Initial Review of Human Subjects Research

Initial Review of Human Subjects Research

INITIAL REVIEW OF HUMAN SUBJECTS RESEARCH

U P Health System - Marquette Institutional Review Board

580 West College Avenue

Marquette, Michigan 49855

Phone: (906)225-7663

Fax: (906) 225-4712

OFFICIAL USE / DATE RECEIVED: / DATE VERIFIED COMPLETE:

PRE-REVIEW REQUIREMENTS:

HAS STUDY BEEN REVIEWED BY THE U P HEALTH SYSTEM - MARQUETTEDIRECTOR OF RESEARCH : YES ☐ NO ☐

If no: Submit study protocol to Dianna Larson at for review before submitting to the Institutional Review Board (IRB) for approval. Attach the Compliance approval letter.

Exceptions: Retrospective Data Collection Studies, Nursing Studies, Medical Student/Resident Studies

IF THIS IS A RETROSPECTIVE DATA COLLECTION STUDY please complete the Retrospective Data Collection Study form on the IRB website.

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TITLE OF STUDY: Click here to enter text.

PRINCIPAL INVESTIGATOR:

Name (Last, First, MI): Click here to enter text.

Mailing Address: Click here to enter text.

E-mail:Click here to enter text.Fax: Click here to enter text.

Phone: Click here to enter text.

CO-INVESTIGATOR(S): ☐YES ☐NO If yes, please provide:

Name (Last, First, MI)Click here to enter text.

Mailing Address: Click here to enter text.

E-mail:Click here to enter text.Fax: Click here to enter text.

Phone: Click here to enter text.

EDUCATION:

Educational requirements (initial and continuing) must be satisfied prior to submitting an application for IRB review.

Have all investigators and co-investigators completed the required web-based Human☐Yes ☐No

Subject Training for the protection of human research subjects?

KEY STUDY PERSONNEL: Names of all personnel involved in design, conduct, or reporting of the research ( All must complete a Disclosure of Commercial Relationships, Affiliations and IRB Policy #22 Review form* regarding this research)
Name / Primary Department (use abbreviation) / Role in the research (e.g. co-investigator, research coordinator, statistician, etc.) / Involved in interpersonal contact communication with subjects, or access to private identifiable data? / Involved in consent process? / Fulfilled education requirements? / Indicated potential or actual financial interest related to this research on COI form?
Yes / No
Ex: Sally Smith, MD / QM / Co-investigator / ☒ / ☒ / ☒ / ☒ / ☒ /
☐ / ☐ / ☐ / ☐ / ☐ /
☐ / ☐ / ☐ / ☐ / ☐ /
☐ / ☐ / ☐ / ☐ / ☐ /
☐ / ☐ / ☐ / ☐ / ☐ /
☐ / ☐ / ☐ / ☐ / ☐ /
☐ / ☐ / ☐ / ☐ / ☐ /
☐ / ☐ / ☐ / ☐ / ☐ /
☐ / ☐ / ☐ / ☐ / ☐ /
☐ / ☐ / ☐ / ☐ / ☐ /
* Clinical Trial Coordinator nurses need not be listed on this form

DISCLOSURE OF COMMERCIAL RELATIONSHIPS, AFFILIATIONS (COI) AND IRB POLICY #22 REVIEW:

All investigators must have a current COI disclosure before IRB review. Examples of financial interests that must be disclosed include (but are not limited to) consulting fees or honoraria; stocks, stock options or other ownership interests; and patents, copyrights and royalties from such rights.

Have all investigators completed the required COI disclosure?☐Yes☐No

Does any investigator (including principal or co-investigator), or their immediate ☐Yes☐No

family members have a financial interest (including salary or other payments for services,

equity interests, or intellectual property rights) that would reasonably appear to be affected

by the research, or a financial interest in any entity whose financial interest would reasonably

appear to be affected by the research?

STUDY OBJECTIVES:

PRIMARY: Click here to enter text.

SECONDARY:Click here to enter text.

STUDY DESIGN:

Study Activities (summarize the proposed research using “non-technical” language that can be readily understood by someone outside the discipline. Explain briefly the research design procedures to be used and the importance of the knowledge that may reasonably be expected to result. Use complete sentences (limit 300 words):

Click here to enter text.

45 CFR 46.111(a)(1), 21 CFR 56.111(a)(1)
☐Risks to subjects are minimized by using procedures that are consistent with sound research design and that do not unnecessarily expose participants to risk.
☐Risks to subjects are minimized, when appropriate, by using procedures already being performed on the participants for diagnostic or treatment purposes.

RISK/BENEFIT ASSESSMENT:

Regulatory definition of minimal risk: Minimal risk means that the probability and magnitude of harm or discomfort anticipated in the research are not greater in and of themselves than those ordinarily encountered in daily life or during the performance of routine physical or psychological examinations or tests (45 CFR 46.102(h)(i)).

Check appropriate risk category:

☐ The research involves no more than minimal risk to subjects.

☐ The research involves more than minimal risk to subjects.

☐The risk(s) represents a minor increase over minimal risk, or

☐The risk(s) represents more than a minor increase over minimal risk.

Describe all reasonably expected risks, harms, and/or discomforts that may apply to the research. Discuss severity and likelihood of occurrence. As applicable, include potential risks to an embryo or fetus if a woman is or may become pregnant. Consider the range of risks, including physical, psychological, social, legal, and economic.

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Describe how risks, harms, and/or discomforts will be minimized. If testing will be performed to identify individuals who may be at increased risk (e.g., pregnant women, individuals with HIV/AIDS, depressive disorders, etc.), address timing and method of testing; include how positive test results will be handled.

Click here to enter text.

BENEFIT

Definition: A research benefit is considered to be something of health-related, psychosocial, or other value to an individual research subject, or something that will contribute to the acquisition of generalizable knowledge. Money or other compensation for participation in research is not considered to be a benefit, but rather compensation for research-related inconveniences.

Check appropriate benefit category(ies):

☐Noprospects of direct benefit to individual subjects, but likely to yield generalizable knowledge about the subject's disorder or condition;

☐No prospect of direct benefit to individual subjects, but likely to yield generalizable knowledge to further society’s understanding of the disorder or condition under study); or

☐The research involves the prospect of direct benefit to individual subjects.

List the potential benefits that participants may expect as a result of this research study. Compensation is not to be considered a benefit.

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List the potential benefits that society and/or others may expect as a result of this research study.

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45 CFR 46.111(a)2, 21 CFR 56.111(a)(2)
☐Risks to subjects are reasonable in relation to anticipated benefits, if any, to subjects, and the importance of the knowledge that may be expected to result.
In evaluating risks and benefits, the IRB should consider only those risks and benefits that may result from the research (as distinguished from risks and benefits of therapies that subjects would receive even if not participating in the research). The IRB should not consider possible long-range effects of applying knowledge gained in the research (for example, the possible effects of the research on public policy) as among those research risks that fall within the purview of its responsibility.

SUBJECT POPULATION:

Specify the age(s) of the individuals who may participate in the research:

Age(s): Click here to enter text.

Specify the participant population(s). Check all that apply:

☐ Adult☐ Pregnant women/fetuses

☐ Children (< 18 years)☐ Neonates (uncertain viability/nonviable)

☐ Adults with decisional impairment☐ Prisoners

☐ Non-English speaking☐ Unknown (e.g. secondary use of data/specimens,

Non-targeted surveys)

Describe the characteristics of the proposed participants, and explain how the nature of the research requires/justifies their inclusion.

Click here to enter text.

Will any participants be excluded based on age, gender, race/ethnicity, pregnancy status, language, ☐Yes☐ No

education, or financial status?

If Yes Explain the criteria and reason(s) for each exclusion. Consider the study’s scientific or scholarly aims and risks. Click here to enter text.

Are any of the participants likely to be vulnerable to coercion or undue influence? ☐ Yes☐ No

Consider students, employees, terminally ill persons, or others who may have limited autonomy.

Click here to enter text.

Target number of subjects to be enrolled at all sites: Click here to enter text. At local site: Click here to enter text.

PARTICIPANT IDENTIFICATION, RECRUITMENT & SELECTION

Describe how potential participants will be identified (e.g., advertising, individuals known to investigator, record review, etc.). Explain how investigator(s) will gain access to this population, as applicable.

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List the names of investigator(s) and/or key personnel who will recruit participants.

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Describe the process that will be used to determine participant eligibility.

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Describe the recruitment process; including the setting in which recruitment will take place. Provide copies of proposed recruitment materials (e.g., ads, flyers, website postings, recruitment letters, and oral/written scripts).

Click here to enter text.

Explain how the process respects potential participants’ privacy.

Click here to enter text.

45 CFR 46.111(a)(3), 21 CFR 56.111(a)(3)
☐Selection of subjects is equitable: Taking into account the purposes of the research and the setting in which the research will be conducted and being particularly cognizant of the special problems of research involving vulnerable populations, such as children, prisoners, pregnant women, mentally disable persons, or economically or educationally disadvantaged persons.
45 CFR 46.111(b), 21 CFR 56.111(b)
☐
When some or all of the subjects, such as children, prisoners, pregnant women, handicapped, or mentally disabled persons, or economically or educationally disadvantaged persons, are likely to be vulnerable to coercion or undue influence, additional safeguards have been included in the study to protect the rights and welfare of these subjects.
☐
Not Applicable

INCENTIVES TO PARTICIPATE

Will participants receive compensation or other incentives (e.g., free services, ☐Yes☐No

cash payments, gift certificates, travel reimbursement) to participate in the research study?

If Yes Describe the incentive, including the amount and timing of all payments.

Click here to enter text.

INFORMED CONSENT PROCESS

45 CFR 46.111(A)(4), 21 CFR 56.111(A)(4)
☐Informed consent will be sought from each prospective subject or the subject’s legally authorized representative, in accordance with, and to the extent required by 45 CFR §46.116 and for FDA-regulated research in accordance with and to the extent required by 21 CFR §50 as follows:
☐Consent will be waived or altered.

OR

(All items in the box below must be true)

☐The investigator will obtain the legally effective informed consent of the subject or the subject’s legally authorized representative.
☐ The circumstances of the consent process provide the prospective subject or the legally authorized representative sufficient opportunity to consider whether to participate.
☐ The circumstances of the consent process minimize the possibility of coercion or undue influence.
☐ The individual’s communication information to the subject or the legally authorized representative during the consent process will provide that information in language understandable to the subject or the representative.
☐ The information being communicated to the subject or the representative during the consent process will not include exculpatory language through which the subject or the legally authorized representative is made to waive or appear to waive any of the subject’s legal rights or through which the subject or the legally authorized representative releases or appears to release the investigator, the sponsor, the institution, or its agents from liability for negligence.
☐ All required and appropriate additional disclosures will be provided to the subject or the subject’s representative.

Describe the consent process -

Explain when and where consent will be obtained and how subjects and/or their legally authorized representatives will be provided sufficient opportunity (e.g., waiting period, if any) to consider participation.

Click here to enter text.

Will any other tools, (e.g., quizzes, visual aids, information sheets) be used during☐ Yes☐ No

the consent process to assist participant comprehension?

If yes, provide copies of these tools. Click here to enter text.

Does the consent form contain an adequate description of the Required Elements and the Additional Elements listed in the Consent Disclosure Checklist below?

CONSENT DISCLOSURE CHECKLIST

Required Elements: (Circle Yes or No)

A statement that the study involves research / Choose an item. /
An explanation of the purposes of the research. / Choose an item. /
A description of the procedures to be followed. / Choose an item. /
Identification of any procedure that is experimental. (May be omitted if there are none) / Choose an item. /
A description of any reasonably foreseeable risks or discomforts to the participant. / Choose an item. /
A description of any benefits to the participant or to others, which may reasonably be expected from the research. / Choose an item. /
A disclosure of appropriate alternative procedures or courses of treatment, if any, that might be advantageous to the participant. (May be omitted if there are none) / Choose an item.
A statement describing the extent, if any, to which confidentiality of records identifying the participant will be maintained. / Choose an item. /
A statement that notes the possibility that the Food and Drug Administration may inspect the records. (May be omitted for research that is not FDA-regulated.) / Choose an item. /
For research involving more than minimal risk, an explanation as to whether compensation is available if injury occurs. (May be omitted if the research involves no more than minimal risk.) / Choose an item. /
If compensation is available when injury occurs, an explanation as to what it consists of or where further information may be obtained. (May be omitted if the research involves no more than minimal risk). / Choose an item. /
An explanation as to whether any medical treatments are available if injury occurs. (May be omitted if the research involves no more than minimal risk.) / Choose an item. /
If medical treatments are available when injury occurs, an explanation as to what it consists of or where further information may be obtained. (May be omitted if the research involves no more than minimal risk.) / Choose an item. /
An explanation of whom to contact for answers to pertinent questions about the research. / Choose an item. /
An explanation of whom to contact for answers to pertinent questions about the research participants’ rights. (“You can call the Patient Advocate at UP Health System - Marquette at (906) 225-3183 or (906) 228-9400, ext. 3183 or 1-800-562-9753, ext. 3183 if you have any questions, comments, or concerns about the study or your rights as a research subject.) / Choose an item. /
An explanation of whom to contact in the event of a research-related injury to the participant. (Note: May not be omitted just because the research involves no more than minimal risk.) / Choose an item. /
A statement that participation is voluntary. / Choose an item. /
A statement that refusal to participate will involve no penalty or loss of benefits to which the participant is otherwise entitled. / Choose an item. /
A statement that the participant can discontinue participation at any time without penalty or loss of benefits to which the participant is otherwise entitled. / Choose an item. /
Additional Elements
A statement that the particular treatment or procedure may involve risks to the participant, which are currently unforeseeable. / Choose an item. /
A statement that if the participant is or becomes pregnant, the particular treatment or procedure may involve risks to the embryo or fetus, which are currently unforeseeable. / Choose an item. /
Anticipated circumstances under which the participant’s participation may be terminated by the investigator without regard to the participant’s consent. / Choose an item. /
Any additional costs to the participant that may result from participation in the research. / Choose an item. /
The consequences of a participant’s decision to withdraw from the research. / Choose an item. /
Procedures for orderly termination of participation by the participant. / Choose an item. /
A statement that significant new findings developed during the course of the research which may relate to the participant’s willingness to continue participation will be provided to the participant. / Choose an item. /
The approximate number of participants involved in the study. / Choose an item. /
The amount and schedule of all payments (if any) to the participant. / Choose an item. /
The duration of subject’s participation in study. / Choose an item. /
FDA Regulation (21 CFR § 50.25(c)) require that informed consent documents and processes for applicable drug (including biological products) and device clinical trials include a specific statement that clinical trial information will be entered into a databank. Applicable clinical trials generally include controlled interventional studies (with one or more arms) of drugs, biological products, or devices that are subject to FDA regulation, meaning that the trial has one or more sites in the United States, involves a drug, biologic, or device that is manufactured in the United States (or its territories), or is conducted under an investigational new drug application (IND) or investigational device exemption (IDE).
The exact statement required to be included in informed consent documents is:
“A description of this clinical trial will be available on as required by U.S. Law. This website will not include information that can identify you. At most, the website will include a summary of the results. You can search this website at any time.” / Choose an item. /
Protected Health Information (PHI)
A specific and meaningful description of what will be used or disclosed. / Choose an item. /
Who may use or disclose the information. / Choose an item. /
To whom the information will be disclosed. / Choose an item. /
The purpose of the disclosure. / Choose an item. /
The expiration date or expiration event related to the consent/authorization. / Choose an item. /
The subject’s signature and date. / Choose an item. /
The right to revoke the consent/authorization. / Choose an item. /
The right to refuse to sign the consent/authorization. / Choose an item. /
If treatment, payment, enrollment or eligibility for benefits will be dependent on signing the consent/authorization document, a statement to that effect. / Choose an item. /
Information disclosed to others not covered by the Privacy Rule may be re-disclosed by them and the re-disclosure will not be protected by the Privacy Rule. / Choose an item. /
The consent/authorization is written in plain language / Choose an item. /
The subject will be provided a copy of his/her signed and dated authorization form. / Choose an item. /
The subject has the right to access his/her own PHI. / Choose an item. /
This right to access may be temporarily denied (for example, for a “blinded” study). / Choose an item. /
Is the consent form understandable to the population? / Choose an item. /
Is the consent form accurate and complete? / Choose an item. /

CONSENT SIGNATURE DOCUMENTATION: