Information and Instructions Regarding Research Approval 

  REQUIREMENTS FOR REVIEW AND APPROVAL OF HUMAN RESEARCH ACTIVITIES 

Institutional Review Boards (IRBs) review, approve and monitor research that directly or indirectly involves living persons, their tissues or personal information, in order to protect the rights of the participants.  There are two main considerations to determine if a particular activity needs IRB review by the MDCH IRB: 

A)   Does the activity involve the systematic collection/analysis of data, from or about living individuals, with the intent to generate new knowledge? 

This can involve an intervention or interaction with living individuals, or only involve the collection of, release of, or access to identifiable private information or biological specimens from or about living individuals.  Since the definition of research (for IRB purposes) may be difficult, the IRB should determine whether activities that involve obtaining and analyzing data to generate new knowledge constitute research in this context.  

B)   MDCH IRB review is required for:  

         All research involving living human participants, if one or more of the following apply: 

1. the research is sponsored by the department, or 
2. the research is conducted by or under the direction of any employee or agent of the department in connection with his or her institutional responsibilities, or 
3. the research is conducted by or under the direction of any employee or agent of the department using any facility of the department, or 
4.  the research involves the use of the department's non-public information to identify, or contact, human research participants or  prospective participants. 

The legal basis for MDCH IRB authority is Title 45 Code of Federal Regulations Part 46.  This document and other IRB material can be found at:  http://ohrp.osophs.dhhs.gov/   

HOW TO SUBMIT MATERIAL FOR IRB REVIEW 

Submit one printed copy of the application form and any other relevant documents to MDCH IRB, Office of Legal Affairs, 7th Floor Capitol View Bldg, 201Townsend St,  Lansing , MI 48913 (phone 517-241-1928; fax 517-241-1200).   The "Responsible MDCH Employee" must sign the application form.  

Documents may also be sent electronically to MDCH-IRB@michigan.gov.  Electronic signatures are acceptable.  Documents are also deemed to be signed, if they are submitted electronically from the Groupwise mailbox of the "Responsible MDCH Employee".  

The MDCH IRB will review the proposed activity and send notification to the "Responsible MDCH Employee" with a copy to the responsible Departmental Bureau, Center or Office director. The "Responsible MDCH Employee" must be a MDCH employee and should be the person most directly responsible for the Department's involvement in the activity.  Written communication between the MDCH IRB and all others involved in the research will be through the "Responsible MDCH Employee," including communication with researchers outside of the department. 

Written IRB approval will include the approval date and expiration date of the approval. All approvals expire one year from the approval date unless otherwise indicated on this form. Whenever a consent document, study protocol or other study material is revised and receives IRB approval, or whenever a project receives continuation approval (renewal), the newly assigned approval date shall appear on all subsequent copies of the study documents.   

The "MDCH IRB Review Application" is designed both for research that involves the direct participation of living persons in the research and also research done only on a living individual's personal information or biological material. All sections of the application that are not relevant should be left blank. 

The application has four main parts:  

General Information on the Project   (Sections 1-4): must be completed. 

Research That Involves Direct Human Subject Participation  (Sections 5-14): complete Sections 5-10 and any relevant sections of 11-14, if living persons participate directly in any way or in any part of the research. 

Research That Does Not Involve Direct Human Subject Participation  (Section 15): complete if living persons do not participate directly in the research but their personal information or biological material is used for the research. 

Please note that if the research involves both direct human subject participation and also a component that does not involve direct human subject participation, complete both the appropriate sections of 5-14 and section 15. 

Completeness Check List: this is to help both the researcher and the MDCH IRB assure that the application documents have been prepared appropriately and are complete. 

__________________________________________________________________________________________ 

ABOUT THE APPLICATION 

SECTIONS 1-4, REQUIRED INFORMATION FOR ALL APPLICATIONS 

Section 1:  Project Identification: information the MDCH IRB needs for tracking and other purposes 

Section 2:  Application Type:  directs the applicant to the relevant sections of the application 

Section3:  Information on the Research:   concise (limit 300 words) description of research 

Section 4:  Information on the Informed Consent Process:   including requests for waivers 

Copies of the most current informed consent instrument(s) must be submitted with the application. 

In certain cases the IRB may approve research that does not include, or that alters, some or all of the required elements of informed consent, waives the requirement for signed informed consent, or waives the requirement for informed consent.    The provisions of 46.116 or 117 that permit these exceptions must be explained when such exceptions are requested. 

A "HIPAA-Compliant Request Form" may also need to be submitted when requesting a waiver of authorization.  For further information, consult the HIPAA Informed Consent Guidelines posted on the MDCH HIPAA Internet Web site.    ( http://www.michigan.gov/mdch/0,1607,7-132-2945_24020---,00.html ) 

Sections 5-14:  Research That Involves Direct Human Subject Participation 

Section 5:    Characteristics of Human Research Participants 

The IRB needs comprehensive information about study participants in order to determine whether they: are suitable for the type of research, are recruited in reasonable numbers, will participate in the study long enough to obtain valid new knowledge, will be vulnerable or prone to coercion and will be selected equitably.  Equitable selection requires that age, gender, ethnic and racial groups within the study communities are fairly represented among the participants in the study, unless the study focuses on a specific subset of the community, for justifiable reasons. 

Section 6:  Participant Recruitment Procedures 

All interested members of the community should have the opportunity to participate but they should not be coerced.  Minority groups should be actively encouraged to take part in the research, especially if the topic health problem under study affects that group with a high prevalence or presents itself in some unique way to them. 

Section 7:  Experimental Treatments or Procedures Involving Human Participants 

A study protocol contains the elements of a scientific plan in sufficient detail to explain the experimental design, the project's merits, and the significance of the new knowledge to be derived.  The protocol could be the relevant section of a grant application, an institutional research proposal, or a study protocol, including one prepared by a sponsor that is to be followed by the investigators.  This information is essential for the IRB to weigh the benefits and risks of the research, and to determine if the informed consent adequately conveys the necessary information to potential study participants. 

A research study protocol must be submitted for any research that involves experimental procedures or treatments of human participants. 

Section 8:  Risks and Benefits of the Research 

No research can be considered totally risk free. Even wasting someone's time is a potential risk of poorly designed research.  The MDCH IRB must have detailed and accurate information on all potential risks of harm to the research participants and the measures that will be employed to minimize this risk. 

There must be some potential benefit from the research.  If there is no potential benefit the research cannot be justified, regardless of how low the risk may be.  At best there is a direct benefit to the research participant, but there must at least be a potential public benefit.  Scientific merit is one of the components of benefit assessment.  In order to justify the participation of human participants in research, expected benefits must outweigh the potential risks.  

Section 9:  Research Records 

Investigators are required to maintain the confidentiality of records that can identify individuals, even indirectly.  Codes can reduce the potential risk of a breach of confidentiality.  However, the key to the codes must be kept separately and securely.  If research records are linkable to participants, they must be told about the potential for a breach of confidentiality in the informed consent process and the measures to protect the information. 

Section 10:  Costs of the Research 

Except in rare circumstances, any costs resulting from the research should not be charged to the research participants or their insurance carriers.  Even the latter constitutes an indirect charge, due to the potential for raising premiums.  

Section 11:  Interviews, Surveys or Group Meetings 

Surveys may be included in research involving treatments or procedures, to measure outcomes, or the research may consist only of survey methods.  In approaching potential participants to collect information for a survey, the investigator must clarify that research is in progress, and that they have no obligation to participate. Survey records that contain personal information, feelings, or opinions may be sensitive, and reveal issues about a person that are embarrassing or incriminating if revealed to others. Some sensitive information could place participants at risk of criminal or civil liability, or be damaging to the person's (or their family's) financial standing, employability or reputation.  Adequate protection of confidential information and a comprehensive informed consent process is required, unless the collected information is recorded in such a way that it cannot be linked to the participants under any circumstance. 

Section 12:  Blood Collected from Participants for the Purposes of Research 

The estimated volume and frequency of blood to be taken, risks associated with blood removal, and the measures to be taken to minimize those risks shall be included in the consent process.  There are guidelines for the amount and frequency of blood that can be collected that include considerations of weight, general health, and hematocrit.  There are also specific criteria for the frequency and volume of blood that can be collected in a research activity that qualifies for expedited review, under 45 CFR 46.110. 

Section 13:   This Section Covers Research that is Infrequently Sponsored by the MDCH.    Address the issues under each of the following topics in Section 13 of the application, only if they apply. 

 Information on biological specimens (other than blood) taken from participants for research purposes 

There are several considerations concerning biological specimens, other than blood, that are used for research.  Specimens obtained by invasive means only for research, or surplus specimens that are obtained only for research in the course of obtaining specimens by invasive means for health care, constitute an inherent research risk. A specimen that is obtained only for health care purposes, but is subsequently used for research may involve a research risk related to confidentiality. Certain specimens obtained by non-invasive means or for certain medical reasons (e.g. a placenta taken at delivery) may qualify for expedited review under the provisions of 45 CFR 46.110.  

Information on investigational, FDA-exempted drugs, biologics or devices in the research 

Drugs, biologics or devices administered to human beings are under the jurisdiction of the US Food and Drug Administration.  Applicable regulations are available on the FDA web site (http://www.fda.gov/default.htm).  

Information on FDA-approved drugs, biologics or devices in the research 

The FDA approves drugs, biologics or devices for human use, for specific indications. A physician may administer an FDA-approved article to a patient for an unapproved health-care indication, without FDA or IRB approval, as long as the physician believes that it will help the patient.  On the other hand, the use of an approved article for research requires the involvement of the FDA and an IRB.  FDA and IRB involvement are also required in conducting research with drugs, biologics or devices in humans, to compare the efficacy and safety of one approved article with that of another approved article, even if the articles are to be tested within the framework of an approved indication. 

Information on ionizing radiation to be administered to research participants 

Ionizing radiation includes x-rays, beta rays, gamma rays, neutrons, and other high-speed particles that can produce cumulative biological effects.  Human subject research that includes such exposure must provide study participants information on the excess exposure expected from the research, in the context of total possible exposure from all other sources. 

Information on any organs, tissues or cells from other humans to be administered to research participants 

The primary concern related to transferring, transplanting or administering biological specimens obtained from human beings to other human beings is the possibility of transferring infectious material to the recipient.  Testing human-derived biological specimens for all detectable infectious material prior to the transfer to human research participants and informing participants of this potential risk is mandatory.  

Information on any genetic material to be transferred to research participants 

The transfer of genetic material to human beings is still experimental and subject to strict Federal regulations.  Any plans to transfer genetic material must be reviewed by the MDCH IRB.  The Office of Recombinant DNA Activities (ORDA) at the National Institutes of Health may decide on a case-by-case basis, whether or not it will also be involved in the approval process.  The FDA and ORDA require that gene transfer projects be approved by an Institutional Review Board prior to the submission of the proposal to their agencies.  

Section 14: Genetic Analysis Performed on Biological Specimens Obtained from Research Participants 

Scientific advances in molecular biology and genetics have raised novel ethical concerns that include: 

a)        the process to inform the participant and relatives, and/or to provide genetic counseling and screening, when a genetic abnormality or conflicting information on parenthood is discovered, 

b)        respect for the participant's wish to know, or not know, the result of a genetic study, 

c)        the process to inform the participant and the proband when the significance of an abnormality is learned at a later date, and this information constitutes a moral obligation to inform the participant about follow-up, 

d)        the extent of the currently planned genetic analysis, and the extent of potential analysis in the future, when specimens are saved for later studies,  

e)        the potential for commercialization of the genetic information or of a product resulting from the information.  

These concerns do not apply if the participant cannot be linked to the genetic information from the analysis of their biological specimen . 

Biological specimens used for genetic analysis in research require the following elements of informed consent when information from the specimen can be linked to the participant: 

a)        the specific purpose of the genetic analysis, 

b)        the particular genetic information to be acquired, 

c)        any known potential consequences of the genetic information to insurability, employability or social esteem of the participant,  or to the participant's family, 

d)        how the genetic information is linkable to the participant and how this link is protected,  

e)        if the genetic information can be provided to the participant, and if so, an explicit statement that they can chose whether or not to get the information, 

f)        any provision for genetic counseling, 

g)        the likelihood of commercialization of the new knowledge and what potential share the participant would have (or not have) in potential financial gains.  

If an existing biological specimen had been obtained from a participant without explicit consent for genetic analysis, the MDCH IRB may consider approving genetic analysis on the specimen, only if the investigators acquire the specimen without any identifiers that could link the specimen to the person from whom the sample was obtained.  

SECTION 15: Research That Does Not Involve Direct Human Subject Participation 

Section 15.  Research with no direct involvement of human participants but where personal information or biological material, that has been collected, or will be collected, for non-research purposes, or material that will otherwise be discarded, is used for the research. 

Existing biological specimens or data are materials already collected prior to the initiation of the research using these materials.  45 CFR 46.101 (b) (4) allows an IRB to exempt "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 participants cannot be identified, directly or through identifiers linked to the subject."  It is important to note that only the IRB has the power to grant this exemption and it does not mean that such activities are exempt from IRB review. 

If the study material is not publicly available or if the researcher records information in a manner that participants can be identified, even indirectly, it is research that requires IRB approval. Informed consent is required unless permission to use the material for research was in place at the time the data or specimens were obtained, or the research meets the criteria for waiver of informed consent.  

If the biological specimens or data are not in existence at the time the research is initiated, the only permissible way the material could be acquired without direct involvement of the participants in the research is for non-research purposes, such as during the course of the delivery of health care. The MDCH IRB expects that the arrangements made by investigators to acquire some of the biological specimens for research be documented as well as the priority of the health care-related use of the specimens.  If acquired for non-research purposes, the MDCH IRB may accept an "Institutional Agreement/Permit" as a substitute for a project-specific consent document. If the material is to be acquired for research purposes, the application sections that apply to  "Research with Direct Involvement of Human Participants" should be used to apply to the MDCH IRB for approval, and a project-specific informed consent should be prepared.  

Application Instructions Summary 

July, 2007