, but simply put forth in your own words the information that the child/adolescent volunteer needs in order to understand the study and assent to participate. Be sure the child understands before obtaining assent.

Please note that an informed consent form must also be completed by one parent (in the case of minimal risk studies) or both parents (in the case of more than minimal risk studies).

Researchers should tailor the assent form to the age and developmental level of the subjects. While the adult/parental consent forms must have all categories, the child assent form may be made shorter and simpler if the child would not be able to understand the more detailed information. Use wording that is as simple as possible. Generally, forms are written at a fifth grade reading level for adolescents ages 13-17 and a third grade reading level for children ages 7-13.

Be sure adequate space is provided on the blank lines (signature, address, date, etc.) and between lines so that the writing is fully legible.

The entire complete assent form (not just the signature page) is to be prepared in duplicate for each child/adolescent volunteer involved in the research. One complete form with signatures is to be given to the child/adolescent and one to the parent/guardian. The original complete form with signatures is to be retained by the investigator (or Department) for a period of not less than three years following the official termination of the project.

Revised 8/15/11

RESEARCH PROJECT DESCRIPTION

[BRIEF TITLE OF THE RESEARCH PROJECT]

TO _________________________________________[Full Name of Volunteer]

My name is [give full name of principal investigator]. I’m a [professor] at [The University of Detroit Mercy]. I’m asking you to be in a research study. Research is a way to help us learn new things. Only people who decide they want to help will be in the study. We’ll tell you about the study and then you should take time to make your decision. You should talk to your parents or your guardian before you decide.

14. Why is this study being done? [Explain the study purpose in simple language.]

15. What will happen to me? [Explain the methods in simple language. The nature of the child’s participation should be described, including any time commitment. If there will be any recording it should be described here.]

16. Will being in the study hurt me? [This section should include basic descriptions of the risks of the study that may include stress, distress, fear, anxiety, or pain. If risks are only minimal, state “we don’t think you will be hurt by being in this study.” If there are more than two risks, number the items or use bullets.]

17. What are the good things about being in the study? [This section should include information about any benefits that might exist for the subject, including payment. If there are none, say there are none. Number the items or use bullets if there are multiple benefits.]

18. How long will I be in the study? [The time commitment should be described.]

19. Do I have other choices? [It should be clear that the child can leave the study or not participate.]

20. Will people know that I am in the study? [This should describe who will know that the child is in the study. Also include a statement such as, “Anything you tell us or do for us might be found out by someone else, but we will do everything we can to keep anyone from knowing who is not supposed to.”]

21. Who should I ask if I have questions? [This should provide children with information about who to contact. Please include contact information, such as phone number and e-mail address. You can also remind children they can ask their parent or guardian questions.]

22. Is it ok if I say “No, I don’t want to be in the study?” [This should state that “You do not have to be a part of this study if you don’t want to. No one will be mad or upset. If you change your mind during the study, you can decide to stop being in the study.”]

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INSTITUTIONAL REVIEW BOARD

ASSENT FORM(Children and Adolescents 7-17)

Do you understand everything I just talked about? I understand. All my questions were answered.

Do you want to be in the study? I want to be in the study. I don’t want to be in the study.

____________________________________________(Your name)

____________________________________________ __________________(Your signature) (Date)

____________________________________________ __________________(Signature of person explaining the study) (Date)

I will give you and your parents a copy of this form for you to keep in a safe place. Your parents will also need to sign a form giving you permission to be in the study, and they will get a copy of that, too.

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INSTITUTIONAL REVIEW BOARD

ADVERTISING FOR STUDY VOLUNTEERS

Institutional Review Boards (IRBs) are responsible for ensuring the equitable selection of research volunteers (21 CFR 56.111 (a) (3). In fulfilling this responsibility, IRBs should review the methods that investigators use to recruit volunteers. One method of recruiting volunteers is through advertisements. Advertising for research volunteers is not in and of itself an objectionable practice. However, when advertising is to be used, the IRB should review the information contained in the advertisement, and the mode of its communication, to determine that the procedure for recruiting volunteers affords adequate protection.

FDA requires that an IRB review and have authority to approve, require modifications in, or disapprove all research activities covered by the IRB regulations (21 CFR 56.109). FDA expects an IRB to review all the research documents and activities that bear directly on the rights and welfare of the volunteers of proposed research. The project protocol, the consent form, and the investigator's brochure have consistently been cited as specific examples of documents that the IRB should review.

Advertisements used to recruit volunteers should be seen as an extension of the informed consent and volunteer selection processes. (See 21 CFR 50.20, 21 CFR 50.25, and 21 CFR 56.111 (a) (3).) Institutions should, therefore, require IRB review of such advertisements. IRB review is necessary to ensure that the information is not misleading to volunteers, especially when a study will involve persons with acute or severe physical or mental illness or persons who are economically or educationally disadvantaged. The IRB is responsible for assuring that appropriate safeguards exist to protect the rights and welfare of research volunteers (21 CFR 56.111 (b)).

Generally, FDA believes that any advertisement to recruit volunteers should be limited to:1. the name and address of the clinical investigator; 2. the purpose of the research and, in summary form, the eligibility criteria that will be used

to admit volunteers to the study; 3. a straightforward and truthful description of the benefits (e.g., payments or free treatment)

to the volunteer from participation in the study; and 4. the location of the research and the person to contact for further information.

If the research involves a drug or devise, no claim should be made, either explicitly or implicitly, that the drug or devise is safe or effective for the purposes under investigation, or that the drug or devise is in any way equivalent or superior to any other drug or devise. Such representation would not only be misleading to volunteers but would also be a violation of the FDA's regulations concerning the promotion of investigational drugs (21 CFR 312.7(a) and of investigational devices (21 CFR 812.7(d).

Source: FDA Announcement -- February, 1989.

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INSTITUTIONAL REVIEW BOARD

REVIEW REPORT

1. Name and Address (Campus) of Principal Investigator (PI):      

2. PI's Campus Telephone #:      

3. PI's Department:      

4. Title of Project:      

5. Assigned IRB Protocol #      

6. Anticipated ending date of research project:      

Do you want your approval to continue past this date?      

New anticipated ending date:      

7. Please mark with a "X" the items that apply to your research:

Abortuses/Fetuses Minors Prisoners Pregnant Women Normal Volunteers Mentally Retarded Mentally Disabled

(Under Family Care) Patients Institutionalized

Mentally Disabled HIV Testing

8. Our records indicate that subjects from the VA Medical Center have participated in this research project. Yes

9. Please mark with an “X” the items that apply to your research.

Investigational New Drugs Approved Drug Being Used for an Unapproved Use

FDA Approval Drug(s) Investigational New Devise None of the Above

10. Please mark with an “X” any other entities involved in your research.

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Institutional Review Board

Federal Industry (other than pharmaceutical) State Pharmaceutical Company Internal University Grant Program Private Foundation/Association Not Applicable

11. Is this research part of a NIH-sponsored multicenter clinical trial? Yes

12. List any facilities used outside UDM.      

13. If there have been any changes in key personnel since your last review, please list the Name and Responsibility in Project for each person.      

14. Provide a brief description of your preliminary results.      

15. Number of volunteer subject withdrawals (drop outs) and reasons given for withdrawing.     

16. Estimated number subjects at completion:       Age level of subjects:      

17. Project funding source:      

18. Total number of subjects to date:       Total number of subjects the last twelve months:      

19. Unless the requirement was waived by the IRB, a signed copy of the approved consent form should have been obtained from each of the volunteer subjects in the study. Has this requirement been met? Yes

20. Where are the records containing the signed consent forms located?      

21. If no volunteer subjects were enrolled during the last 12 months, submit two copies of the currently approved consent forms. If volunteer subjects have been enrolled during the last 12 months, submit two copies of the signed consent forms for each of the two volunteer subjects most recently enrolled in your study.

22. If substantive changes need to be made in the original protocol, on additional sheets describe briefly the changes and explain why they are essential. [NOTE: No material changes in the research procedures should have occurred since the previous IRB review. Approval from the IRB must be obtained before implementing any material changes.]

23. Have any significant new findings developed during the course of the research which may relate to volunteer subject's willingness to continue to participate? YesIf yes, describe the new findings and discuss their implications for volunteer subject participation.     

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Institutional Review Board

24. Since the previous IRB review, has any adverse reaction or fatality occurred to a volunteer subject during the research procedure which was not reported to the IRB? Yes

25. Does your protocol fall under the review of the Food & Drug Administration (FDA)? YesIf Yes, please respond to items 22 and 23.

26. Has your research protocol been audited by an FDA representative since the last IRB review? Yes

27. If Yes, was a FDA 483 issued? Yes If Yes, please include a copy with this form.

28. Additional Certifications:Complete only if research is being submitted to or supported by an extramural funding agency. Check the following, if needed:

HHS Protection of Human Subjects Assurance/Certification/Declaration Other (Please attach)

Principal InvestigatorSignature:_____________________________________________________________ Date:____________

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Institutional Review Board

INSTITUTIONAL REVIEW BOARD

FINAL SUMMARYTitle of Research Project:      

IRB Number:      

Principal Investigator:      

A. Summarize the results of your research study.      

B. Include copies of any adverse experiences that are thought to be related to the drug or any serious adverse experiences of any type that occurred during the study.

C. Attach any abstracts or papers that have resulted from your study.

D. Give the first date any volunteers were enrolled       and the last date that any volunteers were enrolled in your study.      

E. Please note the total number of volunteers enrolled in the study,       those dropped from the study,       and those completing the study.      

I affirm that I have faithfully followed the protocol that I originally submitted to the University of Detroit Mercy Institutional Review Board (IRB) and that there were no revisions to this protocol that were not approved by the IRB. Furthermore, I affirm that the IRB approved Informed Consent was used with all volunteers and understand that I must keep these on file for possible review by the Food and Drug Administration. I agree to send any publications or abstracts that are submitted after the closure of the study to the IRB to be kept on file. Should there be any adverse experiences, litigation, or other events that are reported after this date, I will report these to the IRB within 48 hours.

__________________________________________________________ Principal Investigator (signature) (date)

__________________________________________________________ Co-Investigator (signature) (date)

__________________________________________________________ Co-Investigator (signature) (date)

__________________________________________________________ Co-Investigator (signature) (date)

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Institutional Review Board

INSTITUTIONAL REVIEW BOARD

RESEARCH ACTIVITIES WHICH 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, underno 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 (4 5 CFR 4 6 . 10 1 (b), unless otherwise requiredby 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, 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.

2. 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 subject; and

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Institutional Review Board Exempt from Review

(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 of public behavior that is not exempt under the preceding paragraph, 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 Federal 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 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.

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Institutional Review Board

INSTITUTIONAL REVIEW BOARD

RESEARCH ACTIVITIES WHICH 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 C F R 4 6 . 1 1 0 , 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 anExpedited Review Procedure1

App lic a bi lity

(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 C F R 4 6. 1 10 and 2 1 CFR 5 6. 1 1 0 . 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, orexception) apply regardless of the type of review--expedited or convened--utilized by the IRB.

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

Res earc h Ca teg ories

(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

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Institutional Review Board

this category may be exempt from the HHS regulations for the protection of human subjects. 45 CFR46.101(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 C F R 4 6 .1 10 .

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 4 6. 4 0 2 ( a ) .

S o u rc e: 63 FR 6 0 3 6 4 - 6 0 3 6 7, N o v e m b e r 9, 1 9 9 8 .