IRB Manual
 
Review of Research
   

Researchers are entitled to timely review of their research proposals.  The review process should take no more than three months unless an exception is justified.  It is anticipated that there will be situations in which it is not possible or appropriate to complete the review within a three month period, for example when additional information and review are required.

See Section 6.1 for a discussion of the requirements for documentation of IRB review.
See Section 9.1 for a sample protocol application form. 

For federally funded studies, or studies for which federal funding has been sought, the IRB must review the entire grant application.   The primary reviewer may review the entire application and the remaining members may be given only those sections that are relevant to the human subjects components.   The review of the entire application is intended to ensure that the research described in the IRB application is consistent with the research described in the funding application.

     
  3.1 Actions the IRB can take when reviewing research
   

When conducting an initial or continuing review of a research study, or a review of proposed changes to a previously approved research study, an IRB can take any of the following actions:

   
  1. Approve: the research study or proposed changes are
    (a) approved as submitted
    or
    (b) approved with conditions*

  2. Defer or Table: require modifications to secure approval and defer or table the research study or proposed changes for further review at a future date after the required modifications are submitted by the investigator

  3. Disapprove:  the research study or proposed changes are not approved.  Disapproval can only be determined at a convened IRB meeting.
   

NOTE:  When the  IRB cannot make one or more of the determinations required for approval (See section 3.1.1), or is unable to approve based on other determinations, the IRB must not approve the research project. 

*IRB approval with conditions

     
   

The IRB may approve research with conditions if, given the scope and nature of the conditions, the IRB is able, based on the assumption that the conditions are satisfied, to make all of the determinations required for approval  (See section 3.1.1).  The authority to approve research with conditions extends to the IRB’s initial review of research, continuing review of research, and review of proposed changes to previously approved research.  This authority also applies to IRB review of research at a convened meeting or under an expedited review procedure.  When research is approved  by the IRB with conditions at a convened meeting, further review by IRB at a subsequent convened meeting is not necessary.


   

Whenever the IRB approves a research study with one or more conditions at the time of initial review, the effective date of the initial approval is the date on which the IRB chairperson (or any other individual(s) designated by the IRB) has reviewed and accepted as satisfactory any revised protocol or informed consent documents or any other responsive materials required by the IRB from the investigator.  No research study activities involving human subjects may be initiated until the conditions have been satisfied in the manner set forth by the IRB and the approval becomes effective. 

     
  3.1.1 Basis of Approval
   

   

The IRB may approve a research protocol when it is satisfied that the ethical principles outlined in the Belmont Report have been applied and the following requirements have been met:

     
 
(1)   
Risks to subjects are minimized by using sound research design and by omitting unnecessary risks.  Wherever appropriate, procedures already being performed on the subjects for diagnostic or treatment purposes should be utilized.

 
(2)   
The risks to the subjects are reasonable in relation to the anticipated benefits (if any) to subjects, and to the importance of the knowledge that may reasonably be expected to result.  If the protocol involves treatment and/or diagnostic procedures, which the subject would receive regardless of whether he/she participates in the research, and additional procedures as a result of participation in the research, the evaluation of the risks shall be based on the additional risks imposed by the research component. The long range effects of applying the knowledge to be gained in a research project shall not be considered when the risks are being evaluated.

 
(3)   

Selection of subjects is equitable.  The IRB must ensure that "vulnerable" categories of subjects are not over utilized in research.  Proposed involvement of hospitalized patients, other institutionalized persons or disproportionate numbers of racial or ethnic minorities or persons of low socioeconomic status must be fully justified. The IRB must be particularly cognizant of the special problems of research involving vulnerable populations such as children, prisoners, pregnant women, mentally disabled persons, or economically or
educationally disadvantaged persons.

IRBs must review the methods used to recruit subjects, including any advertisements (internet, newspaper, radio, television, electronic mail, bulletin boards, letters to private practitioners etc.) that will be used.  Advertisements used to recruit subjects should be seen as an extension of the informed consent and subject selection processes.  The IRB must ensure that they are neither misleading nor coercive to potential subjects, and contain straightforward descriptions of the purpose of the research and the eligibility criteria. However, advertisements are not required to provide the amount of information that is required in the consent process/form. When advertisements are to be posted on bulletin boards, IRBs should consider the use of an IRB stamp which could be signed and dated to indicate that the advertisement has been approved for posting.


 
(4)   
Informed consent will be appropriately sought and documented from each prospective subject or the subject's legally authorized representative (See Section 4.5)  unless such requirements have been specifically waived by the IRB.  (See Section 4.6.1 for the conditions under which the IRB may waive documentation of consent or waive some or all of the required elements of consent.)

 
(5)   
Adequate provisions have been made to assess the capacity of prospective subjects to consent. (See Section 4.4)

 
(6)   
The research design makes adequate provisions for monitoring the subjects and the data to ensure that the safety, rights and welfare of the subjects are adequately protected. IRB monitoring procedures have been developed to ensure that the safety, rights and welfare of the subjects are safeguarded. (See Section 3.3.2)

 
(7)   
Adequate provisions have been made to protect the privacy of subjects and maintain the confidentiality of their data. Limits to confidentiality are clearly explained to the prospective subjects. (See also section 5.4 for mandatory reporting requirements.) 

 
(8)   
Adequate procedures have been developed for dealing with any potentially harmful effects that may occur in the course of the research activities.

 
(9)   
Adequate provisions have been made to attempt to remove any confusion, misinformation, stress, physical discomfort, or other harmful consequences that may have arisen with respect to the subjects as a result of the procedures.

 
(10)   
When some or all of the subjects are likely to be vulnerable to coercion or undue influence, such as children, prisoners, pregnant women, mentally disabled persons, or economically or educationally disadvantaged persons, additional safeguards have been included in the study to protect the rights and welfare of these subjects.

   

In addition, the IRB should evaluate the qualifications of the investigator(s) to carry out the proposed research.  Investigators and key personnel must be adequately trained in human subjects research (See Chapter 8 for training requirements). Members of the research team must be privileged for the specific procedures/ techniques involved in the research, in accordance with standard facility privileging procedures. Each investigator is responsible for ensuring that the research complies with the ethical standards of his/her profession. 

During the course of a review, the IRB may identify concerns about the research that are beyond its jurisdiction, e.g. impact on routine facility operations.  These concerns should be reported to the facility director, but should not influence the IRB's decision with regard to approval or disapproval of the study unless the facility director has authorized the IRB to include such issues in its review.

Questions have been raised about special review requirements for research involving persons who are involuntarily retained under Section 9.33 of the Mental Hygiene Law. IRBs should treat these patients as being a vulnerable population and ensure that appropriate safeguards are employed to ensure protection of their rights and welfare.  Voluntary/involuntary status does not determine a patient's capacity to consent to research (See Section 4.5).  An involuntary patient who will remain in a research protocol on an inpatient basis after the expiration of his/her retention order must be converted to voluntary status.


3.1.2 Inclusion of Minorities and Women in Research Populations
     
    Minorities
   

There are clear scientific and public health reasons for specifically including members of minority groups in study populations.  All research which involves human subjects must be designed to include minority populations unless there is a compelling scientific or other justification for not including minorities. For the purpose of this policy, minorities include U.S. racial/ethnic minority populations (specifically : American Indians or Alaskan Natives, Asian/Pacific Islanders, African Americans, and Hispanics) and research includes human studies of etiology, treatment, diagnosis, prevention, and epidemiology of diseases, disorders and conditions, including but not limited to clinical trials and research on health service and its impact on disease.

While the focus of this policy is on inclusion of minorities in general population studies, investigators are encouraged to pay attention to gaps in knowledge about specific U.S. racial/ethnic minorities and health problems that significantly affect them.  Addressing these gaps may be an appropriate justification for focusing a particular study on a single racial/ethnic group.

Applications for approval of research by the Institutional Review Board (IRB) must address the issue of minority representation in relation to the study design and sample sizes.


    Women
   

Research findings should be of benefit to all persons at risk of the disease, regardless of gender. Studies should produce knowledge that is applicable to the general population. Exceptions are those diseases or conditions that occur only in one gender.  Gender representation in studies should be appropriate to the known incidence/prevalence of the condition being studied. If inclusion of women is impossible or inappropriate with respect to the purpose of the research , the health  of the subjects, or other reasons, or if in the only study population available there is a disproportionate representation of one gender, these reasons for excluding men or women must be well explained and justified by the investigator. Similar justification will be required if women will not be included in numbers appropriate to the incidence/prevalence of the disease.

Whenever there are scientific reasons to anticipate differences between men and women with regard to the hypothesis under investigation, investigators should consider the inclusion of an evaluation of gender differences in the proposed study. However, if men and women are enrolled in numbers that reflect the gender proportion of the disease under study it is not an automatic requirement for the study design to include statistical power for men and women separately.


    Review Procedures
   

IRBs have been given the additional responsibility of advising the facility director and central office on the appropriateness of study populations in terms of the inclusion of minorities and women.

Investigators shall provide the IRB with a description of the anticipated racial/ethnic and gender composition of the proposed study population. In attempting to include minority groups in a particular study, attention must be paid to research design and sample size issues OMH recognizes that it will not always be feasible or appropriate to include the full array of racial/ethnic groups and both males and females. However, investigators must carefully assess the feasibility of including the broadest possible representation of minorities, and both genders.

IRBs shall assess following:

 
(1)   
Is there sufficient attention to the inclusion of minorities and women in the study design? If there is not, will this affect the potential to answer the scientific questions addressed?

 
(2)   
If applicable, is there strong scientific rationale or other well-supported justification for limited minority participation or the inclusion of only one racial/ethnic group. It is understood, that the subject population of a pilot study will often not be fully representative of the subject populations that will comprise the main study. 

 
(3)   
If applicable, if the investigator proposes that there is justification for conducting a study in men only, or in a study population in which the proportion of women does not reflect the gender prevalence of the disease or condition under study, a strong scientific rationale, an explanation of the need to protect the health of the subjects, or other well-supported justification must be provided. It is understood that the study population for a pilot study will often not contain the same gender distribution as the main study.

 
(4)   
If the gender composition of the study population is not described BUT the study otherwise has the potential to answer the scientific question(s) posed and translate the findings to all persons at risk of the disease, this shall be noted by the IRB.
     
   

Appropriateness of  the composition of the study population will be considered when facility and agency reviews are conducted.

     
   


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