Initial Review of Human Subjects Research

INITIAL REVIEW OF HUMAN SUBJECTS RESEARCH

Marquette General Hospital Institutional Review Board

580 West College Avenue

Marquette, Michigan 49855

Phone: (906)225-3467

Fax: (906) 225-4712

DATE RECEIVED: DATE VERIFIED COMPLETE:

HAS STUDY BEEN REVIEWED BY THE MARQUETTE GENERAL HOSPITAL

COMPLIANCE COMMITTEE: YES ☐ NO ☐

If no: Submit study protocol to the Risk Management Department –for review before submitting to the Institutional Review Board (IRB) for approval. Attach the Compliance approval letter.

IF THIS IS A DATA COLLECTION STUDY ONLY, HAS STUDY BEEN REVIEWED

BY QUALITY MANAGEMENT: YES ☐ NO ☐

If no: Submit study protocol to the Quality Management Director –for review. Attach the

Quality Management approval.

Data Collection studies may qualify for an IRB exemption – 45 CFR 46.101(b)(4) –

“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 the Basic U.S. Department of Health & Human Services (HHS) Policy for Protection of Human Research Subjects:



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.”

Refer to: Initial Review of Human Subjects Research – Retrospective Data

Collection Study

Initial Review of Human Subjects Research

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.

Phone: Click here to enter text.

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

Fax: Click here to enter text.

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

Mailing Address: Click here to enter text.

E-mail: Click here to enter text.

Phone: Click here to enter text.

EDUCATION:

Fax: Click here to enter text.

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

Have all investigators and co-investigators completed the required web-based Human ☐ Yes

Subject Training in the protection of human research subjects? ☐ No

FINANCIAL CONFLICT OF INTEREST:

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 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:

☐

☐

Yes

No

Form Date: 10/2012, Version 2.0 Page 2


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.


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.


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 researchrelated inconveniences.

Check appropriate benefit category(ies):

☐ no prospect 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.




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


☐

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:

☐ Adults ☐ Pregnant women/fetuses

☐ Children (< 18 years)

☐ Non-English speaking

☐ Adults with decisional impairment

☐

☐

Neonates (uncertain viability/nonviable)

Prisoners

☐ 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.




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

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?

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

☐ Yes

☐ No


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.


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


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


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).




Explain how the process respects potential participants’ privacy.


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

☐ Yes

☐ No

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




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:

Names of investigator(s) and/or the personnel who will obtain consent from participants or their legally authorized representatives




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.


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

An explanation of the purposes of the research.

A description of the procedures to be followed.

Identification of any procedures that are experimental. (May be omitted if there are none)

A description of any reasonably foreseeable risks or discomforts to the participant.

A description of any benefits to the participant or to others, which may reasonably be expected from the research.

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)

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A statement describing the extent, if any, to which confidentiality of records identifying the participant will be maintained.

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.)

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An explanation as to whether compensation is available if injury occurs. (May be omitted if the research involves no more than minimal risk.)

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).

An explanation as to whether any medical treatments are available if injury occurs. (May be omitted if he research involves no more than minimal risk.)

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.)

An explanation of whom to contact for answers to pertinent questions about the research.

An explanation of whom to contact for answers to pertinent questions about the research participants’ rights. ( “You can call the Patient Advocate at Marquette General Health

System 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.)

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.)

A statement that participation is voluntary.

A statement that refusal to participate will involve no penalty or loss of benefits to which the participant is otherwise entitled.

A statement that the participant can discontinue participation at any time without penalty or loss of benefits to which the participant is otherwise entitled.

Additional Elements

A statement that the particular treatment or procedure may involve risks to the participant, which are currently unforeseeable.

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.

Anticipated circumstances under which the participant’s participation may be terminated by the investigator without regard to the participant’s consent.

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Any additional costs to the participant that may result from participation in the research.

The consequences of a participant’s decision to withdraw from the research.

Procedures for orderly termination of participation by the participant.

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.

The approximate number of participants involved in the study.

The amount and schedule of all payments to the participant.

The duration of subject’s participation in study.

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 http://www.ClinicalTrials.gov

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.”

Protected Health Information (PHI)

A specific and meaningful description of what will be used or disclosed.

Who may use or disclose the information.

To whom the information will be disclosed.

The purpose of the disclosure.

The expiration date or expiration event related to the consent/authorization.

The subject’s signature and date.

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The right to revoke the consent/authorization.

The right to refuse to sign the consent/authorization.

If treatment, payment, enrollment or eligibility for benefits will be dependent on signing the consent/authorization document, a statement to that effect.

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.

The consent/authorization is written in plain language

The subject will be provided a copy of his/her signed and dated authorization form.

The subject has the right to access his/her own PHI.

This right to access may be temporarily denied (for example, for a “blinded” study).

Is the consent form understandable to the population?

Is the consent form accurate and complete?

DATA MONITORING:

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☐ subjects.

45 CFR 46.111(a)(6), 21 CFR 56.111(a)(6)

The research plan makes adequate provision for monitoring the data collected to ensure the safety of

Is a data monitoring plan presented in the protocol? (Required for research involving more than minimal risk to subjects)


☐

☐

Yes

No



PRIVACY INTERESTS OF SUBJECTS & CONFIDENTIALITY OF DATA:

☐

45 CFR 46.111(A)(7), 21CFR 56.111(A)(7)

There are adequate provisions to protect the privacy interests of subjects.

“Privacy interests” refer to the interest of individuals in being left alone, limiting access to themselves, and limiting access to their information.

☐ There are adequate provisions to maintain the confidentiality of data.

“Confidentiality” refers to the agreement between the investigator and the subject regarding the use, handling, and management of data, and data disclosures.

Is an adequate plan in the protocol for protecting the confidentiality of subject PHI ☐ Yes

☐ No and study data?

If no, please explain: Click here to enter text.

HIPAA RESEARCH AUTHORIZATION:

Will individually identifiable Protected Health Information (PHI) subject to the HIPAA Privacy Rule requirements be accessed, used, or disclosed in the research study?

☐ No

☐ Yes Check all that apply:

☐ Written Authorization Provide a copy of the Authorization Form

☐ Partial Waiver (recruitment purposes only)

☐ Full Waiver (entire research study)

☐ Alteration (written documentation)

☐ Included in Consent From

DRUGS/DEVICES/BIOLOGICS AND ASSOCIATED COSTS:

In an investigational drug/device/biologic or other chemical, metabolite, nutritional substance or other substance being evaluated in this study?

If “no”, proceed to the next section.

☐ Yes

☐ No

What is the drug/device/biologic or other chemical, metabolite, nutritional substance or other substance being evaluated in this study, and what is its source?




Has an IND/IDE number been provided?

☐ Yes ☐ No If yes, please answer the following:

What is the IND/IDE number? Click here to enter text.

Who is the holder of the IND/IDE?


The drug/device has an IND/IDE number and the IND/IDE number is supported by one of the following ( The

Investigator’s Brochure may not be used for this purpose.):

☐ Sponsor protocol imprinted with the IND/IDE number.

☐ Written communication from the sponsor documenting the IND/IDE number.

☐ Written communication from the FDA documenting the IND/IDE number.

(Required if the investigator holds the IND/IDE.)

If no IND/IDE number is provided, please answer the following:

FOR DRUGS/BIOLOGICS OR OTHER CHEMICAL, METABOLITE, NUTRITIONAL SUBSTANCE OR

OTHER SUBSTANCE:

Have the criteria for exemption* from the requirement for an IND submission been satisfied?

☐ Yes ☐ No

FOR DEVICES:

Have the criteria for an abbreviated IDE been satisfied?

☐ Yes ☐ No

Have the criteria for exemption* from the requirement for an IDE submission been satisfied?

☐ Yes ☐ No

*To see criteria for exemption, search on the following citations at the website below:

21CFR 312.2(b) for IND exemption criteria and 21CFR 812.2(c) for IDE exemption criteria. http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfcfr/CFRSearch.cfm

[A SIGNIFCANT RISK DEVICE is any medical device that presents a potential for serious risk to the health, safety or welfare of a subject; is intended for use as an implant; purported or represented to be used in supporting or sustaining human life; or is intended for a use of substantial importance in diagnosing, curing, mitigating, or treating disease or otherwise preventing impairment of human health.]



If an investigational device will be evaluated in this research, is the device:

A significant risk device? Explain. Click here to enter text.

OR

A non-significant risk device? Explain. Click here to enter text.

CONTROL, HANDLING AND DOCUMENTATION OF AN INVESTIGATIONAL DRUG/BIOLOGIC OR

OTHER CHEMICAL, METABOLITE, NUTRITIONAL SUBSTANCE OR OTHER SUBSTANCE.

Is an investigational drug/biologic or other chemical, metabolite, nutritional substance or other substance to be evaluated in this research subject to the provisions of the Controlled Substances Act?

☐ Yes ☐ No

Who will be responsible for the storage, inventory and control of the investigational drug/biologic or other chemical, metabolite, nutritional substance or other substance to be evaluated in this research?


Where will the investigational drug/biologic or other chemical, metabolite, nutritional substance or other substance be stored?


Who will be designated to dispense the investigational drug/biologic or other chemical, metabolite, nutritional substance or other substance?


At the completion of this research study, what will be done with the unused or returned investigational drug/biologic or other chemical, metabolite, nutritional substance or other substance?


CONTROL, HANDLING AND DOCUMENTATION OF AN INVESTIGATIONAL DEVICE OR A

HUMANITARIAN USE DEVICE:

Who will be responsible for the storage, inventory and control of the investigational device or Humanitarian use Device?


Where will the investigational device or Humanitarian Use Device be stored?


Who will be designated to dispense the investigational device or Humanitarian Use Device?


At the completion of this research study, what will be done with the unused or returned investigational device or

Humanitarian Use Device?




Humanitarian Use Device – Added Considerations

The Humanitarian Use Device will be used only as described in its FDA approved product labeling.

☐ Yes ☐ No

If Yes, the use may be regarded as not research if no research question is being asked.

If No, an IDE is required, and the use must be regarded as research.

Will the planned use of this device be solely for clinical care?

☐ Yes ☐ No

Will the planned use of this device be to assess the safety or effectiveness of this device?

☐ Yes ☐ No

If “Yes”, the use must be regarded as research.

What is the principal risk posed by the device?


What is the principal benefit associated with use of the device?


Does the probable benefit outweigh the risk of injury or illnesses from the device, taking into account the probable risks and benefits of currently available alternative devices or forms of treatment?

☐ Yes ☐ No

Does the consent document make clear that the effectiveness of the device for this planned use has not been proven or demonstrated?

If No, please propose wording and consent form location to meet this requirement.


Does the application meet the requirements presented in the MGH IRB Humanitarian Use Device Policy #15 ?

☐ Yes ☐ No

STORAGE OF DATA AND/OR SAMPLES (if no data and/or samples are being stored, skip this section.)

Data and/or samples are being stored for:

☐ this study only

☐ future specified research

☐ future unspecified research



Does the consent form contain an adequate description of future research?

☐ Yes ☐ No

Data and/or samples for future research will be stored:


If data and/or samples are stored for future research at an external site, does the consent form contain opt in/opt out language?

☐ Yes ☐ No

If no, please explain:


SUBMITTING APPLICATION:

Initial application along with copy of the study protocol, informed consent and study related documents (e.g. marketing materials, data sheets, etc.) should be forwarded to:

E-Mail: Judith.Mixter@mghs.org

Fax: 906-225-4712, Attention Judy Mixter/IRB Coordinator (if less than 25 pages)

Inter-office Hospital mail: Judy Mixter/Institutional Review Board

Mail: Judy Mixter/IRB Coordinator

Marquette General Hospital

580 W. College Ave.

Marquette, MI 49855

Phone: 906-225-3467


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